FDA approves Mounjaro to reduce cardiovascular risk in type 2 diabetes

On August 28, 2026, FDA approved a new indication for Mounjaro (tirzepatide) to reduce the risk of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke in adults with type 2 diabetes who are at high risk for these events. Mounjaro was previously approved to improve glycemic control in adults and children aged 10 years or older with type 2 diabetes.

For practice, the approval adds an outcomes-based reason to consider tirzepatide when selecting diabetes therapy for adults at elevated cardiovascular risk. It may also reduce the need to balance glucose-lowering efficacy against evidence for preventing major cardiovascular events.

Although the indication broadly refers to adults at high cardiovascular risk, the supporting SURPASS-CVOT trial enrolled patients with established atherosclerotic cardiovascular disease. The evidence therefore applies most directly to patients with conditions such as coronary artery disease, prior myocardial infarction or stroke, or peripheral artery disease.

Over a median follow-up of about four years, 13,294 patients received tirzepatide or Trulicity (dulaglutide), a GLP-1 receptor agonist with established cardiovascular benefit. A major cardiovascular event occurred in 12.1% of patients receiving tirzepatide and 13.0% receiving dulaglutide, corresponding to an 8% lower relative rate with tirzepatide. Tirzepatide demonstrated comparable cardiovascular protection but was not superior to dulaglutide.

Safety remained consistent with Mounjaro’s established profile. Gastrointestinal adverse effects were most common, particularly during dose escalation. The boxed warning for thyroid C-cell tumors and precautions related to pancreatitis, hypoglycemia with insulin or sulfonylureas, volume depletion, severe gastrointestinal disease, diabetic retinopathy, and gallbladder disease remain unchanged.

“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,” said study coauthor David D’Alessio, MD, of Duke University School of Medicine.

Source: Eli Lilly and Company. (2026 Aug 28) FDA approves Lilly’s Mounjaro (tirzepatide) to reduce cardiovascular risk in adults with type 2 diabetes