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

The FDA action gives physicians and patients another medication to prevent cardiovascular emergencies in at-risk patients with type 2 diabetes.
GLP-1 Diabetes Drug Mounjaro Gets FDA Okay to Reduce Heart Attack and Stroke
Eli Lilly; Everyday Health
Mounjaro (tirzepatide), the popular injectable GLP-1/GIP drug, is already prescribed to lower blood sugar in people with type 2 diabetes. Now the medication has won authorization by the U.S. Food and Drug Administration (FDA) to prevent heart attack and stroke in high-risk patients with type 2 diabetes.

As many as 1 in 3 adults in the United States with type 2 diabetes are estimated to have undetected cardiovascular disease, research suggests.

“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 works by mimicking the natural gut hormones GLP-1 and GIP, improving blood sugar levels and reducing appetite.

Studies have shown that GLP-1 medications benefit heart health by promoting weight loss and lowering blood pressure, LDL (bad) cholesterol, and triglycerides (a very common type of fat in the blood).

Another injectable GLP-1 diabetes medication on the market, Ozempic (semaglutide), was approved in 2020 for cardiovascular risk reduction in adults with type 2 diabetes.

The GLP-1 medication Trulicity (dulaglutide) was also approved in 2020 to reduce the risk of heart attack and stroke in people with type 2 diabetes with or without established cardiovascular disease.

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.

Mounjaro demonstrated an 8 percent lower rate of cardiovascular death, heart attack or stroke compared with Trulicity.

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.

EDITORIAL SOURCES
Everyday Health follows strict sourcing guidelines to ensure the accuracy of its content, outlined in our editorial policy. We use only trustworthy sources, including peer-reviewed studies, board-certified medical experts, patients with lived experience, and information from top institutions.
Resources
  1. FDA Approves Lilly’s Mounjaro (Tirzepatide) to Reduce Cardiovascular Risk in Adults with Type 2 Diabetes. Eli Lilly and Company. August 28, 2026.
  2. 1 in 3 Adults With Type 2 Diabetes May Have Undetected Cardiovascular Disease. American Heart Association. May 31, 2023.
  3. Tirzepatide Injection. Cleveland Clinic.
  4. How Do GLP-1 Medications Impact Heart Health? Minneapolis Heart Institute Foundation. December 18, 2025.
  5. FDA Approves Ozempic for Cardiovascular Risk Reduction in Adults with Type 2 Diabetes and Known Heart Disease. Novo Nordisk. January 16, 2020.
  6. 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.
  7. Nicholls S et al. Cardiovascular Outcomes with Tirzepatide Versus Dulaglutide in Type 2 Diabetes. The New England Journal of Medicine. December 17, 2025.

Tom Gavin

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Tom Gavin joined Everyday Health as copy chief in 2022 after a lengthy stint as a freelance copy editor. He has a bachelor's degree in psychology from College of the Holy Cross.

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