By Fineline Cube 
Danish biopharmaceutical giant Novo Nordisk A/S (NYSE: NVO) announced on August 15, 2025, that its semaglutide (brand name: Wegovy) has received a new indication from the U.S. FDA for the treatment of metabolic-associated steatohepatitis (MASH) in adults with moderate to advanced fibrosis, characterized by excessive scar tissue in the liver.
Drug Background
Wegovy was first approved in 2017 and is indicated for use in people with obesity or who are overweight, as well as for reducing the risk of cardiovascular events in high-risk individuals. With this new approval, Wegovy addresses an additional critical area of unmet medical need.
Clinical Trial Details
The approval is based on an ongoing Phase 3 clinical trial. The interim analysis at week 72 included 800 participants who were randomly assigned to either the Wegovy group (534 participants) or the placebo group (266 participants), in addition to lifestyle changes such as a reduced-calorie diet and increased physical activity. The primary efficacy endpoint at week 72 was based on histology (liver biopsy results).
Key Findings
Interim results showed that among participants receiving Wegovy:
- 63% experienced MASH resolution with no worsening of liver scarring, compared to 34% in the placebo group.
- 37% showed an improvement in liver scarring with no worsening of MASH, compared to 22% in the placebo group.
Ongoing Trial
The trial will continue for a total of 240 weeks to determine if the improvements observed at week 72 translate into a reduction in death, liver transplants, and other liver-related events.-Fineline Info & Tech