Evaluating efruxifermin for treating NASH/MASH with fibrosis

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 non-cirrhotic nonalcoholic steatohepatitis (NASH) or metabolic dysfunction-associated steatohepatitis (MASH) who have fibrosis stages 2 or 3. The study aims to enroll a total of 1650 participants across two cohorts, focusing on the efficacy and safety of EFX compared to a placebo. Participants will undergo a liver biopsy to confirm their condition and assess the severity of fibrosis and liver inflammation.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Males and non-pregnant, non-lactating females between 18 - 80 years of age inclusive, based on the date of the screening visit.
* Previous history or presence of 2 out of 4 components of metabolic syndrome (obesity, dyslipidemia, elevated blood pressure, elevated fasting glucose) or type 2 diabetes.
* Cohort 1: Biopsy-proven NASH/MASH. Must have had a liver biopsy obtained ≤ 180 days prior to screening with fibrosis stage 2 or 3 and a non-alcoholic fatty liver disease (NAFLD) activity score (NAS) of ≥ 4 with at least a score of 1 in each of the following NAS components:

  * Steatosis (scored 0 to 3),
  * Ballooning degeneration (scored 0 to 2), and
  * Lobular inflammation (scored 0 to 3).
* Cohort 2: Biopsy-proven fibrosis stage 3. Must have had a liver biopsy obtained ≤ 180 days prior to screening. Subjects with NAS \<4 may be enrolled and are not required to meet 1 point in each of the components of NAS.

Exclusion Criteria:

* Other causes of liver disease based on medical history and/or liver histology and/or central laboratory results.
* Presence of cirrhosis on liver biopsy (fibrosis stage 4).
* Type 1 or uncontrolled Type 2 diabetes.

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
  Tucson, Arizona, United States Recruiting
• Akero Clinical Study Site
  Tucson, Arizona, United States Recruiting

+311 more sites. See ClinicalTrials.gov for the full list.

Study contacts

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

Similar studies

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.