Eli Lilly’s diabetes drug Mounjaro approved to reduce cardiovascular risks

The US Food and Drug Administration has approved Eli Lilly’s diabetes drug Mounjaro to reduce the risk of heart attack or stroke in adults with type 2 diabetes who are at high risk of cardiovascular events. This approval expands the use of Mounjaro beyond blood sugar control.

Mounjaro targets two hormones in the incretin class, GLP-1 and GIP. In the US, Lilly markets the obesity version of the drug under the brand name Zepbound. Lilly and Danish competitor Novo Nordisk are both working to extend the applications of their GLP-1 drugs, testing them for conditions including cardiovascular disease and liver disorders.

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Novo Nordisk received FDA approval for its weight-loss drug Wegovy in 2024 to lower heart risks in overweight or obese adults without diabetes. In 2025, the FDA also approved Novo Nordisk's older diabetes drug Rybelsus to reduce major heart risks in diabetic patients.

Lilly's approval was based on results from a large head-to-head trial where Mounjaro outperformed Trulicity, Lilly's older diabetes drug, in lowering the risk of major heart events. The trial compared people with type 2 diabetes taking Mounjaro with those taking Trulicity, which targets only GLP-1.

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Results showed that those on Mounjaro had an 8% lower rate of heart attack, stroke, or heart-related death than those on Trulicity. Earlier studies showed Trulicity reduced the risk of heart events by 12% compared with placebo in people with and without prior heart conditions.

Dr Rachel Batterham, senior vice-president of medical innovation and external engagement for cardiometabolic health at Lilly, said the study focused on patients with type 2 diabetes, where cardiovascular disease is the leading cause of death, as mentioned in TIME. She added that Lilly set a high standard by comparing Mounjaro's heart risk reduction against Trulicity, which had already shown benefits.

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The study design means the heart benefit results cannot be directly compared with Novo Nordisk's Ozempic. Ozempic, approved for diabetes treatment, and Wegovy, approved for overweight and obesity, are both authorised to lower heart disease risk by 20%. Lilly is also conducting a study on people without type 2 diabetes who take Zepbound to track heart events.

According to Reuters, sales of Mounjaro increased by 91% to $9.94 billion in the second quarter, driven by strong demand across global markets. In April, Lilly reported that its oral obesity pill Foundayo was not inferior to a commonly used long-acting insulin in lowering the risk of major heart problems in patients with type 2 diabetes and obesity. The company is conducting two late-stage studies: one on Foundayo's cardiovascular benefits and another on its next-generation obesity drug retatrutide's effects on cardiovascular events and kidney disease progression.