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

Conditions

• MASH With Fibrosis
• NASH With Fibrosis

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• Efruxifermin — DRUG
  Administered by subcutaneous injection
• Placebo — DRUG
  Administered by subcutaneous injection

Study Details

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.

Key Dates

Start date

Dec 1, 2023

Status verified

Jun 2026

Primary completion

Nov 30, 2032

Completion

Nov 30, 2032

Study Design

Enrollment

1,650 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: EFX 28 mg
• Experimental: EFX 50 mg
• Placebo Comparator: Placebo

Primary Outcome Measure

Cohort 1 Only: Resolution of NASH/MASH and a ≥ 1 stage improvement in fibrosis [ Time Frame: 52 Weeks ]

Central Contacts

• Akero Study Director
  650-487-6488
  [email protected]

Locations (205)

Find similar trials in Birmingham, AL

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