FDA approves Mounjaro to reduce cardiovascular risk in adults with type 2 diabetes – Eli Lilly
Eli Lilly and Company announced that the FDA approved Mounjaro (tirzepatide), a dual GIP and GLP-1 hormone receptor agonist, to lower the risk of major adverse cardiovascular (CV) events (MACE), including CV death, non-fatal heart attack, or non-fatal stroke in adults with type 2 diabetes who are at high risk for these events. Mounjaro is already approved as an adjunct to diet and exercise to improve blood sugar in adults and children 10 years of age and older with type 2 diabetes.
“For people with type 2 diabetes, heart disease is the leading cause of death, and Mounjaro – the #1 most prescribed branded type 2 diabetes medicine for adults in the U.S. – now gives them a proven way to lower that risk, adding to the strong foundation it has already built in A1C and weight,” said Kenneth Custer, Ph.D., executive vice president and president, Lilly Cardiometabolic Health. “We set a higher bar by testing Mounjaro against a GLP-1 medicine with proven cardiovascular benefit, one that reflects the depth of evidence Lilly continues to build in this field.”
The approval was based on results from SURPASS-CVOT, the first cardiovascular outcomes trial comparing two incretin medicines head-to-head rather than against a placebo, and the largest and longest tirzepatide study to date, enrolling more than 13,000 participants across 30 countries over more than four and a half years. In the trial, Mounjaro demonstrated non-inferiority to Trulicity (dulaglutide), a GLP-1 treatment with established cardiovascular benefit, with an 8% lower rate of cardiovascular death, heart attack or stroke (MACE-3). The estimated hazard ratio for time to first MACE was 0.92 (95.3% CI: 0.83, 1.01) for Mounjaro compared to Trulicity (dulaglutide).
“Heart health deserves attention throughout the course of treatment, not just after a serious cardiovascular event,” said David A. D’Alessio, M.D., study co-author and director of the Division of Endocrinology and Metabolism at Duke University School of Medicine. “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.”
The safety and tolerability of Mounjaro were generally consistent with its established profile. 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.
About SURPASS-CVOT
SURPASS-CVOT (Cardiovascular Outcomes Trial; NCT04255433) was an event-driven, randomized, double-blind, parallel group Phase 3 trial evaluating the efficacy and safety of Mounjaro (tirzepatide) compared with Trulicity (dulaglutide) in adults with type 2 diabetes and established atherosclerotic cardiovascular disease (ASCVD), which lasted approximately five years (with a median follow-up of four years). In the trial, 13,299 participants were randomized 1:1 across 640 sites in 30 countries to receive Mounjaro (15 mg or the maximum tolerated dose) or Trulicity (1.5 mg) administered subcutaneously once weekly. The primary objective of the trial was to demonstrate that Mounjaro provided a non-inferior reduction in the risk of major adverse cardiovascular events (MACE-3) — a composite of cardiovascular death, heart attack or stroke — compared to Trulicity. Over a median follow-up of 210.1 weeks, Mounjaro was non-inferior to dulaglutide for reducing the occurrence of MACE-3. Superiority to dulaglutide was not established. Full results from SURPASS-CVOT were published in The New England Journal of Medicine (NEJM). Data from the trial has been included in Mounjaro’s product information in the European Union, and regulatory submissions based on the trial are under review in additional markets.
Citation: Cardiovascular Outcomes with Tirzepatide versus Dulaglutide in Type 2 Diabetes. Authors: Stephen J. Nicholls, M.B., B.S., Ph.D., Imre Pavo, M.D., Deepak L. Bhatt, M.D., M.P.H. et al. Published December 17, 2025 N Engl J Med 2025;393:2409-2420 DOI: 10.1056/NEJMoa2505928 VOL. 393 NO. 24
