A Study Evaluating Efruxifermin in Subjects With Non-invasively Diagnosed Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Nonalcoholic Fatty Liver Disease (NAFLD)/Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)

Conditions

• NAFLD/MASLD
• NASH/MASH

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• Efruxifermin — DRUG
  Administered by subcutaneous (SC) injection
• Placebo — DRUG
  Administered by SC injection

Study Details

The aim of this study is to assess the safety and tolerability of EFX compared to placebo in subjects with non-invasively diagnosed NASH/MASH and NAFLD/MASLD.

Key Dates

Start date

Nov 10, 2023

Status verified

Apr 2026

Primary completion

Mar 3, 2026

Completion

Jun 19, 2026

Study Design

Enrollment

700 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: EFX 50 mg
• Placebo Comparator: Placebo
• Experimental: EFX 50 mg (Open-Label Rollover)

Primary Outcome Measure

Extent of exposure [ Time Frame: 52 Weeks ]

Locations (139)

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