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Trial · Observational

CompletedPhase not statedRegistry data

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

NCTNCT07203677 (opens ClinicalTrials.gov in a new tab)Other id2018P002966-DUP-TIRZSITA
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase not stated
Enrollment
49,065 participants (actual)
Sponsor
Brigham and Women's Hospital · Other
Design
Not stated
Countries
1 country

United States

Start
19 Sept 2025
Primary completion
15 Oct 2025
Completion
15 Oct 2025
First posted
2 Oct 2025
Last update posted
30 Apr 2026
Conditions
Type2 Diabetes Mellitus · Atherosclerotic Cardiovascular Disease

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20252026
  1. Ph –

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

    NCT07203677

    19 Sept 2025 to 15 Oct 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

  • Initiation of tirzepatideDrug
  • Initiation of sitagliptinDrug

Arms2

  • Other

    Initiation of tirzepatide

    Exposure group

  • Other

    Initiation of sitagliptin

    Reference group

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Major adverse cardiovascular events

    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 sitagliptin on the composite of myocardial infarction, stroke, or all-cause mortality in patients with type 2 diabetes and atherosclerotic cardiovascular disease when following the inclusion and exclusion criteria of the SURPASS-CVOT trial.

Secondary outcomes(10)

  1. Composite of myocardial infarction or stroke

    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 sitagliptin on the composite of myocardial infarction or stroke in patients with type 2 diabetes and atherosclerotic cardiovascular disease when following the inclusion and exclusion criteria of the SURPASS-CVOT trial.

  2. Myocardial infarction

    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 sitagliptin at preventing myocardial infarction in patients with type 2 diabetes and atherosclerotic cardiovascular disease when following the inclusion and exclusion criteria of the SURPASS-CVOT trial.

  3. Stroke

    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 sitagliptin at preventing stroke in patients with type 2 diabetes and atherosclerotic cardiovascular disease when following the inclusion and exclusion criteria of the SURPASS-CVOT trial.

  4. All-cause mortality

    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 sitagliptin at preventing all-cause mortality in patients with type 2 diabetes and atherosclerotic cardiovascular disease when following the inclusion and exclusion criteria of the SURPASS-CVOT trial.

  5. Infection-related mortality

    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 sitagliptin at preventing infection-related mortality in patients with type 2 diabetes and atherosclerotic cardiovascular disease when following the inclusion and exclusion criteria of the SURPASS-CVOT trial.

  6. Composite of myocardial infarction, stroke, coronary revascularization, or hospitalization for unstable angina.

    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 sitagliptin on the composite of myocardial infarction, stroke, coronary revascularization, or hospitalization for unstable angina in patients with type 2 diabetes and atherosclerotic cardiovascular disease when following the inclusion and exclusion criteria of the SURPASS-CVOT trial.

  7. Serious bacterial infections

    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 sitagliptin on the safety outcome of serious bacterial infections in patients with type 2 diabetes and atherosclerotic cardiovascular disease when following the inclusion and exclusion criteria of the SURPASS-CVOT trial.

  8. Urinary tract infections

    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 sitagliptin on the safety outcome of urinary tract infections in patients with type 2 diabetes and atherosclerotic cardiovascular disease when following the inclusion and exclusion criteria of the SURPASS-CVOT trial.

  9. Gastrointestinal adverse events

    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 sitagliptin on the safety outcome of gastrointestinal adverse events in patients with type 2 diabetes and atherosclerotic cardiovascular disease when following the inclusion and exclusion criteria of the SURPASS-CVOT trial.

  10. Infections across care settings

    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 sitagliptin on the safety outcome of infections across care settings in patients with type 2 diabetes and atherosclerotic cardiovascular disease when following the inclusion and exclusion criteria of the SURPASS-CVOT trial.

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

Indexing hint: Observational study · 2026

7 results

Tirzepatide and the risk of atherosclerotic cardiovascular events: population based cohort study.

Krüger et al. 2026BMJ (Clinical research ed.)

PMID 42556854DOI 10.1136/bmj-2026-100011PUB-42556854

Full text at the publisher7 results
Publisher pageSee results (7)

Eligibility

Who could join, as posted.

Sex
All
Age
from 40 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * History of MI or stroke, surgical or percutaneous coronary/carotid peripheral artery revascularization, amputation, diagnosis of coronary/carotid/peripheral artery disease * BMI ≥25.0kg/m2 * Type 2 diabetes * Age ≥40 years * Male or female sex Exclusion Criteria: * Medullary thyroid carcinoma, MEN syndrome type 2, malignancy * Treatment for diabetic retinopathy/macular edema, heart failure NYHA IV, gastric emptying abnormality/bariatric surgery, end-stage renal disease or dialysis, pregnancy * Prior use of pramlintide or any GLP-1-RA except tirzepatide, * Pancreatitis, liver disease * Cardiovascular event or intervention, hospitalization for heart failure * Concurrent use of both drugs i.e. tirzepatide and sitagliptin

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