The FDA has approved Eli Lilly’s Mounjaro (tirzepatide) to reduce cardiovascular risk in adults with type 2 diabetes who are at high risk for events. The approval is based on results from the SURPASS-CVOT cardiovascular outcomes trial, which compared tirzepatide directly with dulaglutide (Trulicity) rather than placebo. In the trial, tirzepatide met non-inferiority versus dulaglutide for the primary major adverse cardiovascular outcomes composite (MACE-3), with an 8% lower event rate and a reported hazard ratio of 0.92 (95% CI 0.83–1.01). The most common adverse events were gastrointestinal and primarily occurred during dose escalation. This decision extends tirzepatide’s established glycemic control and weight-loss benefits into a formally labeled cardiovascular risk-reduction claim, reinforcing the growing emphasis on evidence-backed outcomes beyond glucose metrics.