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Jump to Key Points Eli Lilly's Mounjaro (tirzepatide) is now FDA-approved to reduce cardiovascular risk in adults with type 2 diabetes (T2D).
Given as a once-weekly subcutaneous injection, tirzepatide is the first dual GIP and GLP-1 receptor agonist shown to lower the risk for heart attack, stroke, or cardiovascular death in those with T2D at high risk for these events.
The approval was based on results from the SURPASS-CVOT trial, a 5-year randomized, double-blind, parallel group phase 3 trial that assessed the efficacy and safety of Mounjaro vs Trulicity (dulaglutide) in adults with T2D and established atherosclerotic cardiovascular disease.
A total of 13,299 participants were randomized 1:1 across 640 sites in 30 countries to receive tirzepatide (15 mg or the maximum tolerated dose) or dulaglutide (1.5 mg) administered subcutaneously once weekly. The trial's primary objective was to demonstrate noninferiority of tirzepatide to dulaglutide in reducing major adverse cardiovascular events (MACE-3) — a composite of cardiovascular death, heart attack, or stroke.
- Tirzepatide now FDA-approved to ↓ CV risk in adults with T2D.
- First dual GIP/GLP-1 RA shown to lower MI, stroke, or CV death risk.
- Approval based on SURPASS-CVOT; 13,299 pts with established ASCVD.
- Tirzepatide noninferior to dulaglutide; HR 0.92 (95.3% CI, 0.83-1.01).
- GI AEs most common; usually mild-moderate, mainly during dose escalation.
Over a median follow-up of 210.1 weeks, tirzepatide was found to be noninferior to dulaglutide, with an 8% lower rate of MACE-3. The estimated hazard ratio for time to first MACE was 0.92 (95.3% CI, 0.83-1.01) for tirzepatide compared to dulaglutide. Superiority to dulaglutide was not established.
The safety and tolerability of Mounjaro were generally consistent with its established profile. The most common adverse events for tirzepatide in SURPASS-CVOT were gastrointestinal-related, generally mild to moderate in severity, and occurred primarily during the dose-escalation period.
The drug is also approved as an adjunct to diet and exercise to improve blood sugar in adults and children 10 years of age and older with T2D.
Lilly also markets tirzepatide as Zepbound, which is approved for chronic weight management and obstructive sleep apnea in adults.
Marilynn Larkin, MA, is an award-winning medical writer and editor based in New York City whose work has appeared in numerous publications, including Medscape Medical News and its sister publication MDedge, The Lancet (where she was a contributing editor), and Reuters Health.
