Comparative Effectiveness of Tirzepatide Versus Sitagliptin in Individuals at Cardiovascular Risk (TIRZSITA-CVOT)

Completed

Conditions studied: Type2 Diabetes Mellitus, Atherosclerotic Cardiovascular Disease

In brief

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.

Key facts

Study ID

NCT07203677

Run by

Brigham and Women's Hospital

People needed

49065

Starts

2025-09-19

Expected to finish

2025-10-15

Last updated by the study team

2026-04-30

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• History of MI or stroke, surgical or percutaneous coronary/carotid peripheral artery revascularization, amputation, diagnosis of coronary/carotid/peripheral artery disease
• BMI ≥25.0kg/m2
• Type 2 diabetes
• Age ≥40 years
• Male or female sex

You may not qualify if…

• Medullary thyroid carcinoma, MEN syndrome type 2, malignancy
• Treatment for diabetic retinopathy/macular edema, heart failure NYHA IV, gastric emptying abnormality/bariatric surgery, end-stage renal disease or dialysis, pregnancy
• Prior use of pramlintide or any GLP-1-RA except tirzepatide,
• Pancreatitis, liver disease
• Cardiovascular event or intervention, hospitalization for heart failure
• Concurrent use of both drugs i.e. tirzepatide and sitagliptin

Where it is running

• Brigham and Women's Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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