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

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a study on Nonalcoholic Steatohepatitis Steatohepatitis Cirrhosis Liver Disease Nonalcoholic Fatty Liver Disease

Summary

Eligibility
for people ages 18-80 (full criteria)
Location
at Sacramento, California and other locations
Dates
study started
study ends around

Description

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.

Official Title

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Efruxifermin in Subjects With Compensated Cirrhosis Due to NASH/MASH

Keywords

NASH - Nonalcoholic Steatohepatitis, MASH - Metabolic Dysfunction-Associated Steatohepatitis, Non-alcoholic Fatty Liver Disease, Efruxifermin, EFX 50 mg

Eligibility

You can join if…

Open to people ages 18-80

  • 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

You CAN'T join if...

  • 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.

Locations

  • Akero Clinical Study Site accepting new patients
    Sacramento California 95817 United States
  • Akero Clinical Study Site accepting new patients
    Folsom California 95630 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Akero Therapeutics, Inc
Links
Sign up for this study
ID
NCT06528314
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 2150 study participants
Last Updated
Contact us about this trial