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Evaluating efruxifermin for treating NASH/MASH with 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

Phase 3 Interventional Akero Therapeutics, Inc · NCT06215716

This study is testing a new medication called efruxifermin to see if it can help people with NASH or MASH and liver fibrosis feel better compared to a placebo.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment1650 (estimated)
Ages18 Years to 80 Years
SexAll
SponsorAkero Therapeutics, Inc Industry-sponsored
Locations349 sites (Birmingham, Alabama and 348 other locations)
Trial IDNCT06215716 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 non-cirrhotic nonalcoholic steatohepatitis (NASH) or metabolic dysfunction-associated steatohepatitis (MASH) who have fibrosis stages 2 or 3. The study aims to enroll a total of 1650 participants across two cohorts, focusing on the efficacy and safety of EFX compared to a placebo. Participants will undergo a liver biopsy to confirm their condition and assess the severity of fibrosis and liver inflammation.

Who should consider this trial

Good fit: Ideal candidates are males and non-pregnant, non-lactating females aged 18 to 80 with biopsy-proven NASH/MASH and fibrosis stages 2 or 3.

Not a fit: Patients with cirrhosis or those with uncontrolled Type 1 or Type 2 diabetes may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve liver health and metabolic conditions for patients with NASH/MASH and fibrosis.

How similar studies have performed: Other studies have shown promise in treating NASH/MASH with similar pharmacological approaches, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Males and non-pregnant, non-lactating females between 18 - 80 years of age inclusive, based on the date of the screening visit.
* Previous history or presence of 2 out of 4 components of metabolic syndrome (obesity, dyslipidemia, elevated blood pressure, elevated fasting glucose) or type 2 diabetes.
* Cohort 1: Biopsy-proven NASH/MASH. Must have had a liver biopsy obtained ≤ 180 days prior to screening with fibrosis stage 2 or 3 and a non-alcoholic fatty liver disease (NAFLD) activity score (NAS) of ≥ 4 with at least a score of 1 in each of the following NAS components:

  * Steatosis (scored 0 to 3),
  * Ballooning degeneration (scored 0 to 2), and
  * Lobular inflammation (scored 0 to 3).

Exclusion Criteria:

* Other causes of liver disease based on medical history and/or liver histology and/or central laboratory results.
* Presence of cirrhosis on liver biopsy (fibrosis stage 4).
* Type 1 or uncontrolled Type 2 diabetes.

Other inclusion and exclusion criteria may apply.

Where this trial is running

Birmingham, Alabama and 348 other locations

+299 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 With FibrosisMASH With Fibrosis
Last reviewed 2026-06-09 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.