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Phase 3Recruiting

A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis

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

Sponsor
Akero Therapeutics, Inc (Industry)
Enrolment
1,650 planned
Conditions
NASH With Fibrosis; MASH With Fibrosis
Interventions
Efruxifermin; Placebo
Ages
adults, older adults
Registry
NCT06215716

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 non-cirrhotic NASH/MASH and fibrosis stage 2 or 3 (F2 or F3). The study will enroll subjects in two cohorts for a total samples size of 1650 subjects.

Primary outcomes

  • Cohort 1 Only: Resolution of NASH/MASH and a ≥ 1 stage improvement in fibrosis
  • Event-free survival

History

  1. Primary completion expected

  2. Last registry update

  3. Registered

  4. Started