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NCT04255433 · ClinicalTrials.gov registry record · Phase 3
A Study of Tirzepatide (LY3298176) Compared With Dulaglutide on Major Cardiovascular Events in Participants With Type 2 Diabetes
A Phase 3 study, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 13,299
- Enrollment target
NCT04255433: Completed Phase 3 study, sponsored by Eli Lilly and Company.
NCT04255433 is a Phase 3 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 13,299 participants, above the 771-participant average among 15,282 other Phase 3 trials with a reported enrollment target (1625% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04255433, a Phase 3 study, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 13,299 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Number of participants with first occurrence of Clinical Endpoint Committee (CEC), a composite endpoint i.e., from time of randomization to first occurrence of cardiovascular (CV) death, myocardial infarction and stroke combined data was reported. Time to event was defined as the number of days from the date of randomization to the first occurrence of any of these events during the study follow-up period. Participants without an event were censored at their last known contact or end of follow-up
Interventions
- DRUG Tirzepatide
- DRUG Dulaglutide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13,299 participants |
| Start Date | 2020-05-29 |
| Est. Completion | 2025-06-12 |
| Phase | Phase 3 |
What the finished NCT04255433 record still lists
NCT04255433 is an interventional study that assigns participants to a tested intervention. Its 13,299 participants enrollment target places it among the larger protocols in the corpus, above the 771-participant average among 15,282 other Phase 3 trials with a reported enrollment target (1625% higher).
The record links to 0 conditions, and to 2 interventions - of which Tirzepatide is the first listed.
NCT04255433 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04255433 about?
NCT04255433 is a clinical study titled "A Study of Tirzepatide (LY3298176) Compared With Dulaglutide on Major Cardiovascular Events in Participants With Type 2 Diabetes". 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.
What is the current status of trial NCT04255433?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 13,299 participants. The study started on 2020-05-29. Estimated completion is 2025-06-12.
What interventions are being tested in trial NCT04255433?
The interventions under investigation include: Tirzepatide (DRUG), Dulaglutide (DRUG).
Who is sponsoring clinical trial NCT04255433?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04255433's enrollment target sits among peer trials
13,299 17th of 2000 higher than 1,984 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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