← Trials/Trial dossier/NCT07619495

Active not recruiting

Injectable Semaglutide vs Dulaglutide in Individuals at Cardiovascular Risk

Comparative Effectiveness of Semaglutide and Dulaglutide in Patients at Low, Moderate, and High Cardiovascular Risk With Type 2 Diabetes and Overweight

Assets

Dulaglutide / Semaglutide

Listed sites

1

Recruiting sites

Enrollment

120,000

estimated

Study population

Cardiovascular disease, Obesity / overweight, Type 2 diabetes

Key I/E criterion

BMI ≥25

Primary endpoint

Composite of all-cause mortality, myocardial infarction, or stroke

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 IDNCT07619495
Org study ID2018P002966-SEMADULA-CVOT

Timeline

Milestones

Study start2026-01-20actual
Primary completion2026-06-01estimated
Study completion2026-06-01estimated
Study first posted2026-06-02actual
Last update posted2026-06-02actual

Assets

Investigational agents

Study populations

Who this study enrolls

Cardiovascular diseaseObesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted
Sampling methodNon probability sample

Study population text

Individuals typically treated in clinical practice who are at low, moderate, and high cardiovascular risk with T2DM and overweight.

Inclusion criteria

Study Period:

Optum: Eligible cohort entry period between December 5, 2017 to November 30, 2025.

MarketScan: Eligible cohort entry period between December 5, 2017 to September 30, 2023.

Medicare: Eligible cohort entry period between December 5, 2017 to September 30, 2020.

Inclusion Criteria:

Men or women aged 18 years or older
History of myocardial infarction, stroke, any surgical or percutaneous revascularization procedure
Use of antihypertensive or lipid-lowering drugs
Coronary, carotid, or peripheral artery disease
BMI greater than or equal to 25.0 mg/m2
Type 2 diabetes

Exclusion criteria

Medullary thyroid carcinoma
MEN syndrome type 2
Malignancy
Type 1 diabetes
Secondary diabetes
End-stage renal disease or dialysis
Uncontrolled diabetic retinopathy or maculopathy
Pregnancy
History of bariatric surgery
Prior use of pramlintide or any GLP-1-RA, except semaglutide or dulaglutide
Cardiovascular event or intervention in the last 7 days

Endpoints (11)

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
4
Other (unclassified)
4
Heart failure
2
Safety / tolerability / PK
1

Cardiovascular outcomes

4 endpoints
Primary/protocol endpoint

Composite of all-cause mortality, myocardial infarction, or stroke.

Time frame:1 day after cohort entry until outcome, disenrollment, end of study period, death, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA

descriptive

Secondary/protocol endpoint

Individual components of the primary endpoint, i.e., all-cause mortality, myocardial infarction, or stroke

Time frame:1 day after cohort entry until outcome, disenrollment, end of study period, death, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA

descriptive

Secondary/protocol endpoint

Hospitalization for unstable angina

Time frame:1 day after cohort entry until outcome, disenrollment, end of study period, death, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA

descriptive

Secondary/protocol endpoint

Coronary revascularization

Time frame:1 day after cohort entry until outcome, disenrollment, end of study period, death, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA

descriptive

Heart failure

2 endpoints
Secondary/protocol endpoint

Composite of myocardial infarction, stroke, hospitalization for unstable angina, coronary revascularization, or hospitalization for heart failure

Time frame:1 day after cohort entry until outcome, disenrollment, end of study period, death, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA

descriptive

Secondary/protocol endpoint

Hospitalization for heart failure

Time frame:1 day after cohort entry until outcome, disenrollment, end of study period, death, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA

descriptive

Safety / tolerability / PK

1 endpoint
Other/protocol endpoint

Gastrointestinal adverse events

Time frame:1 day after cohort entry until outcome, disenrollment, end of study period, death, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA

descriptive

Other (unclassified)

4 endpoints
Other/protocol endpoint/low confidence

Urinary tract infections

Time frame:1 day after cohort entry until outcome, disenrollment, end of study period, death, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA

descriptive

Other/protocol endpoint/low confidence

Serious infections

Time frame:1 day after cohort entry until outcome, disenrollment, end of study period, death, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA

descriptive

Other/protocol endpoint/low confidence

Hernia

Time frame:1 day after cohort entry until outcome, disenrollment, end of study period, death, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA

descriptive

Other/protocol endpoint/low confidence

Lumbar radiculopathy

Time frame:1 day after cohort entry until outcome, disenrollment, end of study period, death, 365 days after cohort entry, discontinuation (45 days grace and risk window), switch between study arms, nursing home admission, or start of any other GLP-1-RA

descriptive

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.