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 @ 1:32 PM
Ignite Modification Date:
2025-12-24 @ 1:32 PM
NCT ID:
NCT02063295
Eligibility Criteria:
Inclusion Criteria:
* Obesity as a consequence of acquired anatomical hypothalamic damage as evidenced by BMI ≥30 and ≤60 kg/m2
* Greater than 6 months post-treatment, including chemotherapy, surgery or radiation with resulting injury to the hypothalamus and/or the pituitary
* Stable body weight for at least 3 months
* Type 2 diabetes mellitus is allowed
Exclusion Criteria:
* Males taking gonadotropin replacement therapy (LH/FSH)
* Subjects who are planning any fertility treatment within 6 months of study participation
* Use of weight loss agents, including herbal medications, in the past 3 months
* Current or anticipated chronic use of narcotics or opiates
* History of severe psychiatric disorders
* Type 1 diabetes mellitus
* Metabolic disorders or genetic disorders linked to obesity
* History of any bariatric surgery
* Participation in any clinical study with an investigational drug or device within the 3 months prior to enrollment in this study
* Blood loss or donation \>500 mL within the past 3 months
* Females who are pregnant, nursing, intend to become pregnant during the study or any males who plan to father/conceive a child within 6 months after completion of study participation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02063295
Study Brief:
Protocol Section:
NCT02063295