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Phase 3Recruiting

A Study Evaluating Efruxifermin in Subjects With Compensated Cirrhosis Due to NASH/MASH

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Efruxifermin in Subjects With Compensated Cirrhosis Due to NASH/MASH

Sponsor
Akero Therapeutics, Inc (Industry)
Enrolment
2,150 planned
Conditions
NASH - Nonalcoholic Steatohepatitis; MASH - Metabolic Dysfunction-Associated Steatohepatitis
Interventions
Efruxifermin; Placebo
Ages
adults, older adults
Registry
NCT06528314

Full record on ClinicalTrials.gov

From the registry

This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study in subjects with compensated cirrhosis due to NASH/MASH.

Primary outcomes

  • Time from randomization to the first significant clinical event including disease progression, liver decompensation events, etc.
  • Cohort 1 only: Proportion of subjects with ≥ 1 stage improvement in fibrosis and no worsening of steatohepatitis

History

  1. Study completion expected

  2. Primary completion expected

  3. Last registry update

  4. Started

  5. Registered