NCT07417618Completed
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.
Source: ClinicalTrials.gov · Last updated 9 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 60000 (actual)
- First submitted
- 11 Feb 2026
- Start date
- 27 Jan 2026
- Primary completion date
- 19 Jun 2026
- Lead sponsor
- Brigham and Women's Hospital
- Diseases
- Obesity, Type 2 diabetes
- NCT number
- NCT07417618
What you commit to
- Study type: Observational
- Participants enrolled: 60000
- From 27 Jan 2026 to the primary completion date, 19 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- POPULATION WITHOUT ASCVD
- 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
Other illness
- MEN syndrome type 2
- Malignancy
- Type 1 diabetes or secondary diabetes
- End-stage renal disease or dialysis
- 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)
- MEN syndrome type 2
- Malignancy
- Type 1 diabetes or secondary diabetes
- End-stage renal disease or dialysis
Other
- Medullary thyroid carcinoma
- Uncontrolled diabetic retinopathy or maculopathy
- Pregnancy
- CV-event or intervention
- Medullary thyroid carcinoma
- Uncontrolled diabetic retinopathy or maculopathy
- Pregnancy
Who the study is looking for
- 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
- BMI \>=25.0kg/m2
- Type 2 diabetes
Criteria the registry did not label
- 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
Age in the registry: 18 years to - · Sex: All
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Brigham and Women's Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.