Efruxifermin in Compensated Cirrhosis Due to NASH/MASH

What is the Purpose of this Study?

The purpose of this study is to evaluate the safety and effectiveness of an experimental drug called efruxifermin (EFX) for the treatment of compensated liver cirrhosis due to nonalcoholic steatohepatitis (NASH)/metabolic dysfunction-associated steatohepatitis (MASH). NASH/MASH is a condition in which there is increased amount of fat, inflammation, and scarring (fibrosis) in the liver. It is similar to the kind of liver disease that is caused by long term heavy drinking, but NASH/MASH occurs in people who do not consume much alcohol. Study procedures include blood draws, physical exam, urine collection, liver biopsy, esophagogastroduodenoscopy, electrocardiogram, imaging, and completion of questionnaires. Participants will be randomly assigned to 1 of 2 groups. One group will receive the study drug (EFX), and the other will receive placebo (inactive substance).


Eligibility

  • * Cohort 1: Biopsy proven compensated cirrhosis (fibrosis stage 4) due to NASH/MASH
  • * Cohort 2: Biopsy proven or non-invasively diagnosed compensated cirrhosis (fibrosis stage 4) due to NASH/MASH
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Where can I participate?

Beverly

More about this Clinical Trial

What is the full name of this clinical trial?

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 /METABOLIC DYSFUNCTION-ASSOCIATED STEATOHEPATITIS

Study Details
Disease Type/Condition

Other

Principal Investigator

Yang, Ju Dong

Age Group

Adult

Phase

III

IRB Number

STUDY00003606

ClinicalTrials.gov ID

NCT06528314

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?
Email
clinicaltrials@cshs.org
Study Detail
Disease Type/Condition

Other

Principal Investigator

Yang, Ju Dong

Age Group

Adult

Phase

III

IRB Number

AK-US-001-0106

ClinicalTrials.gov ID

NCT06528314

Key Eligibility
ClinicalTrials.gov

Contact
Email
clinicaltrials@cshs.org