New drug aims to normalize liver enzyme in bile duct disease

NCT ID NCT06383403

Completed Disease control Sponsor: Ipsen Source: ClinicalTrials.gov ↗

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.

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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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