Core Insights - The FDA has approved Novo Nordisk's Wegovy (semaglutide) for the treatment of metabolic associated fatty liver disease (MASH) with moderate to severe liver fibrosis in non-cirrhotic adult patients, marking it as the first GLP-1 drug approved for this indication [1][2] - MASH is a serious progressive metabolic disease affecting the liver, with over one-third of overweight or obese patients also suffering from MASH, which can lead to delayed diagnosis and higher risks of advanced liver disease [1] Group 1 - The accelerated approval is based on the Phase 1 results of the ESSENCE trial, showing Wegovy can improve liver fibrosis without worsening fatty liver disease, demonstrating statistical significance and superiority [2] - Wegovy also shows improvement in fatty liver disease without worsening liver fibrosis [2] Group 2 - Novo Nordisk submitted a registration application in the EU in February 2025 and in Japan in May 2025 based on the Phase 1 results of the ESSENCE trial [3] - Results from Phase 2 of the ESSENCE trial are expected to be announced in 2029 [3]