FDA Approves Mounjaro to Reduce Cardiovascular Risk in Type 2 Diabetes

The FDA has approved tirzepatide (Mounjaro, Eli Lilly and Company) to reduce the risk of major adverse cardiovascular events (MACE), including cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke, in adults with type 2 diabetes at high risk for these events, according to an Eli Lilly and Company news release.

The action adds cardiovascular-risk reduction to the drug’s existing indication as an adjunct to diet and exercise for glycemic control in adults and children aged 10 years and older with type 2 diabetes. The new cardiovascular indication applies only to adults. Tirzepatide is an injectable dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist.

Approval was based on SURPASS-CVOT, an event-driven, randomized, double-blind, phase 3 trial. Investigators randomized 13,299 adults with type 2 diabetes and established atherosclerotic cardiovascular disease 1:1 to tirzepatide 15mg or the maximum tolerated dose, or dulaglutide (Trulicity, Eli Lilly and Company) 1.5mg, administered subcutaneously once weekly. The trial was conducted at 640 sites in 30 countries, with a median follow-up of 210.1 weeks.

The primary objective was to demonstrate noninferiority of tirzepatide to dulaglutide for MACE-3, a composite of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke. Tirzepatide met the noninferiority criterion; the estimated hazard ratio for time to first MACE was 0.92 (95.3% CI, 0.83-1.01). Superiority to dulaglutide was not established.

Lilly reported that tirzepatide’s safety and tolerability were generally consistent with its established profile. The most commonly reported adverse events with tirzepatide in SURPASS-CVOT were gastrointestinal, generally mild to moderate, and occurred primarily during dose escalation. The Mounjaro safety summary warns of thyroid tumors, including thyroid cancer, and states that the drug should not be used in people with a personal or family history of medullary thyroid carcinoma or with multiple endocrine neoplasia syndrome type 2.

Sources: Eli Lilly and Company. FDA approves Lilly’s Mounjaro (tirzepatide) to reduce cardiovascular risk in adults with type 2 diabetes. News release. Eli Lilly and Company; August 28, 2026. Accessed August 28, 2026.

Nicholls SJ, Pavo I, Bhatt DL, et al. Cardiovascular Outcomes with Tirzepatide versus Dulaglutide in Type 2 Diabetes. N Engl J Med. 2025 Dec 18;393(24):2409-2420. doi: 10.1056/NEJMoa2505928