Tirzepatide's effect on coronary atherosclerosis in diabetes patients
Effect of Tirzepatide on Progression of Coronary Atherosclerosis Using MDCT
This study is testing if the medication tirzepatide can help people with type II diabetes and heart artery disease slow down the buildup of plaque in their arteries over a year.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 40 Years to 80 Years |
| Sex | All |
| Sponsor | Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center Academic / other |
| Locations | 1 site (Torrance, California) |
| Trial ID | NCT05708859 on ClinicalTrials.gov |
What this trial studies
This multi-center, randomized, double-blind, placebo-controlled phase IV study evaluates the impact of tirzepatide on the progression of coronary atherosclerosis in individuals diagnosed with type II diabetes and atherosclerosis. A total of 120 participants will be randomized to receive either tirzepatide or a placebo alongside standard care for a duration of 12 months. The study will measure changes in coronary atheroma volume using coronary computed tomography angiography (CCTA) to assess the effectiveness of tirzepatide in reducing plaque progression. Participants must be on a stable regimen of diabetes medications and statins prior to enrollment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 40 to 80 with type II diabetes for at least 5 years and evidence of coronary atherosclerosis.
Not a fit: Patients with type 1 diabetes or those who have experienced a major cardiovascular event within the last 60 days may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option to slow the progression of coronary atherosclerosis in patients with type II diabetes.
How similar studies have performed: Other studies have shown promising results with similar approaches in managing atherosclerosis in diabetic patients, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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 for 4 weeks after each dose escalation Exclusion Criteria: 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 9. 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 10. Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years 11. Have a family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2) 12. 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 13. Planned or Prior Bypass surgery 14. 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. 15. 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 16. Heart Failure NYHA Class III or IV at the screening visit 17. Renal insufficiency (eGFR \<40 ml/min/1.73m2) as measured by the Modification of Diet in Renal Disease (MDRD) formula at the screening visit. 18. Hospitalization for major cardiovascular event including heart failure in the past 2 months
Where this trial is running
Torrance, California
- Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center (The Lundquist Institute) — Torrance, California, United States (Recruiting)
Study contacts
- Principal investigator: Matthew A Budoff, MD — The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
- Study coordinator: Sajad Hamal, MS
- Email: shamal@lundquist.org
- Phone: 13109749336
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.