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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: NASH - Nonalcoholic Steatohepatitis, MASH - Metabolic Dysfunction-Associated Steatohepatitis

In brief

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.

Key facts

Study ID

NCT06528314

Run by

Akero Therapeutics, Inc

People needed

2150

Starts

2024-09-04

Expected to finish

2030-03-01

Last updated by the study team

2026-07-16

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Cohort 1: Biopsy proven compensated cirrhosis (fibrosis stage 4) due to NASH/MASH and NAS score of >=3 (at least 1 in each category) or evidence of steatosis and 2 current features of metabolic comorbidities
• Cohort 2: Biopsy proven or non-invasively diagnosed compensated cirrhosis (fibrosis stage 4) due to NASH/MASH

You may not qualify if…

• Other causes of liver disease based on medical history and/or liver histology and/or central laboratory results
• Type 1 diabetes or unstable Type 2 diabetes
• Any current or prior history of decompensated liver disease
• Other inclusion and exclusion criteria may apply.

Where it is running

• Akero Clinical Study Site — Sacramento, California, United States (enrolling)
• Akero Clinical Study Site — San Francisco, California, United States (enrolling)
• Akero Clinical Study Site — Dothan, Alabama, United States (enrolling)
• Akero Clinical Study Site — Birmingham, Alabama, United States (enrolling)
• Akero Clinical Study Site — Chandler, Arizona, United States (enrolling)
• Akero Clinical Study Site — Tucson, Arizona, United States (enrolling)
• Akero Clinical Study Site — Tucson, Arizona, United States (enrolling)
• Akero Clinical Study Site — Tucson, Arizona, United States (enrolling)
• Akero Clinical Study Site — Tucson, Arizona, United States (enrolling)
• Akero Clinical Study Site — Peoria, Arizona, United States (enrolling)
• Akero Clinical Study Site — Scottsdale, Arizona, United States (enrolling)
• Akero Clinical Study Site — Little Rock, Arkansas, United States (enrolling)
• Akero Clinical Study Site — North Little Rock, Arkansas, United States (enrolling)
• Akero Clinical Study Site — Coronado, California, United States (enrolling)
• Akero Clinical Study Site — Escondido, California, United States (enrolling)
• Akero Clinical Study Site — Folsom, California, United States (enrolling)
• Akero Clinical Study Site — Fountain Valley, California, United States (enrolling)
• Akero Clinical Study Site — Lancaster, California, United States (enrolling)
• Akero Clinical Study Site — Long Beach, California, United States (enrolling)
• Akero Clinical Study Site — Los Angeles, California, United States (enrolling)
• Akero Clinical Study Site — Newport Beach, California, United States (enrolling)
• Akero Clinical Study Site — Orange, California, United States (enrolling)
• Akero Clinical Study Site — Pasadena, California, United States (enrolling)
• Akero Clinical Study Site — Redwood City, California, United States (enrolling)
• Akero Clinical Study Site — San Francisco, California, United States (enrolling)

Full record on ClinicalTrials.gov

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