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

NCT07203677 · Completed

Last updated 2026-05-28

This clinical trial compares the effects of tirzepatide and sitagliptin on heart-related health outcomes in adults with type 2 diabetes who are also at risk for cardiovascular disease.

Status Completed The study has finished.

Type Observational

Participants 49,065 people

Who can join Ages 40+ · all sexes

Timeline Started 2025-09 · est. completion 2025-10

Where 1 site · United States

What this study is testing ClinicalTrials.gov NCT07203677 ↗

Description as written by the study sponsor.

Investigators are building an empirical evidence base for real world data through large-scale emulation of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.

Treatments tested

Initiation of tirzepatide Drug

New use of tirzepatide dispensing claim is used as the exposure.
Initiation of sitagliptin Drug

New use of sitagliptin dispensing claim is used as the reference.

Main thing measured	Major adverse cardiovascular events
Sponsor	Brigham and Women's Hospital
Conditions studied	Type2 Diabetes Mellitus, Atherosclerotic Cardiovascular Disease
GLP-1 drugs	tirzepatide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT07203677 ↗