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 @ 4:40 PM
Ignite Modification Date:
2025-12-24 @ 4:40 PM
NCT ID:
NCT00518466
Eligibility Criteria:
Inclusion Criteria:
* Obese adults
* Body mass index between 30.0 and 42.0 kg/m2 (inclusive)
* Medically healthy with no clinically significant results of screening exams
Exclusion Criteria:
* History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease
* History of glaucoma or increased intraocular pressure
* History of kidney stones
* Cholelithiasis or cholecystitis within 6 months
* Cardiovascular event within 6 months
* Obesity of known genetic or endocrine origin
* Recent weight instability
* Use of Very Low Calorie diet or participation in organized weight loss program within 3 months
* Systolic blood pressure \> 150 or diastolic \> 95 mm Hg
* Positive urine drug or alcohol screen
* Positive serology for HIV, HBV, or HCV
* History of alcoholism or drug abuse
* History of significant psychiatric disease, current depression of moderate or greater severity, any history of suicidal ideation
* Hypersensitivity to study drug or related compounds
* Use of prescription or OTC medication other than hormonal contraceptive within 14 days prior to first dosing with study drug
* Blood donation or significant blood loss within 56 days or plasma donation within 7 days prior to first dosing with study drug
* Women who are pregnant or lactating
* Hemoglobin \< 12 g/dL
* Use of tobacco or nicotine-containing products within 6 months
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
65 Years
Study:
NCT00518466
Study Brief:
Protocol Section:
NCT00518466