A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis
Recruiting now Phase 3 NCT06215716
Run by Akero Therapeutics, Inc · for 18 to 80 · All sexes
What this study is about
This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study in subjects with non-cirrhotic NASH/MASH and fibrosis stage 2 or 3 (F2 or F3). The study will enroll subjects in two cohorts for a total samples size of 1650 subjects.
Who can join (things the study team will check)
✅ You may be able to join if…
- 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.
🚫 You may not be able to join if…
- 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 this trial is running
- Akero Clinical Study Site, Birmingham, Alabama, United States
- Akero Clinical Study Site, Dothan, Alabama, United States
- Akero Clinical Study Site, Chandler, Arizona, United States
- Akero Clinical Study Site, Flagstaff, Arizona, United States
- Akero Clinical Study Site, Peoria, Arizona, United States
- Akero Clinical Study Site, Tucson, Arizona, United States
- Akero Clinical Study Site, Tucson, Arizona, United States
- Akero Clinical Study Site, Tucson, Arizona, United States
- Akero Clinical Study Site, Tucson, Arizona, United States
- Akero Clinical Study Site, Conway, Arkansas, United States
- Akero Clinical Study Site, Jonesboro, Arkansas, United States
- Akero Clinical Study Site, Little Rock, Arkansas, United States
+ 344 more sites.
Who to contact
Akero Study Director · 650-487-6488 · AkeroSynchrony@akerotx.com
It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT06215716.
Verify everything on the official ClinicalTrials.gov record. Page updated July 2026.
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