> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Wegovoy OK’d for Metabolic Steatohepatitis
- URL: https://www.fdaweb.com/wegovoy-okd-for-metabolic-steatohepatitis/
- Published: 2025-08-18T12:00:00.000Z
- Updated: 2026-09-14T15:19:15.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159705

FDA has granted Novo Nordisk accelerated approval for a new Wegovy (semaglutide) indication for treating metabolic dysfunction-associated steatohepatitis (MASH) in adults with moderate to advanced liver scarring (fibrosis), but not with cirrhosis of the liver, in conjunction with a reduced calorie diet and increased physical activity, according to the company.

The approval is based on data from the phase 3 ESSENCE trial investigating the effects of once-weekly Wegovy 2.4 mg injection on liver histology in adults with MASH and moderate to advanced liver fibrosis at Week 72\. The trial met its primary endpoint, showing 63% of people treated with Wegovy “achieved resolution of steatohepatitis and no worsening of liver fibrosis compared to 34% on placebo,” Novo Nordisk says. Data also showed that 37% of people treated with Wegovy achieved improvement in liver fibrosis and no worsening of steatohepatitis compared to 22% on placebo. There is an ongoing study to confirm the clinical benefit of Wegovy in adults with MASH, it says.

MASH is a serious form of fatty liver disease, which can be potentially life-threatening if not properly managed, Novo Nordisk says, adding that about one out of three people who are overweight or obese are affected by the condition.