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

Completed · Phase 2 · Has a placebo group

Conditions studied: NASH - Nonalcoholic Steatohepatitis

In brief

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.

Key facts

Study ID

NCT05039450

Run by

Akero Therapeutics, Inc

People needed

213

Starts

2021-07-30

Expected to finish

2025-08-28

Last updated by the study team

2026-07-21

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males and non-pregnant, non-lactating females between 18-75 years of age inclusive, based on the date of signing informed consent.
• Main Study Only: 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).
• Main Study Only: Biopsy-proven compensated cirrhosis due to NASH.
• Cohort D Only: Diagnosis of type 2 diabetes
• Cohort D Only: Use of GLP-1R agonist for at least 90 days
• Cohort D Only: Biopsy-proven liver fibrosis stages 1, 2, or 3

You may not qualify if…

• Main Study Only: Weight loss > 10% in the 90 days 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
• Cohort D Only: Weight loss > 5% in the 90 days prior to screening
• Cohort D Only: Presence of cirrhosis on liver biopsy
• Other inclusion and exclusion criteria may apply

Where it is running

• Akero Clinical Study Site — Chandler, Arizona, United States
• Akero Clinical Study Site — Glendale, Arizona, United States
• Akero Clinical Study Site — Tucson, Arizona, United States
• Akero Clinical Study Site — Tucson, Arizona, United States
• Akero Clinical Study Site — North Little Rock, Arkansas, United States
• Akero Clinical Study Site — Fresno, California, United States
• Akero Clinical Study Site — Long Beach, California, United States
• Akero Clinical Study Site — Los Angeles, California, United States
• Akero Clinical Study Site — Pasadena, California, United States
• Akero Clinical Study Site — Englewood, Colorado, United States
• Akero Clinical Study Site — Clearwater, Florida, United States
• Akero Clinical Study Site — Fort Myers, Florida, United States
• Akero Clinical Study Site — Fort Myers, Florida, United States
• Akero Clinical Study Site — Hialeah Gardens, Florida, United States
• Akero Clinical Study Site — Lakewood Rch, Florida, United States
• Akero Clinical Study Site — Miami Lakes, Florida, United States
• Akero Clinical Study Site — Ocala, Florida, United States
• Akero Clinical Study Site — Sarasota, Florida, United States
• Akero Clinical Study Site — South Bend, Indiana, United States
• Akero Clinical Study Site — Topeka, Kansas, United States
• Akero Clinical Study Site — Bastrop, Louisiana, United States
• Akero Clinical Study Site — Marrero, Louisiana, United States
• Akero Clinical Study Site — Las Vegas, Nevada, United States
• Akero Clinical Study Site — Concord, North Carolina, United States
• Akero Clinical Study Site — Fayetteville, North Carolina, United States

Full record on ClinicalTrials.gov

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