The trial will include type 2 diabetes patients with atherosclerotic cardiovascular disease. Credit: StockSnap from Pixabay.

Eli Lilly has dosed the first participants in the Phase III SURPASS-CVOT cardiovascular outcomes trial of tirzepatide in patients with type 2 diabetes and atherosclerotic cardiovascular disease.

The head-to-head trial will evaluate non-inferiority and superiority of tirzepatide compared to 1.5mg Trulicity (dulaglutide), which is indicated for adults with type 2 diabetes to improve blood sugar and to mitigate the risk of major cardiovascular (CV) events.

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Tirzepatide is an investigational dual GIP and GLP-1 receptor agonist, while Trulicity is a GLP-1 receptor agonist.

Lilly distinguished medical fellow Jeff Riesmeyer said: “We are constantly evaluating the needs of people living with diabetes and are committed to researching innovative medicines that reflect the evolution in the standards of diabetes care.

“We are confident in the potential of tirzepatide to help people with type 2 diabetes achieve additional benefits beyond blood glucose control alone and look forward to results from SURPASS-CVOT.”

SURPASS-CVOT is a randomised, double-blind study designed to compare the safety and efficacy of tirzepatide to dulaglutide in 12,500 participants with type 2 diabetes and atherosclerotic cardiovascular disease across 30 countries.

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The study’s primary endpoint measure is time to first occurrence of MACE-3, which is the composite endpoint of CV death, myocardial infarction or stroke.

Key secondary endpoints include time to all-cause mortality and time to occurrence of each component of the primary endpoint. It is expected that the trial will be completed in 2024.

Study co-chairs David D’Alessi and Stephen Nicholls said: “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.”

Earlier this month, Lilly started dosing participants in the Phase I trial of antibody therapy LY-CoV555, which is intended to treat Covid-19 infection.