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

NCT04255433 · Completed

Last updated 2026-05-28

This clinical trial is comparing the effects of tirzepatide to dulaglutide on reducing major heart-related events like heart attack, stroke, or cardiovascular death in adults with type 2 diabetes.

Status Completed The study has finished.

Phase Phase 3 Confirms effectiveness in a large group before approval.

Type Interventional (clinical trial)

Design Randomized, double-blind treatment study

Participants 13,299 people

Who can join Ages 40+ · all sexes

Timeline Started 2020-05 · est. completion 2025-06

Where 635 sites · Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Czechia, France, Germany, Greece, Hungary, India, Israel, Italy, Japan, Mexico, Netherlands, Poland, Puerto Rico, Romania, Russia, Slovakia, South Korea, Spain, Sweden, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom, United States

What this study is testing ClinicalTrials.gov NCT04255433 ↗

Description as written by the study sponsor.

The purpose of the trial is to assess the efficacy and safety of tirzepatide to dulaglutide in participants with type 2 diabetes and increased cardiovascular risk.

Treatments tested

Tirzepatide also known as LY3298176 Drug

Administered SC
Dulaglutide also known as LY2189265 Drug

Administered SC

Main thing measured	Time to First Occurrence of Death from Cardiovascular (CV) Causes, Myocardial Infarction (MI), or Stroke (MACE-3)
Sponsor	Eli Lilly and Company
Conditions studied	Type 2 Diabetes Mellitus
GLP-1 drugs	tirzepatide, dulaglutide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT04255433 ↗