FDA

Wegovy granted accelerated approval for MASH

August 21, 2025

FDA granted accelerated approval to Wegovy (semaglutide injection) for the treatment of noncirrhotic metabolic-associated steatohepatitis (MASH) in adults with moderate-to-advanced fibrosis (stages F2 to F3 fibrosis).

Continued approval for this indication may be contingent upon the verification and description of clinical benefit in a confirmatory trial.

Efficacy

Wegovy’s efficacy was demonstrated in the ongoing phase 3 ESSENCE trial (NCT04822181). The planned interim analysis at week 72 included 800 participants randomly assigned to either Wegovy (n = 534) or placebo (n = 266) in addition to lifestyle changes (e.g., dietary modification such as a reduced calorie diet and increased physical activity). Participants were on stable doses of lipid-lowering, glucose-management, and weight-loss medications. At week 72, the primary efficacy endpoint was based on histology (liver biopsy results).

Interim results showed 63% of participants receiving Wegovy had MASH resolution and no worsening of liver scarring compared with 34% of participants receiving placebo, and 37% of participants on Wegovy had improvement in liver scarring and no worsening of MASH, compared with 22% of participants receiving placebo. The trial will continue for a total of 240 weeks to determine whether inflammation and scarring improvements seen after 72 weeks translate into decreases in mortality, liver transplant, and other liver-related events.

Safety

The most common adverse reactions (incidence ≥5%) reported with Wegovy include nausea, diarrhea, vomiting, constipation, abdominal pain, headache, fatigue, dyspepsia, dizziness, abdominal distension, eructation, hypoglycemia in patients with type 2 DM, flatulence, gastroenteritis, GERD, and nasopharyngitis.

Sources:

FDA Approves Treatment for Sertious Liver Disease Known as ‘MASH.’ [News release]. 2025. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-treatment-serious-liver-disease-known-mash

Novo Nordisk A/S: Wegovy approved in the US for the treatment of MASH. [News release]. 2025. https://www.novonordisk.com/content/nncorp/global/en/news-and-media/news-and-ir-materials/news-details.html

Wegovy (semaglutide injection) [package insert]. Food and Drug Administration. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/215256s024lbl.pdf Revised August 2025. Accessed August 20, 2025.