RecruitingNASH With FibrosisMASH With Fibrosis

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

Eligible age

18–80 yrs

Accepts

All genders

Locations

34 states

Healthy volunteers

See if you qualify for this study

Answer a few quick questions about your location and health. Takes about a minute.

Check my eligibility →

About this study

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.

Sponsor: Akero Therapeutics, Inc

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.