New hope for PBC patients: drug aims to slow liver damage

NCT ID NCT06016842

Recruiting now Disease control Sponsor: Ipsen Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Aug 04, 2026 · Updated 4 times

Summary

This Phase 3 trial tests elafibranor, a daily pill, against a placebo in 276 adults with primary biliary cholangitis (PBC) and cirrhosis. The goal is to see if elafibranor can prevent disease worsening, such as liver failure or death, over up to 3.5 years. Researchers will also monitor side effects and symptoms like itching and fatigue.

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 it works, this could provide a new treatment option to slow liver damage and delay the need for a liver transplant in people with primary biliary cholangitis.
What could go wrong: This is a Phase 3 trial, but it's still testing if elafibranor works better than a placebo. Results may not show a clear benefit, and side effects are possible.

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 (PBC)

Contacts and locations

Locations

Agios Savvas Regional Cancer Hospital
RECRUITING

Athens, Greece
Algemeen Ziekenhuis Delta
RECRUITING

Roeselare, Belgium
American Research Corporation
RECRUITING

Austin, Texas, 78757, United States
American Research Corporation at The Texas Liver Institute
RECRUITING

San Antonio, Texas, 78015, United States
Arizona Liver Health
RECRUITING

Tucson, Arizona, 85641, United States
Arkansas Diagnostic Center, PA
TERMINATED

Little Rock, Arkansas, 55130, United States
Artroscan
RECRUITING

Ostrava, Czechia
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
TERMINATED

Palermo, Italy
Azienda Ospedaliera di Padova - U.O.C. di Gastroenterologia
RECRUITING

Padova, Italy
Azienda Ospedaliero Universitaria Federico II di Napoli
TERMINATED

Naples, Italy
Azienda Ospedaliero Universitaria Modena
WITHDRAWN

Modena, Italy
Azienda Ospedaliero Universitaria Pisana
WITHDRAWN

Pisa, Italy
Baylor Scott & White All Saints Medical Center - Forth Worth
WITHDRAWN

Fort Worth, Texas, 76104, United States
Bispebjerg Hospital
RECRUITING

Copenhagen, Denmark
Bolanos Clinical Research
RECRUITING

Pembroke Pines, Florida, 12105, United States
Bon Secours St. Mary's Hospital of Richmond, Inc
RECRUITING

Richmond, Virginia, 23226, United States
CHA Bundang Medical Center, CHA University
RECRUITING

Seongnam-si, South Korea
CHU Poitiers
RECRUITING

Poitiers, France
CHU de Nice, Hopital de l'Archet
RECRUITING

Nice, France
Canterbury District Health Board
RECRUITING

Christchurch, New Zealand
Cedars-Sinai Medical Center
ACTIVE_NOT_RECRUITING

Los Angeles, California, 90048, United States
Central Hospital of Northern Pest - Military Hospital
RECRUITING

Budapest, Hungary
Centre Hospitalier Regional Universitaire de Lille - Hopital Claude Huriez
RECRUITING

Lille, France
Centro Medico Cedid - Centro de Diagnostico Digestivo
RECRUITING

Viña del Mar, Chile
Centro Medico Colon
RECRUITING

Córdoba, Argentina
Centro de Estudios Clinicos e Investigaciones Medicas (CECIM)
RECRUITING

Santiago, Chile
Centro de Investigacion Clinica y Medicina Traslacional
RECRUITING

Guadalajara, Mexico
Centro de Investigacion Medico Biologica y Terapia Avanzada
RECRUITING

Jalisco, Mexico
Centro de Investigacion y Gastroenterologia SC
RECRUITING

Mexico City, Mexico
Centrul Pentru Studiul Metabolismului
RECRUITING

Bucharest, Romania
Centrum Medyczne Medyk Sp. z o.o. Sp. K.
RECRUITING

Rzeszów, Poland
Chiang Mai University
RECRUITING

Chiang Mai, Thailand
Chung-Ang University Hospital
RECRUITING

Seoul, South Korea
Clinica Universidad Navarra-Sede Madrid
RECRUITING

Madrid, Spain
Clinique Pasteur
RECRUITING

Toulouse, France
Cluj County Clinical Emergency Hospital
RECRUITING

Cluj-Napoca, Romania
DIM Centro Medico
RECRUITING

Buenos Aires, Argentina
Diagnostic-Consultative Center Aleksandrovska EOOD
RECRUITING

Sofia, Bulgaria
Enroll SpA
RECRUITING

Santiago, Chile
Fakultna nemocnica Nitra
RECRUITING

Nitra, Slovakia
Fondazione I.R.C.C.S. Policlinico San Matteo
WITHDRAWN

Pavia, Italy
Footscray Hospital, Western Health
RECRUITING

Footscray, Australia
Fundacion Respirar (Centro Medico Dra. De Salvo) - Instituto Argentino de Investigaciones Clinicas (IAIC) S.R.L
RECRUITING

Buenos Aires, Argentina
FutureMeds Warszawa Centrum
RECRUITING

Warsaw, Poland
FutureMeds sp. z o. o
RECRUITING

Wroclaw, Poland
Galilee Medical Center
TERMINATED

Nahariya, Israel
Galilee Medical Center, ZIV Medical Center
WITHDRAWN

Nahariya, Israel
Gastro health & Nutrition
TERMINATED

Katy, Texas, 77904, United States
GastroIntestinal BioSciences
RECRUITING

Los Angeles, California, 90067, United States
Gastroenterological Centre Thalion
RECRUITING

Bratislava, Slovakia
Gastroenterology Center of the Midsouth
RECRUITING

Cordova, Tennessee, 38138, United States
Gastromedica Srl
RECRUITING

Iași, 700111, Romania
GeneIppokratio General Hospital of Thessaloniki
RECRUITING

Thessaloniki, Greece
General Hospital of Athens Laiko
RECRUITING

Athens, Greece
General Oncological Hospital of Kifisia Oi Agioi Anargyroi
RECRUITING

Athens, Greece
Gent University Hospital
RECRUITING

Ghent, Belgium
Hadassah University Hospital (HUH) - Ein-Kerem
TERMINATED

Jerusalem, Israel
Hallym University Kangnam Sacred Heart Hospital
WITHDRAWN

Seoul, South Korea
Hanyang University Seoul Hospital
RECRUITING

Seoul, South Korea
Hepato-Gastroenterologie HK, s.r.o.
RECRUITING

Hradec Králové, Czechia
Hopital Paul-Brousse - APHP
RECRUITING

Villejuif, France
Hopital Pitie-Salpetriere - APHP
RECRUITING

Paris, 75013, France
Hopital Saint Joseph - Marseille
WITHDRAWN

Marseille, France
Hospices Civils de Lyon (HCL) - Hopital de la Croix-Rousse
RECRUITING

Lyon, France
Hospitais da Universidade de Coimbra (H.U.C) - Universidade de Coimbra
RECRUITING

Coimbra, Praceta Mota Pinto, Portugal
Hospital Angeles Valle Oriente
RECRUITING

Monterrey, Mexico
Hospital Britanico de Buenos Aires
RECRUITING

Buenos Aires, Argentina
Hospital Clinic i Provincial de Barcelona
RECRUITING

Barcelona, Spain
Hospital Clinico de la Pontificia Universidad Catolica de Chile
RECRUITING

Santiago, Chile
Hospital De Montecelo
RECRUITING

Pontevedra, Spain
Hospital Dr. Nelio Mendonca
RECRUITING

Funchal, 9004-514, Portugal
Hospital El Cruce
RECRUITING

San Juan Bautista, Argentina
Hospital Espanol de Mendoza
WITHDRAWN

Mendoza, Argentina
Hospital General Universitario Gregorio Maranon (HGUGM)
ACTIVE_NOT_RECRUITING

Madrid, Spain
Hospital Henri Mondor
RECRUITING

Créteil, 94000, France
Hospital Italiano de Buenos Aires
RECRUITING

Buenos Aires, Argentina
Hospital Queen Elizabeth II
RECRUITING

Kota Kinabalu, Malaysia
Hospital Sultanah Aminah
RECRUITING

Johor Bahru, Malaysia
Hospital Universitario Austral
RECRUITING

Pilar, Argentina
Hospital Universitario La Paz
WITHDRAWN

Madrid, Spain
Hospital Universitario Miguel Servet
RECRUITING

Zaragoza, Spain
Hospital Universitario Puerta de Hierro de Majadahonda
RECRUITING

Majadahonda, Spain
Hospital Universitario Rio Hortega
WITHDRAWN

Valladolid, Spain
Hospital Universitario Vall d'Hebron
RECRUITING

Barcelona, Spain
Hospital Universitario Virgen de la Victoria
RECRUITING

Málaga, Spain
Hospital Universitario Virgen del Rocio
RECRUITING

Seville, Spain
Hospital Universitario y Politecnico La Fe
RECRUITING

Valencia, 46026, Spain
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
RECRUITING

São Paulo, Brazil
Hospital de Base - Centro Integrado de Pesquisa ( CIP )
RECRUITING

São Paulo, Brazil
Hospital de Clinicas de Porto Alegre (HCPA)
RECRUITING

Porto Alegre, Brazil
Hospital of Lithuanian University of Health Sciences Kaunas
RECRUITING

Kaunas, Lithuania
Houston Methodist Cancer Center
RECRUITING

Houston, Texas, 77584, United States
Huron Gastroenterology Associates - Center for Digestive Care
WITHDRAWN

Ypsilanti, Michigan, 48197, United States
Impact Research Tx
WITHDRAWN

Waco, Texas, 76710, United States
Inha University Hospital
RECRUITING

Incheon, South Korea
Inje University Ilsan Paik Hospital
RECRUITING

Goyang-si, South Korea
Institut d Investigacio i Innovacio Parc Tauli, Hospital Universitari Parc Tauli
RECRUITING

Sabadell, Spain
Institute for Clinical and Experimental Medicine - IKEM
RECRUITING

Prague, Czechia
Institute of Gastroenterology and Liver Diseases - Soroka University Medical Center
WITHDRAWN

Beersheba, Israel
Instituto D'Or de Pesquisa e Ensino - Hospital Aliança
RECRUITING

Salvador, Brazil
International Center for Research
RECRUITING

Tampa, Florida, 33614, United States
Keimyung University Dongsan Hospital
RECRUITING

Daegu, South Korea
Kenezy County Hospital
RECRUITING

Debrecen, Hungary
Korea University Ansan Hospital
RECRUITING

Gyeonggi-do, South Korea
Korea University Guro Hospital
RECRUITING

Seoul, South Korea
Krajska Nemocnice Liberec
WITHDRAWN

Liberec, Czechia
Krakowskie Centrum Medyczne Sp.z.o.o - FutureMeds
RECRUITING

Krakow, Poland
Krakowskie Centrum Medyczne Sp.z.o.o. - FutureMeds
NOT_YET_RECRUITING

Małogoskie, Poland
Kyungpook National University Hospital (KNUH)
RECRUITING

Junggu, South Korea
Liver Associates of Texas
RECRUITING

Houston, Texas, 77030, United States
Liver Center of Texas
ACTIVE_NOT_RECRUITING

Dallas, Texas, 75203, United States
Louisiana Research Center, LLC
RECRUITING

Shreveport, Louisiana, 71103, United States
Mayo Clinic
RECRUITING

Rochester, Minnesota, 55905, United States
Medical Care & Research
RECRUITING

Yucatán, Mexico
Medical University of South Carolina
RECRUITING

Charleston, South Carolina, 29425, United States
Medrise Sp. z o.o.
RECRUITING

Lublin, Poland
Medstar Georgetown Transplant Institute University Hospital (MGUH)
WITHDRAWN

Columbia, Washington, 20007, United States
Methodist Transplant Physicians
RECRUITING

Dallas, Texas, 75203, United States
Monash University - Monash Health -Monash Medical Centre
WITHDRAWN

Melbourne, Australia
NUPEC Cardio
RECRUITING

Belo Horizonte, Brazil
NYU Langone Gastroenterology and Hepatology Associates
RECRUITING

New York, New York, 10016, United States
NZOZ Twoje Zdrowie EL Sp. z o.o.
RECRUITING

Elblag, Poland
Nepean Clinical School
WITHDRAWN

Kingswood, Australia
Niepubliczny Zaklad Opieki Zdrowotnej (NZOZ) - Poliklinika Doktora Bessera
WITHDRAWN

Sosnowiec, Poland
Nzoz Centrum BadanKlinicznych
RECRUITING

Wroclaw, Poland
Oddzial Kliniczny Gastroenterologii Ogolnej i Onkologicznej SPZOZ, Uniwersytecki Szpital Kliniczny im. Barlickiego w Lodzi
RECRUITING

Lodz, 90-153, Poland
Ospedale Casa Sollievo della Sofferenza
RECRUITING

San Giovanni Rotondo, Italy
Ospedale San Gerardo
RECRUITING

Monza, Italy
Peak Gastroenterology Associates
RECRUITING

Colorado Springs, Colorado, 80829, United States
PlanetMed Sp. z o.o.
RECRUITING

Wroclaw, Poland
Prince of Songkla University (PSU) - Songklanagarind Hospital
RECRUITING

Hat Yai, Thailand
Pusan National University Hospital (PNUH)
RECRUITING

Busan, South Korea
Rabin Medical Center - Beilinson Hospital - Liver Institute
WITHDRAWN

Petah Tikva, Israel
Rambam Health Care Campus (RHCC)
WITHDRAWN

Haifa, Israel
Research Site s.r.o.
RECRUITING

Pilsen, Czechia
Rocky Mountain Gastroenterology
RECRUITING

Littleton, Colorado, 80120, United States
Rush University Medical Center - University Cardiovascular Surgeons
WITHDRAWN

Dallas, Texas, 60612, United States
Samsung Medical Center
RECRUITING

Seoul, South Korea
Sana S.R.L
RECRUITING

Bucharest, Romania
Seoul National University Bundang Hospital (SNUBH)
RECRUITING

Seoul, South Korea
Seoul National University Hospital
RECRUITING

Seoul, South Korea
Severance Hospital, Yonsei University Health System
WITHDRAWN

Seoul, South Korea
Shaare Zedek Medical Center
TERMINATED

Jerusalem, Israel
South Denver Gastroenterology, P.C.
RECRUITING

Englewood, Colorado, 80113, United States
Southern California Research Center
RECRUITING

Coronado, California, 92118, United States
Southwest Gastroenterology Associates, PC (SWGA)
ACTIVE_NOT_RECRUITING

Albuquerque, New Mexico, 87109, United States
Spital Clinic Dr I Cantacuzino
RECRUITING

Bucharest, Romania
Srinagarind Hospital - Khon Kaen University
RECRUITING

Khon Kaen, Thailand
St George Hospital
WITHDRAWN

Sydney, Australia
Sunshine Coast University Hospital
RECRUITING

Birtinya, Australia
Szegedi Tudomanyegyetem AOK, I. sz Belgyogyaszati Klinika
RECRUITING

Szeged, Hungary
Szpital Uniwersytecki w Krakowie
WITHDRAWN

Krakow, Poland
Texas Clinical Research Institute
RECRUITING

Arlington, Texas, 22201, United States
The Catholic University of Korea Daejeon St.Mary's Hospital
WITHDRAWN

Daejeon, South Korea
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
RECRUITING

Seoul, South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
RECRUITING

Seoul, South Korea
The Catholic University of Korea, Uijeongbu St. Mary's Hospital
RECRUITING

Uijeongbu-si, South Korea
Tokuda Hospital, Dept. of Internal Medicine
RECRUITING

Sofia, Bulgaria
Unidade Local de Saúde de Trás-os-Montes e Alto Douro, E. P. E
RECRUITING

Vila Real, 5000-508, Portugal
Universidad De Los Andes
RECRUITING

Las Condes, Chile
Universidade Estadual Paulista Julio De Mesquita Filho (UNESP) Hospital das Clinicas Faculdade de Medicina de Botucatu (HCFMB)
RECRUITING

São Paulo, Brazil
Universidade Federal de Goias
RECRUITING

Goiânia, Brazil
Universitair Ziekenhuis Antwerpen
RECRUITING

Edegem, Belgium
University Health Network (UHN) - Toronto General Hospital (TGH) - Toronto General Research Institute (TGRI)
RECRUITING

Toronto, Canada
University Hospital City Clinic Cancer Center
RECRUITING

Sofia, Bulgaria
University Of Miami School Of Medicine, Center For Liver Diseases
RECRUITING

Miami, Florida, 33136, United States
University Physicians and Surgeons Inc, dba Marshall Health
RECRUITING

Huntington, West Virginia, 25701, United States
University of Alberta - Faculty of Medicine & Dentistry - The Centre of Excellence for Gastrointestinal Inflammation and Immunity Research (CEGIIR)
RECRUITING

Edmonton, Canada
University of California Davis Medical Center
RECRUITING

Sacramento, California, 95817, United States
University of California Los Angeles
WITHDRAWN

Los Angeles, California, 90404, United States
University of Chile Clinical Hospital (Hospital Clinico de la Universidad de Chile)
RECRUITING

Santiago, Chile
University of Colorado
RECRUITING

Aurora, Colorado, 80045, United States
University of Kansas Medical Center (KUMC) - University of Kansas Liver Center - Hepatology Clinic
NOT_YET_RECRUITING

Kansas City, Kansas, 66160, United States
University of Malaya Medical Centre
RECRUITING

Kuala Lumpur, Malaysia
University of Michigan Health System
RECRUITING

Ann Arbor, Michigan, 48109, United States
University of Pittsburgh
RECRUITING

Pittsburgh, Pennsylvania, 15213, United States
University of Texas Southwestern Medical Center at Dallas
RECRUITING

Dallas, Texas, 75390, United States
University of Virginia Medical Center
RECRUITING

Charlottesville, Virginia, 22903, United States
Univerzitna nemocnica L. Pasteura Kosice
RECRUITING

Košice, Slovakia
Uniwersyteckie Centrum Kliniczne im. Prof. K. Gibinskiego Slaskiego Uniwersytetu Medycznego
RECRUITING

Katowice, Poland
Velocity Clinical Research at Liver Institute Northwest
RECRUITING

Seattle, Washington, 98105, United States
Vilnius University Hospital Santaros Klinikos
RECRUITING

Vilnius, Lithuania
Virginia Commonwealth University Medical Center - West Hospital
NOT_YET_RECRUITING

Richmond, Virginia, 23298, United States
Waikato Hospital
RECRUITING

Hamilton, New Zealand
Westmead Hospital
RECRUITING

Westmead, Australia
Ziekenhuis Oost-Limburg
RECRUITING

Genk, Belgium

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