GLP-1 Diabetes Drug Mounjaro Gets FDA Okay to Reduce Heart Attack and Stroke

“Cardiovascular disease is one of the most common causes of death in patients affected by type 2 diabetes,” says Peminda Cabandugama, MD, an endocrinologist with the Cleveland Clinic and a spokesperson for The Obesity Society who was not involved in Mounjaro’s development. “This approval is in keeping with the direct action of GLP-1 medications and their combinations in reducing this risk.”
Mounjaro Joins the Lineup of Diabetes Meds Showing Heart Health Benefits
Mounjaro Beat Trulicity in Trial Results
The FDA approval was based on results looking at cardiovascular outcomes with Mounjaro and Trulicity, in a trial involving more than 13,000 adults with type 2 diabetes and established atherosclerotic cardiovascular disease who were followed for an average of four years.
The results of the trial demonstrate “meaningful risk reduction” for Mounjaro according to Marilyn Tan, MD, clinical professor of medicine, endocrinology, gerontology and metabolism at Stanford Medicine in Palo Alto, California, who was not involved in the drug development.
Will the FDA Action Expand Insurance Coverage for Mounjaro?
Whether this new FDA authorization will change insurance coverage remains to be seen.
“This new indication may improve and/or expand insurance coverage for such medications, but GLP-1 agonists remain costly, so it’s ultimately up to the individual insurance plans on how they provide coverage,” says Dr. Tan.
- FDA Approves Lilly’s Mounjaro (Tirzepatide) to Reduce Cardiovascular Risk in Adults with Type 2 Diabetes. Eli Lilly and Company. August 28, 2026.
- 1 in 3 Adults With Type 2 Diabetes May Have Undetected Cardiovascular Disease. American Heart Association. May 31, 2023.
- Tirzepatide Injection. Cleveland Clinic.
- How Do GLP-1 Medications Impact Heart Health? Minneapolis Heart Institute Foundation. December 18, 2025.
- FDA Approves Ozempic for Cardiovascular Risk Reduction in Adults with Type 2 Diabetes and Known Heart Disease. Novo Nordisk. January 16, 2020.
- Trulicity (Dulaglutide) Is the First and Only Type 2 Diabetes Medicine Approved to Reduce Cardiovascular Events in Adults With and Without Established Cardiovascular Disease. Eli Lilly. February 21, 2020.
- Nicholls S et al. Cardiovascular Outcomes with Tirzepatide Versus Dulaglutide in Type 2 Diabetes. The New England Journal of Medicine. December 17, 2025.

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