The Food and Drug Administration (FDA) has approved Eli Lilly’s blockbuster diabetes drug Mounjaro to reduce the risk of stroke or heart attack in adults with type 2 diabetes who are at high risk of cardiovascular events.

Mounjaro is an injectable for adults and children aged 10 years or older with type 2 diabetes. The version that’s been approved for obesity is sold as Zepbound.

The new indication was based on the results of a head-to-head clinical trial that compared Mounjaro with Trulicity, Lilly’s older GLP-1 treatment for type 2 diabetes. The study followed more than 13,000 participants across 30 countries for over four and a half years.

Results found that Mounjaro had an 8% lower rate of cardiovascular death, heart attack, or stroke than Trulicity. There were some gastrointestinal-related side effects from Mounjaro, but they were generally mild to moderate in severity.

“Heart health deserves attention throughout the course of treatment, not just after a serious cardiovascular event,” David A. D’Alessio, MD, the study’s co-author, said in a press release. “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.”

6 Supplements That May Help While Taking GLP-1 Medications

Eli Lilly’s tirzepatide isn’t the first GLP-1 drug to receive an FDA indication for reducing cardiovascular risks. Last year, the FDA approved Rybelsus, an oral GLP-1 medicine manufactured by Novo Nordisk, for reducing the risk of cardiovascular events in high-risk adults with type 2 diabetes.

In 2024, the FDA also approved Novo Nordisk’s Wegovy, an injectable version of semaglutide for weight loss, to reduce the risk of serious heart-related issues in adults with cardiovascular disease who have either obesity or overweight.