Study S002323

Comparative Effectiveness of Tirzepatide and Semaglutide in Individuals at Cardiovascular Risk

ClinicalTrials.gov record Study Protocol and Statistical Analysis Plan: Study Protocol and Statistical Analysis Plan (PDF)Study Protocol and Statistical Analysis Plan: Amendment to Study Protocol and Statistical Analysis Plan (PDF)

Registration

Registration: NCT07096063
Acronym: TIRZSEMA-CVOT
Study type: OBSERVATIONAL
Status: COMPLETED
Enrollment: 887132
Start: 2024-10-01
Primary completion: 2025-07-15
Lead sponsor: Brigham and Women's Hospital
Conditions: Type 2 Diabetes; Overweight; Cardiovascular (CV) Risk
Interventions: DRUG:Tirzepatide; DRUG:Dulaglutide; DRUG:Semaglutide; DRUG:Sitagliptin
Results posted: FALSE

Registered primary outcomes

Composite of all-cause mortality, myocardial infarction or stroke (Tirzepatide vs. dulaglutide) [1 day after cohort entry date until the first of outcome or censoring, up to 365 days]
Composite of all-cause mortality, myocardial infarction or stroke (Injectable semaglutide vs sitagliptin) [1 day after cohort entry date until the first of outcome or censoring, up to 365 days]
Composite of all-cause mortality, myocardial infarction or stroke (Tirzepatide vs injectable semaglutide) [1 day after cohort entry date until the first of outcome or censoring, up to 365 days]

Linked records (1)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.

Record	Title	Year	Design	Identifiers	Link basis
R0007550	Cardiovascular outcomes of semaglutide and tirzepatide for patients with type 2 diabetes in clinical practice. Krüger N, Nature medicine	2026	Randomized trial	PMID 41207920 DOI	cites ClinicalTrials.gov:NCT07096063; registry reference DERIVED:41207920