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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
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PubType: Academic Journal
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  Data: Safety and efficacy of elafibranor in primary sclerosing cholangitis: The ELMWOOD phase II randomized-controlled trial.
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  Data: <searchLink fieldCode="AU" term="%22Levy+C%22">Levy C</searchLink>; 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.<br /><searchLink fieldCode="AU" term="%22Abouda+GF%22">Abouda GF</searchLink>; NHS Humber Health Partnership, Hull University Teaching Hospitals NHS Trust, Hull, UK.<br /><searchLink fieldCode="AU" term="%22Bilir+BM%22">Bilir BM</searchLink>; Advent Health Transplant Institute, Denver, Colorado, USA; Rocky Mountain Gastroenterology, Denver, Colorado, USA.<br /><searchLink fieldCode="AU" term="%22Bonder+A%22">Bonder A</searchLink>; Liver Center, Department of Gastroenterology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, USA.<br /><searchLink fieldCode="AU" term="%22Bowlus+CL%22">Bowlus CL</searchLink>; Division of Gastroenterology and Hepatology, UC Davis School of Medicine, Sacramento, California, USA.<br /><searchLink fieldCode="AU" term="%22Campos-Varela+I%22">Campos-Varela I</searchLink>; Liver Unit, Hospital University Vall d'Hebron, Barcelona, Spain.<br /><searchLink fieldCode="AU" term="%22Cazzagon+N%22">Cazzagon N</searchLink>; Department of Surgery, Oncology and Gastroenterology, University of Padova, Gastroenterology Unit, University Hospital of Padova, RARE-LIVER ERN, Padova, Italy.<br /><searchLink fieldCode="AU" term="%22Chandok+N%22">Chandok N</searchLink>; Department of Medicine, William Osler Health System, Brampton, Ontario, Canada.<br /><searchLink fieldCode="AU" term="%22Cheent+K%22">Cheent K</searchLink>; Department of Hepatology, Frimley Health NHS Foundation Trust, Surrey, UK.<br /><searchLink fieldCode="AU" term="%22Cortez-Pinto+H%22">Cortez-Pinto H</searchLink>; Clínica Universitária de Gastrenterologia, Faculdade de Medicina, Universidade de Lisboa, Lisbon, Portugal.<br /><searchLink fieldCode="AU" term="%22Demir+M%22">Demir M</searchLink>; Department of Hepatology and Gastroenterology, Charité Universitätsmedizin Berlin, Berlin, Germany.<br /><searchLink fieldCode="AU" term="%22Dill+MT%22">Dill MT</searchLink>; Department of Gastroenterology, Hepatology, Infectious Diseases & Intoxications, Heidelberg University Hospital, Heidelberg, Germany.<br /><searchLink fieldCode="AU" term="%22Eksteen+B%22">Eksteen B</searchLink>; Aspen Woods Clinic, Calgary, Alberta, Canada.<br /><searchLink fieldCode="AU" term="%22Fenkel+JM%22">Fenkel JM</searchLink>; Division of Gastroenterology & Hepatology, Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, USA.<br /><searchLink fieldCode="AU" term="%22Gilroy+R%22">Gilroy R</searchLink>; Division Hepatology and Abdominal Transplantation, Intermountain Health, Murray, Utah, USA.<br /><searchLink fieldCode="AU" term="%22Ko+HH%22">Ko HH</searchLink>; Division of Gastroenterology and Hepatology, University of British Columbia, Vancouver, British Columbia, Canada.<br /><searchLink fieldCode="AU" term="%22Jacobson+IM%22">Jacobson IM</searchLink>; Division of Gastroenterology and Hepatology, NYU Langone Health, New York City, New York, USA.<br /><searchLink fieldCode="AU" term="%22Kallis+Y%22">Kallis Y</searchLink>; Barts Liver Centre, Blizard Institute, Queen Mary University of London, UK.<br /><searchLink fieldCode="AU" term="%22Kugelmas+M%22">Kugelmas M</searchLink>; South Denver Gastroenterology, Englewood, Colorado, USA.<br /><searchLink fieldCode="AU" term="%22Luketic+V%22">Luketic V</searchLink>; VCU School of Medicine, Stravitz-Sanyal Institute for Liver Disease and Metabolic Health, Richmond, Virginia, USA.<br /><searchLink fieldCode="AU" term="%22Mangia+A%22">Mangia A</searchLink>; Department of Medical Sciences, IRCCS Ospedale Casa Sollievo della Sofferenza, San Giovanni Rotondo, Italy.<br /><searchLink fieldCode="AU" term="%22Montano-Loza+AJ%22">Montano-Loza AJ</searchLink>; Division of Gastroenterology and Liver Unit, University of Alberta, Edmonton, Alberta, Canada.<br /><searchLink fieldCode="AU" term="%22Mukhopadhya+A%22">Mukhopadhya A</searchLink>; Digestive Disorders Department, Aberdeen Royal Infirmary, Aberdeen, UK.<br /><searchLink fieldCode="AU" term="%22Olveira+A%22">Olveira A</searchLink>; Department of Gastroenterology, Hospital Universitario La Paz, Madrid, Spain.<br /><searchLink fieldCode="AU" term="%22Patel+BC%22">Patel BC</searchLink>; Department of Gastroenterology, UCHealth, Colorado Springs, Colorado, USA.<br /><searchLink fieldCode="AU" term="%22Pietrangelo+A%22">Pietrangelo A</searchLink>; Department of Internal Medicine, University Hospital of Modena, Modena, Italy.<br /><searchLink fieldCode="AU" term="%22Pradhan+F%22">Pradhan F</searchLink>; Division of Gastroenterology and Hepatology, University of Nebraska Medical Center, Omaha, Nebraska, USA.<br /><searchLink fieldCode="AU" term="%22Salcedo+M%22">Salcedo M</searchLink>; Liver Unit, Gastroenterology and Hepatology Department, CIBER-Ehd. Hospital General Universitario Gregorio Marañón, Universidad Complutense, Madrid, Spain.<br /><searchLink fieldCode="AU" term="%22Shiffman+ML%22">Shiffman ML</searchLink>; Liver Institute of Virginia, Bon Secours Mercy Health, Richmond, Virginia, USA.<br /><searchLink fieldCode="AU" term="%22Sprinzl+K%22">Sprinzl K</searchLink>; Goethe University Frankfurt, University Hospital, Department of Gastroenterology & Hepatology, Frankfurt/Main, Germany.<br /><searchLink fieldCode="AU" term="%22Swann+R%22">Swann R</searchLink>; Queen Elizabeth University Hospital, Glasgow, UK.<br /><searchLink fieldCode="AU" term="%22Thorburn+D%22">Thorburn D</searchLink>; Sheila Sherlock Liver Centre & UCL Institute for Liver & Digestive Health, Royal Free Hospital, London, UK.<br /><searchLink fieldCode="AU" term="%22Thuluvath+PJ%22">Thuluvath PJ</searchLink>; Clinical Professor of Medicine, University of Maryland School of Medicine, Baltimore, Maryland, USA.<br /><searchLink fieldCode="AU" term="%22Trivedi+PJ%22">Trivedi PJ</searchLink>; 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.<br /><searchLink fieldCode="AU" term="%22Turnes+J%22">Turnes J</searchLink>; Department of Gastroenterology and Hepatology, Pontevedra University Hospital Complex & Galicia Sur Health Research Institute, Pontevedra, Spain.<br /><searchLink fieldCode="AU" term="%22Zein+CO%22">Zein CO</searchLink>; Ipsen, Cambridge, Massachusetts, USA.<br /><searchLink fieldCode="AU" term="%22Gomes+da+Silva+H%22">Gomes da Silva H</searchLink>; Ipsen, Boulogne-Billancourt, France.<br /><searchLink fieldCode="AU" term="%22Jaitly+S%22">Jaitly S</searchLink>; Ipsen, London, UK.<br /><searchLink fieldCode="AU" term="%22Miller+B%22">Miller B</searchLink>; Ipsen, Cambridge, Massachusetts, USA.<br /><searchLink fieldCode="AU" term="%22Milligan+C%22">Milligan C</searchLink>; Ipsen, London, UK.<br /><searchLink fieldCode="AU" term="%22Tavenard+A%22">Tavenard A</searchLink>; Ipsen, Les Ulis, France.<br /><searchLink fieldCode="AU" term="%22Kowdley+KV%22">Kowdley KV</searchLink>; Liver Institute Northwest, Seattle, Washington, USA.
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