RecruitingPhase 3

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

United States2,150 participantsStarted 2024-09-04

Plain-language summary

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.

Who can participate

Age range18 Years – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

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

Timeframe: 5 years

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

Timeframe: 96 Weeks

Trial details

NCT IDNCT06528314

SponsorAkero Therapeutics, Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2030-02

Contact for this trial

Akero Study Director

650-487-6488 AkeroSynchrony@akerotx.com

View on ClinicalTrials.gov More NASH - Nonalcoholic Steatohepatitis trials