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Active Not Recruiting
NCT07619508
Tirzepatide vs Semaglutide in Individuals at Cardiovascular Risk But Without Diabetes.
Conditions: Obesity, Overweight
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 100000
Sponsor: Brigham and Women's Hospital
Location: Brigham and Women's Hospital Boston Massachusetts
Summary
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.
Eligibility 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
Source: ClinicalTrials.gov (NCT07619508). StuddyBuddy aggregates publicly available trial information.