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New drug aims to normalize liver enzyme in bile duct disease

NCT ID NCT06383403

Disease control Sponsor: Ipsen Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 10, 2026 · Updated 3 times

Summary

This study tests whether elafibranor, a daily pill, can normalize alkaline phosphatase (ALP) levels in adults with primary biliary cholangitis (PBC) who did not respond well to or cannot take standard treatment. About 69 participants will receive either elafibranor or a placebo for up to 52 weeks. The main goal is to see if the drug helps bring ALP levels back to normal, which may indicate less liver damage.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
elafibranor
What this could lead to
If successful, elafibranor could offer a new treatment option for people with primary biliary cholangitis who don't respond to standard therapy, potentially slowing liver damage.
What could go wrong
This is a small, early Phase 3 trial with only 69 participants. The drug may not work better than placebo, and side effects are possible. Results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

92 people

The number who actually took part.

Started

Jul 2024

Finished

Jun 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria * Male or female participants age ≥18 years of age. * Participants with a historical diagnosis of PBC as demonstrated by the presence of ≥2 of the following three historical diagnostic criteria: * i. History of elevated ALP levels for ≥6 months prior to the first screening visit (SV1). * ii. Positive Antimitochondrial antibody (AMA) titres (≥1/40 on immunofluorescence or M2 positive by enzyme linked immunosorbent assay) or positive PBC-specific antinuclear antibodies. * iii. Liver biopsy consistent with PBC. * ALP \>1 × ULN and \<1.67 × ULN. * Participants taking UDCA should have been on this medication for at least 6 months and at a stable dose for ≥3 months. Participants who are intolerant to UDCA should have taken the last dose of UDCA ≥3 months prior. * Participants taking medications for management of pruritus must be on a stable dose for ≥3 months. * Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies \* (a) Male participants must agree that, if their partner is at risk of becoming pregnant, they will use an effective method of contraception. The participant must agree to use contraception during the whole period of the study and for 30 days after the last dose of study intervention. * Capable of giving signed informed consent Exclusion Criteria * History or presence of other concomitant liver diseases. * Participants with known cirrhosis who have a Child-Pugh B or C score. Participants with cirrhosis with Child-Pugh A score are allowed. * History of liver transplantation. * History or presence of clinically significant hepatic decompensation. * Known history of human immunodeficiency virus (HIV) infection. * Medical conditions that may cause non-hepatic increases in ALP (e.g. Paget's disease). * Evidence of any other unstable or untreated clinically significant conditions that are not well controlled. * Medical condition with a life expectancy \<2 years. * Known malignancy or history of malignancy within the last 2 years, except for successfully treated localised basal cell carcinoma or squamous cell carcinoma of the skin; or in-situ carcinoma of the uterine cervix. * History of hepatocellular carcinoma. * Alpha-foetoprotein (AFP) \>20 ng/mL with 4-phase liver computed tomography (CT) or magnetic resonance imaging (MRI) scans suggesting presence of liver cancer. * Administration of the following medications is prohibited during the study, and prior to the study as per the timelines specified below: \* i. Systemic (oral or parenteral) use within 3 months prior to SV1 of: fibrates, seladelpar, glitazones, obeticholic acid, azathioprine, cyclosporine, methotrexate, mycophenolate, or long-term systemic corticosteroids (parenteral and oral chronic administration only); potentially hepatotoxic drugs (including α-methyl-dopa, valproic acid, isoniazid or nitrofurantoin) * Participants with previous exposure to elafibranor. * Participants who are currently participating in, plan to participate in, or have participated in an investigational drug study or medical device study containing active substance within 30 days or 5 half-lives, whichever is longer. * Total bilirubin (TB) \>2 × ULN. Participants with Gilbert's syndrome are eligible with a TB above 2 × ULN if direct bilirubin is \<30% of TB. * Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) \>5 × ULN. * Creatine phosphokinase (CPK) \>2 × ULN. * Platelet count \<75,000/µL. * International normalised ratio \>1.3 in the absence of anticoagulant therapy. * Estimated glomerular filtration rate (eGFR) \<45 mL/min/1.73m2. * Significant renal disease, including nephritic syndrome, chronic kidney disease (defined as participants with evidence of significantly impaired kidney function or underlying kidney injury). Other exclusions * For female participants: known pregnancy, or has a positive serum pregnancy test, or is breastfeeding. * Regular alcohol intake in excess of the recommended limit of 2 standard drinks per day for men or 1 standard drink per day for women. * History of alcohol abuse, or other substance abuse within 1 year prior. * Known hypersensitivity to the investigational product or to any of the excipients of elafibranor. * Mental instability or incompetence, such that the validity of informed consent or ability to be compliant with the study is uncertain. * Any other condition that, in the opinion of the investigator, would interfere with study participation or completion, or would put the participant at risk, including a potential participant assessed as being at high risk of noncompliance with the study.

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Conditions

The condition(s) this trial relates to.

primary biliary cholangitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Primary biliary cholangitis

Contacts and locations

Locations

  • Aberdeen Royal Infirmary NHS Grampian Grampian Health Board

    Aberdeen, United Kingdom

  • Ambrose King Centre-Royal London Hospital-Barts Health NHS Trust

    London, United Kingdom

  • American Research Corporation

    San Antonio, Texas, 78215, United States

  • American Research Corporation at The Texas Liver Institute

    San Antonio, Texas, 78215, United States

  • Artroscan

    Ostrava, Czechia

  • Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

    Palermo, Italy

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, Italy

  • Bradford Royal Infirmary - Bradford Teaching Hospitals NHS Foundation

    Bradford, United Kingdom

  • CHA Bundang Medical Center, CHA University

    Seongnam-si, South Korea

  • Charlotte Gastroenterology & Hepatology, PLLC

    Charlotte, North Carolina, 28277, United States

  • Clinique Pasteur

    Toulouse, France

  • Cluj County Clinical Emergency Hospital

    Cluj-Napoca, Romania

  • Coastal Research Institute

    Fayetteville, North Carolina, 28304, United States

  • Delta Research Partners, LLC

    West Monroe, Louisiana, 71291, United States

  • EUGASTRO GmbH

    Leipzig, Germany

  • Frimley Park Hospital - Frimley Health NHS Foundation Trust

    Frimley, United Kingdom

  • FutureMeds Warszawa Centrum

    Warsaw, Poland

  • Gastroenterologsiche Studiengesellschaft Herne

    Hemer, Germany

  • Gastroenterology Center of the Midsouth

    Cordova, Tennessee, 38018, United States

  • Gastromedica Srl

    Iași, Romania

  • Hepato-Gastroenterologie HK, s.r.o.

    Hradec Králové, Czechia

  • Hospital Clinic i Provincial de Barcelona

    Barcelona, Spain

  • Hospital Universitario La Paz

    Madrid, Spain

  • Hospital Universitario Miguel Servet

    Zaragoza, Spain

  • Hospital Universitario Puerta de Hierro de Majadahonda

    Majadahonda, Spain

  • Hospital Universitario Vall d'Hebron

    Barcelona, Spain

  • Hull Royal Infirmary - Hull University Teaching Hospitals NHS Trust

    Hull, United Kingdom

  • Huron Gastroenterology Associates - Center for Digestive Care

    Ypsilanti, Michigan, 48197, United States

  • IRCCS Istituto clinico humanitas - Humanitas Mirasole spa

    Rozzano, Italy

  • Institut d Investigacio i Innovacio Parc Tauli, Hospital Universitari Parc Tauli

    Sabadell, Spain

  • Institute for Clinical and Experimental Medicine - IKEM

    Prague, Czechia

  • International Center for Research

    Tampa, Florida, 33614, United States

  • Keimyung University Dongsan Hospital

    Daegu, South Korea

  • King's College Hospital

    London, United Kingdom

  • Korea University Ansan Hospital

    Ansan-si, South Korea

  • Krakowskie Centrum Medyczne Sp.z.o.o - FutureMeds

    Krakow, Poland

  • Kyungpook National University Hospital (KNUH)

    Daegu, South Korea

  • Methodist Transplant Physicians

    Dallas, Texas, 75203, United States

  • Northwell Health Center for Liver Disease and Transplantation

    Manhasset, New York, 11030, United States

  • Ospedale Policlinico San Martino - IRCCS

    Genova, Italy

  • Peak Gastroenterology Associates

    Colorado Springs, Colorado, 80135, United States

  • Pusan National University Hospital (PNUH)

    Pusan, South Korea

  • Queen Elizabeth University Hospital - Greater Glasgow Health Board

    Glasgow, United Kingdom

  • Research Site s.r.o.

    Pilsen, Czechia

  • Rocky Mountain Gastroenterology

    Littleton, Colorado, 80120, United States

  • Samsung Medical Center

    Seoul, South Korea

  • Seoul National University Bundang Hospital (SNUBH)

    Seongnam-si, South Korea

  • Seoul National University Hospital

    Seoul, South Korea

  • Severance Hospital, Yonsei University Health System

    Seoul, South Korea

  • South Denver Gastroenterology,P.C.

    Englewood, New Jersey, 80113, United States

  • Southern California Research Center

    Coronado, California, 92118, United States

  • Southwest Gastroenterology Associates, PC (SWGA)

    Albuquerque, New Mexico, 87109, United States

  • Stanford University Medical Center

    Stanford, California, 94305, United States

  • The Catholic University of Korea, Eunpyeong St. Mary's Hospital

    Seoul, South Korea

  • Topgraphy Health, Inc.

    Los Angeles, California, 90005, United States

  • Universitaetsklinikum Muenster

    Münster, Germany

  • Universitatsklinikum Heidelberg

    Heidelberg, Germany

  • University of California, Davis

    Sacramento, California, 95616, United States

  • University of Michigan Health System

    Ann Arbor, Michigan, 48109, United States

  • Velocity Liver Institute NW

    Seattle, Washington, 98105, United States

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