RecruitingPhase 4NCT05708859

Effect of Tirzepatide on Progression of Coronary Atherosclerosis Using MDCT

Sponsor

Matthew J. Budoff

Enrollment

120 participants

Start Date

Jan 2, 2024

Study Type

INTERVENTIONAL

Conditions

Atherosclerosis Type II Diabetes

Summary

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.

Eligibility

Min Age: 40 YearsMax Age: 80 Years

Inclusion Criteria6

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

Exclusion Criteria18

Have had a major cardiovascular event within the last 60 days
Have type 1 diabetes mellitus
Current use of GLP1-RA
Have a history of severe hypoglycemia and/or hypoglycemia unawareness within the last 6 months
Are currently planning treatment for diabetic retinopathy and/or macular edema
Have history of, or currently planning a coronary, carotid, or peripheral artery revascularization (ie - stent, bypass)
Have a history of pancreatitis
Have a history of ketoacidosis or hyperosmolar state/coma
Have a known clinically significant gastric emptying abnormality, have undergone or currently planning any gastric outlet obstruction, or have undergone or currently planning any gastric bypass (bariatric) surgery or restrictive bariatric surgery
Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years
Have a family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
Have had a blood transfusion or severe blood loss within 90 days prior to screening or have known hematological conditions that may interfere with HbA1c measurement
Planned or Prior Bypass surgery
Contradiction for CCTA (e.g. serious allergic reaction to the contrast dye) or CCTA not meeting entry standards after two attempts during the Baseline CCTA visit as assessed by the imaging core lab.
Uncontrolled severe hypertension: systolic blood pressure \> 180 mmHg or diastolic BP \> 100 mm Hg prior to randomization (assessed at the screening visit) despite antihypertensive therapy
Heart Failure NYHA Class III or IV at the screening visit
Renal insufficiency (eGFR \<40 ml/min/1.73m2) as measured by the Modification of Diet in Renal Disease (MDRD) formula at the screening visit.
Hospitalization for major cardiovascular event including heart failure in the past 2 months