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:
2025-12-26 @ 5:21 PM
Ignite Modification Date:
2025-12-26 @ 5:21 PM
NCT ID:
NCT05706506
Eligibility Criteria:
Inclusion Criteria:
* Have Type 2 diabetes (T2D)
* Have an HbA1c c ≥6.5% (≥48 mmol/mol) to ≤9.0% (≤75 mmol/mol)
* Have a body mass index (BMI) ≥25 kilogram per square meter (kg/m²) at screening
* Have been on a stable treatment dose of 1 of the listed GLP-1 RAs for ≥3 months
* No treatment with oral antidiabetic medicine (OAM) or on stable doses (for at least 3 months before screening) of up to 3 OAM. The OAM may include metformin, sodium-glucose linked transporter-2 inhibitor (SGLT-2i), thiazolidinediones, or α-glucosidase inhibitors.
Exclusion Criteria:
* Have Type 1 Diabetes (T1D)
* Have a clinical history of
* proliferative diabetic retinopathy
* diabetic maculopathy, or
* non-proliferative diabetic retinopathy that requires acute treatment
* Are at high risk for cardiovascular disease or have a history of
* myocardial infarction
* percutaneous coronary revascularization procedure
* carotid stenting or surgical revascularization
* nontraumatic amputation
* peripheral vascular procedure
* cerebrovascular accident
* or hospitalization for congestive heart failure
* Have New York Heart Association (NYHA) Functional Classification Class IV congestive heart failure
* Have a history of ketoacidosis or hyperosmolar state or coma
* Have a history of severe hypoglycemia or hypoglycemia unawareness within the 6 months.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05706506
Study Brief:
Protocol Section:
NCT05706506