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

← catalyst calendar

NCT04255433 · results posted

Sponsored by Eli Lilly and Company (industry) · LLY — their whole pipeline →.

Phase
Phase 3
Status
Completed
Study type
Interventional
Design
Randomized · Double · Treatment
Enrollment
13,299actual
Sites
635
Countries
Argentina, Australia, Austria +28

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis
DateFiledBasisWhat it is
Start2020-05-29actualWhen the study began enrolling
Primary completion2025-06-12actualThe date the last participant is measured for the primary outcome — the readout window
Study completion2025-06-12actualThe whole study's end, after follow-up
First posted2020-02-05actualWhen this record first appeared on the registry
Results posted2026-07-08actualWhen the sponsor posted results to the registry
Record updated2026-07-08actualThe sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Condition

  • Type 2 Diabetes Mellitus

Interventions

  • Drug: Tirzepatide — also filed as LY3298176
  • Drug: Dulaglutide — also filed as LY2189265

Primary outcome

what the primary-completion date above is the date OF
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]
measured From randomization (week 0) up to week 259

Posted documents

hosted by the registry — we link, never re-serve
Study Protocolposted 2024-04-16 · 3.6 MB · Prot_000.pdf
Statistical Analysis Planposted 2025-07-24 · 1.5 MB · SAP_001.pdf

Publications

Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.

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