FDA Approves Semaglutide for MASH With Advanced Fibrosis
The US Food and Drug Administration (FDA) has approved semaglutide injection for treatment of metabolic-associated steatohepatitis (MASH) in adults with moderate-to-advanced fibrosis.
MASH, previously called nonalcoholic steatohepatitis, is a progressive condition affecting approximately 6% of US adults (14.9 million) and is linked to obesity, type 2 diabetes, dyslipidemia, and other metabolic disorders. Without treatment, MASH can progress to cirrhosis, hepatic decompensation, hepatocellular carcinoma, or death.
Semaglutide, already approved for obesity and cardiovascular risk reduction, promotes weight loss and may improve liver inflammation and fibrosis through additional mechanisms. For this indication, it received breakthrough therapy designation and was approved under the accelerated approval pathway, requiring confirmatory data demonstrating clinical benefit on survival, function, or transplant avoidance.
Approval was based on interim results from an ongoing phase 3 trial (N=800), in which participants were randomized to semaglutide (n=534) or placebo (n=266) alongside lifestyle interventions. At week 72, 63% of patients receiving semaglutide achieved MASH resolution without worsening of fibrosis, compared with 34% on placebo. In addition, 37% of the semaglutide group achieved fibrosis improvement without worsening of MASH, versus 22% in the placebo group.
The trial will continue to 240 weeks to assess long-term outcomes, including transplant-free survival and liver-related events.
The most common adverse effects of semaglutide include nausea, vomiting, diarrhea, constipation, abdominal pain, dyspepsia, bloating, headache, fatigue, and upper respiratory symptoms. Serious risks include contraindications for patients with personal or family history of medullary thyroid carcinoma, multiple endocrine neoplasia type 2, or known hypersensitivity to semaglutide.
Reference
FDA approves treatment for serious liver disease known as ‘MASH’. News release. US Food and Drug Administration; August 15, 2025. Accessed August 20, 2025.
