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Clinical Trials in France / NCT06528314
Recruiting Phase 3

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

NCT06528314 · tracked via the Priya Life Science France tracker
Sponsor
Akero Therapeutics, Inc
Phase
Phase 3
Started
2024-09-04
Last updated
2026-09-21

Condition(s) studied

NASH - Nonalcoholic SteatohepatitisMASH - Metabolic Dysfunction-Associated Steatohepatitis

Investigational drug(s) / intervention(s)

Efruxifermin →Placebo

Efruxifermin: Administered by subcutaneous injection

Placebo: Administered by subcutaneous injection

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • 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 steatohepatitis — 96 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)

Trial sites (331)

FacilityCityRegionStatus
Akero Clinical Study Site Birmingham Alabama Recruiting
Akero Clinical Study Site Dothan Alabama Recruiting
Akero Clinical Study Site Chandler Arizona Recruiting
Akero Clinical Study Site Flagstaff Arizona Completed
Akero Clinical Study Site Peoria Arizona Recruiting
Akero Clinical Study Site Scottsdale Arizona Recruiting
Akero Clinical Study Site Tucson Arizona Recruiting
Akero Clinical Study Site Tucson Arizona Recruiting
Akero Clinical Study Site Tucson Arizona Recruiting
Akero Clinical Study Site Tucson Arizona Recruiting
Akero Clinical Study Site Conway Arkansas Completed
Akero Clinical Study Site Jonesboro Arkansas Completed
Akero Clinical Study Site Little Rock Arkansas Recruiting
Akero Clinical Study Site North Little Rock Arkansas Recruiting
Akero Clinical Study Site Coronado California Recruiting
Akero Clinical Study Site Escondido California Recruiting
Akero Clinical Study Site Folsom California Recruiting
Akero Clinical Study Site Fountain Valley California Recruiting
Akero Clinical Study Site Lancaster California Recruiting
Akero Clinical Study Site Long Beach California Recruiting
Akero Clinical Study Site Los Angeles California Recruiting
Akero Clinical Study Site Newport Beach California Recruiting
Akero Clinical Study Site Orange California Recruiting
Akero Clinical Study Site Pasadena California Recruiting
Akero Clinical Study Site Redwood City California Recruiting
Akero Clinical Study Site Sacramento California Recruiting
Akero Clinical Study Site San Francisco California Recruiting
Akero Clinical Study Site San Francisco California Recruiting
Akero Clinical Study Site San Jose California Recruiting
Akero Clinical Study Site Tarzana California Recruiting
Akero Clinical Study Site Aurora Colorado Recruiting
Akero Clinical Study Site Colorado Springs Colorado Recruiting
Akero Clinical Study Site Englewood Colorado Recruiting
Akero Clinical Study Site New Haven Connecticut Recruiting
Akero Clinical Study Site Washington D.C. District of Columbia Recruiting
Akero Clinical Study Site Bradenton Florida Recruiting
Akero Clinical Study Site Brandon Florida Recruiting
Akero Clinical Study Site Cutler Bay Florida Recruiting
Akero Clinical Study Site Daytona Beach Florida Recruiting
Akero Clinical Study Site Doral Florida Recruiting

+ 291 more sites — see the full list on the official registry below.

More Akero Therapeutics, Inc trials in France

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

Other trials for the same condition

The European NAFLD Registry Recruiting
LITMUS Imaging Study Active, not recruiting
Evaluation of a New Ultrasound System for the Non-invasive Assessment of Liver Steatosis in MASLD/MASH Patients Recruiting
A Phase 3 Study Evaluating Efficacy and Safety of Lanifibranor Followed by an Active Treatment Extension in Adult Patients With (NASH) and Fibrosis Stages F2 and F3 ( NATiV3 ) Active, not recruiting
A Randomized Controlled Study Evaluating Bariatric Surgery as a Treatment for Severe NASH With Advanced Liver Fibrosis in Non-severe Obese Patients Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06528314 on ClinicalTrials.gov ↗ ← All trials in France