A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: NASH With Fibrosis, MASH With Fibrosis

In brief

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.

Key facts

Study ID

NCT06215716

Run by

Akero Therapeutics, Inc

People needed

1650

Starts

2023-12-01

Expected to finish

2033-02-01

Last updated by the study team

2026-08-07

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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 it is running

• Akero Clinical Study Site — Redwood City, California, United States (enrolling)
• Akero Clinical Study Site — Sacramento, California, United States (enrolling)
• Akero Clinical Study Site — Newport Beach, California, United States (enrolling)
• Akero Clinical Study Site — Pasadena, California, United States (enrolling)
• Akero Clinical Study Site — Tucson, Arizona, United States (enrolling)
• Akero Clinical Study Site — Chandler, Arizona, United States (enrolling)
• Akero Clinical Study Site — Tucson, Arizona, United States (enrolling)
• Akero Clinical Study Site — Dothan, Alabama, United States (enrolling)
• Akero Clinical Study Site — Orange, California, United States (enrolling)
• Akero Clinical Study Site — Palm Springs, California, United States (enrolling)
• Akero Clinical Study Site — Little Rock, Arkansas, United States (enrolling)
• Akero Clinical Study Site — North Little Rock, Arkansas, United States (enrolling)
• Akero Clinical Study Site — Tucson, Arizona, United States (enrolling)
• Akero Clinical Study Site — Coronado, California, United States (enrolling)
• Akero Clinical Study Site — Escondido, California, United States (enrolling)
• Akero Clinical Study Site — Folsom, California, United States (enrolling)
• Akero Clinical Study Site — Inglewood, California, United States (enrolling)
• Akero Clinical Study Site — Tucson, Arizona, United States (enrolling)
• Akero Clinical Study Site — Peoria, Arizona, United States (enrolling)
• Akero Clinical Study Site — Lancaster, California, United States (enrolling)
• Akero Clinical Study Site — Long Beach, California, United States (enrolling)
• Akero Clinical Study Site — Birmingham, Alabama, United States (enrolling)
• Akero Clinical Study Site — Los Angeles, California, United States (enrolling)
• Akero Clinical Study Site — Los Angeles, California, United States (enrolling)
• Akero Clinical Study Site — San Diego, California, United States (enrolling)

Full record on ClinicalTrials.gov

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