Matthew J. Budoff
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.
This is a multi-center study in which 120 male and female participants who meet the eligibility criteria will be randomized. Study will assess changes in coronary atheroma volume comparing tirzepatide 15 mg/week plus Standard of Care (SOC), as compared to placebo plus SOC. Potential eligible participants may be prescreened for eligibility prior to the screening visit and must have a diagnosis of atherosclerosis (as assessed by \>10% atheroma on CCTA) and T2DM. Patients must be on a stable medical regiment (\>4 weeks on statin therapy and diabetes medications) and undergo screening CCTA to dem…
Inclusion Criteria: 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…
Tirzepatide 15mg Subcutaneous Solution
Volume matched Subcutaneous Solution
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