Lifestyle Counseling and Medication for Adolescent Weight Management
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.
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 semaglutide
Behavioral: Intensive Behavioral Program, Drug: Semaglutide and Behavioral Program
Aaron Kelly - email@example.com
STUDY00012932See this study on ClinicalTrials.gov