Wegovy (semaglutide) & MASH Approval
- Joshua Silva, MD
- Oct 17
- 3 min read
On August 15, 2025, the FDA granted accelerated approval for Wegovy (semaglutide 2.4 mg) to treat non-cirrhotic MASH (metabolic dysfunction-associated steatohepatitis) with moderate-to-advanced fibrosis (F2–F3) in adults.
This is the first FDA-approved therapy for MASH with fibrosis and represents a significant advance for patients in Utah and beyond — many of whom are also living with obesity. Approval was based on clinical trial data showing histological improvement in both MASH activity and fibrosis progression.
What is MASH and how is it related to obesity?
MASH (metabolic dysfunction-associated steatohepatitis, formerly called NASH) is a form of fatty liver disease that occurs when fat buildup in the liver leads to inflammation and scarring (fibrosis).
It often develops in people with obesity, insulin resistance, type 2 diabetes, or metabolic syndrome.
If untreated, MASH can progress to cirrhosis, liver failure, or hepatocellular carcinoma (liver cancer).
Weight loss of at least 7–10% is known to improve MASH, which is why GLP-1 therapies like Wegovy are promising.
Who qualifies for Wegovy’s new MASH indication?
The FDA approval covers:
Adults with non-cirrhotic MASH (not yet progressed to cirrhosis)
With moderate-to-advanced fibrosis (F2–F3) confirmed by biopsy or non-invasive tests
Patients may also have obesity or metabolic risk factors such as type 2 diabetes.
This is a distinct indication, separate from Wegovy’s approval for obesity and cardiovascular risk reduction.
What does accelerated approval mean?
Accelerated approval is an FDA pathway that allows earlier access to therapies for serious conditions when there is an unmet medical need.
Approval is based on a surrogate endpoint — in this case, liver biopsy results showing improvement in inflammation and fibrosis.
Ongoing confirmatory trials must still demonstrate long-term clinical benefit, such as prevention of cirrhosis, liver failure, or death.
If those trials confirm benefit, approval becomes full; if not, the FDA may withdraw the indication.
What dose of Wegovy is used for MASH?
The approved dose for MASH is the same as for weight management: semaglutide 2.4 mg once weekly.
Patients typically start at a lower dose (0.25 mg) and titrate upward over 16–20 weeks.
The 2.4 mg dose is maintained as long-term therapy under medical supervision.
Can Wegovy treat both MASH and obesity at the same time?
Yes. Many people with MASH also have obesity, and Wegovy’s dual approvals mean it can address both conditions simultaneously.
In trials, patients saw improvements in liver inflammation, fibrosis, body weight, and metabolic markers
(glucose, lipids, blood pressure).
This makes Wegovy uniquely positioned to reduce the burden of MASH in patients already eligible for weight management therapy.
Disclaimer
This article is for educational purposes only and is not a substitute for professional medical advice.
👉 Want to learn if Wegovy is right for MASH and weight management? Book your free consultation at Potere Health MD — in St. George, Cedar City, or from home via telehealth.
About the Author
Dr. Joshua Silva, MD, is a licensed physician and Medical Director of Potere Health MD. He completed residency training in Occupational and Environmental Medicine from the University of Utah and now specializes in evidence-based weight management, including GLP-1/GIP therapies (semaglutide, tirzepatide). Dr. Silva provides in-person and virtual care for patients throughout Utah.
Sources
FDA (2025). FDA Approves Treatment for Serious Liver Disease Known as MASH. FDA Press Release
Newsome PN, et al. Semaglutide in Metabolic Dysfunction–Associated Steatohepatitis with Fibrosis (ESSENCE Trial).N Engl J Med. 2025. Full Text – NEJM
Novo Nordisk (2025). Wegovy® Approved by FDA for Adults with MASH with Moderate to Advanced Fibrosis. Press Release
PubMed (2025). Semaglutide in MASH with Moderate or Advanced Liver Fibrosis: ESSENCE Trial Results. PubMed Abstract
AASLD (2025). AASLD Applauds FDA Approval of First GLP-1 Therapy for MASH. AASLD Statement
Comments