RecruitingType II DiabetesAtherosclerosis
Effect of Tirzepatide on Progression of Coronary Atherosclerosis Using MDCT
Eligible age
40–80 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
A multi-center, randomized, double-blind, placebo-controlled, parallel-group phase IV Study evaluating the effects of tirzepatide on atherosclerotic plaque progression assessed by coronary computed tomography angiography (CCTA) in participants with a diagnosis of type II Diabetes (T2DM) and atherosclerosis.
Sponsor: Matthew J. Budoff
You may qualify if…
- ✓ 1. Male or female 40 years to 80 years of age at signing of informed consent
- ✓ 2. Type 2 DM of minimum 5 years duration with HbA1c ≥7.0% to ≤10.5%
- ✓ 3. Body mass index (BMI) ≥25 kilograms per meter squared (kg/m²)
- ✓ 4. Presence of two discrete coronary artery plaques with visual diameter stenosis \>20% on CCTA
- ✓ 5. At the baseline visit, participants must be on a stable (\>4 weeks) regiment of diabetes medications.
- ✓ 6. Patients using oral hormonal contraceptives must switch to a non-oral contraceptive method, or add a barrier method of contraception for 4 weeks after initiation and for 4 weeks after each dose escalation
You may not qualify if…
- ✕ 1. Have had a major cardiovascular event within the last 60 days
- ✕ 2. Have type 1 diabetes mellitus
- ✕ 3. Current use of GLP1-RA
- ✕ 4. Have a history of severe hypoglycemia and/or hypoglycemia unawareness within the last 6 months
- ✕ 5. Are currently planning treatment for diabetic retinopathy and/or macular edema
- ✕ 6. Have history of, or currently planning a coronary, carotid, or peripheral artery revascularization (ie - stent, bypass)
- ✕ 7. Have a history of pancreatitis
- ✕ 8. Have a history of ketoacidosis or hyperosmolar state/coma
Where it's recruiting
California
Torrance
Source: ClinicalTrials.gov · NCT05708859 · last updated 2024-10-15