With the approval, Eli Lilly’s Mounjaro becomes the first dual GIP/GLP-1 receptor agonist indicated to lower the risk of heart attack, stroke or cardiovascular death in adults with type 2 diabetes.
Everything continues to come up Eli Lilly. The company has now matched its rival Novo Nordisk with an FDA approval for its drug to reduce cardiovascular risk in people who also have a metabolic indication.
Mounjaro—Lilly’s tirzepatide-based type 2 diabetes (T2D) drug—is the first GIP and GLP-1 receptor agonist proven to lower heart attack, stroke or cardiovascular death risk in adults with T2D at high risk for these events, the company said in a press release on Friday. Mounjaro was already indicated as an adjunct to diet and exercise to improve blood sugar for people 10 years and older with T2D.
With the FDA greenlight, Mounjaro joins Novo’s semaglutide drugs Ozempic and Wegovy in the cardiovascular space. Wegovy was approved in March 2024 for adults with heart disease and overweight or obesity, while Ozempic is approved to reduce the risk of major adverse cardiovascular events in adults with T2D and established cardiovascular disease. Semaglutide targets and activates the GLP-1 receptor alone.
Mounjaro’s approval in cardiovascular risk comes as the European Society of Cardiology’s annual Congress kicks off Friday in Munich. Lilly supported its application with data from the SURPASS-CVOT trial, which comprised 13,000 participants across 30 countries over more than four and a half years and compared the dual GLP-1/GIP agonist to the company’s Trulicity, “a GLP-1 treatment with established cardiovascular benefit,” according to the Friday release.
Mounjaro demonstrated non-inferiority to Trulicity, Lilly said, with trial participants on Mounjaro seeing a 8% lower rate of cardiovascular death, heart attack or stroke (MACE-3) than those taking Lilly’s older product.
“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,” Kenneth Custer, executive vice president and president of Lilly Cardiometabolic Health, said in a statement alongside the release.
“Heart health deserves attention throughout the course of treatment, not just after a serious cardiovascular event,” added David A. D’Alessio, the SURPASS-CVOT study’s co-author and director of the Division of Endocrinology and Metabolism at Duke University School of Medicine in the same announcement. “While a large portion of type 2 diabetes care is focused on glucose control, mitigating cardiovascular risk is essential and can be overlooked.”
