Tirzepatide enters SURPASS-CVOT, the phase III cardiovascular outcomes trial,- Eli Lilly

The first patient dose has been delivered in SURPASS-CVOT, the phase III cardiovascular outcomes trial for tirzepatide, Eli Lilly and Company’s investigational dual GIP and GLP-1 receptor agonist. The study will assess both non-inferiority and superiority of tirzepatide in a head-to-head trial against Trulicity (dulaglutide) 1.5 mg – the market leading GLP-1 receptor agonist.

SURPASS-CVOT (NCT04255433) includes 12,500 participants with type 2 diabetes and atherosclerotic cardiovascular disease from 30 countries. The primary endpoint measures time to first occurrence of MACE-3, the composite endpoint of CV death, myocardial infarction or stroke. Key secondary endpoints measure time to all-cause mortality and time to occurrence of each component of the primary endpoint. Lilly anticipates the trial will take just over four years to complete.

“Lilly is making a bold move by comparing tirzepatide to Trulicity, which is already proven to significantly reduce the risk of major adverse cardiovascular events,” said study co-chairs David A. D’Alessio, M.D., Chief in the Division of Endocrinology and Metabolism, Duke University School of Medicine, and Stephen Nicholls, M.B.,B.S., Ph.D., Director of the Monash University Victorian Heart Institute, on behalf of the study’s Academic Executive Committee. “SURPASS-CVOT will provide clinicians of people with type 2 diabetes and established cardiovascular disease with important evidence about the potential of tirzepatide to deliver outcomes beyond today’s best-in-class medicines.”