A Study Evaluating Efruxifermin in Subjects With Non-invasively Diagnosed Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Nonalcoholic Fatty Liver Disease (NAFLD)/Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: NASH/MASH, NAFLD/MASLD

In brief

The aim of this study is to assess the safety and tolerability of EFX compared to placebo in subjects with non-invasively diagnosed NASH/MASH and NAFLD/MASLD.

Key facts

Study ID

NCT06161571

Run by

Akero Therapeutics, Inc

People needed

700

Starts

2023-11-10

Expected to finish

2026-06-19

Last updated by the study team

2026-04-30

Who can join

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

You may qualify if…

• Main Study Only:
• Males and non-pregnant, non-lactating females between 18 - 80 (between 19-80 in the Republic of Korea) years of age inclusive, on the day of signing informed consent
• 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
• Suspected or confirmed diagnosis of NASH/MASH or NAFLD/MASLD or non-invasively diagnosed NASH/MASH or NAFLD/MASLD
• Open-Label Rollover
• Prior participation in a previous Akero Phase 2 study

You may not qualify if…

• Other causes of liver disease based on medical history and/or liver histology and/or central laboratory results, including but not limited to: alcoholic liver disease, autoimmune disorders (e.g., primary biliary cholangitis [PBC], primary sclerosing cholangitis [PSC], autoimmune hepatitis), drug induced hepatotoxicity, Wilson disease, clinically significant iron overload, or alpha-1-antitrypsin deficiency
• Type 1 or unstable Type 2 diabetes
• A reduced list of inclusion and exclusion criteria apply to participants in the open-label rollover extension.
• Other inclusion and exclusion criteria may apply.

Where it is running

• Akero Clinical Study Site — Chandler, Arizona, United States
• Akero Clinical Study Site — Flagstaff, Arizona, United States
• Akero Clinical Study Site — Peoria, Arizona, United States
• Akero Clinical Study Site — Tucson, Arizona, United States
• Akero Clinical Study Site — Tucson, Arizona, United States
• Akero Clinical Study Site — Conway, Arkansas, United States
• Akero Clinical Study Site — Jonesboro, Arkansas, United States
• Akero Clinical Study Site — Little Rock, Arkansas, United States
• Akero Clinical Study Site — North Little Rock, Arkansas, United States
• Akero Clinical Study Site — Chula Vista, California, United States
• Akero Clinical Study Site — Coronado, California, United States
• Akero Clinical Study Site — Cypress, California, United States
• Akero Clinical Study Site — Inglewood, California, United States
• Akero Clinical Study Site — La Mesa, California, United States
• Akero Clinical Study Site — Lancaster, California, United States
• Akero Clinical Study Site — Los Angeles, California, United States
• Akero Clinical Study Site — Los Angeles, California, United States
• Akero Clinical Study Site — Palm Springs, California, United States
• Akero Clinical Study Site — San Diego, California, United States
• Akero Clinical Study Site — San Diego, California, United States
• Akero Clinical Study Site — San Francisco, California, United States
• Akero Clinical Study Site — Santa Maria, California, United States
• Akero Clinical Study Site — Englewood, Colorado, United States
• Akero Clinical Study Site — Bradenton, Florida, United States
• Akero Clinical Study Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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