NCT06215716

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,650 (estimated)
• Sponsor: Akero Therapeutics, Inc · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• NASH With Fibrosis
• MASH With Fibrosis

Interventions

Type	Name	Description
DRUG	Efruxifermin	Administered by subcutaneous injection
DRUG	Placebo	Administered by subcutaneous injection

Timeline

• Start date: 2023-12-01
• Primary completion: 2032-11-01
• Completion: 2032-11-01
• First posted: 2024-01-22
• Last updated: 2026-04-17

Locations

349 sites across 18 countries: United States, Argentina, Australia, Canada, France, Germany, India, Israel, Italy, Mexico, Poland, Puerto Rico, South Korea, Spain, Switzerland, Taiwan, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study