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A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis

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Trial Profile

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 31 May 2025

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At a glance

  • Drugs Efruxifermin (Primary)
  • Indications Fatty liver; Fibrosis; Non-alcoholic steatohepatitis
  • Focus Registrational; Therapeutic Use
  • Acronyms SYNCHRONY Histology
  • Sponsors Akero Therapeutics

Most Recent Events

  • 08 Nov 2024 According to a Akero Therapeutics media release, The primary histology endpoint (Cohort 1 only), to support an application for accelerated approval, is the proportion of patients experiencing >/= 1-stage fibrosis improvement AND resolution of MASH after 52 weeks of treatment.
  • 08 Nov 2024 According to a Akero Therapeutics media release, the increases in RnD expenses in 2024 were attributable to higher expenses associated with the ongoing SYMMETRY study, the ongoing Phase 3 SYNCHRONY Histology and Real-World studies, initiation of the Phase 3 SYNCHRONY Outcomes study, and manufacture of clinical supplies for Phase 3.
  • 08 Nov 2024 According to a Akero Therapeutics media release, company's current cash, cash equivalents, and short- and long-term marketable securities will be sufficient to fund its Phase 3 SYNCHRONY Histology and Real-World studies through readout of their respective primary endpoints.

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