GLP-1 Peptide Atlas, by Delfa

GLP-1 AtlasGLP-1 Peptide Atlas

← Trials/Trial dossier/NCT07619508

Active not recruiting

Tirzepatide vs Semaglutide in Individuals at Cardiovascular Risk But Without Diabetes.

Comparative Effectiveness of Tirzepatide and Semaglutide in Patients at Cardiovascular Risk With Overweight or Obesity But Without Diabetes

Lead sponsor

Brigham and Women's Hospital

Assets

Semaglutide / Tirzepatide

Listed sites

1

Recruiting sites

—

Enrollment

100,000

estimated

Study population

Cardiovascular disease, Obesity / overweight

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 IDNCT07619508

Org study ID2018P002966-TIRZSEMA-MMO

Timeline

Milestones

Study start2026-02-10actual

Primary completion2026-06-01estimated

Study completion2026-06-01estimated

Study first posted2026-06-02actual

Last update posted2026-06-02actual

Assets

Investigational agents

Semaglutide Tirzepatide

Study populations

Who this study enrolls

Cardiovascular diseaseObesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Sampling methodNon probability sample

Study population text

Individuals aged 18 years or older at cardiovascular risk with overweight or obesity but without diabetes treated in clinical practice

Inclusion criteria

Study period:

Optum: Eligible cohort entry period between May 13, 2022 to November 30, 2025. MarketScan: Eligible cohort entry period between May 13, 2022 to September 30, 2023.

Medicare: Eligible cohort entry period between May 13, 2022 to September 30, 2024.

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

Exclusion criteria

•Medullary thyroid carcinoma

•MEN syndrome type 2

•Malignancy

•Type 1 diabetes

•Type 2 diabetes

•Secondary diabetes

•End-stage renal disease or dialysis

•Pregnancy

•History of bariatric surgery

•Prior use of pramlintide or any GLP-1-RA, except tirzepatide or semaglutide

•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 prescription fill of exposure or comparator until outcome, end of data, end of study period, death, discontinuation (45 day grace, risk-window), nursing home admission, augmentation/additional exposure or switch to comparator or other GLP1-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 prescription fill of exposure or comparator until outcome, end of data, end of study period, death, discontinuation (45 day grace, risk-window), nursing home admission, augmentation/additional exposure or switch to comparator or other GLP1-RA

descriptive

Secondary/protocol endpoint

Hospitalization for unstable angina

Time frame:1 day after prescription fill of exposure or comparator until outcome, end of data, end of study period, death, discontinuation (45 day grace, risk-window), nursing home admission, augmentation/additional exposure or switch to comparator or other GLP1-RA

descriptive

Secondary/protocol endpoint

Coronary revascularization

Time frame:1 day after prescription fill of exposure or comparator until outcome, end of data, end of study period, death, discontinuation (45 day grace, risk-window), nursing home admission, augmentation/additional exposure or switch to comparator or other GLP1-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 prescription fill of exposure or comparator until outcome, end of data, end of study period, death, discontinuation (45 day grace, risk-window), nursing home admission, augmentation/additional exposure or switch to comparator or other GLP1-RA

descriptive

Secondary/protocol endpoint

Hospitalization for heart failure

Time frame:1 day after prescription fill of exposure or comparator until outcome, end of data, end of study period, death, discontinuation (45 day grace, risk-window), nursing home admission, augmentation/additional exposure or switch to comparator or other GLP1-RA

descriptive

Safety / tolerability / PK

1 endpoint

Other/protocol endpoint

Gastrointestinal adverse events

Time frame:1 day after prescription fill of exposure or comparator until outcome, end of data, end of study period, death, discontinuation (45 day grace, risk-window), nursing home admission, augmentation/additional exposure or switch to comparator or other GLP1-RA

descriptive

Other (unclassified)

4 endpoints

Other/protocol endpoint/low confidence

Urinary tract infections

Time frame:1 day after prescription fill of exposure or comparator until outcome, end of data, end of study period, death, discontinuation (45 day grace, risk-window), nursing home admission, augmentation/additional exposure or switch to comparator or other GLP1-RA

descriptive

Other/protocol endpoint/low confidence

Serious infections

Time frame:1 day after prescription fill of exposure or comparator until outcome, end of data, end of study period, death, discontinuation (45 day grace, risk-window), nursing home admission, augmentation/additional exposure or switch to comparator or other GLP1-RA

descriptive

Other/protocol endpoint/low confidence

Hernia

Time frame:1 day after prescription fill of exposure or comparator until outcome, end of data, end of study period, death, discontinuation (45 day grace, risk-window), nursing home admission, augmentation/additional exposure or switch to comparator or other GLP1-RA

descriptive

Other/protocol endpoint/low confidence

Lumbar radiculopathy

Time frame:1 day after prescription fill of exposure or comparator until outcome, end of data, end of study period, death, discontinuation (45 day grace, risk-window), nursing home admission, augmentation/additional exposure or switch to comparator or other GLP1-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.