Evaluating efruxifermin for patients with compensated cirrhosis due to NASH/MASH

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial is a multi-center, randomized, double-blind, placebo-controlled evaluation of efruxifermin (EFX) in subjects diagnosed with compensated cirrhosis resulting from nonalcoholic steatohepatitis (NASH) or metabolic dysfunction-associated steatohepatitis (MASH). The study aims to assess the efficacy and safety of EFX compared to a placebo in improving liver health in affected patients. Participants will be monitored for changes in liver function and overall health outcomes throughout the trial.

Why it matters

Who can join: the full rules

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.

Where it's running

• Akero Clinical Study Site
  Birmingham, Alabama, United States Recruiting
• Akero Clinical Study Site
  Dothan, Alabama, United States Recruiting
• Akero Clinical Study Site
  Chandler, Arizona, United States Recruiting
• Akero Clinical Study Site
  Peoria, Arizona, United States Recruiting
• Akero Clinical Study Site
  Scottsdale, Arizona, United States Recruiting
• Akero Clinical Study Site
  Tucson, Arizona, United States Recruiting

+295 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Akero Study Director
• Email: AkeroSynchrony@akerotx.com
• Phone: 650-487-6488

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.