Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-04-01 @ 5:03 PM
Study NCT ID:
NCT07417618
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2026-02-18
First Post:
2026-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
INcreTin-based thERapies for Cardiovascular Event PrevenTion in Patients With and Without ASCVD (INTERCEPT-ASCVD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D050177', 'term': 'Overweight'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C555680', 'term': 'dulaglutide'}, {'id': 'C000591245', 'term': 'semaglutide'}, {'id': 'D000098860', 'term': 'Tirzepatide'}, {'id': 'D000068900', 'term': 'Sitagliptin Phosphate'}], 'ancestors': [{'id': 'D000067757', 'term': 'Glucagon-Like Peptide-1 Receptor'}, {'id': 'D000067756', 'term': 'Glucagon-Like Peptide Receptors'}, {'id': 'D043562', 'term': 'Receptors, G-Protein-Coupled'}, {'id': 'D011956', 'term': 'Receptors, Cell Surface'}, {'id': 'D008565', 'term': 'Membrane Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011964', 'term': 'Receptors, Gastrointestinal Hormone'}, {'id': 'D018000', 'term': 'Receptors, Peptide'}, {'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011719', 'term': 'Pyrazines'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2026-01-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-11', 'studyFirstSubmitDate': '2026-02-11', 'studyFirstSubmitQcDate': '2026-02-11', 'lastUpdatePostDateStruct': {'date': '2026-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Hernia', 'timeFrame': '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', 'description': 'To evaluate the effect of dulaglutide, semaglutide, and tirzepatide vs sitagliptin on negative control outcomes hernia in individuals with T2DM and overweight with ASCVD.'}, {'measure': 'Lumbar radiculopathy', 'timeFrame': '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', 'description': 'To evaluate the effect of dulaglutide, semaglutide, and tirzepatide vs sitagliptin on negative control outcomes lumbar radiculopathy in individuals with T2DM and overweight with ASCVD.'}, {'measure': 'Hernia', 'timeFrame': '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', 'description': 'To evaluate the effect of dulaglutide, semaglutide, and tirzepatide vs sitagliptin on negative control outcomes hernia in individuals with T2DM and overweight without ASCVD.'}, {'measure': 'Lumbar radiculopathy', 'timeFrame': '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', 'description': 'To evaluate the effect of dulaglutide, semaglutide, and tirzepatide vs sitagliptin on negative control outcomes lumbar radiculopathy in individuals with T2DM and overweight without ASCVD.'}], 'primaryOutcomes': [{'measure': 'Composite of myocardial infarction, stroke, or all-cause mortality.', 'timeFrame': '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', 'description': 'To evaluate the comparative effect of dulaglutide, semaglutide, and tirzepatide vs sitagliptin on the composite of myocardial infarction, stroke, or all-cause mortality in individuals with T2DM and overweight with ASCVD.'}, {'measure': 'Composite of myocardial infarction, or stroke.', 'timeFrame': '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', 'description': 'To evaluate the comparative effect of dulaglutide, semaglutide, and tirzepatide vs sitagliptin on the composite of myocardial infarction or stroke in individuals with T2DM and overweight with ASCVD.'}, {'measure': 'Composite of myocardial infarction, stroke, or all-cause mortality.', 'timeFrame': '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', 'description': 'To evaluate the comparative effect of dulaglutide, semaglutide, and tirzepatide vs sitagliptin on the composite of myocardial infarction, stroke, or all-cause mortality in individuals with T2DM and overweight without ASCVD.'}, {'measure': 'Composite of myocardial infarction, or stroke.', 'timeFrame': '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', 'description': 'To evaluate the comparative effect of dulaglutide, semaglutide, and tirzepatide vs sitagliptin on the composite of myocardial infarction or stroke in individuals with T2DM and overweight without ASCVD.'}], 'secondaryOutcomes': [{'measure': 'Myocardial infarction', 'timeFrame': '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', 'description': 'To evaluate the comparative effect of dulaglutide, semaglutide, and tirzepatide vs sitagliptin on the occurrence of myocardial infarction in individuals with T2DM and overweight with ASCVD.'}, {'measure': 'Stroke', 'timeFrame': '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', 'description': 'To evaluate the comparative effect of dulaglutide, semaglutide, and tirzepatide vs sitagliptin on the occurrence of stroke in individuals with T2DM and overweight with ASCVD.'}, {'measure': 'All-cause mortality', 'timeFrame': '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', 'description': 'To evaluate the comparative effect of dulaglutide, semaglutide, and tirzepatide vs sitagliptin on the occurrence of all-cause mortality in individuals with T2DM and overweight with ASCVD'}, {'measure': 'Composite of myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization.', 'timeFrame': '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', 'description': 'To evaluate the comparative effect of dulaglutide, semaglutide, and tirzepatide vs sitagliptin on the composite of myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization in individuals with T2DM and overweight with ASCVD.'}, {'measure': 'Composite of myocardial infarction, stroke, hospitalization for unstable angina, coronary revascularization, or hospitalization for heart failure.', 'timeFrame': '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', 'description': 'To evaluate the comparative effect of dulaglutide, semaglutide, and tirzepatide vs sitagliptin on 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.'}, {'measure': 'Unstable angina', 'timeFrame': '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', 'description': 'To evaluate the comparative effect of dulaglutide, semaglutide, and tirzepatide vs sitagliptin on the occurrence of unstable angina in individuals with T2DM and overweight with ASCVD.'}, {'measure': 'Coronary revascularization', 'timeFrame': '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', 'description': 'To evaluate the comparative effect of dulaglutide, semaglutide, and tirzepatide vs sitagliptin on the occurrence of coronary revascularization in individuals with T2DM and overweight with ASCVD.'}, {'measure': 'Heart failure', 'timeFrame': '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', 'description': 'To evaluate the comparative effect of dulaglutide, semaglutide, and tirzepatide vs sitagliptin on time to first hospitalization for any cause in individuals with T2DM and overweight with ASCVD.'}, {'measure': 'Time to first hospitalization for any cause.', 'timeFrame': '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', 'description': 'To evaluate the comparative effect of dulaglutide, semaglutide, and tirzepatide vs sitagliptin on time to first hospitalization for any cause in individuals with T2DM and overweight with ASCVD.'}, {'measure': 'Myocardial infarction', 'timeFrame': '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', 'description': 'To evaluate the comparative effect of dulaglutide, semaglutide, and tirzepatide vs sitagliptin on the occurrence of myocardial infarction in individuals with T2DM and overweight without ASCVD.'}, {'measure': 'Stroke', 'timeFrame': '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', 'description': 'To evaluate the comparative effect of dulaglutide, semaglutide, and tirzepatide vs sitagliptin on the occurrence of stroke in individuals with T2DM and overweight without ASCVD.'}, {'measure': 'All-cause mortality', 'timeFrame': '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', 'description': 'To evaluate the comparative effect of dulaglutide, semaglutide, and tirzepatide vs sitagliptin on the occurrence of all-cause mortality in individuals with T2DM and overweight without ASCVD.'}, {'measure': 'Composite of myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization.', 'timeFrame': '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', 'description': 'To evaluate the comparative effect of dulaglutide, semaglutide, and tirzepatide vs sitagliptin on the composite of myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization in individuals with T2DM and overweight without ASCVD.'}, {'measure': 'Composite of myocardial infarction, stroke, hospitalization for unstable angina, coronary revascularization, or hospitalization for heart failure.', 'timeFrame': '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', 'description': 'To evaluate the comparative effect of dulaglutide, semaglutide, and tirzepatide vs sitagliptin on the composite of myocardial infarction, stroke, hospitalization for unstable angina, coronary revascularization, or hospitalization for heart failure in individuals with T2DM and overweight without ASCVD.'}, {'measure': 'Unstable angina', 'timeFrame': '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', 'description': 'To evaluate the comparative effect of dulaglutide, semaglutide, and tirzepatide vs sitagliptin on the occurrence of unstable angina in individuals with T2DM and overweight without ASCVD.'}, {'measure': 'Coronary revascularization', 'timeFrame': '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', 'description': 'To evaluate the comparative effect of dulaglutide, semaglutide, and tirzepatide vs sitagliptin on the occurrence of coronary revascularization in individuals with T2DM and overweight without ASCVD.'}, {'measure': 'Heart failure', 'timeFrame': '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', 'description': 'To evaluate the comparative effect of dulaglutide, semaglutide, and tirzepatide vs sitagliptin on the occurrence of heart failure in individuals with T2DM and overweight without ASCVD'}, {'measure': 'Time to first hospitalization for any cause', 'timeFrame': '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', 'description': 'To evaluate the comparative effect of dulaglutide, semaglutide, and tirzepatide vs sitagliptin on time to first hospitalization for any cause in individuals with T2DM and overweight without ASCVD.'}, {'measure': 'Urinary tract infections', 'timeFrame': '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', 'description': 'To evaluate the comparative effect of dulaglutide, semaglutide, and tirzepatide vs sitagliptin on the safety outcome of urinary tract infections in individuals with T2DM and overweight with ASCVD.'}, {'measure': 'Serious infections', 'timeFrame': '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', 'description': 'To evaluate the comparative effect of dulaglutide, semaglutide, and tirzepatide vs sitagliptin on the safety outcome of serious infections in individuals with T2DM and overweight with ASCVD.'}, {'measure': 'Gastrointestinal adverse events', 'timeFrame': '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', 'description': 'To evaluate the comparative effect of dulaglutide, semaglutide, and tirzepatide vs sitagliptin on the safety outcome of gastrointestinal adverse events in individuals with T2DM and overweight with ASCVD.'}, {'measure': 'Urinary tract infections', 'timeFrame': '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', 'description': 'To evaluate the comparative effect of dulaglutide, semaglutide, and tirzepatide vs sitagliptin on the safety outcome of urinary tract infections in individuals with T2DM and overweight without ASCVD.'}, {'measure': 'Serious infections', 'timeFrame': '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', 'description': 'To evaluate the comparative effect of dulaglutide, semaglutide, and tirzepatide vs sitagliptin on the safety outcome of serious infections in individuals with T2DM and overweight without ASCVD.'}, {'measure': 'Gastrointestinal adverse events', 'timeFrame': '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', 'description': 'To evaluate the comparative effect of dulaglutide, semaglutide, and tirzepatide vs sitagliptin on the safety outcome of gastrointestinal adverse events in individuals with T2DM and overweight without ASCVD.'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes', 'Overweight', 'ASCVD']}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': "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).1-3 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.\n\nTo 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.\n\nAlthough 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.\n\nThe 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Individuals with T2DM and overweight with (or without) ASCVD.', 'eligibilityCriteria': '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.\n\nOptum: 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.\n\nPOPULATION WITH ASCVD\n\nInclusion Criteria:\n\n* 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)\n* BMI \\>= 25.0kg/m2\n* Type 2 Diabetes\n\nExclusion Criteria:\n\n* Medullary thyroid carcinoma\n* MEN syndrome type 2\n* Malignancy\n* Type 1 diabetes or secondary diabetes\n* End-stage renal disease or dialysis\n* Uncontrolled diabetic retinopathy or maculopathy\n* Pregnancy\n* Bariatric surgery\n* Prior use of pramlintide, or any GLP-1RA except injectable semaglutide/tirzepatide/dulaglutide, or any DPP4i except sitagliptin\n* CV-event or intervention\n* Concurrent use of both study drugs\n\nPOPULATION WITHOUT ASCVD\n\nInclusion Criteria:\n\n* BMI \\>=25.0kg/m2\n* Type 2 diabetes\n\nExclusion Criteria:\n\n* 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)\n* Medullary thyroid carcinoma\n* MEN syndrome type 2\n* Malignancy\n* Type 1 diabetes or secondary diabetes\n* End-stage renal disease or dialysis\n* Uncontrolled diabetic retinopathy or maculopathy\n* Pregnancy\n* Bariatric surgery\n* Prior use of pramlintide, or any GLP-1RA except injectable semaglutide/tirzepatide/dulaglutide, or any DPP4i except sitagliptin\n* Concurrent use of both study drugs'}, 'identificationModule': {'nctId': 'NCT07417618', 'acronym': 'INTERCEPT', 'briefTitle': 'INcreTin-based thERapies for Cardiovascular Event PrevenTion in Patients With and Without ASCVD (INTERCEPT-ASCVD)', 'organization': {'class': 'OTHER', 'fullName': "Brigham and Women's Hospital"}, 'officialTitle': '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.', 'orgStudyIdInfo': {'id': '2018P002966-INTERCEPT-ASCVD'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Initiation of dulaglutide, semaglutide or tirzepatide', 'description': 'Exposure group.', 'interventionNames': ['Drug: Dulaglutide', 'Drug: Semaglutide', 'Drug: Tirzepatide']}, {'label': 'Initiation of sitagliptin', 'description': 'Reference group.', 'interventionNames': ['Drug: Sitagliptin']}], 'interventions': [{'name': 'Dulaglutide', 'type': 'DRUG', 'description': 'Initiation of dulaglutide dispensing claim is used as the exposure.', 'armGroupLabels': ['Initiation of dulaglutide, semaglutide or tirzepatide']}, {'name': 'Semaglutide', 'type': 'DRUG', 'description': 'Initiation of semaglutide dispensing claim is used as the exposure.', 'armGroupLabels': ['Initiation of dulaglutide, semaglutide or tirzepatide']}, {'name': 'Tirzepatide', 'type': 'DRUG', 'description': 'Initiation of tirzepatide dispensing claim is used as the exposure.', 'armGroupLabels': ['Initiation of dulaglutide, semaglutide or tirzepatide']}, {'name': 'Sitagliptin', 'type': 'DRUG', 'description': 'Initiation of sitagliptin dispensing claim is used as the reference.', 'armGroupLabels': ['Initiation of sitagliptin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02120', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Shirley Wang, PhD, ScM', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Brigham and Women's Hospital"}, {'name': 'Nils Krüger, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Brigham and Women's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Shirley Vichy Wang', 'investigatorAffiliation': "Brigham and Women's Hospital"}}}}