DelfaGLP-1 Atlas

← Trials/Trial dossier/NCT07203677

Completed

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

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

1

Recruiting sites

—

Enrollment

49,065

actual

Study population

Cardiovascular disease, Type 2 diabetes

Key I/E criterion

•BMI ≥25

Primary endpoint

•Expanded / custom MACE composite (Myocardial infarction (any), Stroke (any), All-cause death)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07203677
Org study ID2018P002966-DUP-TIRZSITA

Timeline

Milestones

Study start2025-09-19actual
Study first posted2025-10-02actual
Primary completion2025-10-15actual
Study completion2025-10-15actual
Last update posted2026-04-30actual

Assets

Investigational agents

Tirzepatide

Study populations

Who this study enrolls

Cardiovascular diseaseType 2 diabetes

Eligibility

Who can enroll

Minimum age40 Years
SexAll
Healthy volunteersNot accepted
Sampling methodNon probability sample

Study population text

Individuals aged 40 years or older with T2DM and and atherosclerotic cardiovascular disease.

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

Endpoints (12)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Cardiovascular outcomes
6
Safety / tolerability / PK
4
Other clinical outcomes
2

Cardiovascular outcomes

6 endpoints
Primary/protocol endpoint

Major adverse cardiovascular events

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

Expanded / custom MACE composite

time to event, event

componentsMyocardial infarction (any), Stroke (any), All-cause death

Secondary/protocol endpoint

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

Expanded / custom MACE composite

time to event, event

componentsMyocardial infarction (any), Stroke (any)

Secondary/protocol endpoint

Myocardial infarction

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

Myocardial infarction (any)

time to event, event

SNOMED 22298006

Secondary/protocol endpoint

Stroke

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

Stroke (any)

time to event, event

SNOMED 230690007

Secondary/protocol endpoint

All-cause mortality

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

All-cause death

time to event, event

SNOMED 419620001

Secondary/protocol endpoint

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

Expanded / custom MACE composite

time to event, event

componentsMyocardial infarction (any), Stroke (any), Coronary revascularization, Unstable angina hospitalization

Safety / tolerability / PK

4 endpoints
Secondary/protocol endpoint

Serious bacterial infections

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

time to event, event

Secondary/protocol endpoint

Urinary tract infections

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

time to event, event

Secondary/protocol endpoint

Gastrointestinal adverse events

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

time to event, event

Secondary/protocol endpoint

Infections across care settings

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

time to event, event

Other clinical outcomes

2 endpoints
Secondary/protocol endpoint

Infection-related mortality

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

time to event, event

Other/protocol endpoint

Hernia and lumbar radiculopathy

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

time to event, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.