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 41 people across three groups: 13 received seladelpar 200 mg, 14 received seladelpar 50 mg, and 14 received a placebo (an inactive dummy treatment). The trial was primarily measuring changes in a liver enzyme called alkaline phosphatase (AP) — a substance in the blood that doctors sometimes monitor in liver conditions. Only a small number of participants completed the full study: 2 in the 200 mg group, 4 in the 50 mg group, and 4 in the placebo group, meaning most participants did not finish. The reported data shows that, on average, AP levels fell by about 62.8% from their starting point in the 200 mg seladelpar group, and by about 53.2% in the 50 mg group. In the placebo group, AP levels changed by approximately −1.8% — meaning they stayed roughly the same. For a secondary measure looking at two liver markers together (AP and bilirubin, another substance tracked in liver health), the reported data shows that 100% of participants in the 200 mg group and 69.2% in the 50 mg group met a pre-set combined response target, compared with 8.3% in the placebo group. The trial also tracked other liver enzymes: AST and ALT levels were reported to have increased in both seladelpar groups (rising by roughly 233% and 131% for AST, and 181% and 112% for ALT, in the 200 mg and 50 mg groups respectively), while another enzyme called GGT was reported to have decreased by around 47% and 43% in those same groups. All of these markers stayed relatively unchanged 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.
View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 28818518) ↗
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 given written consent to participate in the study, as required by local rules
- You are between 18 and 75 years old (inclusive)
- You have been diagnosed with Primary Biliary Cholangitis (PBC), confirmed by at least two of the following: abnormal liver enzyme levels (AP) for at least six months, a positive blood test for certain PBC-related antibodies, or a liver biopsy result consistent with PBC
- You have been taking a stable, recommended dose of UDCA (a standard PBC medication) for the past 12 months
- Your AP liver enzyme level is at least 1.67 times above the normal upper limit
- If you are a woman who could become pregnant, you agree to use at least one barrier method of contraception (such as condoms) plus a second form of birth control during the study and for at least two weeks after your last dose
- If you are a man, you agree to use appropriate contraception (such as condoms) during the study and for at least two weeks after your last dose, to prevent your female partner from becoming pregnant
Who may not be able to join:
- You have a serious medical condition other than PBC that the study doctor believes would affect your ability to fully participate or affect the study results (for example, cancer currently being treated)
- Your AST or ALT liver enzyme levels are more than three times above the normal upper limit
- Your total bilirubin level (a measure of liver function) is more than twice the normal upper limit
- You have autoimmune hepatitis (a liver condition caused by the immune system)
- You have primary sclerosing cholangitis (another liver condition affecting the bile ducts)
- You have a known history of alpha-1-antitrypsin deficiency (an inherited condition affecting the liver and lungs)
- You have a known history of long-term viral hepatitis
- Your creatine kinase level (a muscle-related enzyme) is above the normal upper limit
- Your creatinine level (a kidney function marker) is above the normal upper limit
- You are currently pregnant or breastfeeding
- You have taken colchicine, methotrexate, azathioprine, or steroid tablets/injections in the two months before the study screening
- You are currently taking fibrates (including fenofibrates) or simvastatin (types of cholesterol or lipid-lowering medication)
- You are currently using any experimental treatment specifically for PBC
- You are currently using any experimental or unapproved medication that affects the immune system
- The study doctor believes any other health or safety concern makes it unsuitable for you to participate (confirm with trial site)
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
Baseline Alkaline Phosphatase (AP) Levels; Percent Change From Baseline in Alkaline Phosphatase (AP) Levels
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.