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A Phase III Study of Elafibranor in Adults with Primary Sclerosing Cholangitis to Assess Efficacy and Safety

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What is this trial about?

A plain-language summary of the goals, design and what participants do

A rare liver condition called Primary Sclerosing Cholangitis causes the bile ducts to become narrowed and scarred, which can lead to liver damage. The study is testing an oral medication named elafibranor, given as a 120 mg tablet taken once daily, and comparing it with a matching placebo. Both the drug and the placebo look the same, so participants will not know which they receive.

The purpose of the study is to see whether daily treatment with elafibranor can delay serious health problems such as death, the need for liver transplantation, worsening liver function known as hepatic decompensation, high blood pressure in the liver’s blood vessels called portal hypertension, and other complications related to the bile ducts, referred to as cholangiopathy. Participants will be randomly assigned to receive either the active drug or the placebo and will be followed for several years, with regular visits to check their health and any events that occur.

The trial lasts for a few years, during which participants continue their usual care while taking the study medication or placebo. Information on safety and any health events will be collected at each visit, and the overall goal is to determine if the drug can safely improve outcomes for adults living with this condition.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Randomisation

    After giving informed consent, you are randomly assigned to receive either elafibranor or an identical placebo. the assignment is concealed, so neither you nor the study staff knows which one you receive.

  2. Step 2

    Baseline assessments

    Before starting the medication, a series of tests are performed to record your current health status. these may include blood tests, imaging of the liver, and a review of your medical history.

  3. Step 3

    Receiving study medication

    You receive a bottle of film‑coated tablets that look the same for both groups. each tablet contains either 120 mg of elafibranor or no active drug (placebo). the tablets are taken by mouth once each day, with or without food.

  4. Step 4

    Daily dosing

    Take one tablet each day for the entire length of the study, which may last several years. continue the same schedule unless a study doctor advises otherwise.

  5. Step 5

    Regular follow‑up visits

    You attend scheduled clinic visits, typically every few months, to allow the study team to check your health. during each visit, blood samples are taken, and any side effects are recorded.

  6. Step 6

    Safety monitoring

    The study team monitors liver function and other laboratory values at each visit to ensure the medication is safe for you. any concerning results may lead to additional testing or a change in dosing.

  7. Step 7

    Adherence checks

    The number of tablets you have left is counted at each visit to confirm that you are taking the medication as instructed.

  8. Step 8

    Final assessment and study completion

    At the end of the study period, you undergo a final set of examinations similar to the baseline assessments. the study medication is stopped, and you receive a summary of the study findings that pertain to your participation.

Who can join the trial?

6 criteria

  • Be 18 years old or older (adult).
  • Have a confirmed diagnosis of primary sclerosing cholangitis (a long‑term liver condition diagnosed using medical tests, lab results, and imaging scans).
  • Have compensated liver disease (the liver is still working well enough at the time of screening).
  • Be on a stable background therapy (any regular medicines you take for your condition must have been unchanged for a set time before joining the study).
  • If you are a woman who could become pregnant, you must use a highly effective method of birth control throughout the whole study.
  • Be able to sign a written consent form and follow the study’s procedures.

Who cannot join the trial?

23 criteria

  • History or presence of another long‑term chronic liver disease.
  • Positive test for hepatitis B surface antigen or for hepatitis C infection (both antibody and viral RNA positive).
  • History of serious liver failure, such as a previous liver transplant, a high MELD score (≥12), or complications of cirrhosis.
  • Having cirrhosis that is classified as Child‑Pugh B or C (more advanced stages).
  • Having a biliary intervention (procedure on the bile ducts) or a percutaneous drain or bile duct stent in place within the last 60 days.
  • History of bacterial cholangitis (infection of the bile ducts) or taking antibiotics to prevent repeated cholangitis within the last 60 days.
  • Current or suspected cholangiocarcinoma or hepatocellular carcinoma (types of liver cancer).
  • Any cancer diagnosed in the past five years, except a locally treated basal cell skin cancer or an early‑stage cervical cancer that was in‑situ.
  • Medical conditions that can raise alkaline phosphatase (ALP) for reasons other than liver disease, such as Paget’s disease.
  • Use of prohibited medicines within three months before the study, including norursolic acid, ileal bile acid transport inhibitors, fibrates, seladelpar, glitazones, cyclosporine, mycophenolate, pentoxifylline, chronic systemic corticosteroids (unless for stable IBD or adrenal insufficiency), or other liver‑toxic drugs such as α‑methyl‑dopa, sodium valproic acid, isoniazid, or nitrofurantoin.
  • Currently participating in, planning to join, or having participated in another clinical trial with an investigational drug or device within 30 days (or five drug half‑lives) before screening.
  • Previous exposure to the study drug elafibranor.
  • A heart test (electrocardiogram (ECG)) that shows a prolonged QT interval: greater than 450 ms for men, greater than 470 ms for women, or greater than 480 ms if a bundle branch block (a conduction abnormality) is present.
  • Abnormal liver‑related laboratory test results (specific thresholds not listed here).
  • Significant kidney (renal) disease.
  • A creatine phosphokinase (CPK) level more than twice the normal upper limit, indicating possible muscle injury.
  • For women: known pregnancy, a positive pregnancy test, or being lactating (breastfeeding).
  • Regular alcohol consumption that exceeds the recommended limit (more than two standard drinks per day for men or one for women).
  • History of alcohol abuse or other substance abuse within the past year.
  • Allergy or sensitivity to any of the study medications or their ingredients.
  • Mental instability or inability to give informed consent or follow study procedures.
  • Positive test for HIV (human immunodeficiency virus) type 1 or 2.
  • Other serious medical conditions expected to shorten life expectancy to less than two years.
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Investigated drugs

elafibranor is a medication taken by mouth in the form of a film‑coated tablet. In this study, participants with primary sclerosing cholangitis take one tablet each day. The trial is testing whether this drug can help delay or prevent serious health events related to the disease, compared with a placebo. It is being studied because it may offer a new treatment option for this rare liver condition, and it has been designated as an orphan drug, meaning it is intended for a disease that affects a small number of people.

What is already known about the treatment

  • Otherwise identical to the IMP

    This placebo looks identical to the active tablet and is taken as a film‑coated tablet by mouth once daily, but it contains no active drug. It is used only as a control in the study and has no therapeutic effect or approved medical use. The product helps researchers compare the effects of the test drug against a neutral baseline. It does not belong to any pharmacological class.

  • Elafibranor

    Elafibranor is taken as a film‑coated tablet by mouth, 120 mg once daily. It is an experimental orphan‑drug currently being studied for primary sclerosing cholangitis and has not yet received marketing approval. The drug aims to treat this rare liver disease by activating PPAR‑α and PPAR‑δ receptors, which help control fat metabolism and reduce inflammation. It belongs to the class of peroxisome proliferator‑activated receptor (PPAR) agonists.

Investigated diseases

Primary sclerosing cholangitis - Primary sclerosing cholangitis is a long‑lasting disease that causes inflammation and scarring of the bile ducts inside and outside the liver. The scarring narrows the ducts, making it harder for bile to flow. Over time the reduced flow can lead to buildup of bile in the liver and cause the liver to become stiff. The condition often appears in adults and may develop gradually over many years. Symptoms can include fatigue, itching, and yellowing of the skin as the disease advances. The disease can also be associated with other immune‑related conditions.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2026-525242-29-00Protocol codeCLIN-60190-475Estimated enrolment350 patientsSponsorIpsen Bioscience Inc.

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