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:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-25 @ 2:28 AM
NCT ID:
NCT04407234
Eligibility Criteria:
Inclusion Criteria:
* Have a body mass index (BMI) between 27 to 45 kilograms per meter squared (kg/m²), inclusive at screening
* For nondiabetic subjects: as determined by medical history, physical examination, and safety assessments at screening
* For participants with a confirmed type 2 diabetes diagnosis: The condition must be managed either by diet and exercise alone or on a stable dose of metformin for the past 3 months
* Willing and agreeable to commit to the duration of the study and undergo study procedures as instructed by the clinic staff
Key Exclusion Criteria
* Have undergone gastric bypass or bariatric surgery
* Have received prescription drugs or over the counter drugs that promote weight loss in the past 6 months prior to screening
* For participants with a confirmed type 2 diabetes diagnosis: Have experienced more than 1 episode of severe low blood sugar that require emergency treatment, hospitalization or third parties to administer rescue treatment, in the past 6 months
* Have any lifetime history of a suicide attempt
* Have other medical conditions or medical history that make participation in the study unsafe or which may interfere in the interpretation of the results of the study
* Unwilling to comply with smoking and alcohol restrictions during the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04407234
Study Brief:
Protocol Section:
NCT04407234