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 enrolled 71 adults in total across three groups: 28 people received cilofexor 100 mg, 30 received cilofexor 30 mg, and 13 received a placebo (an inactive treatment used for comparison). The trial had two phases — a blinded phase (where participants did not know which treatment they were receiving) and an open-label extension phase (where all participants received active treatment and knew what they were taking). The trial was primarily measuring how often participants experienced unwanted medical events (called adverse events) and abnormal laboratory test results during both phases. The reported data shows that during the blinded phase, unwanted medical events were recorded in 89.3% of participants in the cilofexor 100 mg group, 76.7% in the cilofexor 30 mg group, and 84.6% in the placebo group. Serious unwanted medical events during this phase were reported in 0% of the 100 mg group, 3.3% of the 30 mg group, and 0% of the placebo group. Abnormal laboratory results were recorded in 85.7% of the 100 mg group, 86.7% of the 30 mg group, and 92.3% of the placebo group, with no serious laboratory abnormalities reported in the 100 mg or placebo groups, and 3.3% in the 30 mg group. During the open-label extension phase, unwanted medical events were reported in 95.7%, 89.3%, and 100% of participants from the original 100 mg, 30 mg, and placebo groups respectively, with serious events reported in 4.3% of those from the 100 mg group and none from the other two groups. Abnormal laboratory results in the extension phase were reported in 91.3%, 96.4%, and 100% across the three groups, with no serious laboratory abnormalities recorded in any group during this phase. It is worth noting that the open-label extension phase had a high number of participants who did not complete it — 18 of 23 from the 100 mg group, 25 of 28 from the 30 mg group, and 10 of 12 from the placebo group — though the reasons for this were not detailed in the data provided here. Any figures not listed above were not reported 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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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 Primary Biliary Cholangitis 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 have been diagnosed with a liver condition called Primary Biliary Cholangitis (PBC), confirmed by at least 2 of these 3 things: abnormal liver enzyme levels in your blood (ALP above normal), a positive blood test for certain antibodies (called AMA), or a liver biopsy showing signs typical of PBC.
- Your blood tests show that your ALP level is notably above normal (more than 1.67 times the upper limit), and/or your bilirubin level is above normal but not more than twice the upper limit of normal.
- You have been taking a medication called ursodeoxycholic acid (UDCA) at the same dose for at least 12 months, OR you are unable to tolerate UDCA and have not taken it for at least 12 months before the study screening.
- A liver health score called FibroSURE/FibroTest is below 0.75, OR a liver biopsy taken within the last 12 months showed no signs of advanced scarring (cirrhosis).
Who may not be able to join:
- Your blood test shows a liver enzyme called ALT is more than 5 times the upper limit of normal, suggesting significant liver inflammation.
- Your bilirubin level in your blood is more than twice the upper limit of normal.
- Your blood clotting test (INR) result is above 1.2, unless you are already taking blood-thinning medication.
- You have another cause of liver disease, such as a viral infection, alcohol-related liver disease, or another autoimmune condition (confirm with trial site if you have fatty liver disease).
- You have taken certain medications called fibrates or obeticholic acid within the 3 months before screening.
- You have advanced liver scarring (cirrhosis), shown by any of the following: a liver biopsy confirming cirrhosis, a history of serious liver complications such as fluid build-up in the abdomen, confusion caused by liver failure, or bleeding from swollen veins in the food pipe, OR a liver stiffness scan result above 16.9 kPa.
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.
GP referral letter
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Trial details
Where this trial is recruiting
Primary endpoints
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) in the Blinded Study Phase; Percentage of Participants Experiencing TEAEs and TESAEs in the Open-Label Extension (OLE) Phase; Percentage of Participants Who Experienced Graded Laboratory Abnormalities in the Blinded Study Phase; Percentage of Participants Who Experienced Graded Laboratory Abnormalities in the OLE Phase
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.