On Aug. 15, 2025, FDA granted accelerated approval to Novo Nordisk's Wegovy (semaglutide) for metabolic-associated steatohepatitis (MASH) in adults with moderate-to-advanced liver fibrosis (stages F2 to F3 fibrosis). (Link to Approval Letter)
Efficacy:
In the ongoing phase 3 trial with 800 participants (Wegovy: 534 participants, or placebo: 266 participants) -
- 63% of those receiving Wegovy showed MASH resolution and no worsening of liver scarring at week 72, versus 34% in the placebo group;
- 37% of participants on Wegovy had improvement in liver scarring without worsening MASH compared to 22% on placebo.
Safety:
Common side effects include nausea, diarrhea, vomiting, constipation, abdominal pain, headache, fatigue, dyspepsia (indigestion), dizziness, abdominal distension, eructation (burping), hypoglycemia in patients with type 2 diabetes, flatulence, gastroenteritis (stomach flu), gastroesophageal reflux disease, and nasopharyngitis (common cold).
Expedited Programs/Designations:
Breakthrough Therapy Designation and Accelerated Approval
Background:
- Wegovy, which was first approved in 2017, is also approved for obesity or overweight and to reduce cardiovascular events, such as heart attacks, in individuals at high risk of these events.
- MASH is a severe form of metabolic-associated fatty liver disease that develops when fat buildup in the liver causes inflammation and scarring. Conditions such as obesity, type 2 diabetes, high triglycerides (a type of fat), and high LDL-cholesterol increase the likelihood of developing MASH.
- Approximately 6% of U.S. adults (14.9 million people) have MASH.