Merck's efinopegdutide has received FDA Fast Track designation for the treatment of non-alcoholic steatohepatitis (NASH), and Merck has released Phase IIa study results comparing efinopegdutide to Novo Nordisk's semaglutide. The new NAFLD data will be presented at the upcoming European Association for the Study of the Liver annual congress, and Merck plans to use both this data and the Fast Track designation to advance development of efinopegdutide by initiating a Phase IIb trial in NASH patients. NASH is a more severe form of non-alcoholic fatty liver disease (NAFLD) that can result in cirrhosis. Efinopegdutide is an investigational peptide that binds GLP-1/glucagon receptors, which appears to reduce liver damage, inflammation, and steatosis.
Merck's mid-stage NAFLD study enrolled 145 patients who were randomly assigned either efinopegdutide or Novo Nordisk's semaglutide. Patients taking Merck's hopeful saw an 8.5% body weight reduction compared to those on