Status:
ACTIVE_NOT_RECRUITING
Role of Pharmacotherapy in Counteracting Weight Regain in Adolescents With Severe Obesity
Lead Sponsor:
University of Minnesota
Conditions:
Obesity
Eligibility:
All Genders
12-18 years
Phase:
PHASE2
Brief Summary
Long-term weight loss maintenance is seldom achieved by individuals with obesity owing to numerous biological adaptations occurring in the post-weight loss setting, including neuroendocrine-mediated c...
Detailed Description
Severe obesity, afflicting \~8% of adolescents in the U.S., is a serious and challenging medical and public health problem. The number and levels of cardiovascular risk factors are considerably higher...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 4 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04298203
Start Date
August 4 2021
End Date
June 30 2027
Last Update
April 24 2025
Active Locations (1)
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1
University of Minnesota
Minneapolis, Minnesota, United States, 55455