Study S000794

Comparative Effectiveness of Tirzepatide Versus Sitagliptin in Individuals at Cardiovascular Risk (TIRZSITA-CVOT)

ClinicalTrials.gov record Study Protocol and Statistical Analysis Plan: Amendment 2 to Study Protocol with Statistical Analysis Plan (PDF)Study Protocol and Statistical Analysis Plan: Amendment 3 to Study Protocol with Statistical Analysis Plan (PDF)Study Protocol and Statistical Analysis Plan: Amendment to Study Protocol with Statistical Analysis Plan (PDF)Study Protocol: Study Protocol with Statistical Analysis Plan (PDF)

Registration

Registration: NCT07203677
Study type: OBSERVATIONAL
Status: COMPLETED
Enrollment: 49065
Start: 2025-09-19
Primary completion: 2025-10-15
Lead sponsor: Brigham and Women's Hospital
Conditions: Type2 Diabetes Mellitus; Atherosclerotic Cardiovascular Disease
Interventions: DRUG:Initiation of tirzepatide; DRUG:Initiation of sitagliptin
Results posted: FALSE

Registered primary outcomes

Major adverse cardiovascular events [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
R0013067	Tirzepatide and the risk of atherosclerotic cardiovascular events: population based cohort study. Krüger N, BMJ (Clinical research ed.)	2026	Randomized trial	PMID 42556854 DOI	cites ClinicalTrials.gov:NCT07203677; registry reference DERIVED:42556854