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Trial · Observational

CompletedPhase not statedRegistry data

Comparative Effectiveness of Tirzepatide and Semaglutide in Individuals at Cardiovascular Risk

Short name TIRZSEMA-CVOT

NCTNCT07096063 (opens ClinicalTrials.gov in a new tab)Other id2018P002966-DUP-TIRZSEMA-CVOT

Overview

Status
Completed
Phase
Phase not stated
Enrollment
887,132 participants (actual)
Sponsor
Brigham and Women's Hospital · Other
Design
Not stated
Countries
1 country

United States

Start
1 Oct 2024
Primary completion
15 Jul 2025
Completion
15 Jul 2025
First posted
31 Jul 2025
Last update posted
15 Oct 2025
Conditions
Type 2 Diabetes · Overweight · Cardiovascular (CV) Risk

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202420252026
  1. Ph –

    TIRZSEMA-CVOT

    NCT07096063

    1 Oct 2024 to 15 Jul 2025

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • TirzepatideDrug
  • DulaglutideDrug
  • SemaglutideDrug
  • SitagliptinDrug

Arms3

  • Other

    Cohort 1

    Tirzepatide vs dulaglutide

  • Other

    Cohort 2

    Semaglutide vs sitagliptin

  • Other

    Cohort 3

    Tirzepatide vs semaglutide

Primary outcomes3

Outcomes the sponsor listed as primary.

  1. 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

    Registry description

    To evaluate the comparative effect of tirzepatide vs dulaglutide on the composite of all-cause mortality, myocardial infarction, or death in patients typically treated in clinical practice who are at cardiovascular risk with type 2 diabetes and overweight.

  2. Composite of all-cause mortality, myocardial infarction or stroke (Injectable semaglutide vs sitagliptin)

    Time frame · 1 day after cohort entry date until the first of outcome or censoring, up to 365 days

    Registry description

    To evaluate the comparative effect of injectable semaglutide vs sitagliptin on the composite of all-cause mortality, myocardial infarction, or death in patients typically treated in clinical practice who are at cardiovascular risk with type 2 diabetes and overweight.

  3. Composite of all-cause mortality, myocardial infarction or stroke (Tirzepatide vs injectable semaglutide)

    Time frame · 1 day after cohort entry date until the first of outcome or censoring, up to 365 days

    Registry description

    To evaluate the comparative effect of tirzepatide vs semaglutide on the composite of all-cause mortality, myocardial infarction, or death in patients typically treated in clinical practice who are at cardiovascular risk with type 2 diabetes and overweight.

Secondary outcomes(15)
  1. Individual components of the primary endpoint, i.e., 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

    Registry description

    To evaluate the comparative effect of tirzepatide vs dulaglutide on the individual components of the primary endpoint, i.e., all-cause mortality, myocardial infarction, or stroke in patients typically treated in clinical practice who are at cardiovascular risk with type 2 diabetes and overweight.

  2. Composite of all-cause mortality, hospitalization for heart failure, or urgent heart failure visits requiring intravenous diuretics (Tirzepatide vs dulaglutide)

    Time frame · 1 day after cohort entry date until the first of outcome or censoring, up to 365 days

    Registry description

    To evaluate the comparative effect of tirzepatide vs dulaglutide on all-cause mortality, hospitalization for heart failure, or urgent heart failure visits in patients typically treated in clinical practice who are at cardiovascular risk with type 2 diabetes and overweight.

  3. Urinary tract infections (Tirzepatide vs dulaglutide)

    Time frame · 1 day after cohort entry date until the first of outcome or censoring, up to 365 days

    Registry description

    To evaluate the comparative effect of tirzepatide vs dulaglutide on the safety outcome of urinary tract infections in patients typically treated in clinical practice who are at cardiovascular risk with type 2 diabetes and overweight.

  4. Serious bacterial infections (Tirzepatide vs dulaglutide)

    Time frame · 1 day after cohort entry date until the first of outcome or censoring, up to 365 days

    Registry description

    To evaluate the comparative effect of tirzepatide vs dulaglutide on the safety outcome of serious bacterial infections in patients typically treated in clinical practice who are at cardiovascular risk with type 2 diabetes and overweight.

  5. Gastrointestinal adverse events (Tirzepatide vs dulaglutide)

    Time frame · 1 day after cohort entry date until the first of outcome or censoring, up to 365 days

    Registry description

    To evaluate the comparative effect of tirzepatide vs dulaglutide on the safety outcome of gastrointestinal adverse events in patients typically treated in clinical practice who are at cardiovascular risk with type 2 diabetes and overweight.

  6. Individual components of the primary endpoint, i.e., all-cause mortality, myocardial infarction, or stroke (Injectable semaglutide vs sitagliptin)

    Time frame · 1 day after cohort entry date until the first of outcome or censoring, up to 365 days

    Registry description

    To evaluate the comparative effect of injectable semaglutide vs sitagliptin on the individual components of the primary endpoint, i.e., all-cause mortality, myocardial infarction, or stroke in patients typically treated in clinical practice who are at cardiovascular risk with type 2 diabetes and overweight.

  7. Composite of all-cause mortality, hospitalization for heart failure, or urgent heart failure visits requiring intravenous diuretics (Injectable semaglutide vs sitagliptin)

    Time frame · 1 day after cohort entry date until the first of outcome or censoring, up to 365 days

    Registry description

    To evaluate the comparative effect of injectable semaglutide vs sitagliptin on all-cause mortality, hospitalization for heart failure, or urgent heart failure visits in patients typically treated in clinical practice who are at cardiovascular risk with type 2 diabetes and overweight.

  8. Urinary tract infections (Injectable semaglutide vs sitagliptin)

    Time frame · 1 day after cohort entry date until the first of outcome or censoring, up to 365 days

    Registry description

    To evaluate the comparative effect of injectable semaglutide vs sitagliptin on the safety outcome of urinary tract infections in patients typically treated in clinical practice who are at cardiovascular risk with type 2 diabetes and overweight.

  9. Serious bacterial infections (Injectable semaglutide vs sitagliptin)

    Time frame · 1 day after cohort entry date until the first of outcome or censoring, up to 365 days

    Registry description

    To evaluate the comparative effect of injectable semaglutide vs sitagliptin on the safety outcome of serious bacterial infections in patients typically treated in clinical practice who are at cardiovascular risk with type 2 diabetes and overweight.

  10. Gastrointestinal adverse events (Injectable semaglutide vs sitagliptin)

    Time frame · 1 day after cohort entry date until the first of outcome or censoring, up to 365 days

    Registry description

    To evaluate the comparative effect of injectable semaglutide vs sitagliptin on the safety outcome of gastrointestinal adverse events in patients typically treated in clinical practice who are at cardiovascular risk with type 2 diabetes and overweight.

  11. Individual components of the primary endpoint, i.e., all-cause mortality, myocardial infarction, or stroke (Tirzepatide vs injectable semaglutide)

    Time frame · 1 day after cohort entry date until the first of outcome or censoring, up to 365 days

    Registry description

    To evaluate the comparative effect of tirzepatide vs injectable semaglutide on the individual components of the primary endpoint, i.e., all-cause mortality, myocardial infarction, or stroke in patients typically treated in clinical practice who are at cardiovascular risk with type 2 diabetes and overweight.

  12. Composite of all-cause mortality, hospitalization for heart failure, or urgent heart failure visits requiring intravenous diuretics (Tirzepatide vs injectable semaglutide)

    Time frame · 1 day after cohort entry date until the first of outcome or censoring, up to 365 days

    Registry description

    To evaluate the comparative effect of tirzepatide vs injectable semaglutide on all-cause mortality, hospitalization for heart failure, or urgent heart failure visits in patients typically treated in clinical practice who are at cardiovascular risk with type 2 diabetes and overweight.

  13. Urinary tract infections (Tirzepatide vs injectable semaglutide)

    Time frame · 1 day after cohort entry date until the first of outcome or censoring, up to 365 days

    Registry description

    To evaluate the comparative effect of tirzepatide vs injectable semaglutide on the safety outcome of urinary tract infections in patients typically treated in clinical practice who are at cardiovascular risk with type 2 diabetes and overweight.

  14. Serious bacterial infections (Tirzepatide vs injectable semaglutide)

    Time frame · 1 day after cohort entry date until the first of outcome or censoring, up to 365 days

    Registry description

    To evaluate the comparative effect of tirzepatide vs injectable semaglutide on the safety outcome of serious bacterial infections in patients typically treated in clinical practice who are at cardiovascular risk with type 2 diabetes and overweight.

  15. Gastrointestinal adverse events (Tirzepatide vs injectable semaglutide)

    Time frame · 1 day after cohort entry date until the first of outcome or censoring, up to 365 days

    Registry description

    To evaluate the comparative effect of tirzepatide vs injectable semaglutide on the safety outcome of gastrointestinal adverse events in patients typically treated in clinical practice who are at cardiovascular risk with type 2 diabetes and overweight.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

PubMed tag: none · 2026

5 results

Cardiovascular outcomes of semaglutide and tirzepatide for patients with type 2 diabetes in clinical practice.

Krüger et al. 2026Nature medicinecited by 31

PMID 41207920PMC12823426DOI 10.1038/s41591-025-04102-xPUB-41207920

CC BY5 results

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
ELIGIBILITY FOR TIRZEPATIDE VS DULAGLUTIDE Inclusion criteria * History of MI, stroke, any surgical or percutaneous revascularization procedure, use of any antihypertensive/lipid-lowering drugs, coronary/carotid/peripheral artery disease, hypertension * Type 2 diabetes * BMI ≥25.0kg/m2 * Age ≥18 years * Male or female sex Exclusion Criteria: * Medullary thyroid carcinoma, MEN syndrome type 2 * Malignancy * Type 1 diabetes or secondary diabetes * Chronic kidney disease or dialysis * Uncontrolled diabetic retinopathy or maculopathy * Pregnancy * Prior use of pramlintide or any GLP-1-RA ELIGIBILITY FOR SEMAGLUTIDE VS SITAGLIPTIN Inclusion Criteria: * History of MI, stroke, any surgical or percutaneous revascularization procedure, use of any antihypertensive/lipid-lowering drugs, coronary/carotid/peripheral artery disease, hypertension * Type 2 diabetes * BMI ≥25.0kg/m2 * Age ≥18 years * Male or female sex Exclusion Criteria: * Medullary thyroid carcinoma, MEN syndrome type 2 * Malignancy * Type 1 diabetes or secondary diabetes * Chronic kidney disease or dialysis * Uncontrolled diabetic retinopathy or maculopathy * Pregnancy * Prior use of pramlintide or any GLP-1-RA or DPP4i ELIGIBILITY FOR TIRZEPATIDE VS SEMAGLUTIDE Inclusion Criteria: * History of MI, stroke, any surgical or percutaneous revascularization procedure, use of any antihypertensive/lipid-lowering drugs, coronary/carotid/peripheral artery disease, hypertension * Type 2 diabetes * BMI ≥25.0kg/m2 * Age ≥18 years * Male or female sex Exclusion Criteria: * Medullary thyroid carcinoma, MEN syndrome type 2 * Malignancy * Type 1 diabetes or secondary diabetes * Chronic kidney disease or dialysis * Uncontrolled diabetic retinopathy or maculopathy * Pregnancy * Prior use of pramlintide or any GLP-1-RA

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