Mounjaro Demonstrates Non-Inferior Safety Profile in SURPASS-CVOT Cardiovascular Outcomes Trial

Eli Lilly’s latest clinical data reveals a significant milestone for patients managing both type 2 diabetes and cardiovascular complications. The SURPASS-CVOT Phase 3 trial, a randomized double-blind study comparing Mounjaro against Trulicity in adults with established atherosclerotic cardiovascular disease, has met its primary efficacy benchmark by achieving non-inferior rates of major adverse cardiovascular events.

Beyond cardiovascular safety, the trial unveiled compelling improvements across multiple metabolic markers. Study participants demonstrated measurable gains in A1C reduction, body weight management, and kidney function preservation. Notably, the data also indicated benefits in reducing all-cause mortality—a critical outcome that underscores the drug’s broader therapeutic potential in complex patient populations.

Kenneth Custer, leading Lilly’s Cardiometabolic Health division, highlighted the strategic importance of these findings: “This positions Mounjaro as a viable first-line option for the significant population of diabetes patients who simultaneously face cardiovascular risks.” The dual benefit profile addresses a substantial unmet medical need, as many patients with type 2 diabetes require integrated treatment approaches targeting multiple organ systems.

The regulatory pathway appears accelerated, with Eli Lilly planning to present the SURPASS-CVOT data package to global health authorities throughout 2025. This submission strategy could potentially expand Mounjaro’s approved indications and clinical positioning.

On Thursday’s market activity, LLY shares reflected a modest pullback, trading at $750.86 and declining 1.48 percent during pre-market hours on the New York Stock Exchange—a measured reaction that may indicate investor expectation adjustment following the data release.