The US Food and Drug Administration (FDA) has approved Lilly’s Mounjaro (tirzepatide), a dual GIP and GLP-1 hormone receptor agonist, to lower the risk of major adverse cardiovascular (CV) events (MACE) in adults with type 2 diabetes.  

The drug 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 number one most prescribed branded type 2 diabetes medicine for adults in the US – 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, Executive Vice President and President, Lilly Cardiometabolic Health. 

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. The trial enrolled 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 for Mounjaro compared to Trulicity (dulaglutide). 

“Heart health deserves attention throughout the course of treatment, not just after a serious cardiovascular event,” said Dr David D’Alessio, 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.”