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Evaluating efruxifermin for patients 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

Phase 3 Interventional Akero Therapeutics, Inc · NCT06528314

This study is testing a new medication called efruxifermin to see if it can improve liver health in people with compensated cirrhosis caused by NASH or MASH.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment2150 (estimated)
Ages18 Years to 80 Years
SexAll
SponsorAkero Therapeutics, Inc Industry-sponsored
Locations318 sites (Birmingham, Alabama and 317 other locations)
Trial IDNCT06528314 on ClinicalTrials.gov

What this trial studies

This clinical trial is a multi-center, randomized, double-blind, placebo-controlled evaluation of efruxifermin (EFX) in subjects diagnosed with compensated cirrhosis resulting from nonalcoholic steatohepatitis (NASH) or metabolic dysfunction-associated steatohepatitis (MASH). The study aims to assess the efficacy and safety of EFX compared to a placebo in improving liver health in affected patients. Participants will be monitored for changes in liver function and overall health outcomes throughout the trial.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals with biopsy-proven or non-invasively diagnosed compensated cirrhosis (fibrosis stage 4) specifically due to NASH or MASH.

Not a fit: Patients with other causes of liver disease, unstable diabetes, or a history of decompensated liver disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve liver health and quality of life for patients with compensated cirrhosis due to NASH/MASH.

How similar studies have performed: While this approach is being evaluated in this specific context, similar studies targeting liver conditions have shown promise, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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

Exclusion Criteria:

* 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 this trial is running

Birmingham, Alabama and 317 other locations

+268 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions NASH - Nonalcoholic SteatohepatitisMASH - Metabolic Dysfunction-Associated Steatohepatitis
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.