The U.S. Food and Drug Administration has approved Eli Lilly’s Mounjaro (tirzepatide) to reduce the risk of heart attack, stroke and cardiovascular death in adults with type 2 diabetes who face a high risk of cardiovascular events.

 

The decision expands Mounjaro’s role beyond blood-sugar and weight management, giving the drug a new indication aimed directly at one of the biggest threats facing people with type 2 diabetes: cardiovascular disease.

 

Lilly said Mounjaro is the first and only GIP and GLP-1 receptor agonist shown to reduce the risk of major adverse cardiovascular events in this population.

 

"For people with type 2 diabetes, heart disease is the leading cause of death, and Mounjaro – the #1 most prescribed branded type 2 diabetes medicine for adults in the U.S. – now gives them a proven way to lower that risk, adding to the strong foundation it has already built in A1C and weight," said Kenneth Custer, executive vice president and president, Lilly Cardiometabolic Health. 

 

"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."

 

The approval is based on results from SURPASS-CVOT, a large Phase 3 cardiovascular outcomes trial that directly compared Mounjaro with Trulicity (dulaglutide), a GLP-1 drug with an established cardiovascular benefit.

 

The trial enrolled 13,299 people with type 2 diabetes and established atherosclerotic cardiovascular disease across 640 sites in 30 countries. Participants were followed for a median of more than four years.

 

Mounjaro met the trial’s primary goal by demonstrating non-inferiority to Trulicity in reducing major adverse cardiovascular events — a combined measure of cardiovascular death, non-fatal heart attack and non-fatal stroke.

 

Lilly said the rate of these events was 8% lower with Mounjaro than with Trulicity. The estimated hazard ratio for the time to the first cardiovascular event was 0.92, with a 95.3% confidence interval of 0.83 to 1.01.

 

However, Mounjaro did not demonstrate superiority over Trulicity.

 

The findings mark a significant expansion of evidence for tirzepatide, which activates both GIP and GLP-1 receptors. Mounjaro is already approved to improve blood sugar in adults and children aged 10 and older with type 2 diabetes, when used alongside diet and exercise.

 

"Heart health deserves attention throughout the course of treatment, not just after a serious cardiovascular event," said David A. D'Alessio, study co-author and director of the Division of Endocrinology and Metabolism at Duke University School of Medicine. 

 

"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."

 

The safety profile of Mounjaro in SURPASS-CVOT was generally consistent with its established profile. Lilly said the most common adverse events were gastrointestinal, including nausea, diarrhea, decreased appetite, vomiting, constipation, indigestion and abdominal pain. Most were mild to moderate and occurred primarily during dose escalation.