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Lifestyle Counseling and Medication for Adolescent Weight Management

Recruiting
This study will compare the effectiveness and durability of intensive behavioral counseling vs. medical management plus low-intensity behavioral counseling on BMI, body fat, cardiometabolic risk factors, and quality of life in adolescents with severe obesity. We hypothesize that liraglutide plus low-intensity behavioral counseling will elicit superior reductions in BMI (primary efficacy endpoint) and body fat and greater improvements in cardiometabolic risk factors and quality of life compared to intensive behavioral counseling at 56 weeks.
All
12 Years to 17 Years old
Inclusion Criteria:
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 Criteria:
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 semaglutideBehavioral: Intensive Behavioral Program, Drug: Semaglutide and Behavioral Program
Obesity, Childhood
Aaron Kelly - kelly105@umn.edu
Aaron Kelly
Phase 2
STUDY00012932
STUDY00012932
See this study on ClinicalTrials.gov