A Study of Efruxifermin in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH) (Symmetry)

• Status: Recruiting
• Trial end date: 2024-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study in cirrhotic subjects with biopsy-proven F4 compensated NASH.

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

Details

• Lead Sponsor: Akero Therapeutics, Inc

Criteria

Inclusion Criteria:

• Males and non-pregnant, non-lactating females between 18-75 years of age inclusive, based on the date of signing informed consent.

• Previous history or presence of Type 2 diabetes or 2 out of 4 components of metabolic syndrome (obesity, dyslipidemia, elevated blood pressure, elevated fasting glucose).

• Biopsy-proven compensated cirrhosis due to NASH.

Exclusion Criteria:

• Weight loss > 10% in the 3 months prior to screening until randomization or from the time of collection of the liver biopsy used to assess subject eligibility until randomization, whichever is longer.

• Type 1 diabetes or uncontrolled Type 2 diabetes

Other inclusion and exclusion criteria may apply