Eli Lilly has announced positive topline results from its phase 3 SURPASS-CVOT trial, comparing Mounjaro (tirzepatide) with Trulicity (dulaglutide) in adults with type 2 diabetes and cardiovascular disease.
The study met its primary objective, with Mounjaro showing non-inferiority to Trulicity in reducing major adverse cardiovascular events (MACE-3), including cardiovascular death, heart attack and stroke.
Mounjaro was associated with an 8% lower rate of MACE-3 and a 16% reduction in all-cause mortality compared to Trulicity. The trial also showed improvements in A1C, weight, renal function and cardiovascular biomarkers.
Kenneth Custer, executive vice president and president, Lilly Cardiometabolic Health, said: “The SURPASS-CVOT results show that Mounjaro preserved the cardioprotective benefit of Trulicity, a GLP-1 receptor agonist, while providing additional benefits, including greater kidney protection and a reduced overall risk of death.”
More than 13,000 participants across 30 countries took part in the four-and-a-half-year study, making it the largest and longest trial of tirzepatide to date.
A pre-specified indirect comparison with REWIND data found Mounjaro reduced MACE-3 risk by 28% and all-cause mortality by 39% compared to a putative placebo. In patients with high kidney disease risk, Mounjaro slowed eGFR decline by 3.54 mL/min/1.73 m² at 36 months vs. Trulicity.
Both treatments showed consistent safety profiles, with gastrointestinal events being the most common. Discontinuation due to adverse events was 13.3% for Mounjaro and 10.2% for Trulicity.
Full results will be presented at the EASD Annual Meeting in September and submitted to regulators by year-end.
