Effect of Tirzepatide on Progression of Coronary Atherosclerosis Using MDCT
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.
• Male or female 40 years to 80 years of age at signing of informed consent
• Type 2 DM of minimum 5 years duration with HbA1c ≥7.0% to ≤10.5%
• Body mass index (BMI) ≥25 kilograms per meter squared (kg/m²)
• Presence of two discrete coronary artery plaques with visual diameter stenosis \>20% on CCTA
• At the baseline visit, participants must be on a stable (\>4 weeks) regiment of diabetes medications.
• 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