Tirzepatide Approved by FDA to Reduce Cardiovascular Risk in Adults with Diabetes

The Food and Drug Administration (FDA) approved Mounjaro (tirzepatide; Eli Lilly and Company, Indianapolis, IN) to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes who are at high risk for cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke.

Mounjaro is a once-weekly injectable dual glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1 receptor agonist. Mounjaro was previously approved as an adjunct to diet and exercise to improve glycemic control in adults and children aged 10 years and older with type 2 diabetes.

Cardiovascular Outcomes Data

• The FDA’s decision was based on data from SURPASS-CVOT (NCT04255433), a randomized, double-blind, phase 3 cardiovascular outcomes trial.
• The trial included 13,299 adults with type 2 diabetes and established atherosclerotic cardiovascular disease across 640 sites in 30 countries.
• Participants were randomly assigned to receive Mounjaro 15 mg or the maximum tolerated dose, or dulaglutide 1.5 mg, administered subcutaneously once weekly.
• The primary objective assessed whether Mounjaro was noninferior to dulaglutide for reducing risk of major adverse cardiovascular events, defined as cardiovascular death, myocardial infarction, or stroke.
• Over a median follow-up of 210.1 weeks, Mounjaro was shown to be noninferior to dulaglutide for time to first major adverse cardiovascular event.
• The hazard ratio for time to first major adverse cardiovascular event was 0.92 (95.3% CI, 0.83 to1.01) for Mounjaro compared with dulaglutide.
• Mounjaro showed an 8% lower rate of cardiovascular death, myocardial infarction, or stroke compared with dulaglutide, although superiority was not established.

The safety and tolerability profile of tirzepatide in SURPASS-CVOT was generally consistent with previous data. The most common adverse events were gastrointestinal, were generally mild to moderate in severity, and occurred primarily during dose escalation.

Potential Implications for Neurologic Practice

For neurologists, the expanded indication may be relevant when counseling patients with type 2 diabetes and cerebrovascular risk, particularly because nonfatal stroke was included in the cardiovascular composite endpoint.

Source

Eli Lilly and Company. FDA approves Lilly’s Mounjaro (tirzepatide) to reduce cardiovascular risk in adults with type 2 diabetes. PR Newswire. Published August 28, 2026. Accessed August 28, 2026. https://www.prnewswire.com/news-releases/fda-approves-lillys-mounjaro-tirzepatide-to-reduce-cardiovascular-risk-in-adults-with-type-2-diabetes-302862415.html