The U.S. Food and Drug Administration has approved the diabetes drug Mounjaro to lower the risk of major cardiovascular events in adults with Type 2 diabetes.
Around 40 million Americans suffer from the chronic health condition that leaves them at an increased risk of heart disease and stroke.
And heart disease is the leading cause of death for people with Type 2, Mounjaro’s drugmaker Eli Lilly said on Thursday. A third of U.S. adults with Type 2 may have undetected cardiovascular disease, according to the American Heart Association.
Taking the GLP-1 and GIP drug gives patients a way to reduce their risk, Kenneth Custer, the executive vice president and president of Eli Lilly’s Cardiometabolic Health division, explained in a statement announcing the first-of-its-kind approval.
“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,” he said.
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open image in galleryMounjaro was tested against Trulicity, another Eli Lilly GLP-1 drug that improves blood sugar regulation – high blood sugar is the cause of diabetes – in people with Type 2 and reduces the risk of major cardiovascular events.
In a four-and-a-half-year trial with more than 13,000 participants from 30 countries, Eli Lilly researchers found that Mounjaro outperformed Trulicity in reducing the risk of heart attack and stroke.
Mounjaro reduced the risk of major adverse heart events by 8 percent more than Trulicity.
“Heart health deserves attention throughout the course of treatment, not just after a serious cardiovascular event,” Dr. David D’Alessio, director of the Division of Endocrinology and Metabolism at Duke University School of Medicine, also said. D’Alessio is a co-author of the study with the trial details.
open image in gallery“This approval gives patients a medicine that reduces the risk of cardiovascular events and supports metabolic health at the same time,” he said.
The findings build on years of research showing heart benefits for multiple GLP-1 weight loss drugs. Mounjaro is not approved for weight loss, but is sometimes used off-label for it. Eli Lilly sells the obesity version of the drug under the brand Zepbound.
Millions of Americans use GLP-1 drugs today, with the percentage of adults who currently take the medications rising eight percent from 2024 to 2026, according to July Gallup data.