FDA approves Mounjaro to reduce cardiovascular risk in Type 2 diabetes

The FDA has approved Lilly’s Mounjaro (tirzepatide) to lower the risk of major adverse cardiovascular events (MACE), including cardiovascular death, non-fatal heart attack, or non-fatal stroke in adults with Type 2 diabetes.

“While a large portion of type 2 diabetes care is focused on glucose control, mitigating cardiovascular risk is essential and can be overlooked. This approval gives patients a medicine that reduces the risk of cardiovascular events and supports metabolic health at the same time,” David A. D'Alessio, M.D., study co-author and director of the Division of Endocrinology and Metabolism at Duke University School of Medicine, said in a news release.

Mounjaro is already approved to lower blood sugar in adults and children 10 years of age and older with type 2 diabetes. Tirzepatide is a dual GIP and GLP-1 inhibitor that is also approved at Zepbound for weight loss. For the first half of 2026, Mounjaro generated sales of $18.6 billion, up 106% from the first half of 2025. Zepbound generated $9.09 billion in the first half of this year, up 60% from the first half of last year.

Mounjaro has a wholesale acquisition cost of $1,112.16. Patients with commercial insurance may be eligible for a three-month supply for a $25 copay, with a maximum annual savings of up to $1,950 per calendar year. Lilly also provides Mounjaro through its a direct-to-consumer platform for $499 a month.

The approval was based on results from SURPASS-CVOT, which enrolled more than 13,000 patients across 30 countries over more than four and a half years. In the phase 3 trial, Mounjaro was compared with Lilly’s Trulicity (dulaglutide), a GLP-1 treatment approved for Type 2 diabetes for adults and children 10 and over. Trulicity is also approved to reduce the risk of cardiovascular events. The primary objective of the trial was to demonstrate that Mounjaro provided a non-inferior reduction in the risk of major adverse cardiovascular events compared with Trulicity.

In the trial, Mounjaro demonstrated non-inferiority to Trulicity, with an 8% lower rate of cardiovascular death, heart attack, or stroke. Results were published Dec. 17, 2025, in The New England Journal of Medicine.

The most commonly reported adverse events in SURPASS-CVOT for Mounjaro were gastrointestinal-related, generally mild-to-moderate in severity, and occurred primarily during the dose-escalation period.

Lilly has also conducted an observational claims study that emulated the design of the SURPASS-CVOT trial. This trial will assess will compare new users of tirzepatide with new users of dulaglutide or semaglutide (Ozempic) in adults 40 and over with Type 2 diabetes and established atherosclerotic cardiovascular disease. The outcome being assessed is a composite of cardiovascular measures, including myocardial infarction, stroke, and all-cause mortality, with up to 48 months of follow-up.