Status:
NOT_YET_RECRUITING
Promoting Healthy Children and Youth
Lead Sponsor:
University of Minnesota
Conditions:
Obesity, Childhood
Eligibility:
All Genders
12-18 years
Phase:
PHASE4
Brief Summary
The rapid emergence of new and highly effective obesity medications has turned the field of pediatric weight management on its head. Adolescents living with obesity, their caregivers, healthcare provi...
Detailed Description
The premise underpinning our proposed project stems from the conceptual framework that obesity medications beneficially alter the underlying pathophysiology that largely drives eating behaviors (appet...
Eligibility Criteria
Inclusion
- Aged 12 to \< 18 years at screening
- BMI \>/= 95th percentile based on age and sex
Exclusion
- Diabetes (type 1 or 2) due to safety concerns about properly surveiling glycemic control virtually
- Current or recent (\< 6 months prior to screening) use of obesity medications
- Previous metabolic/bariatric surgery
- Current or recent (\< 6 months prior to screening) use of medication(s) to treat insulin resistance
- Hypertension
- Hypercholesterolemia
- History of treatment with growth hormone
- Eating disorder diagnosis
- Major psychiatric disorder
- Unstable clinically-diagnosed depression
- History of suicide attempt
- History of suicidal ideation or self-harm within 30 days of screening
- Current pregnancy or plans to become pregnant
- Tobacco use
- Uncontrolled hypertension
- Diagnosis of monogenic obesity
- History of cholelithiasis without cholecystectomy
- Untreated thyroid disorder
- History of pancreatitis
- Personal/family history of medullary thyroid carcinoma and/or multiple endocrine neoplasia type 2
Key Trial Info
Start Date :
January 1 2027
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2032
Estimated Enrollment :
1020 Patients enrolled
Trial Details
Trial ID
NCT06977438
Start Date
January 1 2027
End Date
January 31 2032
Last Update
January 9 2026
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