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 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 1:33 AM
NCT ID:
NCT04073394
Eligibility Criteria:
Inclusion Criteria:
* Adults with obesity (BMI \>30Kg/m2); these will be otherwise healthy individuals with no unstable psychiatric disease and uncontrolled life-threatening comorbidities (i.e. unstable angina).
* Age: 18-65 years.
* Gender: Men or women.
Exclusion Criteria:
* Weight change greater than 3% in the previous 3 months (weight stable).
* History of bariatric surgery including lap band and bariatric endoscopy.
* Significant untreated psychiatric dysfunction including binge eating disorders and bulimia.
* Current use of anti-obesity pharmacotherapy, medications known to affect weight (e.g., corticosteroids) or GLP-1 agonist/analog for T2DM
* A positive score on the AUDIT-C questionnaire as judged by an investigator.
* Patient has a known history of any condition or factor judged by the investigator to preclude participation in the study or which might hinder study adherence
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04073394
Study Brief:
Protocol Section:
NCT04073394