FDA approves Lilly’s Mounjaro (tirzepatide) to lower cardiovascular risk in adults with type 2 diabetes

Mounjaro becomes the first and only dual GIP and GLP-1 receptor agonist shown to reduce the risk of heart attack, stroke, or cardiovascular death in adults with type 2 diabetes who face a high risk of these events, adding to its already established benefits for A1C control and weight loss

An estimated one in three adults with type 2 diabetes in the United States may have undiagnosed cardiovascular disease

Eli Lilly and Company announced that the U.S. Food and Drug Administration approved Mounjaro (tirzepatide), a dual GIP and GLP-1 receptor agonist, to reduce the risk of major adverse cardiovascular events, including cardiovascular death, non-fatal heart attack, or non-fatal stroke, in adults with type 2 diabetes who are at high risk for these events. Mounjaro was already approved as an addition to diet and exercise to improve blood sugar levels in adults and children aged 10 and older with type 2 diabetes.

Kenneth Custer, PhD, executive vice president and president of Lilly Cardiometabolic Health, said heart disease is the leading cause of death among people with type 2 diabetes, and that Mounjaro, the most prescribed branded type 2 diabetes medicine among adults in the United States, now gives patients a proven way to lower that risk, building on its already strong track record for reducing A1C and body weight. He said the company set a higher bar for evidence by studying Mounjaro head-to-head against a GLP-1 medicine with established cardiovascular benefits, reflecting the depth of evidence Lilly continues to build in this area.

The approval is based on results from SURPASS-CVOT, the first cardiovascular outcomes trial to compare two incretin medicines directly against each other rather than against a placebo, and the largest and longest tirzepatide study to date, enrolling more than 13,000 participants from 30 countries over more than four and a half years. In the trial, Mounjaro proved non-inferior to Trulicity (dulaglutide), a GLP-1 treatment with an established history of cardiovascular benefit, with an 8 percent lower rate of cardiovascular death, heart attack, or stroke (MACE-3). The estimated hazard ratio for time to first MACE event was 0.92 (95.3% CI: 0.83, 1.01) for Mounjaro compared with Trulicity.

David A. D’Alessio, M.D., a study co-author and director of the Division of Endocrinology and Metabolism at Duke University School of Medicine, said heart health deserves attention throughout the course of treatment, not only after an acute cardiovascular event occurs. He said that while much of type 2 diabetes management focuses on glucose control, reducing cardiovascular risk remains essential and is often overlooked. He said this approval gives patients access to a medicine that lowers cardiovascular risk while also supporting metabolic health.

Mounjaro’s safety and tolerability have remained generally consistent with its established profile. The adverse events reported most frequently during the SURPASS-CVOT study for Mounjaro were gastrointestinal in nature, generally mild to moderate in severity, and occurred mainly during the dose-escalation phase.

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