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

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 non-cirrhotic subjects with biopsy-proven F2 - F3 NASH.

Key facts

Study ID

NCT04767529

Run by

Akero Therapeutics, Inc

People needed

128

Starts

2021-02-16

Expected to finish

2024-05-02

Last updated by the study team

2025-06-18

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 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.
• FibroScan measurement > 8.5 kPa [kilopascal].
• Biopsy-proven NASH. Must have had a liver biopsy obtained ≤ 180 days prior to randomization with fibrosis stage 2 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).

You may not qualify if…

• Weight loss > 5% in the 3 months prior to screening until randomization or from the time of the diagnostic liver biopsy until randomization, whichever is longer.
• Presence of cirrhosis on liver biopsy (stage 4 fibrosis).
• Type 1 or uncontrolled Type 2 diabetes.
• Other inclusion and exclusion criteria may apply.

Where it is running

• Akero Clinical Study Site — Glendale, 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 — Chula Vista, California, United States
• Akero Clinical Study Site — Fresno, California, United States
• Akero Clinical Study Site — La Jolla, 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 — Los Angeles, California, United States
• Akero Clinical Study Site — Orange, California, United States
• Akero Clinical Study Site — Panorama City, California, United States
• Akero Clinical Study Site — Rialto, California, United States
• Akero Clinical Study Site — Santa Ana, California, United States
• Akero Clinical Study Site — Fort Myers, Florida, United States
• Akero Clinical Study Site — Inverness, Florida, United States
• Akero Clinical Study Site — Lakewood Rch, Florida, United States
• Akero Clinical Study Site — Miami, Florida, United States
• Akero Clinical Study Site — Miami, 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 — Marietta, Georgia, United States
• Akero Clinical Study Site — Topeka, Kansas, United States
• Akero Clinical Study Site — Baton Rouge, Louisiana, United States
• Akero Clinical Study Site — Chandler, Arizona, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.