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A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis | Clinical Trials | Clareo Health

RECRUITINGPHASE3

A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis

NCT06215716•Akero Therapeutics, Inc

View on ClinicalTrials.gov

Summary

This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study in subjects with non-cirrhotic NASH/MASH and fibrosis stage 2 or 3 (F2 or F3). The study will enroll subjects in two cohorts for a total samples size of 1650 subjects.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Males and non-pregnant, non-lactating females between 18 - 80 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.
•Cohort 1: Biopsy-proven NASH/MASH. Must have had a liver biopsy obtained ≤ 180 days prior to screening with fibrosis stage 2 or 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).

Exclusion Criteria

•Other causes of liver disease based on medical history and/or liver histology and/or central laboratory results.
•Presence of cirrhosis on liver biopsy (fibrosis stage 4).
•Type 1 or uncontrolled Type 2 diabetes.

Locations (347)

Akero Clinical Study Site

Birmingham, Alabama, United States

Akero Clinical Study Site

Dothan, Alabama, United States

Akero Clinical Study Site

Chandler, Arizona, United States

Akero Clinical Study Site

Flagstaff, Arizona, United States

Akero Clinical Study Site

Mesa, 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

Tucson, Arizona, United States

Akero Clinical Study Site

Tucson, Arizona, United States

Key Dates

Start Date

December 1, 2023

Primary Completion Date

November 1, 2032

Completion Date

November 1, 2032

Last Updated

March 13, 2026

Enrollment

1,650

ESTIMATED participants

Conditions

NASH With FibrosisMASH With Fibrosis

Interventions

Efruxifermin

DRUG

Placebo

DRUG

Contacts

Akero Study Director

CONTACT

650-487-6488 AkeroSynchrony@akerotx.com

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COMPLETEDPHASE2

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 13, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis

Inclusion Criteria

Exclusion Criteria

Effectiveness of Bariatric Surgery for NAFLD/NASH

A Study to Evaluate the Safety and Efficacy of Rencofilstat in Adult Subjects With NASH F3

AGED Diagnostics Liver Disease Assessment