NCT05708859 Effect of Tirzepatide on Progression of Coronary Atherosclerosis Using MDCT
| NCT ID | NCT05708859 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Matthew J. Budoff |
| Condition | Type II Diabetes |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2024-01-02 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 120 participants in total. It began in 2024-01-02 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Matthew A Budoff, MD
PRINCIPAL INVESTIGATOR
The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Frequently Asked Questions
Who can join the NCT05708859 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 80 Years, studying Type II Diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05708859 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05708859 currently recruiting?
Yes, NCT05708859 is actively recruiting participants. Contact the research team at shamal@lundquist.org for enrollment information.
Where is the NCT05708859 trial being conducted?
This trial is being conducted at Torrance, United States.
Who is sponsoring the NCT05708859 clinical trial?
NCT05708859 is sponsored by Matthew J. Budoff. The principal investigator is Matthew A Budoff, MD at The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center. The trial plans to enroll 120 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.