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 (NCT04594694) enrolled 75 adults across four treatment groups during its main double-blind phase (lasting up to three years). The four groups each received a different combination of two medicines: obeticholic acid (OCA) or a placebo, paired with one of two forms of bezafibrate (a lower-dose immediate-release version at 200 mg, or a higher-dose slow-release version at 400 mg). The trial was primarily measuring changes in a liver enzyme called alkaline phosphatase (ALP) — a substance in the blood that doctors use as a marker when monitoring certain liver conditions. A number of secondary measurements were also tracked, including other liver enzymes and bilirubin (a waste product processed by the liver). The reported data shows that all four groups had reductions in ALP levels from where they started. The group receiving placebo plus the lower-dose bezafibrate saw an average drop of around 111 units per litre (U/L), while the group receiving OCA plus the lower-dose bezafibrate saw a drop of around 114 U/L. The group on placebo plus the higher-dose bezafibrate saw a drop of around 137 U/L, and the group on OCA plus the higher-dose bezafibrate had the largest reported drop at around 184 U/L. For the secondary outcomes, the reported data shows that at the 12-week mark, between roughly 79% and 100% of participants across all groups had at least a 10% reduction in ALP from their starting level, depending on the group. The proportion of participants whose ALP returned to a normal range by week 12 ranged from about 21% in the placebo plus lower-dose group up to about 67% in the OCA plus higher-dose group. Changes in other liver markers — including GGT, ALT, AST, and bilirubin — were also reported across all groups, with varying degrees of change from baseline noted in each. 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 19554543) ↗
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 condition called PBC (Primary Biliary Cholangitis), either confirmed or considered likely by your doctor
- Your blood tests show certain elevated liver values (specifically ALP and/or bilirubin) that meet the trial's requirements
- You have either been taking a medication called Ursodeoxycholic Acid (UDCA) for at least 12 months, or you have not taken it for at least 3 months before the trial starts
Who may not be able to join:
- You have or have had another liver disease alongside PBC
- You are experiencing serious complications related to your PBC
- You have had or currently have serious liver failure-related events (confirm with trial site)
- You have or have had any gallbladder disease
- You are female and are currently pregnant, have tested positive for pregnancy, or are breastfeeding
- You have recently used certain medications called OCA or FXR agonists (including in a previous clinical trial) within the last 3 months before joining this study
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
Principal Investigator: Lynda Szczech, Intercept Pharmaceuticals, Inc.
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
Change in Alkaline Phosphatase (ALP) From Baseline in the Double-Blind Treatment Period
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.