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 @ 7:23 PM
Ignite Modification Date:
2025-12-24 @ 7:23 PM
NCT ID:
NCT04298203
Eligibility Criteria:
Inclusion Criteria:
* Severe obesity (BMI \>/= 120% of the 95th percentile or BMI \>/= 35 kg/m2)
* Age 12 to \< 18 years of age at enrollment (screening) and Tanner stage \>/= 2 - Female participants who are sexually active with males and who are able to get pregnant must agree to use two forms of contraception throughout the trial
Exclusion Criteria:
* Diabetes (type 1 or 2)
* Current or recent (\< six months prior to enrollment) use of anti-obesity medication(s) defined as orlistat, phentermine, topiramate, combination phentermine/topiramate, liraglutide, and/or combination naltrexone/bupropion (monotherapy use of naltrexone or bupropion is not an exclusion)
* Previous metabolic/bariatric surgery
* Current use of a stimulant medication
* History of glaucoma
* Current or recent (\<14 days) use of monoamine oxidase inhibitor
* Known hypersensitivity to sympathomimetic amines
* Any history of treatment with growth hormone
* Any history of bulimia nervosa
* Major psychiatric disorder as determined by the local medical monitor
* Unstable and clinically-diagnosed (defined as documented in the medical record, if available) depression
* Any history of active suicide attempt
* History of suicidal ideation or self-harm within the previous 30 days of screening
* Patient Health Questionnaire (PHQ-9) score \>15 at screening
* Current pregnancy or plans to become pregnant during study participation
* Current tobacco use
* Alanine transaminase (ALT) or Aspartate transaminase (AST) \>/= 3 times the upper limit of normal
* Bicarbonate \<18 mmol/L
* Creatinine \> 1.2 mg/dL
* Any history of seizures
* Uncontrolled hypertension as determined by the local medical monitor
* History of structural heart defect or clinically significant arrhythmia
* Diagnosed monogenic obesity
* Any history of cholelithiasis
* Any history of nephrolithiasis
* Clinically diagnosed hyperthyroidism
* Untreated thyroid disorder
* Any disorder, unwillingness, or inability, not covered by any other exclusion criteria, which in the investigator's opinion, might jeopardize the subject's safety or compliance with the protocol
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
18 Years
Study:
NCT04298203
Study Brief:
Protocol Section:
NCT04298203