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  title info:
    title: Safety and efficacy of elafibranor in primary sclerosing cholangitis
    sub title: the ELMWOOD phase II randomized-controlled trial
  name:
    name part: Levy, Cynthia
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      role term: creator
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  name:
    name part: Abouda, George F.
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    name part: Bilir, Bahri M.
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    name part: Bonder, Alan
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    name part: Bowlus, Christopher L.
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  name:
    name part: Campos-Varela, Isabel
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      role term: VerfasserIn
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  name:
    name part: Cazzagon, Nora
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  name:
    name part: Chandok, Natasha
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    name part: Cheent, Kuldeep
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  name:
    name part: Cortez-Pinto, Helena
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    name part: Demir, Münevver
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    name part: Dill, Michael T.
    name part: 1983-
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    name part: Gilroy, Richard
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    name part: Ko, Hin Hin
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    name part: Jacobson, Ira M.
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    name part: Kallis, Yiannis
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    name part: Kugelmas, Marcelo
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    name part: Luketic, Velimir
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    name part: Mangia, Alessandra
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  name:
    name part: Montano-Loza, Aldo J.
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    name part: Mukhopadhya, Ashis
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  name:
    name part: Olveira, Antonio
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    name part: Patel, Bhaktasharan C.
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    name part: Pietrangelo, Antonello
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    name part: Pradhan, Faruq
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    name part: Salcedo, Magdalena
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    name part: Shiffman, Mitchell L.
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  name:
    name part: Sprinzl, Kathrin
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  name:
    name part: Swann, Rachael
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    name part: Thuluvath, Paul J.
  type of resource: text
  abstract: Background & Aims - Primary sclerosing cholangitis (PSC) is a rare, chronic liver disease. Elafibranor, a dual peroxisome proliferator-activated receptor-α/δ agonist, was investigated in the phase II ELMWOOD trial (NCT05627362). - Methods - This 12-week, double-blind trial enrolled adults with PSC and alkaline phosphatase (ALP) ≥1.5× the upper limit of normal. The primary endpoint was elafibranor safety vs. placebo. Additional endpoints included relative mean change from baseline in ALP and enhanced liver fibrosis (ELF) score. - Results - A total of 68 participants (male: 54.4%; mean age: 46.3 years; inflammatory bowel disease: 55.9%) were randomized to elafibranor 80 mg (n = 22), elafibranor 120 mg (n = 23), or placebo (n = 23). At baseline, 70.6% were on ursodeoxycholic acid, 48.5% had ELF scores >9.8, and the mean ALP level was 369.5 U/L. At Week 12, rates of treatment-emergent adverse events (TEAEs) and TEAEs leading to discontinuation in participants on elafibranor 80 mg, 120 mg, and placebo were 68.2%, 78.3%, and 69.6%, and 4.5%, 4.3%, and 8.7%, respectively. Serious TEAEs occurred only in participants on placebo (4.3%). Participants on elafibranor 80 mg and 120 mg had reductions in ALP vs. placebo (least squares mean treatment difference [95% CI]: −35.3% [−49.2, −21.4] and −54.7% [−68.3, −41.0], respectively). ALP normalization occurred only in participants on elafibranor 80 mg (9.1%) and 120 mg (17.4%). The LS mean treatment differences (95% CI) in change from baseline in ELF scores in participants on elafibranor 80 mg and 120 mg vs. placebo were -0.19 (−0.52, +0.15) and -0.28 (−0.62, +0.06), respectively. - Conclusions - Elafibranor was well tolerated in people with PSC and associated with greater biochemical improvements over 12 weeks compared with placebo. A greater magnitude of response was observed with elafibranor 120 mg compared with 80 mg. - Impact and implications - For people with primary sclerosing cholangitis (PSC), there is a need for a well-tol…
  note: Cynthia Levy, George F. Abouda, Bahri M. Bilir, Alan Bonder, Christopher L. Bowlus, Isabel Campos-Varela, Nora Cazzagon, Natasha Chandok, Kuldeep Cheent, Helena Cortez-Pinto, Münevver Demir, Michael T. Dill, Bertus Eksteen, Jonathan M. Fenkel, Richard Gilroy, Hin Hin Ko, Ira M. Jacobson, Yiannis Kallis, Marcelo Kugelmas, Velimir Luketic, Alessandra Mangia, Aldo J. Montano-Loza, Ashis Mukhopadhya, Antonio Olveira, Bhaktasharan C. Patel, Antonello Pietrangelo, Faruq Pradhan, Magdalena Salcedo, Mitchell L. Shiffman, Kathrin Sprinzl, Rachael Swann, Douglas Thorburn, Paul J. Thuluvath, Palak J. Trivedi, Juan Turnes, Claudia O. Zein, Hugo Gomes da Silva, Seema Jaitly, Benjamin Miller, Claire Milligan, Aude Tavenard, Kris V. Kowdley
  note: Gesehen am 07.04.2026
  classification: 33
  identifier: https://doi.org/10.1016/j.jhep.2025.04.025
  identifier: https://www.sciencedirect.com/science/article/pii/S0168827825002521

role term: VerfasserIn

role term: aut

name part: Trivedi, Palak J.
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  role term: VerfasserIn
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name part: Turnes, Juan
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name part: Zein, Claudia O.
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name part: Gomes da Silva, Hugo
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name part: Jaitly, Seema
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  role term: VerfasserIn
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name part: Miller, Benjamin
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  role term: VerfasserIn
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name part: Milligan, Claire
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  role term: aut

name part: Tavenard, Aude
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  role term: aut

name part: Kowdley, Kris V.
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  role term: aut

place:
  place term: xx
date issued: 2026
issuance: monographic

language term: eng

form: remote
extent: Illustrationen
extent: 12

topic: cholestatic diseases

topic: clinical trial

topic: elafibranor

topic: liver disease

topic: primary sclerosing cholangitis

title info:
  title: Journal of hepatology
name:
  name part: Safety and efficacy of elafibranor in primary sclerosing cholangitis the ELMWOOD phase II randomized-controlled trial
origin info:
  publisher: Amsterdam [u.a.] : Elsevier Science, 1985
physical description:
  extent: Online-Ressource
identifier: 1600-0641
identifier: (DE-627)320984486
identifier: (DE-600)2027112-8
identifier: (DE-576)093888856
part:
  text: 84(2026), 1 vom: Jan., Seite 74-85

name:
  name part: Safety and efficacy of elafibranor in primary sclerosing cholangitis the ELMWOOD phase II randomized-controlled trial
part:
  text: volume:84
part:
  text: year:2026
part:
  text: number:1
part:
  text: month:01
part:
  text: pages:74-85
part:
  text: extent:12

record content source: DE-627
record creation date: 260407
record change date: 20260408094218.0
record identifier: 1968024298
language of cataloging:
  language term: ger