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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Brigham and Women's Hospital
Study ID
NCT07203677
Status
Completed

Conditions

  • Atherosclerotic Cardiovascular Disease
  • Type2 Diabetes Mellitus

Eligibility Criteria

Sex
ALL
Age
40 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Sep 19, 2025
Status verified
Sep 2025
Primary completion
Oct 15, 2025
Completion
Oct 15, 2025

Study Design

Enrollment
49,065 participants (actual)

Arms

  • Arm: Initiation of tirzepatide
    Exposure group
  • Arm: Initiation of sitagliptin
    Reference group

Primary Outcome Measure

Major adverse cardiovascular events [ Time Frame: 1 day after cohort entry date until the first of outcome or censoring, up to 365 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02120-

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Brigham and Women's Hospital· Boston, MA

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