A Study of Efruxifermin for Cirrhosis Due to NASH/MASH

This study is evaluating efruxifermin in people with compensated cirrhosis (advanced scarring of the liver) caused by NASH (Nonalcoholic Steatohepatitis) or MASH (Metabolic Dysfunction-Associated Steatohepatitis). You may be able to join if you are between 18 and 80 years old and have biopsy-proven or non-invasively diagnosed compensated cirrhosis due to NASH/MASH. The study will compare efruxifermin to a placebo (an inactive substance) given by injection under the skin. Researchers want to see if efruxifermin can delay serious liver-related events over 5 years. For some participants, they will also look for improvement in liver scarring without worsening of steatohepatitis (liver inflammation and fat) after 96 weeks. The current recruitment status is unclear, but the study plans to enroll 2150 participants.

Study design
This is a randomized, double-blind, placebo-controlled study, meaning participants are randomly assigned to receive either efruxifermin or a placebo, and neither you nor your doctor will know which you are receiving. The study aims to enroll 2150 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 5 years to track significant clinical events. For some participants, liver changes will be assessed at 96 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06528314

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

Recruiting
PHASE3Ages 18–80InterventionalTreatment
Akero Therapeutics, Inc
~2,150 participants
Updated 2026-09-08 on ClinicalTrials.gov
What's tested:EfruxiferminPlacebo

At a glance

Recruiting sites
310 of 331 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Time from randomization to the first significant clinical event including disease progression, liver decompensation events, etc.
Measured over 5 years
+1 more outcome measured
NASH - Nonalcoholic Steatohepatitis
MASH - Metabolic Dysfunction-Associated Steatohepatitis

NCT06528314

Where you'd take part

This study runs at 331 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Akero Clinical Study Site

    Birmingham, Alabamano site contact published

    Recruiting

  • Akero Clinical Study Site

    Dothan, Alabamano site contact published

    Recruiting

  • Akero Clinical Study Site

    Chandler, Arizonano site contact published

    Recruiting

  • Akero Clinical Study Site

    Peoria, Arizonano site contact published

    Recruiting

  • Akero Clinical Study Site

    Scottsdale, Arizonano site contact published

    Recruiting

  • Akero Clinical Study Site

    Tucson, Arizonano site contact published

    Recruiting

  • Akero Clinical Study Site

    Tucson, Arizonano site contact published

    Recruiting

  • Akero Clinical Study Site

    Tucson, Arizonano site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Opens a ready-to-send draft in your own email app — review before sending.

Want this trial checked against your situation?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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
  • Time from randomization to the first significant clinical event including disease progression, liver decompensation events, etc.5 years

    Measured by composite of protocol-specified clinical events

  • Cohort 1 only: Proportion of subjects with ≥ 1 stage improvement in fibrosis and no worsening of steatohepatitis96 Weeks

    Based on NASH CRN fibrosis score (scored by a fibrosis score of 0-4, where 0 = no fibrosis, 1 = centrilobular pericellular fibrosis, 2 = centrilobular and periportal fibrosis, 3 = bridging fibrosis, 4 = cirrhosis)