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 @ 11:28 PM
Ignite Modification Date:
2025-12-24 @ 11:28 PM
NCT ID:
NCT02022956
Eligibility Criteria:
Inclusion Criteria:
1. Adolescent subjects aged 12 to 17 years, inclusive at screening
2. a. Eligible female subjects who are sexually active will be:
* non-pregnant
* non-lactating
* agree to continue to use an accepted method of birth control for at least 1 month after study medication administration
3. BMI ≥ 95th percentile for age and gender, but ≤ 44 kg/m21
4. Considered to be in stable health in the opinion of the Investigator.
5. Parent or guardian who can sign written informed consent and subject willing to sign assent
Exclusion Criteria:
1. Clinically significant new illness in the 1 month before screening and any time prior to randomization
2. Significant renal or hepatic disease
3. Secondary (chromosomal, endocrine, or metabolic) causes of obesity
4. Use of medications other than hormonal contraceptives and acetaminophen
5. Use of drugs with serotonergic activity within 1 month before screening
6. Recent treatment with over-the-counter weight loss products or appetite suppressants, or within 3 months of screening and any time prior to randomization with a prescription weight loss drug or lipid dissolving injections or ongoing psychotherapy for weight loss outside of this trial
7. Recent history of alcohol, tobacco, or recreational drug/solvent use
8. Any history of major depression, anxiety, bipolar disorder, schizophrenia, or Axis II psychiatric disease requiring treatment with prescription medication within six months prior to screening
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
17 Years
Study:
NCT02022956
Study Brief:
Protocol Section:
NCT02022956