A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating The Safety and Efficacy Of Efruxifermin In Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH) and Fibrosis

Clinical Trial Details

The purpose of this research study is to evaluate the effect of Efruxifermin compared to placebo on achieving nonalcoholic steatohepatitis (NASH) resolution and fibrosis regression in participants with fibrosis stage 2 or 3.

NASH is the most severe form of nonalcoholic fatty liver disease (NAFLD) and is characterized by an excessive accumulation of fat in the liver, live cell injury and inflammation, ultimately leading to fibrosis. Efruxifermin (EFX) is being developed to reduce NASH and is experimental/investigational, meaning it is not approved by the U.S. Food and Drug Administration (FDA).

Participants will be randomized to receive either placebo, or Efruxifermin. Randomization is like flipping a coin and there is a 50/50 chance of being assigned to either group.

Participants will receive 28 mg and 50 mg tablets of Efruxifermin or placebo.

Participation in this study will last for up to 96 weeks and participants will be compensated for their time.

Key Eligibility:

Men and women who are 18 years of age and older.
Have been diagnosed with nonalcoholic fatty liver disease (NAFLD)

Detailed eligibility reviewed when contacting the study team.

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Study contact by location

Upper East Side - Manhattan

Contact(s)

646‐962‐4040
GIHepResearch@med.cornell.edu

Primary Investigator(s)

Sonal Kumar, MD, MPH

Protocol ID(s)

Weill Cornell Medicine IRB #:

2310026580

ClinicalTrials.gov:

NCT06215716

Status

Open to Enrollment

Age Group

Adult

Disease

Liver Disease

Non-Alcoholic Liver Disease

Non-Alcoholic Steatohepatitis (NASH)