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Evaluation of Efficacy, Safety and Tolerability of NGM282 (Aldafermin) in a Phase 2b, Randomized, Double-blind, Placebo-controlled, Multi-center Study in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (ALPINE 4)

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Trial Profile

Evaluation of Efficacy, Safety and Tolerability of NGM282 (Aldafermin) in a Phase 2b, Randomized, Double-blind, Placebo-controlled, Multi-center Study in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (ALPINE 4)

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 28 Dec 2023

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At a glance

  • Drugs Aldafermin (Primary)
  • Indications Non-alcoholic steatohepatitis
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms ALPINE 4
  • Sponsors NGM Biopharmaceuticals

    • Most Recent Events

    • 14 Nov 2023 Primary endpoint results presented at The Liver Meeting 2023: 74th Annual Meeting of the American Association for the Study of Liver Diseases
    • 13 Nov 2023 Results presented in an NGM Biopharmaceuticals media release.
    • 13 Nov 2023 According to an NGM Biopharmaceuticals media release, today shared positive, comprehensive results from its Phase 2b ALPINE 4 trial of aldafermin, an engineered FGF19 analog product candidate, in patients with compensated cirrhosis (liver fibrosis stage 4 or F4) due to NASH in an oral plenary presentation at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting.

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