Cardiovascular Atlas
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SURPASS-CVOT: tirzepatide against dulaglutide on major cardiovascular events

A large trial of people with type 2 diabetes and heart or blood-vessel disease that compared tirzepatide with dulaglutide, another weekly diabetes injection that has been shown to lower the chance of heart events. Tirzepatide was found to be no worse than dulaglutide for heart attack, stroke and heart-related death. It was not shown to be better.

Also called SURPASS-CVOT

  • Study
  • In this atlas

Overview

Design
Multicenter, randomized (1:1), double-blind, active-comparator-controlled noninferiority trial with parallel groups. The registry records phase 3 and double masking.
Phase
Phase 3
Enrolled
  • 13,299 participants (enrolled count) (A Study of Tirzepatide (LY3298176) Compared With Dulaglutide on Major Cardiovascular Events in Participants With Type 2 Diabetes, retrieved )
Sponsor
Funder
Not recorded
Registry
  • NCT NCT04255433
Started
(actual) (A Study of Tirzepatide (LY3298176) Compared With Dulaglutide on Major Cardiovascular Events in Participants With Type 2 Diabetes, retrieved )
Primary completion
(actual) (A Study of Tirzepatide (LY3298176) Compared With Dulaglutide on Major Cardiovascular Events in Participants With Type 2 Diabetes, retrieved )
Completion
(actual) (A Study of Tirzepatide (LY3298176) Compared With Dulaglutide on Major Cardiovascular Events in Participants With Type 2 Diabetes, retrieved )
Results first posted
(actual) (A Study of Tirzepatide (LY3298176) Compared With Dulaglutide on Major Cardiovascular Events in Participants With Type 2 Diabetes, retrieved )
Countries
United States, 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, Ukraine, United Kingdom, Türkiye (A Study of Tirzepatide (LY3298176) Compared With Dulaglutide on Major Cardiovascular Events in Participants With Type 2 Diabetes, retrieved )
Care setting
Not reported
Registry status
  • “COMPLETED” (U.S. National Library of Medicine (ClinicalTrials.gov), retrieved )

Technical summary

Active-comparator, double-blind, noninferiority trial sponsored by Eli Lilly (NCT04255433). 13,299 patients were randomized; the modified intention-to-treat population was 6586 on tirzepatide (up to 15 mg weekly) and 6579 on dulaglutide (1.5 mg weekly). The primary composite (cardiovascular death, myocardial infarction or stroke) occurred in 801 (12.2%) and 862 (13.1%): hazard ratio 0.92 (95.3% CI 0.83 to 1.01; P=0.003 for noninferiority; P=0.09 for superiority).

Arms

  • Tirzepatide

    Intervention Tirzepatide

    Weekly subcutaneous tirzepatide, up to 15 mg (registry arm: maximum tolerated dose).

  • Dulaglutide 1.5 mg

    Intervention None named

    Weekly subcutaneous dulaglutide 1.5 mg, described in the abstract as an agent shown to reduce the incidence of cardiovascular events.

Findings

No findings are published for this study.

Record details

Record id
cardio:surpass-cvot
Content hash
1622ad6331e40209c3b76e3ad3780185ef655de5ec7bdf118f7244c432299989