Trial 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
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.
View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 36797481) ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 2 Non-Alcoholic Fatty Liver Disease Trial, Terminated
Who may be able to join
AI generated eligibility 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
Who might be able to join this trial:
- You are 18 years old or older, male or female
- You are willing and able to sign a written consent form to participate
- For Parts A and B: You have been diagnosed with a specific type of liver disease called NASH (fatty liver with inflammation), confirmed by a liver biopsy taken within the last 2 years, with a moderate level of liver scarring (but not full cirrhosis), and no other long-term liver disease — plus either an elevated liver enzyme level (ALT), OR a combination of elevated ALT, higher body weight (BMI), and Type 2 diabetes
- For Part C: You have NASH confirmed by a liver biopsy taken during the screening period or within the last 6 months, with a moderate level of liver scarring (but not full cirrhosis), and no other long-term liver disease
- Your liver enzyme levels (ALT) are above a certain level: at least 43 IU/L if you are male, or at least 28 IU/L if you are female
- Your liver contains 10% or more fat, as measured by an MRI scan
Who may not be able to join:
- You have previously taken a medication called OCA (obeticholic acid)
- You are currently taking certain medications that are not allowed in this trial
- You are taking certain medications — such as diabetes medicines, insulin, beta-blockers, water pills, cholesterol medicines, vitamin E (above certain doses), thyroid hormones, some mental health medications, or estrogen-based contraceptives — and your dose has not been stable for at least 1 month before joining (confirm with trial site for Part C-specific timing requirements)
- You are pregnant or currently breastfeeding
- You have drunk significant amounts of alcohol for more than 3 months in a row at any point in the year before screening
- Your diabetes is not well controlled
- You have recently started (within the last 3 months) taking certain diabetes medications known as GLP-1 agonists, such as liraglutide, exenatide, or similar drugs
- You have been diagnosed with cirrhosis (advanced liver scarring)
- You have serious liver failure or your liver is not functioning properly
- You have previously been diagnosed with another type of long-term liver disease
- You are unable to have an MRI scan for any reason
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
2 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Number of Nonalcoholic Steatohepatitis (NASH) Patients With Treatment Emergent Adverse Events (TEAE); Change in Transaminase Levels (ALT); Change in Aspartate Transaminase (AST); Change From Baseline in % of Fat in the Liver Assessed Using Magnetic Resonance Imaging (MRI)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.