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

Akero Therapeutics

Status and phase: Enrolling; Phase 3

Conditions: NASH With Fibrosis; MASH With Fibrosis

Treatments: Drug: Efruxifermin; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06215716

AK-US-001-0105

Details and patient eligibility

About

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.

Enrollment: 1,650 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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.

Other inclusion and exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,650 participants in 3 patient groups, including a placebo group

EFX 28 mg

Experimental group

Treatment:

Drug: Efruxifermin

EFX 50 mg

Experimental group

Treatment:

Drug: Efruxifermin

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo