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 @ 11:36 PM
Ignite Modification Date:
2025-12-24 @ 11:36 PM
NCT ID:
NCT06557356
Eligibility Criteria:
Inclusion Criteria:
* Have a body weight not exceeding 150 kilograms (kg) or 330 pounds (lb) and body mass index (BMI) within the range of 30 to 40 kilogram per square meter (kg/m²)
* Have had a stable body weight that is less than or equal to 5% change in body weight for 3 months prior to screening and enrollment
Exclusion Criteria:
* Have a lifetime history of a suicide attempt
* Have a history or presence of psychiatric disorders, including a history of major depressive disorder within the last 2 years
* Have a baseline Patient Health Questionnaire-9 (PHQ-9) score of 15 or greater, and/or a score of 2 or greater for either of the first 2 questions on the PHQ-9 questionnaire
* Have a known clinically significant gastric emptying abnormality, have undergone gastric bypass surgery or restrictive bariatric surgery
* Have taken approved or investigational medication for weight loss, within the previous 3 months or 5 half-lives of study screening, whichever is earlier
* Intend to use any weight-loss medications during study participation
* Have obesity induced by other endocrinologic disorders or diagnosed monogenetic or syndromic forms of obesity
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06557356
Study Brief:
Protocol Section:
NCT06557356