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Study of Efruxifermin for NASH/MASH with Fibrosis

This study is evaluating a drug called efruxifermin for people with non-cirrhotic Nonalcoholic Steatohepatitis (NASH) or Metabolic Dysfunction-Associated Steatohepatitis (MASH) and liver scarring (fibrosis). Researchers want to see if efruxifermin can help resolve NASH/MASH and improve liver scarring. You might be eligible if you are between 18 and 80 years old, have a history of metabolic syndrome or type 2 diabetes, and have biopsy-proven NASH/MASH with moderate to severe fibrosis (F2 or F3). The study is comparing efruxifermin to a placebo (an inactive substance) and plans to enroll about 1650 participants. The study is currently ongoing, but its exact status is unclear.

Study design
This is a Phase 3, multi-center, randomized, double-blind, placebo-controlled study involving approximately 1650 participants.
What's involved
You would participate in a screening period (up to 12 weeks), a treatment period (52 or 96 weeks depending on your group), and long-term follow-up for up to 240 weeks.
Compensation
Not stated in the trial record.
Follow-up
Participants will have long-term follow-up for up to approximately 240 weeks total treatment duration, with a follow-up visit about 30 days after the last treatment.

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

NCT06215716

A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis

Recruiting
PHASE3Ages 18–80InterventionalTreatment
Akero Therapeutics, Inc
~1,650 participants
Updated 2026-08-07 on ClinicalTrials.gov
What's tested:EfruxiferminPlacebo

At a glance

Recruiting sites
319 of 356 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Cohort 1 Only: Resolution of NASH/MASH and a ≥ 1 stage improvement in fibrosis
Measured over 52 Weeks
+1 more outcome measured

Conditions

NASH With Fibrosis
MASH With Fibrosis

Explore related trials

Nonalcoholic Steatohepatitis

NCT06215716

Where you'd take part

This study runs at 356 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

    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

  • 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.

Who to contact

Akero Study Director
[email protected]
650-487-6488
Email the study team

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Eligibility criteria

Inclusion

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).
Cohort 2: Biopsy-proven fibrosis stage 3. Must have had a liver biopsy obtained ≤ 180 days prior to screening. Subjects with NAS \<4 may be enrolled and are not required to meet 1 point in each of the components of NAS.

Exclusion

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.

What this trial measures

  • Cohort 1 Only: Resolution of NASH/MASH and a ≥ 1 stage improvement in fibrosis52 Weeks

    Based on NAS (scored by 0-3 for steatosis, 0-3 for inflammation, and 0-2 for ballooning) and NASH CRN fibrosis score (scored by a fibrosis score of 0-4, where 0 = no fibrosis, 1 = perisinusoidal or periportal fibrosis, 2 = perisinusoidal and portal/periportal fibrosis, 3 = bridging fibrosis, 4 = cirrhosis)

  • Event-free survival240 Weeks

    Based on time from randomization to the first clinical event including evidence of disease progression, liver decompensation events, liver transplantation or eligibility for liver transplantation, and all-cause mortality.