A Study of Tirzepatide (LY3298176) Compared With Dulaglutide on Major Cardiovascular Events in Participants With Type 2 Diabetes
NCT04255433 on ClinicalTrials.gov · last registry update 2026-07-08
An unusually large phase 3: 13,299 participants, more than double the 424 typical for the stage. Completed 12 June 2025. tirzepatide is already approved in the US for type 2 diabetes, so this is asking a further question rather than establishing the drug works at all.
- Status
- COMPLETED
- Phase
- P3
- Drug
- tirzepatideZepbound, Mounjaro
- Sponsor
- Eli Lilly and Company
- Sponsor type
- Industry
- Enrollment
- 13,299
- Started
- 2020-05-29
- Primary completion
- 2025-06-12 actual
Observed history
No changes recorded since monitoring began on 2026-08-21. This record has held steady. If a reporting date moves, a status changes or enrollment is resized, it will appear here with the previous value alongside the new one.
Primary outcome
Number of Participants From Randomization to First Occurrence of Death From MACE-3 [Composite Endpoint of Major Adverse Cardiovascular Events Death From Cardiovascular Causes, Myocardial Infarction (MI) or Stroke]
Conditions studied
Type 2 Diabetes Mellitus
Every field above is taken directly from the registry record. See all detected changes across the class, or the tirzepatide page for this molecule’s full trial and approval history.