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A Phase 2B Randomized Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of BMS-986036 (PEG-FGF21) in Adults With Nonalcoholic Steatohepatitis (NASH) and Stage 3 Liver Fibrosis

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Trial Profile

A Phase 2B Randomized Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of BMS-986036 (PEG-FGF21) in Adults With Nonalcoholic Steatohepatitis (NASH) and Stage 3 Liver Fibrosis

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 29 Dec 2023

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At a glance

  • Drugs Pegbelfermin (Primary)
  • Indications Hepatic fibrosis; Non-alcoholic steatohepatitis
  • Focus Therapeutic Use
  • Acronyms FALCON 1
  • Sponsors Bristol-Myers Squibb

    • Most Recent Events

    • 14 Nov 2023 Results of an analysis describing limitations of conventional histological examination, fibrosis changes and drug-induced effects using biopsy slide samples obtained from this trial presented at The Liver Meeting 2023: 74th Annual Meeting of the American Association for the Study of Liver Diseases
    • 14 Nov 2023 Results of exploratory post-hoc analysis using FibroNest digital pathology to identify fibrosis traits of treatment, and dose response from this study, presented at The Liver Meeting 2023: 74th Annual Meeting of the American Association for the Study of Liver Diseases
    • 14 Nov 2023 Results obtaining biopsy slide from NCT03486899and NCT03486912, investigating the possibility to overcome this limitation using multi parametric measurements like Somalogic (a biomarker) and qFibrosis (AI histology), presented at The Liver Meeting 2023: 74th Annual Meeting of the American Association for the Study of Liver Diseases

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