A Study of Efruxifermin in Non-Cirrhotic Subjects With Histologically Confirmed Nonalcoholic Steatohepatitis (NASH)

Conditions

• NASH - Nonalcoholic Steatohepatitis

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Efruxifermin — DRUG
  subcutaneous injection
• Placebo — DRUG
  subcutaneous injection

Study Details

This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study in non-cirrhotic subjects with biopsy-proven F2 - F3 NASH.

Key Dates

Start date

Feb 16, 2021

Status verified

Jun 2025

Primary completion

May 2, 2024

Completion

May 2, 2024

Study Design

Enrollment

128 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Placebo Comparator: placebo
  double-blind, once-weekly subcutaneous injection
• Experimental: Efruxifermin 28 mg
  double-blind, once-weekly subcutaneous injection
• Placebo Comparator: Efruxifermin 50 mg
  double-blind, once-weekly subcutaneous injection

Primary Outcome Measure

Effect of Efruxifermin (EFX) vs Placebo on Fibrosis Regression in Participants With Metabolic Dysfunction-associated Steatohepatitis (MASH)-Associated Stage 2 or 3 Fibrosis (F2 or F3) [ Time Frame: 24 Weeks ]

Locations (54)

Find similar trials in Chandler, AZ

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