Comparative Effectiveness of Tirzepatide and Semaglutide in Individuals at Cardiovascular Risk

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Brigham and Women's Hospital
Study ID
NCT07096063
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Tirzepatide — DRUG
    New use of tirzepatide dispensing claim is used as the exposure.
  • Dulaglutide — DRUG
    New use of dulaglutide dispensing claim is used as the comparator.
  • Semaglutide — DRUG
    New use of semaglutide dispensing claim is used as the exposure/comparator.
  • Sitagliptin — DRUG
    New use of sitagliptin dispensing claim is used as the comparator.

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
Oct 1, 2024
Status verified
Aug 2025
Primary completion
Jul 15, 2025
Completion
Jul 15, 2025

Study Design

Enrollment
887,132 participants (actual)

Arms

  • Arm: Cohort 1
    Tirzepatide vs dulaglutide
  • Arm: Cohort 2
    Semaglutide vs sitagliptin
  • Arm: Cohort 3
    Tirzepatide vs semaglutide

Primary Outcome Measure

Composite of all-cause mortality, myocardial infarction or stroke (Tirzepatide vs. dulaglutide) [ 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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By research site
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