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:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-26 @ 3:16 PM
NCT ID:
NCT07487103
Eligibility Criteria:
Inclusion Criteria:
1. Female or male，age 18 to 75.
2. Body mass index (BMI) ≥ 22 kg/m² and ≤ 35 kg/m² at screening.
3. HbA1c of 7.0-10.5 %.
4. Diagnosed with type 2 diabetes mellitus at least 90 days prior to day of screening.
5. Stable daily dose of metformin (at least 1500 mg or maximum tolerated dose≥1000 mg/day) at least 90 days prior to the day of screening.
Exclusion Criteria:
1. Family or personal history of Multiple Endocrine Neoplasia Type 2 or Medullary Thyroid Carcinoma.
2. History of pancreatitis (acute or chronic).
3. History of major surgical procedures involving the stomach potentially affecting absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery).
4. Subjects presently classified as being in New York Heart Association Class IV.
5. Planned coronary, carotid or peripheral artery revascularisation known on the day of screening.
6. Renal impairment defined as Estimated Glomerular Filtration Rate below 60 mL/min/1.73 m\\\^2 as per Chronic Kidney Disease Epidemiology Collaboration formula (CKD-EPI).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT07487103
Study Brief:
Protocol Section:
NCT07487103