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

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What is this study about?

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.

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 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 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 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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Hospital Da Luz S.A. Lisbon Portugal
Turku University Hospital Turku Finland
Centre Hospitalier Universitaire De Nantes Nantes France
Medrise Sp. z o.o. Lublin Poland
Azienda Ospedaliero Universitaria Di Modena Modena Italy
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Del Mar Barcelona Spain
Otto Von Guericke Universitaet Magdeburg Magdeburg Germany
Institutul Regional De Gastroenterologie Hepatologie Prof. Dr. Octavian Fodor Cluj Cluj Napoca Romania
Fundeni Clinical Institute Bucharest Romania
Karolinska University Hospital Solna Sweden
Hopital Beaujon Clichy France
Cfnqhkbzg Ucfvnzlvmamdon Swhyydmrl Woluwe-Saint-Lambert Belgium
Agoahqu Odugypgqtej dk Pxdqqk Padua Italy
Hplhghthefha Dmxmuzeyo Spezvsa As Bergen Norway
Nvi Lgy Gisylwovqt Rhaxhw Mqpyv Gfki St. Poelten Austria
Iv Cmwdfv Myslowice Poland
Rslyvxyw Szob snucn Plzen Czechia
Hhofnqwh Vgir dabrfexx Barcelona Spain
Uxfsvzrqxjqodilylpsyn Tyslssans Amn Tuebingen Germany
Acph Gvuubz Osgsqntk Mfvatlylhfkvt Nrrusplg Milan Italy
Apnfvrmco Uyl Amsterdam The Netherlands
Rihqmc Smcqg Sfmvqy Upldfcqqnzmqsiqnrsi Lund Sweden
Uusmophexjkn Muqsyoa Cptmrep Uwzwhlo Utrecht The Netherlands
Agmwohxg Uvtrftivcd Hysscdth Lorenskog Norway
Hbjwuznw Crjigh Dx Bbcabjebt Barcelona Spain
Evlzasx Ufyugecnicyx Mbewjdk Cmregzv Rrinkxjzv (bbdjmsb Mph Rotterdam The Netherlands
Iqetc Okndostt Pfjbtgnsbcc Sqy Mqchfgu Genoa Italy
Cswdav Hrhxiyncduk Urmlbjvvrockr Dt Mhjvrbhkwyo Montpellier France
Uceydciffzheiggkoncnm Hkcpdwmznw Auh Heidelberg Germany
Azggwle Otzgivqaehsklbrlbvawnjcaj Mxxdoonl Dffzc Cocscj Novara Italy
Uhaewocfpejs Lzwfrwv Leipzig Germany
Rcesveezuxbdiu Copenhagen Denmark
Uvrawxxdoq Od Acgnuyy Edegem Belgium
Roncyt Okhuldf Lqcw Orebro Sweden
Ijcnyebxv Fkl Cxiyosyl Axl Erkyeafpnpwa Moaxxfqa Prague Czechia
Ixrdte ahkf Prague Czechia
Uwmufbqikewn Zgksbxnpwo Gyzp Gent Belgium
Uvejpyvrktcm Mmagrjv Carcggw Gfsrdfojz Groningen The Netherlands
Aaqmyax Sfllzqsjm Urumnpemwjwbj Fvrrmz Clgxwxgd Udine Italy
Hrkczdbj Dq Sfhbg Mbenx Eivppt Lisbon Portugal
Fwpsxvdkf Pdab Lu Ihgqxzbclrnxe Brwyswfdn Dtv Hroptatt Ugnqcyfwyuxqd Lk Phk Madrid Spain
Cozgvuwf Haiisrldqhzp Ukvnibwaduohy Dp Poxiaaqjti Pontevedra Spain
Fnrifqabua Iwrux Sgy Ggiybet Dmy Tgloydt Monza Italy
Sla Juqqfponntxqtlb Wrfntpneq Gzcq Wiesbaden Germany
Htcovjaf Cmc Ppmav Suby Porto Portugal
Gltvjkskigoi Scyxth Iasi Romania
Smuspcpd Cdujkt &ioerypzqg Is Cytgqvzmyesjzseffe Bucharest Romania
Smrygp Jowazrca Db Unveviy Sgkr Mddq Satu Mare Romania
Wvh Wbslop Ijc Pzfjp Pligjvpm Krugrtk Warsaw Poland
Ubglbuk Ueltsawwdq Hwbmkalv Uppsala Sweden
Suaijjrek Rzzjylw Uevljtpuqf Mumwdnj Ctzvqx Nijmegen The Netherlands
Ayrlsjj Uazhombxcu Hkqelurn Aalborg Denmark
Unerdxxljpzymxensmiev Wqxqbtnro Aan Wuerzburg Germany
Rpqgov Magzwctrzko Aarhus Denmark
Ckkqqv Hlsetyqwlu Uhvzmdichgctw Dq Sqrqv Akkujrf Eppuiv Porto Portugal
Cmvegq Hkoizvijnfw Lspc Sor Pierre Benite France
Qcwal Sdcgoq Cskampvhe Hbslyrfy &bqjpkk Sulnvfbcikz Urqspmyydm Htrlepaw &cdbgxr Vbjslpn Gynyasjxvsrxmdsxxi Gothenburg Sweden

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not yet recruiting
15.07.2026
Belgium Belgium
Not yet recruiting
15.07.2026
Czechia Czechia
Not yet recruiting
15.07.2026
Denmark Denmark
Not yet recruiting
15.07.2026
Finland Finland
Not yet recruiting
15.07.2026
France France
Not yet recruiting
15.07.2026
Germany Germany
Not yet recruiting
15.07.2026
Italy Italy
Not yet recruiting
15.07.2026
Norway Norway
Not yet recruiting
15.07.2026
Poland Poland
Recruiting
15.07.2026
Portugal Portugal
Not yet recruiting
15.07.2026
Romania Romania
Recruiting
15.07.2026
Spain Spain
Not yet recruiting
15.07.2026
Sweden Sweden
Not yet recruiting
15.07.2026
The Netherlands The Netherlands
Not yet recruiting
15.07.2026

Trial locations

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.

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 ID:
2026-525242-29-00
Protocol code:
CLIN-60190-475
Trial Phase:
Therapeutic confirmatory (Phase III)

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