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 60 people across three groups in its main double-blind phase: 20 received a 10 mg dose of obeticholic acid (OCA), 16 received a 50 mg dose, and 24 received a placebo (a dummy treatment with no active ingredient). The trial was primarily measuring changes in a liver enzyme called alkaline phosphatase (ALP) — a substance found in the blood that doctors sometimes use as a marker of liver activity — after about 12 weeks (Day 85). A separate longer-term follow-up phase then tracked 28 participants over several years. The reported data shows that, by Day 85, the group taking 10 mg OCA had an average ALP level that was 44.5% lower than at the start, and the 50 mg group showed a 37.6% reduction, while the placebo group's ALP level was essentially unchanged (up by 0.4%). For two other liver markers — GGT and ALT — the reported data shows reductions of around 73% and 37% respectively in the 10 mg group, 65% and 35% in the 50 mg group, and much smaller changes (around −3% and −4%) in the placebo group. For a further marker called conjugated bilirubin, the reported numbers were small changes in the OCA groups (0.7% and −1.7%), compared with a 30.3% rise in the placebo group. Blood concentration levels of OCA were listed as a secondary measure but no numerical results were reported in the data. For the longer-term follow-up phase, the reported data shows median ALP reductions ranging from approximately 31.8% to 44.4% at various time points up to 72 months, though data on drug concentration levels 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.
View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 29023915) ↗
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, Completed
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:
- Women who are past menopause, have had surgery to prevent pregnancy, or (if still able to become pregnant) are willing to use an effective form of contraception throughout the study and for 14 days after finishing the medication.
- Men who are willing to use an effective form of contraception throughout the study, unless they have previously had a vasectomy.
- People who have a confirmed or likely diagnosis of Primary Biliary Cholangitis (PBC), shown by having at least 2 of these 3 things: abnormally high alkaline phosphatase (a liver-related blood marker) for at least 6 months; a positive result on a specific blood test linked to PBC (confirm with trial site); or a liver biopsy result that matches PBC.
- People whose alkaline phosphatase blood level (a liver marker) falls within a specific range at the screening appointment (between 1.5 and 10 times the normal upper limit — confirm with trial site).
Who may not be able to join:
- People who have taken any of the following medications in the 3 months before screening: ursodeoxycholic acid, colchicine, methotrexate, azathioprine, or steroid medicines taken throughout the body (not just applied to the skin).
- People whose screening blood test shows a bilirubin level (a measure of liver function) more than twice the normal upper limit.
- People whose screening blood test shows certain liver enzyme levels (ALT or AST) more than 5 times the normal upper limit.
- People whose screening blood test shows kidney function below a certain level (confirm with trial site).
- People who have had, or currently have, signs of serious liver failure, such as bleeding from swollen veins, confusion caused by liver problems, or uncontrolled fluid build-up in the abdomen.
- People who have, or have had, other liver conditions alongside PBC, such as hepatitis B or C, primary sclerosing cholangitis, alcohol-related liver disease, autoimmune liver disease, or a specific type of fatty liver disease confirmed by biopsy.
- People who are currently pregnant.
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
DB Phase: Mean Percent Change In Serum Alkaline Phosphatase (ALP) From Baseline To Day 85
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.