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 @ 4:16 AM
Ignite Modification Date:
2025-12-25 @ 4:16 AM
NCT ID:
NCT00537420
Eligibility Criteria:
Inclusion Criteria:
* Male or Female patients 18 and 65 years, inclusive;
* BMI 30-43 kg/m2, inclusive;
* In good health, determined by medical history and physical examination, as well as normal 12-lead ECG and vital signs;
* Non-smoker and no use of tobacco or nicotine products for at least 3 months;
* Females will be non-pregnant, non-lactating, and either post-menopausal for at least 1 year, surgically sterile (including tubal ligation, hysterectomy) for at least 3 months, until 30 days following Study Completion be willing to use an approved method of contraception;
* Has normal nasal mucosa.
Exclusion Criteria:
* Previous surgical treatment for obesity;
* Serious Medical Condition
* Serious Psychiatric illness
* Organic causes of obesity (e.g. untreated hypothyroidism)
* Type 1 or Type 2 Diabetes;
* Presence of uncontrolled hypertension
* On prohibited concomitant medication
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00537420
Study Brief:
Protocol Section:
NCT00537420