Survodutide Enters Phase 3 Trial for NASH/MASH Cirrhosis Treatment
Background
Non-alcoholic steatohepatitis (NASH), now increasingly referred to as Metabolic Dysfunction Associated Steatohepatitis (MASH), is a progressive and severe form of fatty liver disease. It is characterized by liver inflammation and damage, which can lead to fibrosis (scarring) and ultimately progress to cirrhosis, a severe and irreversible scarring of the liver that significantly impairs its function and can lead to liver failure or liver cancer. Currently, there are no FDA-approved pharmacological treatments specifically for NASH/MASH cirrhosis, leaving a critical unmet medical need for effective interventions to halt or reverse disease progression. This Phase III study directly addresses this gap by aiming to evaluate if survodutide can improve liver-related clinical outcomes and safety in individuals with compensated NASH/MASH cirrhosis, a stage where the liver is scarred but still able to perform most of its functions.