Back to what changed for Non-Alcoholic Fatty Liver Disease

Reported trial results for Non-Alcoholic Fatty Liver Disease

Every Non-Alcoholic Fatty Liver Disease trial Voxsanity tracks that has reported results to a public registry, newest first. These trials have finished, so they are not recruiting. Not medical advice.

87 trials have reported results.

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

NCT04365868 · results posted 30 June 2026

According to the results reported on ClinicalTrials.gov, this trial (NCT04365868) enrolled 357 adults across three groups: 118 received a placebo (a dummy treatment with no active ingredient), 119 received a lower dose of a drug called belapectin (2 mg/kg of lean body mass), and 120 received a higher dose of belapectin (4 mg/kg of lean body mass). The trial ran for approximately 18 months and was primarily measuring how many people in each group developed new varicose veins in the food pipe (known as oesophageal varices), which are a complication of liver scarring. Most participants completed the study — around 95–99 people per group — with 21 to 23 people in each group not finishing. The reported data shows that, for the main outcome at 18 months, 56 participants in the placebo group, 45 in the lower-dose belapectin group, and 51 in the higher-dose belapectin group were recorded as having developed new oesophageal varices. For the secondary outcomes, the numbers were notably small across all groups. The reported data shows that varicose veins requiring treatment were recorded in 3 placebo participants, 4 in the lower-dose group, and 3 in the higher-dose group. Bleeding from varicose veins serious enough to need hospitalisation was recorded in 0, 1, and 0 participants respectively. Serious fluid build-up in the abdomen requiring hospitalisation was recorded in 1, 0, and 0 participants. A serious liver-related brain condition requiring hospitalisation was recorded in 2, 1, and 1 participants. No participants in any group were recorded as developing a serious abdominal infection called spontaneous bacterial peritonitis. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT05338034 · results posted 28 May 2026

According to the results reported on ClinicalTrials.gov, this trial enrolled 87 people in total, split across four groups: 22 received a placebo (a dummy treatment with no active ingredient), 22 received a 3 mg dose of HPG1860, 21 received a 5 mg dose, and 22 received an 8 mg dose. The trial was measuring the safety and tolerability of the drug (meaning how many people experienced unwanted side effects or reactions), as well as changes in the amount of fat in participants' livers over 12 weeks, measured using a specialised type of MRI scan. The reported data shows that the primary thing being tracked — the number of people who experienced treatment-emergent adverse events (that is, unwanted health events that appeared after starting the study treatment) — was 12 out of 22 in the placebo group, 13 out of 22 in the 3 mg group, 13 out of 21 in the 5 mg group, and 18 out of 22 in the 8 mg group. For liver fat content, the reported data shows average changes from the starting point to week 12 of minus 20.1% for the 3 mg group, minus 7.1% for the 5 mg group, minus 38.6% for the 8 mg group, and plus 0.7% (a very slight increase) for the placebo group. When looking at how many participants achieved a 30% or greater reduction in liver fat by week 12, the reported figures were 5 people in the 3 mg group, 1 in the 5 mg group, 12 in the 8 mg group, and 1 in the placebo group. It is worth noting that 73 out of 87 participants completed the study, with between 3 and 4 people in each group not completing it; the data does not report the reasons for non-completion in this summary. No information about why individuals did not complete the trial was included in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT06007651 · results posted 13 April 2026

According to the results reported on ClinicalTrials.gov, this trial (NCT06007651) tested a drug called LY3885125 and was split into two parts. Part A looked at single doses (SAD = single ascending dose), where participants received one of five increasing dose levels of the drug or a placebo (a dummy treatment with no active ingredient). Part B was designed to look at multiple doses over time (MAD = multiple ascending dose), but the reported data shows that zero participants were enrolled or dosed in Part B. In total, 49 people started Part A across all groups, with 47 completing it; 2 participants in one of the dose groups did not end up receiving the drug and did not complete the study. The reported data shows that the primary outcome being tracked was the number of participants who experienced a serious unwanted health event that investigators believed was related to the study drug. Across all five active dose groups and the placebo group in Part A, the number reported was zero — meaning no participants in any group were recorded as having a serious related event. No data was reported for Part B's primary outcome, as no participants took part in that portion. The secondary outcomes tracked how the drug moved through the body (for example, how much of it was in the blood and when it peaked). The reported figures show that as the dose increased across the five cohorts, the amount of drug measured in the blood also increased — for instance, the peak blood concentration rose from 14.8 ng/mL in the lowest dose group to 1,400 ng/mL in the highest, and the time it took to reach that peak ranged from 6 to 9 hours across groups. The placebo group showed zero drug in the blood, as expected. The trial also measured changes in a protein called PCSK9 (a substance in the blood linked to cholesterol); changes from starting levels were reported across all groups, but no conclusions about what those changes mean can be drawn from the numbers alone. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04929483 · results posted 6 January 2026

According to the results reported on ClinicalTrials.gov, this trial (NCT04929483) tested a medicine called pegozafermin in people with a liver condition called NASH (non-alcoholic steatohepatitis), which involves fat build-up and inflammation in the liver. The main 24-week study enrolled 222 people across three pegozafermin dose groups (15 mg weekly, 30 mg weekly, and 44 mg every two weeks) and a placebo group of 71 people. A further extension study followed most of these participants for another 24 weeks. The trial was primarily measuring two things in liver tissue samples: whether the NASH showed signs of resolution without the scarring (fibrosis) getting worse, and whether the fibrosis improved by at least one stage without the NASH getting worse. The reported data shows the following for the primary outcomes at 24 weeks. For NASH resolution without worsening of fibrosis, the numbers of participants who met this measure were: 5 out of those in the 15 mg weekly group, 12 in the 30 mg weekly group, 11 in the 44 mg every-two-weeks group, and 1 in the placebo group. For fibrosis improvement of at least one stage without worsening of NASH, the reported numbers were: 3 in the 15 mg weekly group, 14 in the 30 mg weekly group, 11 in the 44 mg every-two-weeks group, and 4 in the placebo group. For secondary outcomes, more participants in the pegozafermin groups also showed at least a 2-point improvement on the liver disease activity score (NAS) without fibrosis worsening — 5, 34, and 26 respectively across the three dose groups, compared with 13 in the placebo group. Blood triglyceride (fat) levels showed a reported percentage change from the starting point of −5.79%, −14.87%, and −7.79% in the three pegozafermin groups respectively, compared with a change of +1.02% in the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04971785 · results posted 26 November 2025

According to the results reported on ClinicalTrials.gov, this trial (NCT04971785) enrolled 457 adults with a liver condition called NASH (nonalcoholic steatohepatitis), which involves liver inflammation and scarring. Participants were divided into four groups and received different combinations of two medicines — semaglutide and cilofexor/firsocostat — or matching dummy treatments (placebos). The trial ran for 72 weeks and was mainly measuring whether participants' liver scarring (fibrosis) improved by at least one stage without their liver inflammation getting worse. The reported data shows that for the main outcome — improvement in liver scarring without worsening inflammation — 13.7% of participants in the combination medicine group (semaglutide plus cilofexor/firsocostat) reached this milestone, compared with 8.3% in the group that received dummy treatments for both medicines. For a secondary outcome comparing the combination group to semaglutide alone, the reported figures were 13.7% versus 15.6%. The reported data also shows results for a separate measure called "NASH resolution" (meaning liver inflammation returning to a very low level without scarring getting worse): 57.3% of the combination group reached this point, compared with 22.4% in the all-placebo group and 31.8% in the group that received only the cilofexor/firsocostat component of the combination. It is worth noting that not all participants completed the trial — for example, 22 out of 125 in the main combination group and 20 out of 85 in the all-placebo group did not finish. The reasons for not completing were not detailed in the data submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04202354 · results posted 3 October 2025

According to the results reported on ClinicalTrials.gov, this trial (NCT04202354) enrolled 50 people in total across eight groups. Most groups received different doses of an investigational drug called ARO-HSD — either 25 mg, 50 mg, 100 mg, or 200 mg — while 16 participants received a placebo (an inactive dummy injection used for comparison). The trial was primarily looking at how many participants experienced unwanted medical events (called adverse events) that were thought to be possibly or probably linked to the study drug. It also measured how the drug moved through the body — for example, how quickly it was absorbed into the blood, how high blood levels got, and how long the drug stayed in the body. The reported data shows that, for the primary measure, no participants in the 25 mg or 50 mg groups, and none in the placebo group, had adverse events judged possibly or probably related to the drug. One participant in the 100 mg group and three in the 200 mg group did. In the repeat-dose groups (labelled "b"), one person each in the 25 mg and 100 mg groups, and two in the 200 mg group, had such events. For the blood-level measurements in healthy volunteers, the highest recorded blood concentration of ARO-HSD (Cmax) rose with increasing dose — from 74 ng/mL at 25 mg up to 644 ng/mL at 200 mg. The time it took to reach that peak ranged from 2.5 to 8 hours depending on the dose, and the drug's "half-life" — meaning the time for blood levels to fall by half — ranged from roughly 2.5 to 4.5 hours across the dose groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04004403 · results posted 25 September 2025

According to the results reported on ClinicalTrials.gov, this trial enrolled 80 adults across four groups of 20 people each: one group followed an alternate day fasting plan (eating very little every other day), one group did supervised exercise, one group combined both approaches, and one group acted as a control (no intervention). The trial was measuring changes in liver fat (the primary focus), body weight, and several blood markers related to liver health and blood sugar. Of the 80 who started, 74 completed the trial — all 20 in both the combination and control groups finished, 19 of 20 in the fasting-only group finished, and 15 of 20 in the exercise-only group finished. The reported data shows that all four groups had some reduction in liver fat percentage over the study period (measured by MRI scan). The combination group had the largest reported change at minus 5.48 percentage points, followed by the fasting-only group at minus 2.25 percentage points, the exercise-only group at minus 1.3 percentage points, and the control group at minus 0.17 percentage points. For body weight (in kilograms), the reported changes were: fasting-only minus 4.45 kg, exercise-only minus 1.79 kg, combination minus 4.18 kg, and control minus 0.52 kg. Two liver-related blood markers — ALT and AST (enzymes that doctors measure to check on liver health) — showed reductions across the active groups, with the fasting-only group showing the largest reported drops in ALT (minus 11.24 units) and AST (minus 5.39 units). Blood sugar and insulin levels also showed reported reductions in the active groups, while the control group showed small increases in both. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT05364931 · results posted 3 September 2025

According to the results reported on ClinicalTrials.gov, this trial looked at a drug called cotadutide and involved 54 people in total. Participants were split into four groups: 17 received a lower dose of cotadutide (300 micrograms), 18 received a higher dose (600 micrograms), 9 received a matching dummy treatment (placebo) for the higher dose, and 10 received a matching dummy treatment for the lower dose. Not everyone finished the trial — 14 people completed the lower-dose cotadutide group, 14 completed the higher-dose group, 5 completed one placebo group, and 8 completed the other. The trial was primarily measuring how often participants experienced side effects, unusual test results, or developed antibodies (immune proteins) against the drug. The reported data shows the following counts across the three reporting groups (the two placebo groups were combined into one for reporting). Regarding side effects (called adverse events): 16 out of 17 participants in the lower cotadutide dose group, 16 out of 18 in the higher dose group, and 13 out of 19 in the combined placebo group had at least one adverse event recorded. For abnormal vital signs (things like blood pressure or heart rate): 13, 14, and 17 participants respectively were recorded as having an abnormality. For abnormal laboratory test results: 16, 17, and 19 participants respectively had at least one abnormal result. For unusual heart tracing (ECG) results: 4, 2, and 6 participants respectively had a notable finding. The reported data also shows that antibodies against the drug developed in 7 participants in the lower dose group and 11 in the higher dose group, while none were recorded in the placebo group. The reported median antibody levels (measured as a dilution ratio with no units) were 240 in the lower dose group and 60 in the higher dose group. It is worth noting that these numbers reflect how many people had a particular measurement recorded, not a judgment about whether those findings were harmful or significant — that interpretation requires medical expertise. The trial appears to have been an early-phase study focused on monitoring and measuring these signals rather than testing whether the drug improved a particular health condition. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT07052682 · results posted 19 August 2025

According to the results reported on ClinicalTrials.gov, this trial involved 11 participants, all of whom received a treatment called ontamalimab. Seven participants completed the study, while four did not finish. The trial was primarily measuring whether participants experienced any unexpected medical events (called treatment-emergent adverse events, or TEAEs) after receiving the treatment, as well as whether there were any notable changes in blood test results, heart tracings (ECGs), vital signs such as blood pressure and pulse, and body weight. The reported data shows that out of the 11 participants, 6 experienced at least one treatment-emergent adverse event — meaning a medical occurrence that appeared or got worse after starting the treatment. However, the data does not break down what those events were or how serious they were. For the other measurements, the reported results show that zero participants had clinically significant (that is, medically noteworthy, as judged by the study doctor) abnormalities in their blood tests, heart tracings, vital signs, or body weight. The trial also measured a secondary outcome: a blood marker called Pro-C3, which is linked to liver scarring activity. The reported data shows an average reduction of approximately 11.88% in Pro-C3 levels from the start of the study to week 24. It is important to note this is simply the number reported, and what this change may or may not mean clinically was not described in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT05211284 · results posted 16 July 2025

According to the results reported on ClinicalTrials.gov, this trial (NCT05211284) was designed to compare a medication called saroglitazar magnesium (4 mg) against a placebo (a dummy treatment with no active ingredient) in people with liver disease. The trial aimed to measure changes in the amount of fat stored in the liver, liver stiffness, and certain markers in the blood related to liver scarring and fat. In total, only four people were enrolled — three in the saroglitazar magnesium group and one in the placebo group. The reported data shows that none of the four participants completed the trial, with all four recorded as "not completed." The reported data shows that no numerical results were submitted for any of the outcome measures — neither the primary measure (change in liver fat content as assessed by a specialised MRI scan) nor any of the secondary measures (including liver stiffness, other liver scan readings, or blood markers). In other words, for every single thing the trial set out to measure, no figures have been provided on ClinicalTrials.gov. Given that the trial enrolled only four participants and none completed it, it is not possible to draw any conclusions from this study. The absence of reported numbers means the questions the trial was designed to answer remain unanswered based on this data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02500147 · results posted 2 July 2025

According to the results reported on ClinicalTrials.gov, this trial set out to compare the amount of fat in the liver between two small groups of adolescents and young women with Polycystic Ovary Syndrome (PCOS) — one group taking metformin (a medicine commonly used for blood sugar) and one group taking a placebo (a dummy treatment with no active ingredient). The trial enrolled 3 participants in total — 1 in the metformin group and 2 in the placebo group — and none of them completed the study. Because so few people were enrolled and no one finished, the results should be interpreted with great caution. The reported data shows that the primary outcome measured was the percentage of fat in the liver, detected using a specialised type of scan called magnetic resonance spectroscopy. The reported figure for the metformin group was 7.4% liver fat, and for the placebo group it was 3.1% liver fat. These appear to be the values recorded, though given that no participants completed the trial, it is unclear at what point these measurements were taken. For the secondary outcome — looking at the relationship between liver fat and a measure of how the body responds to insulin (called HOMA-IR) — the reported data shows no numerical results were submitted. Similarly, no numbers were reported for any of the other planned measurements, such as liver cell stress markers, pancreatic hormone levels, or body fat distribution. In summary, this trial was very small and did not reach completion, meaning the data it generated is extremely limited. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02443116 · results posted 26 June 2025

According to the results reported on ClinicalTrials.gov, this trial tested a drug called aldafermin across three separate parts, each looking at different doses. In total, the trial enrolled 254 participants across all three parts — 82 in Part 1, 94 in Part 2, and 78 in Part 3. The main thing being measured in all three parts was the change in the amount of fat stored in the liver, which was assessed using a type of MRI scan. Parts 1 and 3 also included groups who received a placebo (a dummy treatment with no active ingredient), allowing the researchers to compare results. The reported data shows the following changes in liver fat levels (measured as percentage points of fat in the liver). In Part 1, participants receiving aldafermin 3.0 mg had an average reduction of 9.68 percentage points and those on 6.0 mg had a reduction of 11.91 percentage points, while the placebo group had a reduction of just 0.85 percentage points. In Part 2, the reported reductions were 4.95 percentage points for the 0.3 mg dose, 10.69 for the 1.0 mg dose, 11.55 for the 3.0 mg dose, and 10.85 for a separate 1.0 mg group. In Part 3, the aldafermin 1.0 mg group had a reported average reduction of 7.70 percentage points compared with 2.73 percentage points in the placebo group. Secondary measures looking at the *percentage change* in liver fat (that is, how much of the original fat was reduced) showed similar patterns across the groups, with larger reductions reported in the higher-dose aldafermin groups compared with placebo. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04210245 · results posted 26 March 2025

According to the results reported on ClinicalTrials.gov, this trial (NCT04210245) enrolled 160 participants across four groups: 7 people received a daily 0.3 mg dose, 42 received a daily 1 mg dose, 55 received a daily 3 mg dose, and 56 received a placebo (a dummy treatment with no active ingredient). The trial's main focus was measuring changes in something called the Enhanced Liver Fibrosis (ELF) score — a blood test used to estimate the level of liver scarring (fibrosis). A higher ELF score indicates more severe disease. This score was measured at the start of the trial and again at 48 weeks, to see how much it changed. The reported data shows the following changes in ELF score after 48 weeks: the 0.3 mg group had a small decrease of 0.071 points; the 1 mg group had a small increase of 0.125 points; the 3 mg group had a decrease of 0.213 points; and the placebo group had an increase of 0.263 points. To put these numbers in context, the ELF scale ranges from zero upward, with scores above 9.8 considered severe — so all of the reported changes were quite small in absolute terms. No secondary outcome measure data was included in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04321031 · results posted 21 March 2025

According to the results reported on ClinicalTrials.gov, this trial (NCT04321031) enrolled 255 adults across seven groups to study a liver condition called NASH (non-alcoholic steatohepatitis), which involves inflammation and cell damage in the liver. Participants were assigned to receive either a placebo (inactive treatment), one of four doses of an investigational medicine called PF-06865571 (taken twice daily), or one of those doses combined with a second investigational medicine called PF-05221304. The trial ran for 48 weeks and was primarily measuring how many participants showed signs of NASH resolution on liver biopsy — meaning no cell ballooning, minimal inflammation, and no worsening of liver scarring (fibrosis) — compared to when they started. The reported data shows that, for the main goal, the number of participants recorded as meeting the NASH resolution criteria at week 48 was: 13 out of 34 in the placebo group, 16 out of 35 in the lowest dose group (25 mg), 25 out of 48 in the 75 mg group, 21 out of 42 in the 150 mg group, 23 out of 35 in the 150 mg combination group, 14 out of 31 in the 300 mg group, and 19 out of 30 in the 300 mg combination group. For the secondary measure of liver fat, the reported data shows a change in liver fat content (measured by a type of MRI scan) from the start of the trial to week 48. The placebo group showed approximately a 1% increase in liver fat, while the investigational medicine groups showed reported reductions ranging from around 41% to roughly 69%, depending on dose and combination. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04052516 · results posted 28 February 2025

According to the results reported on ClinicalTrials.gov, this trial (NCT04052516) enrolled 280 people across three groups: 92 received a placebo (a dummy treatment with no active ingredient), 93 received a lower dose of icosabutate (300 mg), and 95 received a higher dose (600 mg). The trial was measuring changes in liver tissue in people with a condition called NASH (non-alcoholic steatohepatitis), a form of liver disease involving inflammation and cell damage. The main thing the trial looked at was whether signs of NASH visible on a liver biopsy had resolved — specifically, whether certain types of liver cell damage had disappeared — without the scarring in the liver getting worse. The reported data shows that for the primary measure — resolution of NASH without worsening of liver scarring — 8.7% of participants in the placebo group, 17.3% in the 300 mg group, and 20.8% in the 600 mg group met that definition. For one of the secondary measures — improvement in liver scarring by at least one stage without worsening of inflammation or cell damage — the reported figures were 13.0% (placebo), 26.9% (300 mg), and 24.5% (600 mg). When looking at scarring improvement alone (without the additional condition), the figures were 13.0%, 30.8%, and 28.3% respectively. The reported data also shows changes in liver enzyme levels (blood markers that can reflect liver activity): for example, one enzyme called ALT fell by an average of 9.8 units in the placebo group, compared with 27.9 units and 30.1 units in the two icosabutate groups. Similar patterns in the same direction were reported for other liver enzymes (AST and GGT), a substance called bilirubin, and an inflammation marker called hsCRP. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT05792423 · results posted 14 February 2025

According to the results reported on ClinicalTrials.gov, this trial enrolled 24 healthy adult volunteers to test a new ultrasound method called "Conditionally Increased Output" (CIO) enhanced ultrasound, which is designed to measure how stiff the liver is. Stiffer livers can be a sign of liver disease. Twenty-two of the 24 participants completed the study, and two did not finish. The trial was primarily focused on monitoring whether the ultrasound procedure had any impact on the liver, by checking blood markers of liver health before and after the scan. The reported data shows that three specific liver-related blood markers — AST, ALT, and ALP (all enzymes that can rise if the liver is under stress) — were measured before the scan and again seven days afterwards. The average difference in AST between the pre-scan and day-7 readings was −0.5 international units per litre, meaning the group average was very slightly lower after the scan. The average difference in ALT was −0.3 units, and the average difference in ALP was +2.2 units. Additional secondary measurements looked at AST at one and two days after the scan, with reported average differences of −0.9 and −1.0 units respectively. The trial also compared a measure of consistency (how variable the readings were) between the standard ultrasound mode and the new CIO mode, with a reported average difference of −0.019 (no units), though what this means in a clinical sense was not explained further in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04166773 · results posted 24 January 2025

According to the results reported on ClinicalTrials.gov, this trial (NCT04166773) enrolled 190 adults in total, split across four groups: 47 people received 5 mg of tirzepatide, 47 received 10 mg, 48 received 15 mg, and 48 received a placebo (a dummy treatment with no active ingredient). The trial ran for 52 weeks and was primarily measuring whether tirzepatide could clear up a liver condition called NASH (a form of liver inflammation linked to fat build-up) without causing the liver scarring — known as fibrosis — to get worse. A number of secondary measures were also tracked, including changes in liver fat, body weight, and liver scarring scores. The reported data shows that for the main outcome — the percentage of participants whose NASH resolved without worsening of liver scarring — the figures were 51.8% in the 5 mg group, 63.1% in the 10 mg group, and 73.9% in the 15 mg group, compared with 12.6% in the placebo group. For the secondary outcomes, the reported data shows that between 53% and 59% of participants in the tirzepatide groups showed at least a one-point improvement in their liver scarring score (without worsening of NASH), compared with about 32.5% in the placebo group. Between 81% and 89% of those on tirzepatide showed a meaningful improvement in their overall liver disease activity score, compared with about 38% on placebo. Regarding liver fat measured by a specialised scan, the tirzepatide groups showed average reductions of around 10–11 percentage points, versus roughly 1.3 percentage points in the placebo group. Average body weight changes over 52 weeks were reported as −11.5 kg, −14.2 kg, and −17.9 kg for the 5 mg, 10 mg, and 15 mg groups respectively, compared with −1.0 kg for placebo. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03938246 · results posted 19 December 2024

According to the results reported on ClinicalTrials.gov, this trial looked at a drug called TVB-2640 in people with excess fat in their liver. A total of 142 people started the trial across two countries — the United States and China. Participants were split into six groups: some received TVB-2640 at different doses (25 mg, 50 mg, or 75 mg), and others received a placebo (a dummy treatment with no active ingredient). The main thing being measured was how much the amount of fat in the liver changed after 12 weeks, using a specialised type of MRI scan. The reported data shows that, on average, liver fat levels changed differently across the groups. In the placebo groups, liver fat went up slightly in the US group (about +2.5%) and went down in the China group (about −15.6%). Among those taking TVB-2640, the reported average reductions in liver fat were: −11.3% for the 25 mg US group, −27.6% for the 50 mg US group, −28.7% for the 50 mg China group, and −35.8% for the 75 mg US group. For a secondary measure — the number of participants who had at least a 30% reduction in liver fat — the reported figures were 7 people in the 25 mg US group, 16 in the 50 mg US group, 4 in the 75 mg US group, 10 in the 50 mg China group, 3 in the US placebo group, and 2 in the China placebo group. The trial also tracked changes in a liver enzyme called ALT (a marker measured in the blood that can indicate liver stress), with reported average changes ranging from a rise of about +14% in the China placebo group to a drop of about −28% in the 50 mg China TVB-2640 group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04771273 · results posted 3 December 2024

According to the results reported on ClinicalTrials.gov, this trial tested three different doses of a medicine called survodutide (2.4 mg, 4.8 mg, and 6.0 mg) against a placebo (an inactive dummy treatment) in people with a liver condition called NASH — a form of liver disease where fat builds up and causes inflammation and damage. A total of 295 people were enrolled across the four groups and went through an initial dose-build-up period followed by a maintenance period lasting 48 weeks in total. The trial's main goal was to measure whether liver tissue, examined under a microscope via a biopsy, showed signs of improvement after 48 weeks of treatment. The reported data shows that, looking at the primary measure — the proportion of participants whose liver biopsy showed improvement — the placebo group had a reported rate of around 13–15%, depending on how the analysis was run. By comparison, the survodutide groups had higher reported rates: approximately 39–47% in the 2.4 mg group, 63% in the 4.8 mg group, and 43–56% in the 6.0 mg group (two slightly different analysis methods were used, which is why ranges are given). For a secondary measure — the proportion of people whose liver fat content dropped by at least 30% as measured by a specialised scan (MRI) — the reported figures were again higher in the survodutide groups (roughly 51–77%, depending on dose and analysis method) compared with around 14–17% in the placebo group. The reported average absolute reduction in liver fat across all survodutide doses ranged from approximately 10 to 13 percentage points, compared with around 2 percentage points in the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03061721 · results posted 24 October 2024

According to the results reported on ClinicalTrials.gov, this trial tested three different doses of a medicine called saroglitazar magnesium (1 mg, 2 mg, and 4 mg) against a dummy pill (placebo) in people with a liver condition. A total of 106 people were enrolled across the four groups — 26 in the 1 mg group, 25 in the 2 mg group, 27 in the 4 mg group, and 28 in the placebo group. Not everyone finished the trial: 5 people in the 2 mg group and 3 in the placebo group did not complete it. The main thing the trial was measuring was the change in a liver enzyme called ALT (alanine aminotransferase) — a blood marker that doctors often monitor to get a sense of how the liver is doing — after 16 weeks. The reported data shows that ALT levels fell in all three saroglitazar magnesium groups by the end of the 16 weeks, while they rose slightly in the placebo group. Specifically, the reported percentage changes from the starting level were: a drop of 26.2% in the 1 mg group, a drop of 27.0% in the 2 mg group, a drop of 44.9% in the 4 mg group, and a rise of 2.6% in the placebo group. For the secondary measurements, the reported data shows changes in liver fat content (measured by a type of MRI scan) of +0.53 percentage points for 1 mg, −0.36 for 2 mg, −4.21 for 4 mg, and −0.28 for placebo. The number of participants recorded as having a sustained drop in ALT over time was 22 (1 mg), 22 (2 mg), 26 (4 mg), and 14 (placebo). Two scores used to assess liver scarring risk — the Enhanced Liver Fibrosis score and the APRI score — each showed small decreases in all three saroglitazar groups and small increases in the placebo group, as reported. Changes in another liver marker called cytokeratin-18 were also reported, with the placebo group showing a rise of 97.4 U/L while the saroglitazar groups showed varying decreases. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03783195 · results posted 23 October 2024

According to the results reported on ClinicalTrials.gov, this trial enrolled 15 people in total — 8 in a group with a high genetic risk score (a measure based on genes linked to fat processing in the liver) and 7 in a group with a low genetic risk score. All 15 participants completed the study. The trial was measuring whether people's genetic profile made a difference to how their liver fat and certain blood fats changed over a 3-week period. Liver fat was measured in two ways — using a specialised ultrasound scan called elastography (FibroScan) and an MRI scan — and blood levels of specific fat particles called VLDL-triglycerides (a type of fat carried in the bloodstream) were also tracked. The reported data shows the following changes from the start to the end of the study. For liver fat measured by elastography (in units called kilopascals), the high genetic risk group showed a mean change of −0.15 and the low genetic risk group showed a mean change of +1.10. For liver fat measured by MRI (as a percentage), the high genetic risk group showed a mean change of −0.54% and the low genetic risk group showed −0.33%. For VLDL-triglyceride levels in the blood, the high genetic risk group showed a mean change of −0.021 mg/dl and the low genetic risk group showed −0.007 mg/dl. A related measure (the area under the curve, which captures how these blood fat levels changed over a 3-hour period) showed a change of +0.66 for the high genetic risk group and +0.75 for the low genetic risk group. The reported data for the secondary measures shows that fasting triglyceride levels (another type of blood fat) changed by a mean of +21.75 mg/dl in the high genetic risk group and −2.14 mg/dl in the low genetic risk group. The 3-hour area-under-the-curve measure for triglycerides showed a mean change of +0.59 in the high genetic risk group and +0.57 in the low genetic risk group. No other secondary outcome data was reported beyond these figures. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03863574 · results posted 15 October 2024

According to the results reported on ClinicalTrials.gov, this trial (NCT03863574) enrolled 16 people in total across three groups: 6 received saroglitazar magnesium at a 2 mg dose, 7 received it at a 4 mg dose, and 3 received a placebo (a dummy treatment with no active ingredient). All 16 participants completed the study. The trial was measuring changes in liver disease activity over 24 weeks in people with a condition called NASH (non-alcoholic steatohepatitis, a form of fatty liver disease). The main thing being tracked was a liver scoring system called the NAFLD Activity Score, or NAS — a number between 0 and 8 where a higher score means more disease activity in the liver, based on fat build-up, inflammation, and cell damage seen in a liver biopsy. The reported data shows that after 24 weeks, the average NAS score changed by −1.50 points in the 2 mg group, −1.86 points in the 4 mg group, and −1.33 points in the placebo group (all reductions from where they started). For the secondary outcomes — additional things being tracked — the reported data shows that 4 out of 6 participants in the 2 mg group, 3 out of 7 in the 4 mg group, and 1 out of 3 in the placebo group met a pre-defined improvement threshold across multiple NAS components with no worsening of liver scarring (fibrosis). Regarding the disappearance of the liver inflammation condition altogether, this was reported in 5 of 6 participants in the 2 mg group, 6 of 7 in the 4 mg group, and 0 of 3 in the placebo group. Changes in liver scarring scores averaged −0.50 (2 mg), −0.43 (4 mg), and +0.33 (placebo). Liver enzyme levels — blood markers that can reflect liver stress — also showed reductions from the starting point across most groups, with the specific figures varying by enzyme type and group. It is worth noting that this was a very small trial with only 16 participants in total, so the reported numbers represent a very limited group of people. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04283942 · results posted 23 September 2024

According to the results reported on ClinicalTrials.gov, this trial (NCT04283942) enrolled 60 people in total — 30 in an intermittent calorie restriction (ICR) group, where calories were reduced on certain days in a pattern, and 30 in a continuous calorie restriction (CCR) group, where calories were reduced steadily every day. Both groups had 28 people complete the study, with 2 in each group not finishing. The trial was primarily measuring changes in the amount of fat stored in the liver, and also tracked body weight, blood sugar levels, a longer-term blood sugar marker called HbA1c (a measure of average blood sugar over roughly three months), and liver enzyme levels (substances in the blood that can indicate how the liver is functioning). The reported data shows that liver fat content — the primary measure — fell by an average of 20.5 percentage points in the ICR group and 15.5 percentage points in the CCR group. A second set of figures in that same outcome also shows changes of −7.6 and −7.3 percentage points respectively, though the data as submitted does not clearly label what these two sets of numbers represent separately. For body weight, the reported data shows an average reduction of 5.3 kg in the ICR group and 3.8 kg in the CCR group. Fasting blood sugar (measured after not eating overnight) fell by an average of 12.6 units in the ICR group and 10.8 units in the CCR group. Blood sugar measured two hours after a glucose drink fell by 50.6 units in the ICR group and 71.6 units in the CCR group. The HbA1c marker fell by 0.5 percentage points in the ICR group and 0.1 percentage points in the CCR group. Liver enzyme levels (alanine aminotransferase) fell by an average of 24.8 units in the ICR group and 10.1 units in the CCR group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04857437 · results posted 20 September 2024

According to the results reported on ClinicalTrials.gov, this trial (NCT04857437) tested a investigational medicine called PF-07202954 in a small group of healthy adult volunteers. The study was conducted in two parts, though only Part 1 appears to have reported results. In Part 1, participants were assigned to one of eight sub-groups across two cohorts, receiving different single doses of the medicine (10 mg, 30 mg, 100 mg, 300 mg, or 600 mg) or a placebo (a dummy treatment with no active ingredient), and some doses were given with different meals or in a fasted state. The total number of participants across all groups was small — ranging from 1 to 2 people per sub-group in each study period. The trial was primarily measuring unwanted medical events that occurred after taking the treatment, unusual changes in blood and urine test results, heart readings (ECG), and blood pressure or pulse readings. The reported data shows the following for Part 1: When it came to unwanted medical events (called "adverse events") that happened after taking the treatment, 3 out of the participants who received placebo reported such an event, compared to small numbers in the active-dose groups — ranging from 0 to 2 participants depending on the dose. For unusual blood or urine test results that met pre-set thresholds of concern, the reported data shows between 0 and 6 participants across the different dose groups had at least one such result, with 0 in the placebo group. For heart tracing (ECG) readings, no participants in any group recorded readings that met the pre-defined concern thresholds. For blood pressure and pulse readings, 1 participant in the placebo group and 1 in the 100 mg high-fat meal group met those thresholds, with zero in all other groups. No results data was reported for Part 2 of the trial. It is worth noting that the group sizes in this trial were very small (often just 1–2 people per group), which is typical of early-stage studies designed to gather initial information rather than draw broad conclusions. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02548351 · results posted 5 September 2024

According to the results reported on ClinicalTrials.gov, this trial (NCT02548351) enrolled 2,477 adults in total — 825 received a 10 mg dose of obeticholic acid (OCA), 827 received a 25 mg dose of OCA, and 825 received a placebo (a dummy treatment with no active ingredient). All participants had a liver condition called NASH (a form of fatty liver disease that can cause scarring). The trial was measuring whether OCA delayed or reduced serious liver-related events over time, as well as whether it changed the level of liver scarring (called fibrosis) seen in tissue samples taken by biopsy. The reported data shows that for the main (primary) goal — tracking how many participants experienced a serious liver-related event such as death from any cause, liver transplant, severe liver disease scores, or certain liver complications — 15.8% of the 10 mg OCA group, 14.7% of the 25 mg OCA group, and 18.8% of the placebo group had such an event. For one key secondary goal, looking at liver biopsy results, the reported data shows that 17.1% in the 10 mg group and 19.5% in the 25 mg group showed at least one stage of improvement in liver scarring without their NASH getting worse, compared with 10.0% in the placebo group. A broader secondary measure — improvement in scarring and/or reduction in NASH without either getting worse — was reported at 18.5% (10 mg), 20.8% (25 mg), and 11.8% (placebo). Regarding unwanted medical events during the trial, 798 participants in the 10 mg group, 813 in the 25 mg group, and 781 in the placebo group reported at least one treatment-emergent adverse event; serious adverse events were reported in 273, 276, and 248 participants respectively across those same three groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04267393 · results posted 4 September 2024

According to the results reported on ClinicalTrials.gov, this trial (NCT04267393) enrolled 124 adults in total — 40 in the placebo group, 42 in Treatment 1, and 42 in Treatment 2. The trial was looking at people with a liver condition called NASH (non-alcoholic steatohepatitis), which involves scarring (fibrosis) of the liver. The main thing researchers were measuring was whether liver scarring improved by at least one stage on a standard scoring scale, assessed through a liver biopsy taken after 12 weeks of treatment. The reported data shows that for the primary measure — the percentage of participants whose liver scarring improved by at least one stage — 20.5% of those in the placebo group, 12.2% in the Treatment 1 group, and 7.1% in the Treatment 2 group met that threshold. The secondary outcomes told a similar story: when looking at scarring improvement of at least one stage without any worsening of NASH overall, the figures were 20.5% (placebo), 12.2% (Treatment 1), and 4.8% (Treatment 2). For a larger improvement of two or more stages without NASH worsening, the reported figures were 2.6% (placebo), 0% (Treatment 1), and 0% (Treatment 2). Using a different but related scoring system (the modified Ishak scale), the reported rates of at least one stage improvement were 30.8% (placebo), 26.8% (Treatment 1), and 21.4% (Treatment 2). The reported data also shows a secondary measure called collagen proportionate area (CPA) — a way of quantifying the amount of scarring tissue in a liver sample as a percentage. The average change from the start of the trial was −3.67% for the placebo group, −0.35% for Treatment 1, and −3.67% for Treatment 2. No other secondary outcome figures were missing from the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03987451 · results posted 29 May 2024

According to the results reported on ClinicalTrials.gov, this trial enrolled 71 adults in total — 47 received semaglutide 2.4 mg (a weekly injection) and 24 received a placebo (an inactive treatment). Of those, 45 and 23 participants respectively completed the study. The trial was looking at a liver condition called non-alcoholic steatohepatitis (NASH), which involves inflammation and damage to liver cells, often alongside scarring (fibrosis). The main thing the trial measured after 48 weeks was how many participants showed at least one stage of improvement in liver scarring without their NASH getting worse. The reported data shows that for the primary measure — improvement in liver scarring without worsening of NASH — 10.6% of participants in the semaglutide group met this outcome, compared with 29.2% in the placebo group. For a number of secondary measures, the reported data shows the following at 48 weeks: liver fat content (measured by a specialised MRI scan) had a ratio-to-baseline of 0.62 in the semaglutide group versus 1.01 in the placebo group, suggesting a greater reduction from starting levels in the semaglutide group; liver stiffness (a measure of scarring, also by MRI) had a ratio-to-baseline of 0.87 versus 0.98; and a blood-test score used to estimate liver scarring (called Fibrosis-4) had a ratio-to-baseline of 0.9 versus 1.0. Regarding NASH resolution specifically (reduced inflammation and cell damage), 34.0% of the semaglutide group and 20.8% of the placebo group met that definition. For overall disease activity score (NAS), 61.7% of the semaglutide group showed improvement compared with 58.3% in the placebo group, while 2.1% of the semaglutide group worsened compared with 16.7% in the placebo group. It is worth noting that this was a relatively small trial, and the numbers above are simply what was recorded and submitted to the clinical trial registry — they do not on their own tell us whether any difference between groups was meaningful or due to chance. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04031729 · results posted 24 May 2024

According to the results reported on ClinicalTrials.gov, this trial enrolled 80 adults in total — 40 in a group that received aspirin and 40 in a group that received a placebo (a dummy pill with no active ingredient). Of those, 37 in the aspirin group and 34 in the placebo group completed the study. The trial was measuring changes in the amount of fat stored inside the liver, using a specialised scanning technique called 1H-MRS (a type of MRI-based measurement that can estimate liver fat levels). The reported data shows that, on average, the aspirin group's liver fat level changed by −6.6 percentage points in absolute terms over the course of the study, while the placebo group's average changed by +3.6 percentage points. For the secondary measure — which looked at the relative (proportional) shift in liver fat — the reported data shows an average change of −8.8 percentage points for the aspirin group compared with +30.0 percentage points for the placebo group. These numbers describe the average changes seen across each group; they do not tell us how any individual participant responded. It is worth noting that this summary only covers what was measured and the figures that were submitted to ClinicalTrials.gov — it does not account for other aspects of the study design, such as whether the differences between the two groups were considered statistically meaningful (i.e., unlikely to be due to chance), as that information was not included in the structured data provided here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04583423 · results posted 29 April 2024

According to the results reported on ClinicalTrials.gov, this trial tested three different doses of a drug called MK-3655 (50 mg, 100 mg, and 300 mg) against a placebo (an inactive treatment) in people with a liver condition called non-alcoholic steatohepatitis, or NASH — a form of liver disease involving fat build-up, inflammation, and cell damage. A total of 183 people started the trial across the four groups. The trial ran for 52 weeks and was primarily measuring how many participants showed signs of NASH resolution on liver biopsy without their liver scarring (fibrosis) getting worse, as well as tracking how many participants experienced unwanted health events during the study. The reported data shows that, after 52 weeks, the percentage of participants whose NASH appeared to resolve without worsening of fibrosis was 16.7% in the 50 mg group, 14.3% in the 100 mg group, 17.6% in the 300 mg group, and 5.9% in the placebo group. Regarding unwanted health events (called adverse events) that occurred during the study, the reported figures were 73.3% in the 50 mg group, 70.2% in the 100 mg group, 76.1% in the 300 mg group, and 77.3% in the placebo group. A small number of participants stopped taking the study medication due to an adverse event — 2.2% in the 50 mg group and 0% in each of the other three groups. For a secondary measure looking at liver fat content after 24 weeks (measured by a specialised MRI scan), the reported average relative reductions were 30.1%, 30.0%, and 37.2% for the three MK-3655 doses respectively, compared with 11.0% for placebo. The reported data also shows that, at 52 weeks, the percentage of participants with at least a one-stage improvement in liver scarring without worsening of inflammation was 22.2% (50 mg), 38.1% (100 mg), 29.4% (300 mg), and 17.6% (placebo). It is worth noting that the number of participants who completed the full study was low across all groups — around 8 to 11 people per group — which means these percentages are based on relatively small numbers of completed participants. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04048135 · results posted 2 April 2024

According to the results reported on ClinicalTrials.gov, this trial tested a drug called pegozafermin in people with a liver condition. The trial had two parts. Part 1 enrolled 81 people across six different dose groups (ranging from 3 mg to 36 mg, given either once a week or once every two weeks) plus a placebo group of 19 people who received a dummy treatment. Part 2 enrolled a further 20 people, all receiving 27 mg of pegozafermin once a week. The trial was measuring how the drug moved through the body (for example, how quickly it reached peak levels in the blood and how long it took to clear), as well as tracking any unwanted medical events that occurred during the study. The reported data shows that, in Part 1, the peak level of pegozafermin detected in the blood ranged from around 103 ng/mL (nanograms per millilitre — a measure of how much of the drug was in the blood) in the lowest-dose group up to around 1,674 ng/mL in the highest-dose group. The time it took to reach that peak level was reported as roughly 48 to 72 hours across the different groups. The drug's "half-life" — meaning the time it took for the amount in the blood to drop by half — was reported as roughly 46 to 68 hours across the groups. Regarding unwanted medical events during the study, the reported data shows that in Part 1, between 4 and 8 participants in each active-dose group experienced such events, as did 8 participants in the placebo group. In Part 2, 18 out of 20 participants in the 27 mg weekly group were reported as experiencing an unwanted medical event. The data does not include a detailed breakdown of what those events were in this summary, and no comparison against a placebo was reported for Part 2. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04065841 · results posted 26 December 2023

According to the results reported on ClinicalTrials.gov, this trial (NCT04065841) enrolled 234 adults with a liver condition called NASH (non-alcoholic steatohepatitis) — a form of fatty liver disease where the liver becomes inflamed and scarred. Participants were assigned to one of four groups: tropifexor alone (54 people), licogliflozin alone (55 people), both medicines combined (84 people), or a placebo — a dummy treatment with no active ingredient (41 people). The trial ran for 48 weeks and used liver biopsies (small tissue samples) to measure two main things: whether scarring (called fibrosis) improved by at least one stage, and whether the NASH itself resolved, without the other condition getting worse. The reported data shows the following for the two primary (main) measures. For fibrosis improvement without worsening of NASH, 6 participants in the tropifexor group, 9 in the licogliflozin group, 10 in the combination group, and 4 in the placebo group met that marker. For resolution of NASH without worsening of fibrosis, the numbers were 5, 3, 10, and 2 respectively. It is worth noting that a large proportion of participants did not complete the trial — roughly half in the tropifexor and combination groups, and around half in the other groups as well — so the numbers above relate only to those who had assessable data. For a secondary measure looking at body weight reduction of 5% or more, 12 participants in the tropifexor group, 9 in the licogliflozin group, 28 in the combination group, and 3 in the placebo group reached that threshold. The reported data also shows results for several secondary (additional) measures. When the two main liver outcomes were combined into a single measure, 8, 10, 14, and 5 participants across the four groups respectively met that combined marker. For any improvement of at least one stage in fibrosis (regardless of NASH status), the numbers were 6, 10, 11, and 4. For a larger improvement of at least two stages in fibrosis without worsening of NASH, 3, 4, 3, and 3 participants respectively reached that point. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04134091 · results posted 14 December 2023

According to the results reported on ClinicalTrials.gov, this trial enrolled 56 people across three groups — 18 in Treatment A, 19 in Treatment B, and 19 in Treatment C (which was the placebo, or dummy treatment, group). The trial was measuring changes in liver fat and liver tissue health in people with a liver condition called non-alcoholic steatohepatitis (NASH), a form of fatty liver disease involving inflammation and cell damage. The main thing being measured was the change in the amount of fat in the liver after 12 weeks, assessed using a specialised MRI scan. A small number of participants did not complete the full study — two from each of Treatment B and Treatment C. The reported data shows that, for the primary (main) outcome — the change in liver fat percentage after 12 weeks — Treatment A participants had an average reduction of 7.68 percentage points, Treatment B participants had an average reduction of 9.17 percentage points, and placebo participants had an average reduction of 1.54 percentage points. In relative terms (that is, as a proportion of each person's starting liver fat level), the reported reductions were approximately 40% for Treatment A, 47% for Treatment B, and 9% for the placebo group. For the liver tissue (biopsy) outcomes measured at 36 weeks, the reported data shows that NASH was considered resolved in 7 Treatment A participants, 9 Treatment B participants, and 1 placebo participant. When also requiring that liver scarring (fibrosis) had not worsened, those numbers were 6, 9, and 0 respectively. For improvement in NASH alongside no worsening of fibrosis based on a separate blinded biopsy comparison, the reported figures were 9 for Treatment A, 8 for Treatment B, and 2 for placebo. Changes in individual liver tissue scoring components (such as inflammation, fat accumulation, and cell ballooning) were also reported as small reductions across all groups, with the placebo group generally showing smaller changes. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04944992 · results posted 15 November 2023

According to the results reported on ClinicalTrials.gov, this trial (NCT04944992) enrolled 145 adults — 72 assigned to a medicine called efinopegdutide and 73 assigned to semaglutide (a medicine already used for type 2 diabetes and weight management). The trial ran for 24 weeks and was primarily measuring changes in the amount of fat in participants' livers, using a specialised type of MRI scan. It also tracked how many participants experienced any unwanted medical events during the trial, and whether any of those events led someone to stop taking the medicine. The reported data shows that, on average, participants in the efinopegdutide group had a 72.7% relative reduction in liver fat content from their starting level, compared with 42.3% in the semaglutide group. In more concrete terms, the absolute amount of liver fat (measured as a percentage of the liver) fell by an average of 14.9 percentage points in the efinopegdutide group and 8.8 percentage points in the semaglutide group. For body weight, the reported average change was −8.5% in the efinopegdutide group and −7.1% in the semaglutide group. Total cholesterol (a type of fat in the blood) changed by an average of −15.2% in the efinopegdutide group and −8.0% in the semaglutide group. Regarding unwanted medical events, the reported data shows that 88.9% of participants in the efinopegdutide group and 72.6% in the semaglutide group experienced at least one adverse event during the study. Of those, 5.6% of participants in the efinopegdutide group stopped taking the medicine because of an adverse event, compared with 0% in the semaglutide group. It is important to note that an "adverse event" as used in clinical trials simply means any unwanted medical occurrence that happened during the study period — it does not automatically mean the medicine caused it. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03439254 · results posted 23 October 2023

According to the results reported on ClinicalTrials.gov, this trial involved 919 adults across two phases. In the first phase — an 18-month double-blind period — participants were randomly assigned to one of three groups: a placebo (313 people), a fixed 10 mg dose of obeticholic acid (OCA) (296 people), or a dose that started at 10 mg and could be increased to 25 mg (310 people). After the double-blind phase, 659 participants who chose to continue moved into a 12-month open-label extension (OLE) where everyone received OCA. The trial was measuring several things, including changes in liver scarring (fibrosis) on biopsy, changes in liver stiffness using a scanning device, blood-based markers of liver health, adverse events (unwanted medical occurrences), and deaths. The reported data shows that in the double-blind phase, 31 out of the placebo group, 33 out of the 10 mg OCA group, and 37 out of the titrated-dose OCA group were classed as "responders" — meaning their liver scarring improved by at least one stage on biopsy without their liver inflammation getting worse. In the open-label extension phase, the reported data shows that liver stiffness (measured in kilopascals, a unit of pressure reflecting how stiff or scarred the liver is) changed from the start of that phase by an average of −2.10 kPa for those who had previously been on placebo, −2.90 kPa for those who had previously been on 10 mg OCA, and −3.45 kPa for those on the titrated dose — all representing reductions. Blood-based fibrosis scores (FIB-4 and ELF) at the start of the extension phase were broadly similar across all three groups, suggesting comparable liver disease severity at that point; changes from those starting values during the extension were not reported in the submitted data. Regarding deaths during the open-label extension, 1 death was reported in the group previously on placebo, 0 in the group previously on fixed-dose OCA, and 1 in the group previously on the titrated dose. Adverse events (unwanted medical occurrences) during the extension were reported in 199, 213, and 197 participants respectively across the three groups, while serious adverse events were reported in 26, 50, and 48 participants respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04321343 · results posted 29 August 2023

According to the results reported on ClinicalTrials.gov, this trial (NCT04321343) enrolled 117 adults in total across four groups: 25 people received PXL065 at 7.5 mg once daily, 32 received 15 mg once daily, 30 received 22.5 mg once daily, and 30 received a placebo (a dummy treatment with no active ingredient). The trial was measuring changes in the amount of fat in the liver over 36 weeks, using a specialised MRI scan technique. A secondary focus was on changes in a liver enzyme called ALT, which is found in the blood and can be used as a marker of liver activity. The reported data shows that, for the primary outcome — the relative (proportional) change in liver fat from the start of the trial to week 36 — the three PXL065 groups showed reductions of approximately 19% to 23% in liver fat, while the placebo group showed a small increase of around 2.4%. A separate supporting analysis reported reductions of roughly 25% to 27% across all three PXL065 doses, compared with under 1% for placebo. In absolute terms (the actual percentage-point change in liver fat content), the PXL065 groups showed reductions of approximately 4.4 to 4.9 percentage points, while the placebo group showed a reduction of around 0.3 percentage points. Among participants whose liver fat dropped by at least 30% — a level the trial defined as a meaningful response — 8, 11, and 12 participants achieved this in the three PXL065 dose groups respectively, compared with 5 in the placebo group. For ALT, all groups including placebo showed reductions from baseline; the reported changes ranged from a drop of about 6.7 units per litre in the highest PXL065 dose group to 18.4 units per litre in the lowest dose group, with the placebo group dropping by about 11.9 units per litre. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04048876 · results posted 7 June 2023

According to the results reported on ClinicalTrials.gov, this trial (NCT04048876) looked at a medicine called CC-90001 in people with a liver condition involving scarring (fibrosis) related to NASH — a form of fatty liver disease. A total of 56 people took part in the placebo-controlled phase, split across four groups: 13 received the lowest dose (100 mg), 15 received the middle dose (200 mg), 13 received the highest dose (400 mg), and 15 received a placebo (a dummy treatment with no active medicine). The trial's main goal was to measure, at 52 weeks, what share of participants in each group showed at least a one-stage improvement in their liver scarring, as rated by a standard liver-tissue scoring system. The reported data shows that, for the primary measure — at least one stage of improvement in liver scarring at week 52 — 15.4% of the 100 mg group, 0% of the 200 mg group, 7.7% of the 400 mg group, and 6.7% of the placebo group met this threshold. The reported data shows similar figures for several of the secondary measures, including improvement in liver scarring without worsening of the broader liver inflammation condition, and resolution of the active liver inflammation. For the secondary measure looking at a broader improvement in overall liver disease activity score (without worsening of scarring), 7.7% of the 100 mg group, 6.7% of the 200 mg group, 15.4% of the 400 mg group, and 13.3% of the placebo group were reported as responders. For the measure tracking progression to cirrhosis (the most severe stage of scarring), 0% of the 100 mg group, 0% of the 200 mg group, 7.7% of the 400 mg group, and 6.7% of the placebo group were reported to have progressed. It is worth noting that the numbers of participants who completed the full trial were very small — only 2, 0, 3, and 2 people in each group respectively — so the percentages above are based on very few people. This means the figures should be interpreted with considerable caution. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04198805 · results posted 25 May 2023

According to the results reported on ClinicalTrials.gov, this trial (NCT04198805) enrolled 205 adults across four groups to investigate whether Vitamin E (1,000 mg), a fish-oil-derived fatty acid called DHA ethyl ester or "DHA EE" (1.89 g), a combination of both, or a placebo (dummy treatment) affected the amount of fat stored in the liver. Participants took their assigned treatment for six months, and liver fat was measured using a type of MRI scan before and after the treatment period. Of the 205 people who started, 177 completed the trial. The reported data shows the following changes in liver fat percentage from the start to the end of the six months. For the primary question — comparing the combination of DHA EE and Vitamin E against placebo — the combination group's liver fat percentage changed by −6.8 percentage points, while the placebo group's changed by −8.2 percentage points. Looking at Vitamin E alone compared to placebo, the reported changes were −10.4 and −8.2 percentage points respectively. For DHA EE alone compared to placebo, the reported change was +2.2 percentage points in the DHA EE group versus −8.2 in the placebo group. Regarding body measurements, the reported data shows very small average changes across all groups in waist circumference (ranging from −0.5 cm to +0.8 cm), body weight (ranging from 0.0 kg to +0.5 kg), and waist-to-hip ratio (effectively 0.0 in all groups). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04399538 · results posted 13 April 2023

According to the results reported on ClinicalTrials.gov, this trial enrolled 75 people across five groups. Participants received either a placebo (a dummy treatment with no active ingredients) or one of four different dose combinations of two investigational medicines — PF-06865571 and PF-05221304. The trial was primarily measuring how much the percentage of fat in the liver changed after six weeks of treatment, using a specialised MRI scan technique that estimates how much of the liver is made up of fat. A secondary measure looked at changes in fasting blood triglycerides (a type of fat found in the blood), as well as tracking unwanted medical events that occurred during the trial. The reported data shows that, after six weeks, the placebo group had an average reduction in liver fat of about 3.6%. By comparison, the four active treatment groups showed larger reported reductions: approximately 54% for the lowest dose combination, 58% for the next dose up, 60% for the once-daily higher dose combination, and 48% for the highest twice-daily dose combination. For fasting blood triglyceride levels, the placebo group showed an average increase of around 3.7%, while all four active treatment groups also showed increases, ranging from approximately 15% to 28%. Regarding unwanted medical events during the trial, the reported data shows these occurred in 2 participants in the placebo group, and in 4, 5, 6, and 7 participants across the four active treatment groups respectively. The reported data shows that some participants did not complete all stages of the trial — most notably one to two people in the higher-dose groups — though the reasons were not detailed in the data provided here. For several of the secondary laboratory measurements, the full breakdown of results was not completely reported in the structured data, so a complete picture of those figures cannot be provided here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02681055 · results posted 15 March 2023

According to the results reported on ClinicalTrials.gov, this trial enrolled 19 participants, all placed in a single open-label group (meaning everyone knew what treatment they were receiving — there was no comparison or placebo group). The trial was investigating a drug called MN-001 in people with a fatty liver condition and high triglycerides (a type of fat found in the blood). All 19 participants completed the first four weeks of the trial, and 18 of the 19 completed the full 12 weeks. The reported data shows that the two primary things being measured were: (1) a change in how well the body's "good" cholesterol (HDL) was able to remove cholesterol from cells — a process thought to be linked to heart disease risk — and (2) a change in triglyceride levels in the blood. After 12 weeks, the reported average change in the cholesterol removal measure was −0.013 percentage points. After 8 weeks, the reported average change in triglyceride levels was −21.67 mg/dL (milligrams per decilitre, a standard unit for measuring substances in blood). For other blood fats measured at 8 weeks, the reported data shows average changes of −15.2 mg/dL for total cholesterol, +3.2 mg/dL for HDL cholesterol, and −13.7 mg/dL for LDL (another type of blood fat). Two liver-related measurements also changed on average by −5.7 and +1.2 units respectively. The reported data also includes drug concentration levels measured in six participants after a single dose, with average readings of 0.434 and 3.44 micrograms per millilitre for the drug and its breakdown product. Regarding unwanted medical events that arose during the treatment period, the reported data shows a figure of 18 treatment-emergent adverse events (unexpected medical occurrences noted during the trial), though the breakdown of those events by type was not reported in the data available here. No further detail about the nature of those events was provided in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03518294 · results posted 3 February 2023

According to the results reported on ClinicalTrials.gov, this trial (NCT03518294) enrolled 28 people in total — 10 in a standard of care group and 18 in an aerobic exercise group. Of those, 8 and 16 people respectively completed the study (2 people in each group did not finish). The trial was measuring how levels of certain blood-clotting and blood-thinning proteins changed over five months, comparing people who followed standard medical care alone against those who also took part in an aerobic exercise programme. The main protein being tracked was called PAI-1, which is involved in the body's ability to break down clots. The reported data shows that for the primary measure — the change in PAI-1 levels over five months — the standard of care group recorded an average value of 151.4 ng/mL, while the aerobic exercise group recorded 176.2 ng/mL. For the secondary measures, the reported data shows the following average values at five months: Von Willebrand factor (another clotting-related protein) was 140.1 in the standard care group and 128.4 in the exercise group; Protein S was 106.3 versus 101.5; Factor VIII was 210.0 versus 188.6; Fibrinogen was 352.4 versus 377.2; and Antithrombin was 95.6% versus 102.2%. It is worth noting that the data as submitted does not include information about whether these differences between the two groups were considered statistically meaningful (that is, whether they were large enough to be unlikely due to chance), so that detail was not reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04147195 · results posted 26 January 2023

According to the results reported on ClinicalTrials.gov, this trial looked at two treatment approaches in a total of 41 people — 20 received a medicine called LYS006 on its own, and 21 received LYS006 combined with a second medicine called LJN452. The trial was studying a liver condition (non-alcoholic fatty liver disease) and was primarily tracking how many participants experienced unwanted health events (called adverse events, or AEs) while on these treatments. It also measured several secondary things, including liver scarring (fibrosis) scores, liver fat content, cholesterol levels, body weight, and a measure of how well the body responds to insulin. The reported data shows that, for the primary outcome, 14 out of 20 people in the LYS006-only group and 17 out of 21 in the combination group experienced at least one adverse event. Serious adverse events were reported in 2 people in the LYS006-only group and 15 in the combination group; 3 people in the combination group had adverse events that led them to stop the study, while none in the LYS006-only group did. For the secondary outcomes, the reported data shows that liver fat (measured by a type of MRI scan) changed by an average of −3.74 percentage points in the LYS006-only group and −7.52 percentage points in the combination group — where a negative number means a reduction in liver fat. Body weight on average decreased more in the combination group (up to around −3.33 kg at one time point) compared to the LYS006-only group (up to around −0.54 kg). The liver fibrosis score showed a small average decrease (−0.25) in the LYS006-only group and a small average increase (0.29) in the combination group at one measured time point. The insulin resistance score changed by an average of −3.74 in the LYS006-only group and +1.67 in the combination group. Cholesterol levels showed modest changes in both groups across different time points. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02217345 · results posted 22 November 2022

According to the results reported on ClinicalTrials.gov, this trial enrolled 53 people in total — 27 in the growth hormone group and 26 in the placebo (dummy treatment) group. The trial ran for 6 months and was primarily measuring changes in the amount of fat stored in the liver, using a specialised type of scan called magnetic resonance spectroscopy (a detailed imaging test). It also measured changes in a blood marker called high-sensitivity C-reactive protein (hsCRP), which is a substance the body produces that can reflect certain internal processes. The reported data shows that, on average, the liver fat percentage changed by −5.2% in the growth hormone group (meaning it went down) and by +3.8% in the placebo group (meaning it went up slightly) over the 6 months. For the blood marker hsCRP, the reported data shows an average change of −0.8 mg/L in the growth hormone group and +0.3 mg/L in the placebo group. It is worth noting that not everyone who started the trial finished it — 20 out of 27 people completed it in the growth hormone group, and 21 out of 26 in the placebo group. The data does not report on the reasons why some participants did not complete the trial. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03976401 · results posted 4 August 2022

According to the results reported on ClinicalTrials.gov, this trial (NCT03976401) enrolled 110 people across six groups to study a drug called EFX (tested at three different doses — 28 mg, 50 mg, and 70 mg) compared to a placebo (an inactive treatment). The main part of the study included 80 participants, and a separate smaller group (called Cohort C) included 30 participants. The trial was primarily measuring changes in the amount of fat in the liver, assessed using a type of MRI scan (a non-invasive imaging test that estimates the percentage of fat in liver tissue), after 12 weeks of treatment. The reported data shows that, at week 12, participants in the three EFX dose groups had average reductions in liver fat of approximately 12.3, 13.4, and 14.1 percentage points (for the 28 mg, 50 mg, and 70 mg groups respectively), while the placebo group had an average reduction of less than 0.3 percentage points. In percentage-change terms, the reported reductions from starting levels were around 63%, 71%, and 72% for the three EFX doses, compared to less than 1% for placebo. The reported data also shows that at week 12, 16, 17, and 15 participants (out of 19–20 per group) in the EFX dose groups achieved at least a 30% relative reduction in liver fat, compared to 2 out of 21 in the placebo group. For a later follow-up assessment (weeks 22–24), which only included participants who had already shown at least a 30% fat reduction at week 12, liver fat changes and liver tissue scores were also reported, though the placebo group's week 22–24 figures reflect a very small number of participants and should be interpreted with that in mind. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04427917 · results posted 21 July 2022

According to the results reported on ClinicalTrials.gov, this trial (NCT04427917) involved a total of 8 participants. Two people received a placebo (a dummy treatment with no active ingredient) once daily, and six people received a 300 mg daily dose of the investigational medicine called PF-06835919. All 8 participants who started the study completed it. The trial was measuring how the body handled the medicine — tracking things like unwanted medical events, blood and urine test results, heart rhythm readings (ECG), blood pressure, pulse, and how much of the medicine appeared in the bloodstream over time. The reported data shows that 3 out of 6 participants in the PF-06835919 group experienced what are called "treatment-emergent adverse events" — that is, unwanted medical occurrences that happened during the treatment period — compared with 0 out of 2 in the placebo group. No serious adverse events and no events leading to a participant dropping out were reported in either group. No participants in either group had notable abnormalities flagged in their blood or urine laboratory tests, or in their blood pressure and pulse readings. For heart rhythm (ECG) measurements, all 2 placebo participants and all 6 active-treatment participants fell into the standard acceptable range for the main heart-rhythm measurement (QTcF at or below 450 milliseconds); no participants in either group exceeded the thresholds of concern for the other ECG measurements recorded. Regarding how much medicine was absorbed into the bloodstream, the reported data shows a peak blood concentration (the highest level measured) of 23.39 micrograms per millilitre on Day 1 and 30.49 micrograms per millilitre on Day 7 for the active-treatment group. The total amount of medicine in the blood over the dosing period was reported as 169.3 on Day 1 and 230.9 on Day 7 (measured in micrograms × hours per millilitre). No equivalent pharmacokinetic data was reported for the placebo group, as would be expected. It is worth noting that with only 8 participants in total, this was a very small study, and the numbers above reflect only those 8 individuals. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04480710 · results posted 15 July 2022

According to the results reported on ClinicalTrials.gov, this trial (NCT04480710) enrolled 47 people with presumed non-alcoholic steatohepatitis (a form of liver disease involving inflammation and scarring). Participants were divided into four groups: some received a placebo (dummy treatment) at either a low or high dose level, and others received the investigational drug CRV431 at either 75 mg or 225 mg once daily for 28 days. The trial was primarily measuring safety-related events and how the drug moved through the body (for example, how quickly it reached its peak level in the blood and how much of it was present over time). The reported data shows that across the four groups, the number of treatment-related adverse events (unwanted health occurrences recorded during the trial) varied. In the low-dose (75 mg) groups, 4 events were recorded in the placebo group and 8 in the CRV431 group. In the high-dose (225 mg) groups, 3 events were recorded in the placebo group and 21 in the CRV431 group. Regarding how the drug behaved in the body, the reported data shows that at the 75 mg dose, the drug reached its peak blood level at around 4.4 hours on Day 1 and 4 hours on Day 28; at the 225 mg dose, peak levels were reached at around 2.6 hours on Day 1 and 2 hours on Day 28. The peak blood concentrations and overall exposure to the drug were higher with the 225 mg dose and also appeared to increase from Day 1 to Day 28 across both dose levels. Of the 47 people who started the trial, 43 completed it — 3 people in the 75 mg CRV431 group and 1 person in the 225 mg placebo group did not complete the study, though the reasons were not detailed in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04328077 · results posted 14 June 2022

According to the results reported on ClinicalTrials.gov, this trial enrolled 101 people across four groups: 26 received a placebo (a dummy treatment with no active ingredient), 25 received a 5 mg dose of TERN-101, 26 received a 10 mg dose, and 24 received a 15 mg dose. The trial was measuring how many people experienced unwanted health events (called adverse events) across the groups, as well as tracking how the drug moved through the body and its effect on a liver enzyme called ALT — a protein that can be measured in the blood as an indicator of liver activity. The reported data shows that, out of those who started the trial, 10 of the 26 placebo participants experienced an adverse event, compared with 13 out of 25 in the 5 mg group, 14 out of 26 in the 10 mg group, and 15 out of 24 in the 15 mg group. Regarding the liver enzyme ALT, the reported change from the starting point was a decrease of about 5% in the placebo group, roughly 3% in the 5 mg group, around 18% in the 10 mg group, and about 13% in the 15 mg group. The trial also tracked how TERN-101 was absorbed into the bloodstream. The reported data shows that the peak level of the drug in the blood (the highest concentration recorded) was 116, 155, and 389 nanograms per millilitre for the 5 mg, 10 mg, and 15 mg doses respectively, and that peak levels were reached within half an hour to one hour after taking the dose across all three groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02704403 · results posted 23 March 2022

According to the results reported on ClinicalTrials.gov, this trial involved 2,157 people with a liver condition called nonalcoholic steatohepatitis (NASH) — a form of fatty liver disease where the liver becomes inflamed and scarred. Of these, 1,437 were assigned to receive a daily 120 mg dose of a medicine called elafibranor, and 720 received a placebo (a dummy tablet with no active ingredient). The trial had two main things it was measuring: first, how many participants showed improvement in their liver condition (specifically, resolution of NASH without their liver scarring getting worse) after about 72 weeks; and second, how many participants over the longer term experienced serious outcomes such as death from any cause, cirrhosis (severe liver scarring), or other serious liver-related events. The reported data shows that for the first main measure, 138 out of 1,437 participants in the elafibranor group showed resolution of NASH without worsening of liver scarring, compared with 52 out of 720 in the placebo group. For the longer-term serious outcomes measure, the reported figures show 48 participants in the elafibranor group and 26 in the placebo group experienced one of the listed serious liver-related events, with the vast majority in both groups (1,388 and 693 respectively) not reaching those events during the study period. Notably, the trial report states that the primary goal was not met, and as a result the secondary measures were not formally tested. For the secondary measures, the reported data shows that 176 participants in the elafibranor group versus 79 in the placebo group showed at least one stage of improvement in liver scarring. Small changes in blood markers — including HbA1c (a measure of blood sugar control in diabetic participants) and cholesterol levels — were also recorded at 72 weeks, with only minor numerical differences between the two groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03028740 · results posted 10 March 2022

According to the results reported on ClinicalTrials.gov, this trial (NCT03028740) looked at a medicine called cenicriviroc (150 mg) compared to a placebo (a dummy pill with no active ingredient) in people with a liver condition called NASH (non-alcoholic steatohepatitis), which involves liver inflammation and scarring. A total of 1,778 people started the trial — 593 in the placebo group and 1,185 in the cenicriviroc group. The trial was measuring two main things: whether liver scarring (called "fibrosis") improved on a liver tissue sample after 12 months, and how long it took for serious liver-related events (such as death, progression to severe scarring known as cirrhosis, or the need for a liver transplant) to first occur over the full study period. The reported data shows that for the 12-month liver biopsy result, 22.3% of participants in the cenicriviroc group and 25.5% in the placebo group showed at least a one-stage improvement in liver scarring without their liver inflammation getting worse. For the second main measure — tracking the time to serious liver events — the data submitted to ClinicalTrials.gov shows the result as "not available," meaning a figure was not reported for either group. For the additional measures, the reported data shows that improvement of at least two stages of scarring (without worsening inflammation) was seen in 6.6% of the cenicriviroc group and 8.3% of the placebo group. When inflammation was not taken into account, at least one stage of scarring improvement was reported in 30.6% (cenicriviroc) and 33.3% (placebo), and at least two stages in 8.8% (cenicriviroc) and 10.3% (placebo). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03059446 · results posted 2 February 2022

According to the results reported on ClinicalTrials.gov, this trial (NCT03059446) enrolled 167 people, all of whom received a medicine called Cenicriviroc (CVC) at a dose of 150 mg. The trial was measuring how many participants experienced what are called "treatment-emergent adverse events" — that is, any unexpected or unwanted medical occurrences that happened after a person started taking the study drug. It is worth noting that the data shows none of the 167 participants were recorded as having formally "completed" the study. The reported data shows that out of the 167 people who started the trial, 140 participants experienced at least one treatment-emergent adverse event — meaning an untoward medical occurrence that arose after they began taking the study drug. The results do not tell us what those events were, how serious they were, or how they compared to a group not taking the medicine, as this trial had only one group and no comparison group was reported. No secondary outcome measures were included in the submitted results data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03517540 · results posted 12 November 2021

According to the results reported on ClinicalTrials.gov, this trial (NCT03517540) enrolled 193 people with a liver condition called non-alcoholic steatohepatitis (NASH) — a form of fatty liver disease involving inflammation and scarring. Participants were split into four groups: one group received a lower dose of a drug called tropifexor on its own (50 people); one received a drug called cenicriviroc on its own (48 people); one received the lower dose of tropifexor combined with cenicriviroc (47 people); and one received a higher dose of tropifexor combined with cenicriviroc (48 people). The trial was measuring adverse events (unexpected health issues that occurred during the study) as its main focus, and also looked at changes in liver scarring and inflammation after 48 weeks of treatment. The reported data shows that when it came to adverse events — that is, unwanted signs or symptoms experienced during the study — 42 out of 50 participants in the lower-dose tropifexor-only group, 41 out of 48 in the cenicriviroc-only group, 40 out of 47 in the lower-dose combination group, and 42 out of 48 in the higher-dose combination group experienced at least one such event. Serious adverse events were reported in 5, 3, 4, and 10 participants in those same groups respectively. No deaths were reported in any group. For the secondary measures, the reported data shows that the number of participants whose liver scarring improved by at least one stage was 10, 12, 11, and 13 across the four groups. The number of participants in whom liver inflammation (steatohepatitis) was recorded as resolved was 8, 8, 5, and 9 respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03763877 · results posted 28 October 2021

According to the results reported on ClinicalTrials.gov, this trial (NCT03763877) enrolled 121 participants across four groups: one group received a placebo (a dummy treatment with no active ingredient), and three groups received different doses of a medicine called PXL770 — either 250 mg once a day, 250 mg twice a day, or 500 mg once a day. The trial ran for 12 weeks and was primarily measuring changes in the amount of fat in participants' livers, using a specialised type of MRI scan (a non-invasive imaging technique that estimates fat content in the liver). The reported data shows that, looking at the relative (percentage-based) change in liver fat from the start of the trial to week 12, the placebo group showed a change of approximately −1.1%, and the 250 mg once-daily PXL770 group showed approximately −1.0% — both very small changes. The 250 mg twice-daily group showed approximately −14.3%, and the 500 mg once-daily group showed approximately −14.7%. A secondary measure looked at the actual numerical drop in liver fat percentage points: the placebo group showed a change of +0.02 percentage points, the 250 mg once-daily group −0.22 percentage points, the 250 mg twice-daily group −2.55 percentage points, and the 500 mg once-daily group −2.39 percentage points. The reported data also shows that, when counting how many participants achieved at least a 30% reduction in liver fat, that number was 2 out of 25 in the placebo group, 4 out of 22 in the 250 mg once-daily group, 4 out of 19 in the 250 mg twice-daily group, and 8 out of 16 in the 500 mg once-daily group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02855164 · results posted 29 July 2021

According to the results reported on ClinicalTrials.gov, this trial tested a drug called tropifexor (also known as LJN452) in people with a liver condition called NASH (non-alcoholic steatohepatitis, a form of fatty liver disease involving inflammation). The trial was run in three parts (Parts A, B, and C) and tested several different doses of tropifexor against a placebo (a dummy treatment with no active ingredient). In Parts A and B, 198 people took part across four dose levels (10, 30, 60, and 90 micrograms) and a placebo group. In Part C, 152 people took part across two higher dose levels (140 and 200 micrograms) and a separate placebo group. The trial measured things like side effects, liver enzyme levels in the blood, the amount of fat in the liver, and body weight. The reported data shows the following numbers after approximately 12 weeks of treatment. Regarding side effects (called "treatment-emergent adverse events"), the number of participants who experienced at least one was: 5 out of 14 on the 10 μg dose, 11 out of 16 on the 30 μg dose, 24 out of 37 on the 60 μg dose, 61 out of 85 on the 90 μg dose, 31 out of 46 in the Parts A+B placebo group, 49 out of 50 on the 140 μg dose, 49 out of 51 on the 200 μg dose, and 46 out of 51 in the Part C placebo group. For liver enzyme levels — two blood markers called ALT and AST that can indicate liver stress — all groups, including the placebo groups, showed reductions from their starting levels. For ALT, reported changes ranged from –12.0 to –28.7 units (IU/L) across the tropifexor groups, compared with –8.1 and –11.7 in the two placebo groups. For AST, reported changes ranged from –2.1 to –16.7 units across the tropifexor groups, compared with –7.1 and –13.1 in the two placebo groups. For liver fat measured by MRI scan, the reported relative changes ranged from –7.5% to –39.5% across the tropifexor dose groups, compared with –6.2% and –3.6% in the placebo groups. On the secondary measures, the reported changes in body weight ranged from –0.78 kg to –5.89 kg across the tropifexor groups, compared with no change (0.00 kg) and –2.48 kg in the placebo groups. BMI changes followed a similar pattern. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03987074 · results posted 15 July 2021

According to the results reported on ClinicalTrials.gov, this trial (NCT03987074) enrolled 108 people across five groups. Each group received a different combination of study drugs: semaglutide alone, or semaglutide combined with one or two other investigational medicines (firsocostat and/or cilofexor). The trial's main focus was on tracking and measuring any unwanted medical events (called "adverse events") and any unusual changes in blood or laboratory test results that occurred during treatment. The reported data shows that, when it came to unwanted medical events during the study, the percentage of participants who experienced at least one such event ranged from about 73% to 91% across the five groups — specifically: 81% in the semaglutide-only group, 86% in the semaglutide plus firsocostat group, 82% in the semaglutide plus cilofexor 30 mg group, 73% in the semaglutide plus cilofexor 100 mg group, and 91% in the group taking all three drugs together. For unusual laboratory test results, the reported data shows the percentage of participants with worsening results (compared to their starting point) ranged from about 36% to 67% across the groups. Some additional breakdowns of laboratory abnormality data appear in the submitted results, but not all categories were fully labelled in the data provided, so a complete group-by-group description of those figures cannot be given here. It is also worth noting that not everyone who started the trial finished it — between 1 and 4 people dropped out in each group before the study ended. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03294850 · results posted 14 June 2021

According to the results reported on ClinicalTrials.gov, this trial (NCT03294850) enrolled 14 people in total — 4 in the "NASH Group" (people with a more severe form of fatty liver disease) and 10 in the "Non-NASH Group" (people with a milder form of fatty liver disease or normal liver). All 14 participants completed the study. The trial was measuring changes in two things in the liver — the amount of fat stored there, and how stiff the liver tissue was — both checked using specialised MRI scans, at the start of the study and again 12 weeks after surgery. The reported data shows that, for the NASH Group, the amount of fat in the liver changed by an average of −16.4% (meaning it was measured as lower at 12 weeks compared to the start). Also for the NASH Group, liver stiffness — a measure that can be related to scarring in the liver — changed by an average of +1.9% (meaning it was measured as slightly higher at 12 weeks compared to the start). Results for the Non-NASH Group were not reported in the data submitted to ClinicalTrials.gov, so those figures cannot be described here. It is worth noting that this was a very small study with only 14 participants across both groups, and the data as submitted does not include a comparison group or further breakdown beyond the figures above. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02970942 · results posted 21 April 2021

According to the results reported on ClinicalTrials.gov, this trial (NCT02970942) enrolled 320 adults across four groups: 80 received a low dose of semaglutide (0.1 mg), 78 received a medium dose (0.2 mg), 82 received a higher dose (0.4 mg), and 80 received a placebo (inactive treatment). The trial ran for 72 weeks and was measuring outcomes in people with a liver condition called non-alcoholic steatohepatitis (NASH) — a form of liver disease involving inflammation and cell damage caused by fat build-up. The main thing researchers were tracking was whether participants' NASH resolved (cleared up on liver biopsy) without their liver scarring (fibrosis) getting worse. The reported data shows that for the primary outcome — NASH resolution without worsening of liver scarring — the percentages of participants who achieved this were: 40.4% in the 0.1 mg group, 35.6% in the 0.2 mg group, 58.9% in the 0.4 mg group, and 17.2% in the placebo group. For the secondary outcome of at least one stage of improvement in liver scarring without NASH getting worse, the reported figures were: 49.1% (0.1 mg), 32.2% (0.2 mg), 42.9% (0.4 mg), and 32.8% (placebo). The reported data also shows changes in overall liver disease activity scores and individual features like fat accumulation, inflammation, and cell ballooning (a type of cell damage). Across those measures, higher proportions of participants in the semaglutide groups were reported to show improvement compared with the placebo group, though some participants in all groups — including placebo — also showed improvement or no change. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03008070 · results posted 12 April 2021

According to the results reported on ClinicalTrials.gov, this trial (NCT03008070) enrolled 247 adults across three groups: 83 people received the higher dose of lanifibranor (1200 mg), 83 received the lower dose (800 mg), and 81 received a placebo (a dummy treatment with no active ingredient). The trial was looking at changes in liver tissue, assessed through liver biopsies scored using established rating systems. The main thing being measured was whether a specific liver damage score — called the SAF Activity score, which combines measures of liver cell injury and inflammation — fell by at least 2 points, without the scarring (fibrosis) in the liver getting worse. The reported data shows that for the primary measure, 41 out of 83 participants in the 1200 mg group and 34 out of 83 in the 800 mg group met that target, compared with 22 out of 81 in the placebo group. For the secondary measures, the reported data shows: on an overall liver disease improvement score (NAS score dropping by at least 2 points without worse scarring), 53 of the 1200 mg group and 43 of the 800 mg group met the threshold, versus 26 in the placebo group. On a measure of liver disease "resolution" without worse scarring, 37 in the 1200 mg group and 27 in the 800 mg group met the criteria, versus 15 in the placebo group. On improvement in scarring by at least one stage without worsening of other features, 35 in the 1200 mg group and 23 in the 800 mg group met the criteria, compared with 19 in the placebo group. Improvements in a general liver activity score and a fat accumulation score were also reported, with higher numbers in the lanifibranor groups than in the placebo group across those measures as well. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02369536 · results posted 15 February 2021

According to the results reported on ClinicalTrials.gov, this trial (NCT02369536) enrolled 126 people in total — 62 in the nutraceutical mixture group and 64 in the placebo group. Of those, 55 and 58 participants respectively completed the study. The trial was measuring blood levels of certain liver-related markers — specifically liver enzymes (AST, ALT, and GGT), direct bilirubin (a substance processed by the liver), a general inflammation marker called CRP (C-reactive protein), and a blood-clotting-related protein called t-PA — comparing the nutraceutical mixture group against the placebo group. The reported data shows the following numbers at the start and end of the study. For the liver enzymes (measured in IU/L, a standard unit for enzyme activity): AST started at 35.4 (nutraceutical) and 37.5 (placebo), ending at 31.6 and 31.2 respectively; ALT started at 45.5 and 48.3, ending at 43.8 and 40.0; and GGT started at 101.4 and 98.5, ending at 87.2 and 75.6. For direct bilirubin, levels were 2.05 and 2.74 at the start, moving to 2.22 and 2.39 by the end. The inflammation marker CRP started at 21.0 and 28.3, ending at 17.1 and 24.0. The clotting-related protein t-PA was reported at 8.6 and 10.1 at the start, and 8.7 and 9.9 at the end. No additional context or statistical analysis figures were included in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01680640 · results posted 5 February 2021

According to the results reported on ClinicalTrials.gov, this trial enrolled 104 people in total — 55 in the synbiotic group (a combination of probiotics and prebiotics) and 49 in a comparison group that received maltodextrin (a plain starchy powder with no active ingredients). By the end of the trial, 45 people in the synbiotic group and 44 in the maltodextrin group had completed it. The trial was measuring changes in liver fat, two different scores used to assess scarring in the liver (known as fibrosis), and changes in a type of gut bacteria called Bifidobacterium. The reported data shows the following numbers at the end of the study. For liver fat, the synbiotic group showed an average change of −3.8 percentage points, while the maltodextrin group showed −6.0 percentage points (a negative number meaning less liver fat compared to the start — lower is considered better). For the Enhanced Liver Fibrosis (ELF) score — a blood-based measure of liver scarring where a lower score is considered better — both groups showed a small average increase: +0.12 in the synbiotic group and +0.13 in the maltodextrin group. For the NAFLD Fibrosis Score, another liver scarring measure where a decrease is considered better, both groups showed a decrease: −1.3 in the synbiotic group and −1.2 in the maltodextrin group. Finally, for Bifidobacterium bacteria in the gut (where an increase is considered better), the synbiotic group showed an average increase of +1.72%, while the maltodextrin group showed an average change of −0.02%. These numbers describe what was recorded and reported for the groups as a whole during this trial — they do not indicate what any individual person might experience. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03449446 · results posted 3 December 2020

According to the results reported on ClinicalTrials.gov, this trial (NCT03449446) enrolled 395 adults across seven groups to test three investigational drugs — selonsertib, firsocostat, and cilofexor — both alone and in combinations, compared with a placebo (an inactive treatment). The trial was measuring how many participants experienced side effects or changes in laboratory test results (the main safety tracking), and also how many showed an improvement of at least one stage in liver scarring (fibrosis) without their liver inflammation getting worse, after 48 weeks. The reported data shows that the proportion of participants who experienced at least one treatment-related adverse event (an unwanted health change during the study) ranged from about 79.5% in the placebo group to 96.1% in the selonsertib-plus-cilofexor group, with the other groups falling between roughly 85% and 92.5%. For laboratory test abnormalities, the reported figures were high across all groups — ranging from about 94.9% to 100% — and this was similarly true for the placebo group (94.9%). Regarding the liver scarring outcome, the reported data shows that between 10.5% (placebo) and 28.6% (selonsertib alone) of participants in each group met the improvement target at week 48, with the combination groups sitting between approximately 15.5% and 20.9%. It is also worth noting that a large number of participants in the selonsertib-alone group did not complete the study (36 out of 39 started), which the reported data does not fully explain. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02808312 · results posted 30 September 2020

According to the results reported on ClinicalTrials.gov, this trial looked at how the body processes a drug called cilofexor in people with different levels of liver impairment. A total of 57 people were enrolled across five groups: 10 with mild liver impairment, 10 with moderate liver impairment, 10 with severe liver impairment, and comparison groups of people with normal liver function (17 in one group and 10 in another). All but one participant completed the trial — that one person was in the normal liver function comparison group for cohorts 1 and 2. The reported data shows that the trial measured how much of the drug entered the bloodstream and how quickly, using several standard drug-tracking measures. One key measure was how much drug was present in the blood over time (referred to as "AUC," or area under the curve — essentially a running total of drug exposure). The reported numbers show that people with mild liver impairment had a total drug exposure (AUClast) of around 5,382 units, compared to roughly 2,973 units in their matched healthy comparison group. For moderate liver impairment, the figure was around 8,224 units versus 2,757 units in the healthy comparison group. For severe liver impairment, it was around 6,534 units versus 960 units in that group's healthy comparators. The reported peak drug level in the blood (the highest concentration reached) was 994 ng/mL for the mild impairment group, 909 ng/mL for moderate, and 427 ng/mL for severe, compared to 604, 496, and 182 ng/mL respectively in each matched healthy group. The time it took to reach that peak level ranged from about 3 to 5 hours across all groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03776175 · results posted 23 September 2020

According to the results reported on ClinicalTrials.gov, this trial enrolled 99 participants across four groups: 14 received a placebo (a dummy treatment with no active ingredient), 29 received a drug called PF-05221304 (15 mg) alone, 28 received a drug called PF-06865571 (300 mg) alone, and 28 received both drugs together. The trial ran for about six weeks of treatment followed by a five-week follow-up period. The main thing being measured was the change in the amount of fat stored in the liver, assessed using a specialised type of MRI (magnetic resonance imaging) scan that estimates the proportion of fat across different sections of the liver. The reported data shows that, after 42 days, the placebo group's liver fat fraction increased by around 8%, while the group taking PF-05221304 alone showed an average decrease of about 40%, the group taking PF-06865571 alone showed an average decrease of about 30%, and the group taking both drugs together showed an average decrease of about 40%. These are percentage changes from where each participant started, not absolute fat levels. For the secondary measures, the reported data shows that 3 out of 14 placebo participants, and 10 out of roughly 28–29 participants in each active treatment group, experienced treatment-emergent adverse events (unexpected medical occurrences that arose or worsened during treatment). One serious adverse event was reported in the group receiving both drugs combined, and none in the other groups. Laboratory abnormalities (unusual blood test results) were recorded in 6, 17, 11, and 6 participants across the four groups respectively. Changes in blood pressure, pulse rate, and heart electrical readings (ECG) were also tracked; small fluctuations were noted across all groups, and three participants (two in the PF-05221304-alone group and one in the combination group) met a pre-specified threshold for a change in one ECG measurement. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03508687 · results posted 17 August 2020

According to the results reported on ClinicalTrials.gov, this trial looked at a drug called gemcabene in two small groups of participants — 2 people took 300 mg of gemcabene daily for the full 24 weeks, and 3 people took 300 mg for the first 12 weeks and then moved up to 600 mg for weeks 12 to 24. All 5 participants completed the study. The trial was measuring changes in blood fat levels (specifically triglycerides — a type of fat found in the blood), the amount of fat in the liver, and the stiffness of the liver (a marker related to scarring), at various points over 24 weeks. The reported data shows the following numbers for the primary outcome — the percentage change in fasting triglycerides at 12 weeks: the 300 mg group showed a change of −0.44% (essentially no change), while the group that had moved to 600 mg by week 12 showed a change of −20.27%. For the secondary outcomes looking further through 24 weeks, the reported data shows a range of changes in triglyceride levels, liver fat content, and liver stiffness across the two groups. Notably, liver fat content (measured using a type of MRI scan) showed an increase of around 25–105% in the 300 mg group at various time points, while the 600 mg group showed smaller changes ranging from approximately −3% to +12%. Changes in liver stiffness (measured in a unit called kilopascals) were small across both groups at both time points. It is worth noting that with only 5 participants in total, this was a very small study, and the numbers above simply reflect what was recorded for those individuals. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01066364 · results posted 21 July 2020

According to the results reported on ClinicalTrials.gov, this trial enrolled 50 people in total — 25 in each group. One group took a sugar (placebo) pill and the other took a medication called colesevelam (3.75 grams per day by mouth). All participants had a liver condition called nonalcoholic steatohepatitis, which had been confirmed by a liver biopsy. The trial was measuring whether colesevelam could reduce the amount of fat in the liver, as well as looking at blood sugar regulation, liver enzyme levels, and cholesterol and fat levels in the blood. By the end of the study, 22 people in the placebo group and 23 in the colesevelam group had completed the trial. The reported data shows that, for the main outcome — fat in the liver as measured by MRI — the placebo group had an average liver fat level of 17.9% and the colesevelam group had an average of 14.2%. For a measure of how well the body handles blood sugar (called HOMA-IR, a score where a higher number suggests the body is working harder to manage blood sugar), the placebo group scored 8.3 and the colesevelam group scored 7.6. For liver enzymes in the blood (ALT and AST, which doctors use as a signal of liver stress), the reported data shows ALT values of 79.1 (placebo) and 86.6 (colesevelam), and AST values of 49.9 (placebo) and 56.2 (colesevelam), measured in standard laboratory units. For blood fat levels, one measure (likely LDL cholesterol) was 115.8 (placebo) versus 124.0 (colesevelam), and another measure (likely total cholesterol) was 202.4 (placebo) versus 200.2 (colesevelam). The specific labels for each lipid measure were not fully detailed in the reported data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03053050 · results posted 29 June 2020

According to the results reported on ClinicalTrials.gov, this trial (NCT03053050) enrolled 808 people across three groups in a randomised phase: 324 received a higher dose of the study drug (selonsertib 18 mg), 323 received a lower dose (selonsertib 6 mg), and 161 received a placebo (an inactive tablet). A further 99 participants entered a separate open-label phase in which everyone received the higher dose. The trial was looking at a liver condition called NASH (non-alcoholic steatohepatitis), specifically whether the study drug could reduce scarring (fibrosis) in the liver, and over the longer term, whether it could delay serious liver-related events such as cirrhosis, liver failure, transplant, or death. The reported data shows that at the 48-week mark, the percentage of participants who showed at least a one-stage improvement in liver scarring without their NASH getting worse was 9.6% in the higher-dose group, 12.1% in the lower-dose group, and 13.2% in the placebo group. For liver scarring improvement alone (without the NASH condition), the figures were 12.7%, 13.7%, and 16.4% respectively. The reported data also shows that the percentage of participants whose scarring progressed to the most severe stage (cirrhosis) by week 48 was 13.0% in the higher-dose group, 15.6% in the lower-dose group, and 15.7% in the placebo group. Results for the longer-term outcomes measured at week 240 — including survival free from serious liver events and scarring improvement — were not reported in the data submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03053063 · results posted 7 May 2020

According to the results reported on ClinicalTrials.gov, this trial (NCT03053063) looked at a drug called SEL (selonsertib) in people with a liver condition called NASH (non-alcoholic steatohepatitis) — a form of liver disease where fat, inflammation, and scarring build up in the liver. The trial had two phases: a randomised phase in which 355 people received SEL 18 mg, 354 received SEL 6 mg, and 174 received a placebo (a dummy treatment with no active ingredient); and a smaller open-label phase involving 23 participants who all received SEL 18 mg. The trial was primarily measuring whether the treatment reduced liver scarring (called fibrosis) without making the liver inflammation worse, and — over a longer timeframe of about four and a half years — whether it reduced serious liver-related events such as liver failure, transplant, or death. The reported data shows the following numbers for the main outcome measured at around one year (Week 48): 14.4% of participants in the SEL 18 mg group, 12.8% in the SEL 6 mg group, and 12.8% in the placebo group showed at least a one-stage improvement in liver scarring without their inflammation getting worse. For a related measure — improvement in scarring alone, without the inflammation condition — the reported figures at Week 48 were 18.9% (SEL 18 mg), 16.8% (SEL 6 mg), and 15.7% (placebo). For a measure called "NASH resolution" (meaning both inflammation and cell damage in the liver reached low levels) at Week 48, the reported figures were 2.3% (SEL 18 mg), 3.7% (SEL 6 mg), and 4.1% (placebo). The reported data shows that several other planned outcomes — including the longer-term (Week 240) measures of scarring improvement, NASH resolution, and the rate of serious liver events — were not reported in the submitted results on ClinicalTrials.gov, so those figures are not available here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03248882 · results posted 10 March 2020

According to the results reported on ClinicalTrials.gov, this trial enrolled 305 adults across five groups. Participants were randomly assigned to take either a placebo (a dummy pill with no active ingredient) or one of four doses of an investigational drug called PF-05221304 — 2 mg, 10 mg, 25 mg, or 50 mg — taken daily for 16 weeks. The trial's main goal was to measure changes in the amount of fat stored in the liver, using a specialised type of MRI scan. Secondary goals included tracking changes in a liver-related blood marker called ALT (alanine aminotransferase, an enzyme that can rise when the liver is under stress), as well as recording any unwanted medical events, unusual blood test results, changes in blood pressure or pulse, and heart rhythm readings. The reported data shows that, for the primary measure — percentage change in liver fat at 16 weeks — the placebo group showed an average reduction of 7.2%, while the four PF-05221304 groups showed average reductions of 17.1% (2 mg), 49.9% (10 mg), 55.9% (25 mg), and 64.8% (50 mg). For the ALT blood marker, the reported average reductions were 8.5% in the placebo group, and 12.5%, 27.7%, 31.3%, and 46.8% in the four ascending dose groups respectively. These are the numbers as submitted; what they mean clinically is a matter for medical interpretation. The reported data also shows that unwanted medical events during the study (called treatment-emergent adverse events) were recorded in 41 of 61 placebo participants and in 40, 42, 45, and 40 participants across the four dose groups. Serious adverse events — those considered potentially life-threatening or requiring hospitalisation — were reported in 0 placebo participants and 1, 1, 2, and 2 participants in the dose groups. Laboratory abnormalities were recorded in 39, 44, 36, 33, and 40 participants across the five groups. Some participants in some groups also had blood pressure or heart rhythm readings that met pre-set alert thresholds, though the full breakdown across all sub-categories was not completely reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02316717 · results posted 21 February 2020

According to the results reported on ClinicalTrials.gov, this trial (NCT02316717) enrolled 133 people across three groups: 43 people received a lower dose of IMM-124E (600 mg), 46 received a higher dose (1200 mg), and 44 received a placebo (a dummy treatment with no active ingredient). The trial was measuring changes in the amount of fat in the liver, as well as tracking adverse events (unwanted health effects that occurred during the study). By the end of the trial, 32, 39, and 41 people had completed each group respectively. The reported data shows that, when looking at the percentage of fat in the liver as measured by MRI scans at 24 weeks, the average change from the starting point was −1.55% in the 600 mg group, −0.90% in the 1200 mg group, and −1.85% in the placebo group. Regarding adverse events, the 600 mg group recorded 185 adverse events in total, the 1200 mg group recorded 207, and the placebo group recorded 155. The number of participants who experienced treatment-related adverse events was 17, 14, and 13 across the three groups respectively. More serious adverse events (graded 3–5, meaning more severe in nature) numbered 12, 10, and 7 across the same groups. For the secondary outcomes, average systolic blood pressure (the "top number" in a blood pressure reading) changed by +6.1 mmHg, +2.0 mmHg, and +0.2 mmHg in each group, and average pulse rate changed by −0.8, −1.9, and +2.1 beats per minute respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02913105 · results posted 26 November 2019

According to the results reported on ClinicalTrials.gov, this trial (NCT02913105) enrolled 121 participants across three groups: 37 people received LMB763 at a 100 mg dose, 44 received it at a 50 mg dose, and 40 received a placebo (a dummy treatment with no active ingredient). The trial was primarily measuring two things: how many participants experienced any unwanted medical events (called adverse events) or serious adverse events during the study, and how a liver enzyme called ALT — a marker used to check on liver health — changed from the start of the trial to the end. A secondary focus was how the drug moved through the body (its levels in the blood over time). The reported data shows that when it came to adverse events, 35 out of 37 participants in the 100 mg group, 37 out of 44 in the 50 mg group, and 33 out of 40 in the placebo group had at least one reported adverse event. Serious adverse events were reported in 2 participants in the 100 mg group, 3 in the 50 mg group, and none in the placebo group. The trial's sponsors noted that no statistical comparison was planned for this outcome. For the ALT liver enzyme measure, the reported data shows the starting (baseline) average levels were 67.2 units per litre in the 100 mg group, 48.1 in the 50 mg group, and 59.5 in the placebo group. The reported ratios of change from baseline were 0.667, 0.702, and 0.901 for the three groups respectively — a ratio below 1.0 indicates the level was lower at the end than at the start, though the trial did not pre-plan a statistical comparison of these figures either. For the blood-level measurements, the reported data shows that the peak concentration of LMB763 in the blood was 3,080 nanograms per millilitre in the 100 mg group and 1,290 in the 50 mg group, with both groups reaching that peak at around 2 hours after taking the dose. The drug accumulation ratio — a measure of how much the drug builds up in the body with repeated doses compared to a single dose — was reported as 0.903 for the 100 mg group and 1.31 for the 50 mg group; the trial did not include a statistical analysis for any of these secondary measures. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02217475 · results posted 10 May 2019

According to the results reported on ClinicalTrials.gov, this trial (NCT02217475) enrolled 289 adults with a liver condition called non-alcoholic steatohepatitis (NASH) — a form of liver disease involving fat build-up, inflammation, and cell damage. Participants were divided into three groups: one group received a dummy pill (placebo) for both years of the study, a second group received the placebo in year one and then switched to the study drug cenicriviroc (CVC) 150 mg in year two, and a third group received CVC 150 mg for both years. The trial used liver biopsies (small tissue samples taken from the liver) to look at changes in disease activity and scarring (fibrosis) over one and two years. The reported data shows that for the main (primary) outcome at the end of year one — a meaningful improvement in a liver disease activity score without the liver scarring getting worse — 27 out of the placebo group and 23 out of the CVC group met that measure. For several secondary outcomes, the reported data shows: at year one, 15 placebo participants and 29 CVC participants showed at least a one-stage improvement in liver scarring without their liver inflammation getting worse; 8 placebo and 11 CVC participants had complete resolution of the active inflammation without scarring worsening; and 4 placebo versus 7 CVC participants met both the resolution of inflammation and at least a one-stage improvement in scarring. At year two, the reported numbers for complete resolution of inflammation without scarring worsening were 3 (placebo) and 11 (CVC), and for both resolution and scarring improvement, 2 (placebo) and 5 (CVC). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03256526 · results posted 4 April 2019

According to the results reported on ClinicalTrials.gov, this trial (NCT03256526) enrolled 53 participants across three groups: 19 received a placebo (an inactive treatment used for comparison), 17 received a lower dose of the investigational drug PF-06835919 (75 mg), and 17 received a higher dose (300 mg). The trial ran for 6 weeks and was primarily measuring changes in the amount of fat stored in the liver, using a specialised type of MRI scan. A number of secondary measures were also tracked, including unwanted medical events that occurred during the study, changes in blood pressure and heart readings, and laboratory test results. The reported data shows that, for the main measure — the percentage change in liver fat from the start of the study to week 6 — the placebo group showed an average reduction of about 8%, the 75 mg dose group showed a small average increase of roughly 3%, and the 300 mg dose group showed an average reduction of about 25%. For the secondary measures, the reported data shows that treatment-emergent adverse events (unexpected medical occurrences that appeared or worsened after treatment began) were recorded in 5 participants in the placebo group, 4 in the 75 mg group, and 5 in the 300 mg group. Regarding blood pressure and heart rhythm monitoring, small numbers of participants across all groups had readings that met certain pre-defined noteworthy thresholds, with figures ranging from 0 to 2 participants depending on the specific measurement. Laboratory abnormalities were noted in 9 placebo participants, 8 in the 75 mg group, and 8 in the 300 mg group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02314026 · results posted 19 March 2019

According to the results reported on ClinicalTrials.gov, this trial enrolled 135 adults who were suspected of having a liver condition called non-alcoholic steatohepatitis (NASH) — a form of liver disease where fat builds up and causes inflammation. Of those 135 participants, 107 completed the study, while 28 did not finish. The trial was looking at whether a breath test could identify people who actually had NASH (confirmed by a liver biopsy — a small tissue sample taken from the liver) and whether the breath test results could predict serious liver complications. The reported data shows that, of the participants, 74 were found to have NASH confirmed by liver biopsy, 20 did not have NASH, and 13 returned results that were described as indeterminate (meaning the biopsy result was unclear). For the second main measurement — whether the breath test could predict serious liver complications such as fluid build-up in the abdomen, bleeding, or confusion caused by liver problems — the reported figure was 0.852 on a scale from 0 to 1, where a score of 1 would mean perfect prediction and 0.5 would mean no better than chance. The trial also tracked whether the breath test itself caused any unwanted effects, and the reported data shows that zero participants out of the 135 experienced any adverse events (unexpected harmful effects) linked to the breath test. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02854605 · results posted 29 January 2019

According to the results reported on ClinicalTrials.gov, this trial (NCT02854605) looked at a drug called GS-9674 in 140 people total. Participants were split into three groups: 56 people received a 100 mg dose of GS-9674, 56 received a 30 mg dose, and 28 received a placebo (a dummy treatment with no active ingredient). The trial's main focus was on monitoring and recording unwanted health events (called adverse events) and changes in laboratory test results that occurred during the study period. The reported data shows that when it came to unwanted health events during the study, 89.3% of people in the 100 mg group, 76.8% in the 30 mg group, and 67.9% in the placebo group experienced at least one such event. A smaller proportion in each group had events that led to them stopping the study drug early — 1.8% in the 100 mg group, 8.9% in the 30 mg group, and 7.1% in the placebo group. Regarding laboratory test result changes (meaning blood or other test results that shifted to a worse category compared to the start of the study), the reported data shows high proportions across all groups experienced at least one such change: 89.3% in the 100 mg group, 92.9% in the 30 mg group, and 92.9% in the placebo group. Further breakdowns of laboratory abnormalities by severity were also reported, though the specific categories those additional figures relate to were not clearly labelled in the submitted data. It is worth noting that this trial was measuring and recording these numbers rather than comparing outcomes in a way that draws conclusions about one group being better or worse than another. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02365233 · results posted 31 July 2018

According to the results reported on ClinicalTrials.gov, this trial (NCT02365233) set out to compare three types of diabetes medication — a Thiazolidinedione, Lantus Insulin, and a DPP4 Inhibitor (a DPP4 Inhibitor is a type of tablet used to lower blood sugar) — on their effect on fat levels in the liver. The main thing being measured was the change in liver fat content, assessed using MRI scans, between the start of the study and a six-month follow-up visit. A total of five people began the trial: one in the Thiazolidinedione group and two each in the Lantus Insulin and DPP4 Inhibitor groups. The reported data shows that none of the five participants who started the trial completed it — all five are recorded as "not completed" across all three groups. Because no participants finished the study, the primary outcome measure — the change in liver fat content from the start to six months — has no results reported. The data was not reported for this outcome measure. Given that the trial did not reach completion and no outcome data was submitted, it is not possible to describe any findings about the medications being studied. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02633956 · results posted 4 June 2018

According to the results reported on ClinicalTrials.gov, this trial enrolled 84 people in total who had a confirmed diagnosis of a liver condition called non-alcoholic steatohepatitis (NASH). Participants were divided into four groups: those taking 5 mg, 10 mg, or 25 mg of a medicine called obeticholic acid, or a placebo (a dummy pill with no active ingredient). The trial was measuring how obeticholic acid affected LDL cholesterol — often called "bad" cholesterol — specifically its amount in the blood, the size of LDL particles, and the total number of LDL particles, after 16 weeks. All participants were also taking atorvastatin (a common cholesterol-lowering medicine) to see how it interacted with obeticholic acid. The reported data shows changes from each group's starting point after 16 weeks. For LDL cholesterol levels (measured in mg/dL), the reported average changes were: minus 33.2 for the 5 mg group, minus 44.27 for the 10 mg group, minus 39.54 for the 25 mg group, and minus 53.33 for the placebo group — meaning all groups, including the placebo group, showed a reduction from their starting levels. For LDL particle size (measured in nanometres), the reported changes were: plus 0.02 for the 5 mg group, minus 0.41 for the 10 mg group, minus 0.09 for the 25 mg group, and minus 0.49 for the placebo group. For the total number of LDL particles, the reported changes were: minus 224.79 for the 5 mg group, minus 325.04 for the 10 mg group, minus 336.22 for the 25 mg group, and minus 439.84 for the placebo group. The reported data does not include any secondary outcome measure results in the information submitted to ClinicalTrials.gov for this trial, so those figures cannot be described here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01529268 · results posted 5 September 2017

According to the results reported on ClinicalTrials.gov, this trial enrolled 169 children and teenagers — 88 received a capsule called DR Cysteamine Bitartrate and 81 received a placebo (a dummy capsule with no active ingredient). The trial was measuring changes in a liver condition called non-alcoholic fatty liver disease (NAFLD), which involves fat build-up and inflammation in the liver. The main thing the researchers were looking at was whether liver tissue samples (biopsies) taken after 52 weeks showed meaningful improvement compared to biopsies taken at the start of the trial. The reported data shows that for the primary goal — which was defined as a meaningful drop in a liver damage score (called the NAFLD Activity Score, or NAS) alongside no worsening of liver scarring — 25 out of 71 participants in the treatment group and 18 out of 75 participants in the placebo group met this definition of improvement at 52 weeks. For the secondary measures, the reported data shows that the average change in the overall NAS score was identical in both groups (a decrease of 0.8 points on an 8-point scale, where a lower number means less disease activity). Regarding liver inflammation specifically, 32 participants in the treatment group and 17 in the placebo group showed any improvement in that measure. For fat build-up in the liver (steatosis), 26 in the treatment group and 33 in the placebo group showed any improvement. Average changes in both the fat and inflammation scores were small and broadly similar across both groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02086708 · results posted 1 February 2017

According to the results reported on ClinicalTrials.gov, this trial enrolled 24 participants, and all 24 completed the study — none dropped out. The trial was looking at how well a type of ultrasound scan called shear wave sonoelastography (a technique that uses sound waves to measure how stiff the liver is) compared to liver biopsy results when assessing liver scarring (fibrosis). Liver scarring was graded using a standard scale called METAVIR, which runs from F0 (no scarring) to F4 (the most severe scarring). The reported data shows the average liver stiffness readings, measured in kilopascals (kPa — a unit of pressure), for participants grouped by their biopsy-confirmed fibrosis stage. Participants with no fibrosis (F0) had an average reading of 6.93 kPa, while those with stage F1 fibrosis recorded 8.33 kPa. Those at stage F2 recorded 6.12 kPa, stage F3 recorded 8.86 kPa, and those with the most severe fibrosis (F4) recorded the highest average reading of 17.85 kPa. No additional outcome measures beyond this primary measure were included in the reported data. It is worth noting that the trial was small, with only 24 participants across five fibrosis groups, meaning some groups may have had very few people in them. No data was reported on how many participants fell into each fibrosis stage, so the group sizes are not known from the available information. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02279407 · results posted 27 January 2017

According to the results reported on ClinicalTrials.gov, this trial (NCT02279407) enrolled 84 adults across four groups: one group received a combination of Epanova (a type of omega-3 fatty acid) and dapagliflozin (a diabetes/blood sugar medicine), one received dapagliflozin alone, one received Epanova alone, and one received a placebo (a dummy treatment with no active ingredient). The trial ran for 12 weeks and was primarily measuring changes in the amount of fat in participants' livers, assessed using MRI scans. Group sizes at the start ranged from 20 to 22 people, and the number who completed the trial ranged from 15 to 20 per group. The reported data shows results as a ratio comparing liver fat at the end of the study to liver fat at the start — a ratio below 1.0 means the measured liver fat was lower at week 12 than at the beginning. For the primary comparison (combination treatment versus placebo), the combination group had a reported ratio of 0.79, while the placebo group had a ratio of 0.97. For the secondary comparison between the active treatment groups, the reported ratios were 0.79 for the combination group, 0.87 for the dapagliflozin-alone group, and 0.85 for the Epanova-alone group. No statistical significance figures (such as p-values, which indicate how likely a result is due to chance) were included in the data submitted to ClinicalTrials.gov, so those cannot be reported here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00596934 · results posted 9 December 2016

According to the results reported on ClinicalTrials.gov, this trial (NCT00596934) enrolled 9 people in a single group, all of whom received a treatment called metreleptin. Seven participants completed the full 12 months of treatment, while 2 did not finish. The trial was measuring several things related to a liver condition called non-alcoholic steatohepatitis (NASH) — a type of liver disease linked to fat build-up — including a scored assessment of liver tissue, the amount of fat in the liver, liver enzyme levels (which can give clues about how the liver is functioning), body weight, and fasting blood sugar levels. The reported data shows that after 12 months, the average NASH score — a scale from 0 to 14, where higher numbers indicate more severe liver disease — was recorded as 5 for those who completed the study. The reported average body weight at 12 months was 86.4 kg. Liver fat content, measured by MRI scan, was reported at 13.7%. Two liver enzyme measurements were also recorded: ALT (alanine aminotransferase) averaged 44.3 IU/L, and AST (aspartate aminotransferase) averaged 34.9 IU/L — both are proteins in the blood that doctors measure to check on the liver. Average fasting blood sugar (measured after not eating overnight) was reported as 92.1 mg/dL. It is worth noting that because only 7 people completed the trial, these numbers come from a very small group. It is also important to note that there was no comparison group in this trial, so the reported numbers reflect only the one treatment group with no alternative to compare against. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01963845 · results posted 20 October 2016

According to the results reported on ClinicalTrials.gov, this trial (NCT01963845) involved 50 people in total — 25 received an active drug and 25 received a placebo (a dummy treatment with no active ingredient). All 50 participants completed the study. The trial was measuring changes in liver fat and several blood markers over 24 weeks, comparing the two groups. The primary thing being measured was the percentage change in liver fat, assessed using a specialised MRI scan called MRI-PDFF (a type of scan that estimates how much fat is in the liver). The reported data shows that, at the end of 24 weeks, the placebo group had an average 13.9% change in liver fat, while the active drug group had an average 8.4% change. For the secondary measures — blood tests taken at the start and again at 24 weeks — the reported data shows the following: a liver enzyme called AST went from 28.5 to 23.5 (IU/L) in the placebo group, and from 28.0 to 27.0 in the active drug group; another liver enzyme called ALT went from 40.0 to 28.5 in the placebo group, and from 43.0 to 34.0 in the active drug group; LDL cholesterol (a type of fat in the blood) went from 99.0 to 101.0 in the placebo group, and from 100.0 to 98.0 in the active drug group; and a measure of how the body handles insulin called HOMA-IR went from 5.4 to 4.9 in the placebo group, and from 5.9 to 6.8 in the active drug group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00025883 · results posted 16 August 2016

According to the results reported on ClinicalTrials.gov, 103 people took part in this trial, all of whom received a treatment called metreleptin. Of those, 63 had a condition called generalised lipodystrophy (where the body has very little fat tissue across the whole body) and 40 had partial lipodystrophy (where fat tissue is missing from certain parts of the body). The trial tracked participants over 12 months and measured two things: blood sugar control (using a test called glycated haemoglobin, or HbA1c — a percentage that reflects average blood sugar levels over roughly three months) and triglycerides (a type of fat found in the blood, measured in mg/dL). Eighty-six participants completed the study, and 17 did not. The reported data shows the following for the glycated haemoglobin (HbA1c) measurements. In the generalised lipodystrophy group, the figure started at 8.4%, was recorded at 6.6% at six months, and 6.4% at twelve months. In the partial lipodystrophy group, it started at 8.1%, was recorded at 7.2% at six months, and 7.3% at twelve months. For triglycerides, the generalised lipodystrophy group started at 467 mg/dL, which was recorded as 198 mg/dL at six months and 180 mg/dL at twelve months. The partial lipodystrophy group started at 483 mg/dL, recorded at 339 mg/dL at six months and 326 mg/dL at twelve months. No data on variation or statistical measures around these figures was included in the reported results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01703260 · results posted 23 February 2016

According to the results reported on ClinicalTrials.gov, this trial (NCT01703260) looked at three groups of people: those taking a combination of roflumilast and pioglitazone (7 people), those taking roflumilast only (7 people), and those taking pioglitazone only (6 people) — 20 participants in total. The trial measured levels of certain liver enzymes in the blood — called ALT and AST — which are often used as markers of liver stress, as well as the amount of fat in the liver as measured by MRI scans. Not everyone completed the study: 4 people finished in the combination group, 3 in the roflumilast-only group, and 3 in the pioglitazone-only group. The reported data shows that, at the start of the trial, average ALT blood levels were 101.7 units per litre in the combination group, 83.4 in the roflumilast-only group, and 118.8 in the pioglitazone-only group. By the four-month mark, the reported percent change in ALT from those starting levels was approximately minus 54% in the combination group, minus 56% in the roflumilast-only group, and minus 29% in the pioglitazone-only group. A similar pattern was reported for AST levels, with reductions of around minus 41%, minus 43%, and minus 18% respectively. For liver fat content, the reported data shows reductions from baseline across all three groups at month 4, with the combination group showing changes in the range of approximately minus 14% to minus 19% across different liver segments, the roflumilast-only group around minus 10% to minus 12%, and the pioglitazone-only group around minus 8% to minus 10%. It is worth noting that this was a very small study, and a large proportion of participants did not complete it, which the data does not fully explain. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01754714 · results posted 19 February 2016

According to the results reported on ClinicalTrials.gov, this trial enrolled 108 people across four groups. Three groups took different daily doses of a supplement called SAMe (S-adenosyl-L-methionine) — either 1,000 mg, 1,500 mg, or 2,000 mg — while a fourth group received no treatment. Most participants completed the study: all 27 in the 1,000 mg group, 26 of 27 in the 1,500 mg group, 24 of 26 in the 2,000 mg group, and 27 of 28 in the no-treatment group. The trial was measuring how the body processed an amino acid called methionine (a building block of protein), as well as a range of liver, metabolic, and immune-related blood markers. The reported data shows that the main thing being measured — how long it took the body to clear methionine from the blood (called the "elimination half-life", meaning the time for blood levels to fall by half) — was broadly similar across all four groups. The figures reported were 4.29 hours for the 1,000 mg group, 4.66 hours for the 1,500 mg group, 4.25 hours for the 2,000 mg group, and 4.26 hours for the no-treatment group. For the secondary measures, the reported data shows small numerical differences between groups in fasting methionine levels, a breath test measuring how the body processed a special form of carbon, liver enzyme readings, cholesterol and blood sugar markers, and immune-related proteins — however, the data as submitted does not include the statistical context needed to interpret whether those differences were considered meaningful by the researchers. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00736385 · results posted 26 March 2015

According to the results reported on ClinicalTrials.gov, this trial looked at a medicine called metformin compared to a placebo (a dummy treatment with no active ingredient) in people with a liver condition called NAFLD (non-alcoholic fatty liver disease). The trial aimed to measure things like how well the body responds to insulin, how the liver processes insulin, fat levels in the blood, changes in liver tissue, and the amount of fat stored around the organs and body. A total of 9 people were enrolled — 4 in the metformin group and 5 in the placebo group. Of those, only 2 people in each group finished the study, meaning 2 from the metformin group and 3 from the placebo group did not complete it. The reported data shows that, unfortunately, no numerical results were submitted to ClinicalTrials.gov for any of the outcome measures — neither the primary outcomes (such as insulin sensitivity, liver fat changes, or lipid levels) nor any of the secondary outcomes (such as inflammation markers or liver cell structure). This means there are no specific figures available to describe or compare between the two groups. It is worth noting that the very small number of participants and the high proportion who did not finish the study are also part of the record as reported. Because no measurement data was provided in the trial's reported results, it is not possible to draw any conclusions from this study about the outcomes that were being investigated. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00799578 · results posted 31 January 2014

According to the results reported on ClinicalTrials.gov, this trial (NCT00799578) involved 13 participants who were all placed in a single group receiving a treatment called Cystagon-EC. The trial was measuring changes in a liver enzyme called ALT (alanine aminotransferase) — a substance found in the blood that doctors sometimes check as an indicator of liver activity. Specifically, the trial looked at how many participants either returned their ALT levels to a normal range, or saw their ALT levels drop by more than half compared to where they started. The reported data shows that 11 out of the 13 participants completed the trial, while 2 did not complete it (the reasons were not detailed in the data provided). Of those involved, 7 participants were reported as showing either a return to normal ALT levels or a drop of more than 50% in their ALT levels from their starting point. No other outcome measures were included in the submitted results data, so no further figures are available to describe. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00063635 · results posted 27 September 2012

According to the results reported on ClinicalTrials.gov, this trial enrolled 173 children and teenagers across three groups — 57 received metformin (a diabetes medication sometimes used in liver conditions), 58 received vitamin E, and 58 received a placebo (an inactive treatment). The trial was studying non-alcoholic fatty liver disease (NAFLD), a condition where excess fat builds up in the liver. By the end of the study, 51, 50, and 49 participants in the respective groups had completed the full trial. The main thing researchers were measuring was whether a liver enzyme called ALT — a marker found in the blood that can indicate liver stress — dropped to a significantly lower level and stayed there over the final stretch of the trial (weeks 48 to 96). The reported data shows that, for the main outcome, 9 out of 57 participants in the metformin group, 15 out of 58 in the vitamin E group, and 10 out of 58 in the placebo group achieved that sustained reduction in ALT levels. For the secondary measurements, all three groups showed a reduction in another liver enzyme called AST (also a blood marker of liver stress): metformin minus 21.5 units, vitamin E minus 22.8 units, and placebo minus 20.4 units. Researchers also scored liver tissue taken by biopsy on a scale of 0–8 (higher meaning more severe disease); the reported average change in that score was minus 1.1 for metformin, minus 1.8 for vitamin E, and minus 0.7 for placebo. The reported data also shows results for several other liver features measured from biopsy at 96 weeks. For scarring of the liver (fibrosis, scored 0–4), 22 metformin, 18 vitamin E, and 19 placebo participants showed a decrease in their score. For fat accumulation in the liver (steatosis, scored 0–3), 26 metformin, 27 vitamin E, and 19 placebo participants showed a decrease. For inflammation inside the liver (lobular inflammation, scored 0–3), 23 metformin, 22 vitamin E, and 20 placebo participants showed a decrease. In each case, a decrease in score was counted as an improvement. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00063622 · results posted 1 August 2012

According to the results reported on ClinicalTrials.gov, this trial enrolled 247 adults across three groups: 80 received pioglitazone (a diabetes-related medicine), 84 received Vitamin E, and 83 received a placebo (a dummy treatment with no active ingredient). The trial was measuring changes in non-alcoholic fatty liver disease (NAFLD) — a condition where fat builds up in the liver — over 96 weeks. To assess this, participants had liver biopsies (small tissue samples taken from the liver) at the start and end of the trial, which were then scored on standardised scales to measure things like fat accumulation, inflammation, cell damage, and scarring. The reported data shows that for the main measure — a combined improvement across several liver biopsy scores — 27 out of 80 participants in the pioglitazone group, 36 out of 84 in the Vitamin E group, and 16 out of 83 in the placebo group met the criteria for improvement. For the additional measures, the reported data shows improvements in fat accumulation (steatosis) for 48, 43, and 22 participants respectively; improvements in liver inflammation for 41, 43, and 25 participants; improvements in cell damage (ballooning) for 31, 40, and 21 participants; and improvements in scarring (fibrosis) for 31, 33, and 22 participants across the three groups. The number of participants whose liver disease (steatohepatitis) was considered resolved was reported as 33, 29, and 15 across the pioglitazone, Vitamin E, and placebo groups respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00501592 · results posted 27 January 2012

According to the results reported on ClinicalTrials.gov, this trial looked at a drug called INT-747 (tested at two different doses — 25 mg and 50 mg) compared to a dummy treatment (placebo) in people with a liver condition. A total of 64 people were enrolled across the three groups: 20 in the 25 mg group, 21 in the 50 mg group, and 23 in the placebo group. By the end of the six-week study, 20, 16, and 20 people respectively had completed the trial. The trial was primarily measuring insulin resistance — broadly, how well the body responds to the hormone insulin to control blood sugar — using a specialised test called a euglycemic clamp, which was done at the start and again after six weeks. The reported data shows that, for the primary measurement of insulin resistance and glucose (blood sugar) control, the change from the start of the study was +0.69 units (mg/kg/min) in the 25 mg INT-747 group and +0.24 units in the 50 mg INT-747 group, while the placebo group showed a change of −0.51 units. A second set of figures in the same measure showed +0.73, +0.42, and −0.61 for the three groups respectively, though the data as submitted does not clearly label what each specific set of numbers refers to. For the secondary measure — changes in liver enzyme levels (a way of checking how the liver is functioning) — the reported data shows mixed changes across the three groups, though the specific enzyme names for each set of numbers were not reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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Not medical advice. These are results as reported by the trial sponsor to a public registry, summarised in plain English. They describe what a trial recorded, not whether a treatment is suitable for any person. Verify anything important against the original registry record and discuss what it means for you with your doctor.