• Semaglutide, the key ingredient in Ozempic and Wegovy, significantly improves liver health in patients with MASH, reducing fat, inflammation, and scarring.
• A Phase 3 clinical trial involving 800 participants showed that nearly 63% of patients treated with semaglutide experienced MASH resolution compared to 34% in the placebo group.
• Experts believe semaglutide could become a crucial treatment option for MASH, especially considering its established benefits for related conditions like obesity and Type 2 diabetes.

A Phase 3 clinical trial has revealed that semaglutide, the active ingredient in the well-known drugs Ozempic and Wegovy, demonstrates significant potential in treating Metabolic Dysfunction-Associated Steatohepatitis (MASH), a severe form of fatty liver disease. The study, involving 800 adults with moderate to advanced liver scarring across 37 countries, found that a weekly dose of semaglutide led to significant improvements in liver health, including reduced fat, inflammation, and scarring. These findings offer hope for a new therapeutic approach to manage this increasingly prevalent liver condition.

• What: Semaglutide, a GLP-1 receptor agonist found in Ozempic and Wegovy, has shown promise in a Phase 3 clinical trial for treating Metabolic Dysfunction-Associated Steatohepatitis (MASH), a serious form of fatty liver disease characterized by fat buildup, inflammation, and scarring in the liver.
• Who: The key individuals involved include Dr. Arun Sanyal of Virginia Commonwealth University, Dr. Philip Newsome of King's College London, Dr. Vandana Khungar of Yale New Haven Hospital, and Grace Su, president of the American Association for the Study of Liver Diseases. Novo Nordisk, the manufacturer of Ozempic and Wegovy, sponsored the study. The study involved 800 adult participants with moderate to advanced liver scarring.
• When: The study, published on April 30, 2025, in the New England Journal of Medicine, involved a 72-week treatment period. Follow-up studies are planned to run through 240 weeks, with results expected in 2029.
• Where: The clinical trial was conducted across 37 countries, indicating a broad international effort to assess the effectiveness of semaglutide in treating MASH.

The study's findings suggest that semaglutide can address not only liver health but also the underlying metabolic issues contributing to MASH. As MASH is closely linked with obesity, Type 2 diabetes, and cardiovascular, metabolic, and renal conditions, semaglutide's benefits could extend beyond the liver. While resmetirom was the first FDA-approved drug for MASH, semaglutide represents another potential therapeutic option. However, questions remain regarding long-term treatment duration, assessment of success, and the drug's potential for other liver diseases. The ongoing trial expansion will help determine whether semaglutide reduces the risk of serious outcomes such as cirrhosis, liver failure, and liver transplantation.

The results provide strong evidence that semaglutide can help by not only improving liver health, but also addressing the underlying metabolic issues that contribute to the disease.

If approved, this could offer an additional therapeutic option for patients with MASH and fibrosis. This is crucial, given the strong link between MASH and cardiovascular, metabolic, and renal conditions, where semaglutide has already shown established health benefits.

One of the scary things about liver disease is that for a very long time you have almost no symptoms. And then suddenly, all hell breaks loose, and everything starts going wrong.

The Phase 3 clinical trial (ESSENCE) demonstrates that semaglutide offers a significant advancement in MASH treatment by improving liver health, reducing liver fibrosis, resolving steatohepatitis, and addressing underlying metabolic dysfunction. Interim analysis at 72 weeks showed that 62.9% of participants achieved resolution of steatohepatitis with no worsening of liver fibrosis, compared to 34.3% in the placebo group. Additionally, 36.8% of the semaglutide group experienced an improvement in liver fibrosis without worsening of steatohepatitis, versus 22.4% in the placebo group. Beyond these key histological improvements, semaglutide also led to a mean weight reduction of 10.5% and improved cardiometabolic markers. While awaiting the full results in 2029, which will assess long-term clinical outcomes such as progression to cirrhosis and liver-related events, semaglutide presents a promising multi-targeted therapeutic option for MASH, especially considering the limited existing treatment options. Further studies are warranted to determine optimal treatment duration and its potential application to other liver diseases. The FDA has accepted the sNDA and granted Priority Review for Wegovy (semaglutide) for treating noncirrhotic MASH.