The Phase 3 study (NCT04255433) comparing dulaglutide with tirzepatide in participants with Type 2 Diabetes Mellitus and increased cardiovascular risk completed its primary data collection on 2025-06-12. This trial, which enrolled 13,299 participants, aimed to assess the efficacy and safety of tirzepatide compared to dulaglutide on major cardiovascular events.
Background
Dulaglutide (Trulicity) is an established treatment for Type 2 Diabetes Mellitus. This study investigated its role as a comparator against tirzepatide in assessing cardiovascular outcomes in a large patient population.
Trial design
The study, identified as NCT04255433, is a Phase 3 trial with an enrollment of 13,299 participants. It focused on individuals diagnosed with Type 2 Diabetes Mellitus. The trial's purpose was to assess the efficacy and safety of tirzepatide compared to dulaglutide, specifically looking at major cardiovascular events.
What this means
The completion of primary data collection for this large Phase 3 study marks a significant step towards understanding the comparative cardiovascular safety and efficacy of tirzepatide against dulaglutide in patients with Type 2 Diabetes Mellitus. Clinicians and researchers will await the full results to evaluate the implications for treatment strategies and patient care.
Source
The information regarding the primary completion of this trial was obtained from ClinicalTrials.gov, a public database of clinical studies. The record for study NCT04255433, titled "A Study of Tirzepatide (LY3298176) Compared With Dulaglutide on Major Cardiovascular Events in Participants With Type 2 Diabetes," was updated on 2025-06-12 on clinicaltrials.gov.