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 (NCT03124108) enrolled 45 people in total — 15 in each of three groups: one group received a daily 80 mg dose of elafibranor, one received a 120 mg dose, and one received a placebo (a dummy treatment with no active ingredient). Nearly all participants finished the study; only one person in the 120 mg group did not complete it. The trial ran for 12 weeks and was primarily measuring changes in a blood marker called alkaline phosphatase (ALP) — a substance that can be elevated in certain liver conditions — to see how much it changed from the start to the end of the study. The reported data shows that, on average, ALP levels fell by about 48% in the 80 mg group and about 41% in the 120 mg group over the 12 weeks, while in the placebo group ALP levels rose by roughly 3%. For the secondary measures, researchers used several scoring systems that combine ALP levels with other blood markers to define a "response." The reported data shows that under one combined measure, approximately 67% of the 80 mg group and 79% of the 120 mg group met the response criteria, compared with about 7% in the placebo group. Under another combined measure, around 73% of the 80 mg group and 43% of the 120 mg group met the criteria, while 0% of the placebo group did. Other scoring systems (Paris I, Paris II, and Toronto I) showed similar patterns of differences between the groups, with the placebo group generally recording lower response rates than either elafibranor 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 33484775) ↗
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:
- You are willing and able to sign a consent form agreeing to take part in the study
- You have been diagnosed with, or are likely to have, a liver condition called Primary Biliary Cholangitis (PBC), confirmed by at least 2 of these 3 things: abnormal liver enzyme (ALP) levels for at least 6 months, a positive blood test for certain antibodies linked to PBC, or a liver biopsy showing signs of PBC
- Your ALP liver enzyme level is at least 1.67 times higher than the normal upper limit on blood tests
- You have been taking a medication called UDCA (ursodeoxycholic acid) for at least 12 months, with the same dose for at least the last 6 months
- If you are a woman who could become pregnant, you must be using a highly effective form of contraception throughout the study and for 1 month after finishing treatment
Who may not be able to join:
- You have, or have had, another liver disease alongside PBC
- Certain blood test results at screening are too high, including a muscle enzyme called CPK being above the normal range
- Your liver enzyme levels (ALT or AST) are more than 5 times the normal upper limit on blood tests
- Your bilirubin level (a substance processed by the liver) is more than twice the normal upper limit
- Your creatinine level (a marker of kidney function) is above 1.5 mg/dL on blood tests
- You have significant kidney disease, including conditions causing kidney damage or poor kidney function (confirm with trial site)
- Your liver disease is considered moderate or severe based on a medical scoring system called Child-Pugh B or C
- Your platelet count (cells that help blood clot) is below a certain level on blood tests
- Your albumin level (a protein in your blood) is below 3.5 g/dL
- You are experiencing serious complications or a significant decline in liver function related to PBC
- You are pregnant, have a positive pregnancy test, or are currently breastfeeding
- You have a known history of HIV infection
- You have a medical condition that can raise ALP levels for reasons unrelated to the liver, such as a bone condition called Paget's disease
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
Relative Change From Baseline in Serum Alkaline Phosphatase (ALP) Levels at Week 12 (Endpoint)
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.