Mounjaro (tirzepatide)

Aug. 28, 2026: Eli Lilly and Company (NYSE: LLY) said the FDA approved Mounjaro (tirzepatide) to reduce the risk of major adverse cardiovascular events (CV death, non-fatal heart attack, or non-fatal stroke) in adults with type 2 diabetes who are at high risk for these events.

The label expansion was based on the Phase 3 SURPASS-CVOT trial (NCT04255433), a randomized, double-blind cardiovascular outcomes study comparing Mounjaro with Trulicity (dulaglutide) in 13,299 adults with type 2 diabetes and established atherosclerotic cardiovascular disease across 640 sites in 30 countries. Over a median follow-up of 210.1 weeks, Mounjaro was non-inferior to dulaglutide for time to first MACE-3, with an 8% lower event rate and a hazard ratio of 0.92 (95.3% CI: 0.83, 1.01). Superiority was not established.

Lilly said safety and tolerability were generally consistent with Mounjaro’s established profile; the most common adverse events in SURPASS-CVOT were gastrointestinal and generally mild to moderate, mainly during dose escalation.

The company also noted full SURPASS-CVOT results were published in NEJM and that regulatory submissions based on the trial are under review in additional markets.