Diabetes Dialogue: FDA Approves Semaglutide (Wegovy) for MASH

Welcome back to Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives!

In this episode, cohosts Diana Isaacs, PharmD, an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and codirector of Endocrine Disorders in Pregnancy at the Cleveland Clinic, and Natalie Bellini, DNP, program director of Diabetes Technology at University Hospitals Diabetes and Metabolic Care Center, explore the latest milestone for semaglutide (Wegovy): US Food and Drug Administration (FDA) approval for the treatment of metabolic dysfunction–associated steatohepatitis (MASH) with moderate to advanced fibrosis. They frame the decision as a breakthrough in addressing a disease that affects an estimated 6% of the U.S. population, with even higher prevalence among individuals with type 2 diabetes and obesity. MASH, often underrecognized and asymptomatic in its early stages, carries serious long-term consequences, including cirrhosis, hepatocellular carcinoma, liver transplantation, and premature mortality.

The hosts review key risk factors—including obesity, type 2 diabetes, hypertriglyceridemia, and elevated LDL cholesterol—emphasizing the need for clinicians to consider MASH in patients with complex cardiometabolic profiles. They highlight the ease of screening with the Fib-4 score, a tool now embedded in ADA Standards of Care that relies on routine laboratory tests. From there, patients at elevated risk can be referred to hepatology or assessed further with noninvasive imaging such as FibroScan. Isaacs and Bellini stress that the new indication not only broadens treatment options but also raises awareness of MASH as a progressive, life-limiting condition that warrants active management.

They position semaglutide as uniquely impactful in this setting, given its established role in improving glycemic control, reducing cardiovascular risk, and supporting weight management. By layering liver protection on top of these existing benefits, the drug represents a “holistic” therapeutic option. The discussion also touches on future directions, including the potential complementary use of semaglutide with resmetirom, a newly available agent for MASH that works through a different mechanism. Drawing parallels to the synergistic success of SGLT2 inhibitors and finerenone in chronic kidney disease, the hosts anticipate similar additive effects in liver disease management.

The conversation then shifts to accessibility, with Novo Nordisk’s recent announcement that Ozempic is now available at $499 through GoodRx. Isaacs and Bellini discuss how this move could reduce reliance on compounded alternatives and improve patient access to genuine, reliably manufactured products. They also note the practical advantages of multi-dose pens, which can be more cost-effective for patients and easier for prescribers to manage in routine clinical practice.

They conclude by situating semaglutide’s expanding therapeutic footprint—spanning diabetes, obesity, cardiovascular disease, kidney disease, and now MASH—within the broader evolution of GLP-1–based therapies. With each new indication, these agents are reshaping standards of care for interrelated metabolic and hepatic diseases, offering clinicians versatile tools to improve long-term outcomes across specialties.

Relevant disclosures for Isaacs include Eli Lilly and Company, Novo Nordisk, Sanofi, Abbott Diabetes Care, Dexcom, Medtronic, and others. Relevant disclosures for Bellini include Abbott Diabetes Care, MannKind, Provention Bio, and others.

References

1. US Food and Drug Administration. FDA Approves Treatment for Serious Liver Disease Known as ‘MASH’. August 15, 2025. Accessed August 22, 2025. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-treatment-serious-liver-disease-known-mash

2. GoodRx. GoodRx Announces Collaboration with Novo Nordisk to Expand Access to Ozempic® and Wegovy® for $499-Per-Month. August 18, 2025. Accessed August 22, 2025. https://investors.goodrx.com/news-releases/news-release-details/goodrx-announces-collaboration-novo-nordisk-expand-access