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).
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