A Study Evaluating Efruxifermin in Subjects With Compensated Cirrhosis Due to NASH/MASH

Akero Therapeutics

Status and phase: Enrolling; Phase 3

Conditions: NASH - Nonalcoholic Steatohepatitis; MASH - Metabolic Dysfunction-Associated Steatohepatitis

Treatments: Drug: Placebo; Drug: Efruxifermin

Study type: Interventional

Funder types: Industry

Identifiers

NCT06528314

AK-US-001-0106

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 compensated cirrhosis due to NASH/MASH.

Enrollment: 1,150 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Cohort 1: Biopsy proven compensated cirrhosis (fibrosis stage 4) due to NASH/MASH
• Cohort 2: Biopsy proven or non-invasively diagnosed compensated cirrhosis (fibrosis stage 4) due to NASH/MASH

Exclusion criteria

• Other causes of liver disease based on medical history and/or liver histology and/or central laboratory results
• Type 1 diabetes or unstable Type 2 diabetes
• Any current or prior history of decompensated liver disease

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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1,150 participants in 2 patient groups, including a placebo group

EFX 50 mg

Experimental group

Treatment:

Drug: Efruxifermin

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo