Eli Lilly’s tirzepatide, branded as Mounjaro, won FDA approval to reduce cardiovascular risk in adults with type 2 diabetes at high risk for heart attack, stroke or cardiovascular death. The decision is based on SURPASS-CVOT, a head-to-head outcomes trial comparing tirzepatide against dulaglutide (Trulicity), rather than placebo. Lilly reported that Mounjaro met non-inferiority versus Trulicity, with an 8% lower rate of the composite major adverse cardiovascular events (MACE-3). The estimated hazard ratio for time to first MACE was 0.92 (95.3% CI: 0.83–1.01), and Lilly said the safety profile in SURPASS-CVOT matched the established tirzepatide experience, with gastrointestinal events concentrated around dose escalation. Clinically, the approval extends tirzepatide’s labeled impact beyond glycemic control and weight loss into a core cardiometabolic outcome category. Commercially, it strengthens Lilly’s position in the incretin class as cardioprotection becomes a major differentiator in payer and guideline decisions.