Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:05 PM
Ignite Modification Date:
2025-12-24 @ 3:05 PM
NCT ID:
NCT05708859
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
80 Years
Study:
NCT05708859
Study Brief:
Protocol Section:
NCT05708859