DelfaGLP-1 Atlas

← Trials/Trial dossier/NCT07417618

INTERCEPT

Active not recruiting

INcreTin-based thERapies for Cardiovascular Event PrevenTion in Patients With and Without ASCVD (INTERCEPT-ASCVD)

Comparative Effectiveness of Dulaglutide, Semaglutide, and Tirzepatide in Preventing Cardiovascular Events in Patients With Type 2 Diabetes and Obesity With or Without Atherosclerotic Cardiovascular Disease.

Assets

Dulaglutide / Semaglutide / Tirzepatide

Listed sites

1

Recruiting sites

—

Enrollment

60,000

estimated

Study population

Cardiovascular disease, Obesity / overweight, Type 2 diabetes

Key I/E criterion

•BMI ≥25

Primary endpoints

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

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 IDNCT07417618
Org study ID2018P002966-INTERCEPT-ASCVD

Timeline

Milestones

Study start2026-01-27actual
Study first posted2026-02-18actual
Last update posted2026-05-13actual
Primary completion2026-05-22estimated
Study completion2026-05-22estimated

Assets

Investigational agents

DulaglutideSemaglutideTirzepatide

Study populations

Who this study enrolls

Cardiovascular diseaseObesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Sampling methodNon probability sample

Study population text

Individuals with T2DM and overweight with (or without) ASCVD.

Inclusion criteria

The database analyses will be new-user active-comparative studies, conducted using 3 national United States claims databases, where we compare the effect of dulaglutide, semaglutide, and tirzepatide vs sitagliptin on preventing atherosclerotic cardiovascular events.

Optum: Eligible cohort entry period from September 18, 2014 to August 31, 2025. Marketscan: Eligible cohort entry from October 1, 2016 to October 31, 2023. Medicare: Eligible cohort entry from September 18, 2014 to October 31, 2020.

POPULATION WITH ASCVD

Inclusion Criteria:

•History of ASCVD (defined as MI, ACS, stable/unstable angina surgical or percutaneous coronary/other arterial revascularization procedure, ischemic stroke, TIA, aortic aneurysm, peripheral artery disease)
•BMI >= 25.0kg/m2
•Type 2 Diabetes

Exclusion criteria

•Medullary thyroid carcinoma
•MEN syndrome type 2
•Malignancy
•Type 1 diabetes or secondary diabetes
•End-stage renal disease or dialysis
•Uncontrolled diabetic retinopathy or maculopathy
•Pregnancy
•Bariatric surgery
•Prior use of pramlintide, or any GLP-1RA except injectable semaglutide/tirzepatide/dulaglutide, or any DPP4i except sitagliptin
•CV-event or intervention
•Concurrent use of both study drugs

POPULATION WITHOUT ASCVD

Inclusion Criteria:

•BMI >=25.0kg/m2
•Type 2 diabetes

Exclusion Criteria:

•History of ASCVD (defined as MI, ACS, stable/unstable angina surgical or percutaneous coronary/other arterial revascularization procedure, ischemic stroke, TIA, aortic aneurysm, peripheral artery disease)
•Medullary thyroid carcinoma
•MEN syndrome type 2
•Malignancy
•Type 1 diabetes or secondary diabetes
•End-stage renal disease or dialysis
•Uncontrolled diabetic retinopathy or maculopathy
•Pregnancy
•Bariatric surgery
•Prior use of pramlintide, or any GLP-1RA except injectable semaglutide/tirzepatide/dulaglutide, or any DPP4i except sitagliptin
•Concurrent use of both study drugs

Endpoints (32)

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
21
Safety / tolerability / PK
6
Other clinical outcomes
4
Heart failure
1

Cardiovascular outcomes

21 endpoints
Primary/protocol endpoint

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

Time frame:Through study completion until first of outcome, disenrollment, end of study period, 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 or DPP4i

Expanded / custom MACE composite

time to event, event

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

Primary/protocol endpoint

Composite of myocardial infarction, or stroke.

Time frame:Through study completion until first of outcome, disenrollment, end of study period, 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 or DPP4i

Expanded / custom MACE composite

time to event, event

componentsMyocardial infarction (any), Stroke (any)

Primary/protocol endpoint

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

Time frame:Through study completion until first of outcome, disenrollment, end of study period, 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 or DPP4i

Expanded / custom MACE composite

time to event, event

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

Primary/protocol endpoint

Composite of myocardial infarction, or stroke.

Time frame:Through study completion until first of outcome, disenrollment, end of study period, 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 or DPP4i

Expanded / custom MACE composite

time to event, event

componentsMyocardial infarction (any), Stroke (any)

Secondary/protocol endpoint

Myocardial infarction

Time frame:Through study completion until first of outcome, disenrollment, end of study period, 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 or DPP4i

Myocardial infarction (any)

time to event, event

SNOMED 22298006

Secondary/protocol endpoint

Stroke

Time frame:Through study completion until first of outcome, disenrollment, end of study period, 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 or DPP4i

Stroke (any)

time to event, event

SNOMED 230690007

Secondary/protocol endpoint

All-cause mortality

Time frame:Through study completion until first of outcome, disenrollment, end of study period, 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 or DPP4i

All-cause death

time to event, event

SNOMED 419620001

Secondary/protocol endpoint

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

Time frame:Through study completion until first of outcome, disenrollment, end of study period, 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 or DPP4i

4-point MACE

time to event, event

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

Secondary/protocol endpoint

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

Time frame:Through study completion until first of outcome, disenrollment, end of study period, 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 or DPP4i

Expanded / custom MACE composite

composite event, event

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

Secondary/protocol endpoint

Unstable angina

Time frame:Through study completion until first of outcome, disenrollment, end of study period, 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 or DPP4i

Unstable angina hospitalization

time to event, event

Secondary/protocol endpoint

Coronary revascularization

Time frame:Through study completion until first of outcome, disenrollment, end of study period, 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 or DPP4i

Coronary revascularization

time to event, event

SNOMED 415070008

Secondary/protocol endpoint

Heart failure

Time frame:Through study completion until first of outcome, disenrollment, end of study period, 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 or DPP4i

All-cause hospitalization

time to event, event

Secondary/protocol endpoint

Time to first hospitalization for any cause.

Time frame:Through study completion until first of outcome, disenrollment, end of study period, 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 or DPP4i

All-cause hospitalization

time to event, event

Secondary/protocol endpoint

Myocardial infarction

Time frame:Through study completion until first of outcome, disenrollment, end of study period, 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 or DPP4i

Myocardial infarction (any)

time to event, event

SNOMED 22298006

Secondary/protocol endpoint

Stroke

Time frame:Through study completion until first of outcome, disenrollment, end of study period, 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 or DPP4i

Stroke (any)

time to event, event

SNOMED 230690007

Secondary/protocol endpoint

All-cause mortality

Time frame:Through study completion until first of outcome, disenrollment, end of study period, 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 or DPP4i

All-cause death

time to event, event

SNOMED 419620001

Secondary/protocol endpoint

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

Time frame:Through study completion until first of outcome, disenrollment, end of study period, 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 or DPP4i

Expanded / custom MACE composite

time to event, event

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

Secondary/protocol endpoint

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

Time frame:Through study completion until first of outcome, disenrollment, end of study period, 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 or DPP4i

5-point MACE

time to event, event

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

Secondary/protocol endpoint

Unstable angina

Time frame:Through study completion until first of outcome, disenrollment, end of study period, 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 or DPP4i

Unstable angina hospitalization

time to event, event

Secondary/protocol endpoint

Coronary revascularization

Time frame:Through study completion until first of outcome, disenrollment, end of study period, 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 or DPP4i

Coronary revascularization

time to event, event

SNOMED 415070008

Secondary/protocol endpoint

Time to first hospitalization for any cause

Time frame:Through study completion until first of outcome, disenrollment, end of study period, 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 or DPP4i

All-cause hospitalization

time to event, event

Heart failure

1 endpoint
Secondary/protocol endpoint

Heart failure

Time frame:Through study completion until first of outcome, disenrollment, end of study period, 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 or DPP4i

time to event, event

SNOMED 84114007

Safety / tolerability / PK

6 endpoints
Secondary/protocol endpoint

Urinary tract infections

Time frame:Through study completion until first of outcome, disenrollment, end of study period, 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 or DPP4i

time to event, event

Secondary/protocol endpoint

Serious infections

Time frame:Through study completion until first of outcome, disenrollment, end of study period, 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 or DPP4i

time to event, event

Secondary/protocol endpoint

Gastrointestinal adverse events

Time frame:Through study completion until first of outcome, disenrollment, end of study period, 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 or DPP4i

descriptive, event

Secondary/protocol endpoint

Urinary tract infections

Time frame:Through study completion until first of outcome, disenrollment, end of study period, 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 or DPP4i

time to event, event

Secondary/protocol endpoint

Serious infections

Time frame:Through study completion until first of outcome, disenrollment, end of study period, 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 or DPP4i

time to event, event

Secondary/protocol endpoint

Gastrointestinal adverse events

Time frame:Through study completion until first of outcome, disenrollment, end of study period, 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 or DPP4i

descriptive, event

Other clinical outcomes

4 endpoints
Other/protocol endpoint

Hernia

Time frame:Through study completion until first of outcome, disenrollment, end of study period, 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 or DPP4i

time to event, event

Other/protocol endpoint

Lumbar radiculopathy

Time frame:Through study completion until first of outcome, disenrollment, end of study period, 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 or DPP4i

time to event, event

Other/protocol endpoint

Hernia

Time frame:Through study completion until first of outcome, disenrollment, end of study period, 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 or DPP4i

time to event, event

Other/protocol endpoint

Lumbar radiculopathy

Time frame:Through study completion until first of outcome, disenrollment, end of study period, 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 or DPP4i

time to event, event

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

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.