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

Study on Investigational Medicine for Liver Disease

R
Raj Vuppalanchi, MD

Primary Investigator

Enrolling By Invitation
18 years - 80 years
All
Phase 3
1 participants needed
2 Locations

Brief description of study

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.

THIS STUDY IS ENROLLING BY INVITATION ONLY

Detailed description of study

PRIMARY OUTCOME:

  • Time from randomization to first occurrence of disease progression as measured by composite of protocol-specified clinical events
  • Cohort 1 only: ≥ 1 stage improvement in fibrosis and no worsening of steatohepatitis

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Metabolic Dysfunction-Associated Steatohepatitis, MASH, Nonalcoholic Steatohepatitis, NASH
  • Age: 18 years - 80 years
  • Gender: All

Inclusion Criteria:

  • Cohort 1: Biopsy proven compensated cirrhosis (fibrosis stage 4) due to NASH/MASH
  • 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

This study investigates the safety and effectiveness of an investigational medication in people with compensated cirrhosis caused by NASH/MASH. Cirrhosis is a condition where the liver becomes scarred and cannot work properly. NASH/MASH stands for non-alcoholic steatohepatitis and metabolic dysfunction-associated steatohepatitis, which are liver diseases that cause inflammation and scarring.

Participants will be randomly assigned to receive either the investigational medication or a placebo. A placebo is an inactive substance that looks like the investigational medicine but does not contain any medicine. The study will measure how the medication affects liver health and if it can prevent the liver from getting worse.

  • Who can participate: Adults with biopsy-proven or non-invasively diagnosed compensated cirrhosis due to NASH/MASH can participate. People with other liver diseases or diabetes, like Type 1 diabetes or unstable Type 2 diabetes, are not eligible.
  • Study details: Participants will receive either the investigational medication or a placebo. They will be monitored to see if the investigational medication improves liver health without worsening liver inflammation.
Updated on 23 Dec 2025. Study ID: GI-AKERO-AK-US-001-0106, 28974
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Interested in the study?

This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.

Accepting Referrals by Invitation Only