Role of Pharmacotherapy in Counteracting Weight Regain in Adolescents With Severe Obesity
Obesity
About this trial
This is an interventional treatment trial for Obesity focused on measuring Childhood, Adolescent
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
- PHQ-9 score >15
- Current pregnancy or plans to become pregnant during study participation
- Current tobacco use
- ALT or 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
Sites / Locations
- University of MinnesotaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Active Comparator
Placebo Comparator
Meal Replacement Therapy
Phentermine/Topiramate
Placebo
Participants who are enrolled in the study will be administered a short-term (six weeks) meal replacement induction period. Because the trial is deigned to evaluate weight loss maintenance, participants must achieve at least 5% BMI reduction at week six of the meal replacement period in order to be randomized. Subjects will be asked to strictly follow the eating regimen, which will include a total of approximately 1,000 kcals per day of commercially-available liquid shakes (breakfast and lunch), pre-packaged frozen entrée meals for dinner, two servings of fruit, and three servings of vegetables. Shakes/meals will be provided free of charge - fruits/vegetables will be purchased by the participants. Guidance will be provided regarding the use of the meal replacement shakes at school, and participants will be encouraged to engage in family meal sessions despite eating different foods.
Participants who achieve at least 5% BMI reduction at week six of the meal replacement period will be randomized (1:1) to receive either phentermine/topiramate or placebo. Participants randomized to phentermine/topiramate will start treatment at 3.75 mg/23 mg orally once daily in the morning for 14 days, then increased to 7.5 mg/46 mg orally once daily in the morning for 14 days, then be increased to 11.25 mg/69 mg orally once daily in the morning for 14 days, then increased to 15 mg/92 mg orally once daily in the morning for the remainder of the trial. Following the final study visit, participants will be down-titrated gradually by taking medication every other day for seven days before stopping treatment altogether.
Participants who achieve at least 5% BMI reduction at week six of the meal replacement period will be randomized (1:1) to receive either phentermine/topiramate or placebo. Participants randomized to the placebo will receive inert tablets that look like the active comparator. In order to mimic the active comparator arm, subjects randomized to the placebo arm will up titrate their placebo at the beginning of the study treatment and will down titrate as in the active comparator arm. Participants will be instructed to take the medication under the supervision of a parent/guardian and pill counts of returned product will serve as a proxy of treatment compliance.