Safety and efficacy of elafibranor in primary sclerosing cholangitis: The ELMWOOD phase II randomized-controlled trial.

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Title: Safety and efficacy of elafibranor in primary sclerosing cholangitis: The ELMWOOD phase II randomized-controlled trial.
Authors: Levy C; Schiff Center for Liver Diseases, University of Miami, Miami, Florida, USA; Division of Digestive Health and Liver Diseases, University of Miami School of Medicine, Miami, Florida, USA. Electronic address: clevy@med.miami.edu., Abouda GF; NHS Humber Health Partnership, Hull University Teaching Hospitals NHS Trust, Hull, UK., Bilir BM; Advent Health Transplant Institute, Denver, Colorado, USA; Rocky Mountain Gastroenterology, Denver, Colorado, USA., Bonder A; Liver Center, Department of Gastroenterology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, USA., Bowlus CL; Division of Gastroenterology and Hepatology, UC Davis School of Medicine, Sacramento, California, USA., Campos-Varela I; Liver Unit, Hospital University Vall d'Hebron, Barcelona, Spain., Cazzagon N; Department of Surgery, Oncology and Gastroenterology, University of Padova, Gastroenterology Unit, University Hospital of Padova, RARE-LIVER ERN, Padova, Italy., Chandok N; Department of Medicine, William Osler Health System, Brampton, Ontario, Canada., Cheent K; Department of Hepatology, Frimley Health NHS Foundation Trust, Surrey, UK., Cortez-Pinto H; Clínica Universitária de Gastrenterologia, Faculdade de Medicina, Universidade de Lisboa, Lisbon, Portugal., Demir M; Department of Hepatology and Gastroenterology, Charité Universitätsmedizin Berlin, Berlin, Germany., Dill MT; Department of Gastroenterology, Hepatology, Infectious Diseases & Intoxications, Heidelberg University Hospital, Heidelberg, Germany., Eksteen B; Aspen Woods Clinic, Calgary, Alberta, Canada., Fenkel JM; Division of Gastroenterology & Hepatology, Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, USA., Gilroy R; Division Hepatology and Abdominal Transplantation, Intermountain Health, Murray, Utah, USA., Ko HH; Division of Gastroenterology and Hepatology, University of British Columbia, Vancouver, British Columbia, Canada., Jacobson IM; Division of Gastroenterology and Hepatology, NYU Langone Health, New York City, New York, USA., Kallis Y; Barts Liver Centre, Blizard Institute, Queen Mary University of London, UK., Kugelmas M; South Denver Gastroenterology, Englewood, Colorado, USA., Luketic V; VCU School of Medicine, Stravitz-Sanyal Institute for Liver Disease and Metabolic Health, Richmond, Virginia, USA., Mangia A; Department of Medical Sciences, IRCCS Ospedale Casa Sollievo della Sofferenza, San Giovanni Rotondo, Italy., Montano-Loza AJ; Division of Gastroenterology and Liver Unit, University of Alberta, Edmonton, Alberta, Canada., Mukhopadhya A; Digestive Disorders Department, Aberdeen Royal Infirmary, Aberdeen, UK., Olveira A; Department of Gastroenterology, Hospital Universitario La Paz, Madrid, Spain., Patel BC; Department of Gastroenterology, UCHealth, Colorado Springs, Colorado, USA., Pietrangelo A; Department of Internal Medicine, University Hospital of Modena, Modena, Italy., Pradhan F; Division of Gastroenterology and Hepatology, University of Nebraska Medical Center, Omaha, Nebraska, USA., Salcedo M; Liver Unit, Gastroenterology and Hepatology Department, CIBER-Ehd. Hospital General Universitario Gregorio Marañón, Universidad Complutense, Madrid, Spain., Shiffman ML; Liver Institute of Virginia, Bon Secours Mercy Health, Richmond, Virginia, USA., Sprinzl K; Goethe University Frankfurt, University Hospital, Department of Gastroenterology & Hepatology, Frankfurt/Main, Germany., Swann R; Queen Elizabeth University Hospital, Glasgow, UK., Thorburn D; Sheila Sherlock Liver Centre & UCL Institute for Liver & Digestive Health, Royal Free Hospital, London, UK., Thuluvath PJ; Clinical Professor of Medicine, University of Maryland School of Medicine, Baltimore, Maryland, USA., Trivedi PJ; National Institute of Health and Social Care Research Birmingham Biomedical Research Centre, Centre for Liver and Gastrointestinal Research, University of Birmingham, Birmingham, UK; Liver Unit, University Hospitals Birmingham, Birmingham, UK., Turnes J; Department of Gastroenterology and Hepatology, Pontevedra University Hospital Complex & Galicia Sur Health Research Institute, Pontevedra, Spain., Zein CO; Ipsen, Cambridge, Massachusetts, USA., Gomes da Silva H; Ipsen, Boulogne-Billancourt, France., Jaitly S; Ipsen, London, UK., Miller B; Ipsen, Cambridge, Massachusetts, USA., Milligan C; Ipsen, London, UK., Tavenard A; Ipsen, Les Ulis, France., Kowdley KV; Liver Institute Northwest, Seattle, Washington, USA.
Source: Journal of hepatology [J Hepatol] 2026 Jan; Vol. 84 (1), pp. 74-85. Date of Electronic Publication: 2025 May 10.
Publication Type: Journal Article; Randomized Controlled Trial; Clinical Trial, Phase II; Multicenter Study
Journal Info: Publisher: Elsevier Country of Publication: Netherlands NLM ID: 8503886 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1600-0641 (Electronic) Linking ISSN: 01688278 NLM ISO Abbreviation: J Hepatol Subsets: MEDLINE
Database: MEDLINE Ultimate
Description
ISSN:1600-0641
DOI:10.1016/j.jhep.2025.04.025