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

Conditions

• MASH - Metabolic Dysfunction-Associated Steatohepatitis
• NASH - Nonalcoholic Steatohepatitis

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 compensated cirrhosis due to NASH/MASH.

Key Dates

Start date

Sep 4, 2024

Status verified

Jun 2026

Primary completion

Feb 28, 2030

Completion

Mar 31, 2030

Study Design

Enrollment

2,150 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: EFX 50 mg
• Placebo Comparator: Placebo

Primary Outcome Measure

Time from randomization to the first significant clinical event including disease progression, liver decompensation events, etc. [ Time Frame: 5 years ]

Central Contacts

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

Locations (168)

Find similar trials in Birmingham, AL

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