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A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Efficacy and Safety of Elafibranor in Patients With Nonalcoholic Steatohepatitis (NASH) and Fibrosis

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Trial Profile

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Efficacy and Safety of Elafibranor in Patients With Nonalcoholic Steatohepatitis (NASH) and Fibrosis

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 12 Dec 2023

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At a glance

  • Drugs Elafibranor (Primary)
  • Indications Fibrosis; Non-alcoholic steatohepatitis
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms RESOLVE-IT
  • Sponsors Genfit

    • Most Recent Events

    • 15 Nov 2023 Results comparing the performance of screening pathways that incorporate NIS2+, an optimized version of the blood-based NIS4 technology designed to identify at-risk MASH, with those incorporating fibrosis (FIB)-4 within the RESOLVE-IT clinical trial (NCT02704403), aiming for optimal selection of patients for liver biopsy, published in the Journal of Hepatology.
    • 14 Nov 2023 Results assessing the effect of body mass index on non-invasive tests and assess their clinical reliability across the body mass index spectrum, presented at The Liver Meeting 2023: 74th Annual Meeting of the American Association for the Study of Liver Diseases.
    • 14 Nov 2023 Results assessing the performance of a sequential use of FIB-4 (for ruling-out F4 patients) followed by NIS2+ (for ruling-in at-risk NASH) to optimize the screening of NASH trials, presented at The Liver Meeting 2023: 74th Annual Meeting of the American Association for the Study of Liver Diseases.

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