A Study of Tirzepatide (LY3298176) Compared With Dulaglutide on Major Cardiovascular Events in Participants With Type 2 Diabetes

What Was Tested

The trial (phase 3) is built around Tirzepatide and Dulaglutide.

It had two arms (groups): one (experimental) and one (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 13299 actual participants took part.

It was open to people of any sex aged from 40 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Men or women at least 40 years old with a diagnosis of type 2 diabetes. Established cardiovascular disease, including at least 1 of the following:. Coronary artery disease (CAD) with any of the following:. Documented history of spontaneous myocardial infarction (MI). History of surgical or percutaneous coronary revascularization procedure.

The full record lists 34 inclusion and 28 exclusion criteria; among the exclusions: have type 1 diabetes mellitus; have uncontrolled diabetes requiring immediate therapy (such as diabetic ketoacidosis) at screening or randomization, in the judgment of the physician; have had 1 or more events of severe hypoglycemia and/or 1 or more events of hypoglycemia unawareness within 6 months prior to screening.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

The participants were allocated by chance, so the Tirzepatide group and the comparison group should start out alike.

The Tirzepatide group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the participants and researchers unaware of who received Tirzepatide.

Those kept unaware of assignments: participant and investigator.

It started in 2020-05-29 with completion listed for 2025-06-12.

It ran at 635 sites in United States (121), Germany (47), Argentina (31), Canada (29), Mexico (24) and China (23).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 13 secondary outcomes, for example Number of Participants From Randomization to Time to First Occurrence of Myocardial Infarction (MI), Number of Participants From Randomization toTime to First Occurrence of Stroke, Number of Participants From Randomization to Time to First Occurrence of Revascularization, Number of Participants From Randomization to Time to First Occurrence of New or Worsening Nephropathy, Change From Baseline to 36 Months in Hemoglobin A1c (HbA1c) and Percent Change From Baseline to 36 Months in Body Weight.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Tirzepatide and Dulaglutide in 13299 people.

With 13299 participants it is a large trial for this field.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Tirzepatide compound page and the Dulaglutide compound page, all human trials.