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 @ 9:21 PM
Ignite Modification Date:
2025-12-24 @ 9:21 PM
NCT ID:
NCT04095104
Eligibility Criteria:
Inclusion Criteria:
* Status post sleeve gastrectomy or roux-en-y gastric bypass
* At 6 months after bariatric surgery, has not achieved \>= 26% decrease in weight from preoperative weight (within 1 week of surgery) OR remains severely obese (\>=120% of 95th%ile or BMI \>=35kg/m2 for 12-17yo; BMI \>=35kg/m2 for 18-24yo)
Exclusion Criteria:
* Absolute contraindication to phentermine or topiramate (i.e. phentermine:
history of coronary artery disease, stroke, arrhythmia, congestive heart failure, uncontrolled hypertension), hypersensitivity to sympathomimetic amines, current or recent (within 14 days) use of monoamine oxidase inhibitors, glaucoma, or hyperthyroidism; topiramate: hypersensitivity to topiramate, history of nephrolithiasis)
* Concomitant use of phenytoin, carbamazepine, or carbonic anhydrase inhibitors (e.g. zonisamide, acetazolamide, or dichlorphenamide)
* Use of anti-obesity medication within 6 months of screening
* Initiation of a new medication associated with weight loss or gain within 30 days of screening
* Type 2 diabetes mellitus
* Hypothalamic obesity
* Unmanaged (e.g. without medications and/or psychotherapy) clinically significant (determined by a mental health professional using diagnostic instruments and/or clinical interview) depression or anxiety
* History of any suicidal behavior within 30 days of screening or any suicidal ideation with either some intent to act or with intent and a specific plan within 30 days of screening
* History of schizophrenia
* Severe hepatic impairment (ALT \>10x upper limit of normal or known synthetic liver dysfunction)
* Moderate or severe renal impairment (GFR \<30mL/min/1.73m2)
* Dosage change to hypertension, dyslipidemia, depression, or anxiety medication \<4 weeks prior to study enrollment
* Contraception started \<7 days prior to study enrollment
* Current pregnancy/plans to become pregnant within 16 weeks from study drug start date
* Females without a long acting reversible contraceptive (LARC) who do not commit to using 2 forms of birth control
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
24 Years
Study:
NCT04095104
Study Brief:
Protocol Section:
NCT04095104