Status:
ACTIVE_NOT_RECRUITING
Lifestyle Counseling and Medication for Adolescent Weight Management
Lead Sponsor:
University of Minnesota
Conditions:
Obesity, Childhood
Eligibility:
All Genders
12-17 years
Phase:
PHASE2
Brief Summary
The prevalence of adolescent severe obesity is at an all-time high in the United States and the refractory nature of this disease has led to a serious and challenging conundrum in terms of how to prov...
Detailed Description
This is a two-arm, randomized clinical trial in adolescents with severe obesity evaluating 52 weeks of intensive behavioral counseling, aligned with USPSTF recommendations (52 contact hours), vs. 52 w...
Eligibility Criteria
Inclusion
- Severe obesity (Body Mass Index (BMI) \>/= 120% of the 95th percentile or BMI \>/= 35 kg/m2)
- Age 12 to \< 18 years old and Tanner stage \>1
Exclusion
- Diabetes (type 1 or 2)
- Current or recent (\< 6 months prior to enrollment) use of anti-obesity medication(s) defined as orlistat, phentermine, topiramate, combination phentermine/topiramate, liraglutide (or other GLP-1RA) and/or combination naltrexone/bupropion (monotherapy use of naltrexone or bupropion is not an exclusion)
- Previous bariatric surgery
- Any history of treatment with growth hormone
- Medically-documented history of bulimia nervosa
- Major psychiatric disorder as determined by the local medical monitor
- Unstable depression requiring hospitalization within the previous 6 month
- Any history of suicide attempt
- History of suicidal ideation or self-harm within the previous 30 days
- Current pregnancy or plans to become pregnant
- ALT or AST \>/= 5 times the upper limit of normal
- Creatinine \> 1.2 mg/dL
- Uncontrolled hypertension as determined by the local medical monitor
- Diagnosed and medically-documented monogenic obesity
- Medically-documented history of cholelithiasis
- Untreated thyroid disorder
- Medically documented history of pancreatitis
- Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2
- Clinically significant heart disease as determined by the local medical monitor
- Personal history of malignant neoplasms within the past five years
- Hypersensitivity to any component of semaglutide
Key Trial Info
Start Date :
March 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2027
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04873245
Start Date
March 15 2022
End Date
July 31 2027
Last Update
May 15 2025
Active Locations (1)
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1
University of Minnesota, Delaware Clinical Research Unit
Minneapolis, Minnesota, United States, 55414