Eli Lilly and Co. (NYSE:LLY) released topline results from SURPASS-CVOT, a head-to-head Phase 3 cardiovascular outcomes trial comparing Mounjaro (tirzepatide), a GIP/GLP-1 dual receptor agonist, to Trulicity (dulaglutide), a GLP-1 receptor agonist.
In SURPASS-CVOT, Mounjaro achieved the primary objective by demonstrating a non-inferior rate of major adverse cardiovascular events (MACE-3), including cardiovascular death, heart attack, or stroke, versus Trulicity.
In addition, while not controlled for multiplicity-adjusted type-1 error, Mounjaro showed improvements on key measures of A1C, weight, renal function, and all-cause mortality.
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The trial, which enrolled more than 13,000 participants and lasted more than four and a half years, is the largest and longest study of tirzepatide to date, the company said in a statement on Thursday.
In the trial, the risk of cardiovascular death, heart attack, or stroke was 8% lower for Mounjaro vs. Trulicity, meeting the prespecified criteria for non-inferiority.
Mounjaro showed consistent results across all three components of the MACE-3 composite endpoint. The all-cause mortality rate was 16% lower for Mounjaro vs. Trulicity.
A prespecified indirect comparison analysis of matched patient-level data from the REWIND (2019 study) and SURPASS-CVOT studies found that Mounjaro reduced the risk of MACE-3 by 28% and all-cause mortality by 39% compared to a putative placebo.
The REWIND study, published in 2019, showed a definitive cardiovascular benefit. It was a multicenter, randomized, double-blind, placebo-controlled trial designed to assess the effect of Trulicity (1.5 mg) compared to placebo in adults with type 2 diabetes with and without established cardiovascular disease.
In participants with a high or very high risk of chronic kidney disease, Mounjaro slowed eGFR decline by 3.54 mL/min/1.73 m2 at 36 months vs. Trulicity.
Mounjaro improved A1C, weight, and cardiovascular biomarkers, including lipids and systolic blood pressure, compared to Trulicity.
The safety and tolerability of Mounjaro and Trulicity were generally consistent with their established profiles.
13.3% of participants taking Mounjaro discontinued treatment due to adverse events, compared to 10.2% of participants taking Trulicity.
Lilly plans to submit these data to global regulatory authorities by the end of this year.
Two years ago, Novo Nordisk A/S’ (NYSE:NVO) headline results from the SELECT cardiovascular outcomes trial demonstrated a statistically significant and superior reduction in MACE of 20% for people treated with semaglutide 2.4 mg compared to placebo, better than the 15-17% expected by investors and analysts.
Price Action: LLY stock is down 1.40% at $749.45 during the premarket session at the last check Thursday.
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