Eli Lilly's diabetes drug Mounjaro has shown non-inferiority to Trulicity in preventing heart attacks, strokes, and cardiovascular death in a trial of over 13,000 patients. Mounjaro also resulted in greater weight loss and improvements in blood sugar levels and blood pressure. The findings support the expansion of Mounjaro's label to include cardiovascular risk reduction and strengthen its case as a front-line treatment for type 2 diabetes and cardiovascular disease.
Eli Lilly and Company (NYSE: LLY) has reported groundbreaking results from the SURPASS-CVOT trial, a Phase 3 cardiovascular outcomes study comparing Mounjaro (tirzepatide) to Trulicity (dulaglutide) in type 2 diabetes patients with cardiovascular disease. The trial, which enrolled over 13,000 participants across 30 countries, demonstrated Mounjaro's cardiovascular protection with an 8% lower rate of major adverse cardiovascular events (MACE-3) compared to Trulicity [1].
Key findings include a 16% reduction in all-cause mortality, superior A1C and weight reductions, and enhanced kidney protection with Mounjaro. The drug showed a 28% reduction in MACE-3 events and 39% reduction in all-cause mortality compared to placebo in indirect comparison analyses [2]. The safety profile remained consistent with previous studies, with 13.3% discontinuation rate due to adverse events.
The SURPASS-CVOT trial results represent a significant milestone for Eli Lilly's Mounjaro, positioning it as a potential front-line therapy for type 2 diabetes patients with established cardiovascular disease. The trial demonstrated non-inferior cardiovascular protection with an 8% lower rate of MACE-3 compared to Trulicity, while also showing numerical advantages across multiple important endpoints.
The renal protection data is compelling, with Mounjaro slowing eGFR decline by 3.54 mL/min/1.73 m² compared to Trulicity in high-risk kidney disease patients [1]. Metabolically, Mounjaro continues to demonstrate superior efficacy with substantially greater reductions in A1C (-1.73% vs -0.90%) and body weight (-12.06% vs -4.95%) at 36 months compared to Trulicity [2].
These results solidify Mounjaro's position as a potential front-line therapy for type 2 diabetes patients with established cardiovascular disease, offering comprehensive cardiometabolic protection beyond glycemic control alone. The 8% reduction in MACE-3 events and particularly the 16% reduction in all-cause mortality provide Lilly with powerful differentiation points against competitors in the increasingly crowded GLP-1/dual agonist space.
The pre-specified indirect comparison showing 28% MACE-3 reduction and 39% all-cause mortality reduction versus putative placebo gives Lilly compelling marketing narratives. The kidney protection data opens potential expansion into diabetic kidney disease indications. With superior glycemic control and weight reduction maintained over 4.5 years, Lilly now has long-term efficacy data to support Mounjaro's premium positioning.
The planned regulatory submissions by year-end could lead to expanded indications and label enhancements in 2026, further distancing Mounjaro from competitors. These results likely strengthen Lilly's pricing power and market share potential in both diabetes and obesity markets, reinforcing their leadership position in the rapidly growing GLP-1/dual agonist therapeutic area.
References:
[1] https://www.stocktitan.net/news/LLY/lilly-s-mounjaro-tirzepatide-a-gip-glp-1-dual-agonist-demonstrated-qyylayoeqlv2.html
[2] https://investor.lilly.com/news-releases/news-release-details/lillys-mounjaro-tirzepatide-gipglp-1-dual-agonist-demonstrated
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