Current partner codePEPTIDESDE
PeptideStat
Menu

Vendors

Compare pricesVendor directoryVendor reviewsDiscount codesLab tests & COAs

Research

ResearchDatabaseClinical trials

Tools

All calculatorsReconstitutionAccumulationUnit converterPeptide chemistry
NCT07417618·Not applicable·OBSERVATIONAL

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

TirzepatideSemaglutideDulaglutideGlucagonWeight lossType 2 diabetesCompleted

Status

Completed

Phase

Not applicable

Enrollment

60,000

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Full detailed description

This is a non-randomized, non-interventional study that is part of the Randomized Controlled Trials Duplicated Using Prospective Longitudinal Insurance Claims: Applying Techniques of Epidemiology (RCT-DUPLICATE) initiative (www.rctduplicate.org) of the Brigham and Women's Hospital, Harvard Medical School. Randomized controlled trials (RCTs) have demonstrated cardiovascular benefits of the modern incretin therapies semaglutide and tirzepatide in selected populations. SUSTAIN-6 (NCT01720446) and SURPASS-CVOT (NCT04255433) showed reductions in cardiovascular events with semaglutide and tirzepatide among patients with T2DM at high cardiovascular risk, findings that were also replicated in clinical practice settings (NCT06659744, NCT07088718). The REWIND trial (NCT01394952) demonstrated similar cardiovascular efficacy for dulaglutide and suggested benefit in both patients with and without prior cardiovascular disease.4 These findings raise the broader question of whether cardiovascular benefits of modern incretin therapies extend to individuals without established atherosclerotic cardiovascular disease (ASCVD) when used in routine clinical practice. To address this question, this comparative effectiveness study using a target trial emulation framework will assess the incretin therapies dulaglutide, semaglutide, and tirzepatide vs sitagliptin (used as an active comparator placebo proxy) on major adverse cardiovascular events (MACE) among individuals with type 2 diabetes (T2DM) and overweight with or without ASCVD. Although many features of the target trial cannot be directly replicated in healthcare claims, measurements of key design features, including outcomes, exposures, and inclusion/exclusion criteria, were designed to proxy those features from the target trial. Randomization cannot be achieved in healthcare claims data but was proxied through a statistical balancing of measured covariates according to standard practice. 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.

Interventions

Treatment arms and agents.

DRUG

Dulaglutide

Initiation of dulaglutide dispensing claim is used as the exposure.

DRUG

Semaglutide

Initiation of semaglutide dispensing claim is used as the exposure.

DRUG

Tirzepatide

Initiation of tirzepatide dispensing claim is used as the exposure.

DRUG

Sitagliptin

Initiation of sitagliptin dispensing claim is used as the reference.

Timeline

From registration to results.

  1. First posted

    Feb 18, 2026

  2. Study start

    Jan 27, 2026

  3. Primary completion

    Jun 19, 2026

  4. Study completion

    Jun 19, 2026

  5. Results posted

    Not reported

  6. Registry updated

    Jul 9, 2026

Outcomes

What the study measures.

Primary outcomes

Composite of myocardial infarction, stroke, or all-cause mortality (with ASCVD)

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

Hazard ratio of the composite of myocardial infarction, stroke, or all-cause mortality in individuals with T2DM and overweight with ASCVD, comparing dulaglutide, semaglutide, and tirzepatide vs sitagliptin.

Composite of myocardial infarction, or stroke (with ASCVD)

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

Hazard ratio of the composite of myocardial infarction or stroke in individuals with T2DM and overweight with ASCVD, comparing dulaglutide, semaglutide, and tirzepatide vs sitagliptin.

Composite of myocardial infarction, stroke, or all-cause mortality (without ASCVD)

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

Hazard ratio of the composite of myocardial infarction, stroke, or all-cause mortality in individuals with T2DM and overweight without ASCVD, comparing dulaglutide, semaglutide, and tirzepatide vs sitagliptin.

Composite of myocardial infarction, or stroke (without ASCVD)

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

Hazard ratio of the composite of myocardial infarction or stroke in individuals with T2DM and overweight without ASCVD, comparing dulaglutide, semaglutide, and tirzepatide vs sitagliptin.

Secondary outcomes

Myocardial infarction (with ASCVD)

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

Hazard ratio of the occurrence of myocardial infarction in individuals with T2DM and overweight with ASCVD, comparing dulaglutide, semaglutide, and tirzepatide vs sitagliptin.

Stroke (with ASCVD)

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

Hazard ratio of the occurrence of stroke in individuals with T2DM and overweight with ASCVD, comparing dulaglutide, semaglutide, and tirzepatide vs sitagliptin.

All-cause mortality (with ASCVD)

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

Hazard ratio of the occurrence of all-cause mortality in individuals with T2DM and overweight with ASCVD, comparing dulaglutide, semaglutide, and tirzepatide vs sitagliptin.

Composite of myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization (with ASCVD)

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

Hazard ratio of the composite of myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization in individuals with T2DM and overweight with ASCVD, comparing dulaglutide, semaglutide, and tirzepatide vs sitagliptin.

Composite of myocardial infarction, stroke, hospitalization for unstable angina, coronary revascularization, or hospitalization for heart failure (with ASCVD)

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

Hazard ratio of the composite of myocardial infarction, stroke, hospitalization for unstable angina, coronary revascularization, or hospitalization for heart failure in individuals with T2DM and overweight with ASCVD, comparing dulaglutide, semaglutide, and tirzepatide vs sitagliptin.

Unstable angina (with ASCVD)

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

Hazard ratio of the occurrence of unstable angina in individuals with T2DM and overweight with ASCVD, comparing dulaglutide, semaglutide, and tirzepatide vs sitagliptin.

Coronary revascularization (with ASCVD)

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

Hazard ratio of the occurrence of coronary revascularization in individuals with T2DM and overweight with ASCVD, comparing dulaglutide, semaglutide, and tirzepatide vs sitagliptin.

Hospitalization for heart failure (with ASCVD)

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

Hazard ratio of the occurrence of hospitalization for heart failure in individuals with T2DM and overweight with ASCVD, comparing dulaglutide, semaglutide, and tirzepatide vs sitagliptin.

Time to first hospitalization for any cause (with ASCVD)

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

Hazard ratio of time to first hospitalization for any cause in individuals with T2DM and overweight with ASCVD, comparing dulaglutide, semaglutide, and tirzepatide vs sitagliptin.

Myocardial infarction (without ASCVD)

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

Hazard ratio of the occurrence of myocardial infarction in individuals with T2DM and overweight without ASCVD, comparing dulaglutide, semaglutide, and tirzepatide vs sitagliptin.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
Not reported

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

Study locations

1 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

Brigham and Women's Hospital

Boston, Massachusetts, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

ClinicalTrials.gov ↗Search PubMed ↗Search FDA ↗Search EMA ↗

Related trials

More studies on Tirzepatide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.

TrialsTirzepatide trial dashboard →DatabaseTirzepatide database entry →ResearchTirzepatide research guide →TrialsSemaglutide trial dashboard →DatabaseSemaglutide database entry →ResearchSemaglutide research guide →TrialsDulaglutide trial dashboard →DatabaseDulaglutide database entry →ResearchDulaglutide research guide →TrialsGlucagon trial dashboard →DatabaseGlucagon database entry →ResearchGlucagon research guide →