A Study of Efruxifermin in Subjects With Histologically Confirmed Nonalcoholic Steatohepatitis (NASH)

• Status: Active, not recruiting
• Trial end date: 2021-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study administered for 16 weeks in subjects with biopsy proven F1 - F4 NASH.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Akero Therapeutics, Inc

Criteria

Key Inclusion Criteria:

• Males and non-pregnant, non-lactating females between 18 - 80 years of age inclusive, based on the date of the screening visit.

• Main Study only: Body mass index (BMI) > 25 kg/m^2 (unless the patient has biopsy-proven NASH documented within the last 2 years).

• Main Study only: Must have confirmation of ≥ 10% liver fat content on MRI-PDFF at screening.

• Main Study only: Biopsy-proven NASH. Must have had a liver biopsy within 180 days of randomization with fibrosis stage 1 to 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 C only: FibroScan® measurement > 13.1 kPa.

• Cohort C only: Cirrhosis due to NASH. Liver biopsy consistent with F4 fibrosis according to the NAS system, confirmed by the central or local reader.

Exclusion Criteria:

• Weight gain or loss > 5% in the 3 months prior to randomization or > 10% in the 6 months prior to screening.

• Type 1 and insulin-dependent Type 2 diabetes.

• Poorly controlled hypertension (blood pressure > 160/100).