A Phase 3, Randomized, Double-Blind, Placebo-Controlled study Evaluating the Safety and Efficacy of Efruxifermin in Subjects with Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH)

Clinical Trial Details

The purpose of this research study is to evaluate the effect of the investigational study drug Efruxifermin (EFX) in treating compensated liver cirrhosis due to nonalcoholic steatohepatitis (NASH)/metabolic dysfunction-associated steatohepatitis (MASH) and how safe it is to use in people.

NASH/MASH is a condition with an increased amount of fat, inflammation, and scarring (fibrosis) in the liver. Individuals will be asked to be participants in this research study because they have scarring of the liver due to NASH/MASH. NASH/MASH is part of a group of conditions called nonalcoholic fatty liver disease (NAFLD)/metabolic dysfunction-associated steatotic liver disease (MASLD).

Efruxifermin (EFX) is being developed to reduce NASH and is experimental/investigational. Investigational means that the drug has not been approved by regulatory authorities such as the United States Food and Drug Administration (FDA).

Participants will be randomly (like flipping a coin) assigned to one of the following study groups:
- Study Drug Group 1: Placebo
- Study Drug Group 2: EFX 50 mg

Key Eligibility:

Men and women who are 18 years of age and older.
Have been diagnosed with liver scarring due to NASH/MASH.

Detailed eligibility will be 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 #:

2404027357

Status

Open to Enrollment

Age Group

Adult

Disease

Metabolic Dysfunction-Associated Steatohepatitis (MASH)

Non-Alcoholic Steatohepatitis (NASH)