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 @ 12:58 PM
Ignite Modification Date:
2025-12-24 @ 12:58 PM
NCT ID:
NCT05407961
Eligibility Criteria:
Inclusion Criteria:
* Participants with type 2 diabetes mellitus (T2DM) for at least 3 months before screening
* Have the following glycosylated hemoglobin (HbA1c) levels at screening:
1. HbA1c \>/= 7.0% to \</= 10.0% for participants treated with diet and exercise alone and participants treated with metformin alone, and
2. HbA1c \>/= 6.0% to \</= 9.5% for participants treated with dipeptidyl peptidase inhibitor-4 (DPP-4) (with/without metformin) inhibitors and participants treated with metformin and sodium-glucose cotransporter-2 (SGLT-2) inhibitor
* Participants treated with diet and exercise alone or on a stable dose of metformin for at least 3 months
* Participants with body weight up to 150 kilograms (kg) and body mass index (BMI) of 23.0 to 45.0 kilograms per meter squared (kg/m²)
* Male participants who agree to use effective methods of contraception and female participants not of childbearing potential
Exclusion Criteria:
* Participants who have uncontrolled diabetes defined as an episode of ketoacidosis or hyperosmolar state requiring hospitalization in the 6 months prior to screening
* Have a clinically significant abnormality ECG
* Have obesity induced by other endocrine disorders such as Cushing's syndrome or Prader-Willi syndrome
* Are on any glucose-lowering medications other than metformin, SGLT-2 inhibitors and/or DPP4
* Have received chronic systemic glucocorticoid therapy (\>2 weeks) in the past 6 months
* Have an average weekly alcohol intake that exceeds 21 units per week (males 65 years of age or lesser) and 14 units per week (females and males 65 years of age or older)
* Smoke more than 10 cigarettes, or cigarette equivalent, per day
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT05407961
Study Brief:
Protocol Section:
NCT05407961