NCT02496611.

Trial name or title	Enhancing Weight Loss Maintenance With GLP‐1RA (BYDUREON™) in Adolescents with Severe Obesity
Methods	Type of trial: interventional Allocation: randomised Intervention model: parallel assignment Masking: double blind (participant, carer, investigator, outcomes assessor) Primary purpose: treatment
Participants	Condition: severe obesity Enrolment: estimated 100 Inclusion criteria: BMI ≥ 1.2 times the 95th percentile (based on sex and age) or BMI ≥ 35 kg/m2 aged 12 to 17 years Exclusion criteria: type 1 or 2 diabetes mellitus previous (within 6 months) or current use of medication(s) prescribed primarily for weight loss (refer to appendix material for comprehensive list) if currently using weight altering drug(s) for nonobesity indication(s) (refer to appendix material for comprehensive list), any change in drug(s) or dose within the previous 6 months previous bariatric surgery if currently using anti‐hypertensive medication(s), lipid medication(s), medication(s) to treat insulin resistance (refer to appendix material for comprehensive list) (or a combination) any change in drug(s) or dose within the previous 6 months if currently using continuous positive airway pressure/bilevel positive airway pressure (for sleep apnoea), change in frequency of use or settings within the previous 6 months history of treatment with growth hormone neurodevelopmental disorder severe enough to impair ability to comply with trial protocol clinical diagnosis of bipolar illness, schizophrenia, conduct disorder, substance use/abuse, or a combination females: currently pregnant, planning to become pregnant, or unwilling to use ≥ 2 acceptable methods of contraception when engaging in sexual activity throughout the trial tobacco use liver/renal dysfunction ALT or AST > 2 times the upper limit of normal bicarbonate < 18 mmol/L creatinine > 1.2 mg/dL history of pancreatitis personal or family history (or both) of medullary thyroid carcinoma personal or family history (or both) of multiple endocrine neoplasia type 2 calcitonin level > 50 ng/L bulimia nervosa neurological disorder hypothalamic obesity obesity associated with genetic disorder (monogenetic obesity) hyperthyroidism or uncontrolled hypothyroidism history of suicide attempt history of suicidal ideation or self‐harm within the past year history of cholelithiasis
Interventions	Intervention: exenatide extended‐release for injectable suspension (BYDUREON™) Comparator: placebo
Outcomes	Primary outcomes: weight loss maintenance (time frame: 52 weeks) improvement of obesity will be measured by reduction in body fat content and BMI Secondary outcomes: maintenance of body fat changes (time frame: 52 weeks) maintenance of blood pressure (time frame: 52 weeks) maintenance of improved insulin sensitivity (time frame: 52 weeks) Other outcomes: none given
Starting date	Trial start date: December 2015 Trial completion date: July 2020
Contact information	Responsible party/principal investigator: University of Minnesota ‐ Clinical and Translational Science Institute
Study identifier	NCT number: NCT02496611
Official title	Enhancing Weight Loss Maintenance with GLP‐1RA (BYDUREON™) in Adolescents with Severe Obesity
Stated purpose of study	Primary objective: evaluate the effect of GLP‐1RA treatment on the maintenance of weight loss and durability of cardiometabolic risk factor improvements among adolescents with severe obesity following a meal replacement induction period Secondary objectives: investigate the mechanisms by which glucagon‐like peptide‐1 receptor agonists treatment facilitates weight loss maintenance and identify predictors of response to treatment
Notes	Trial sponsored by University of Minnesota ‐ Clinical and Translational Science Institute; recruitment status when identified: this trial is currently recruiting participants; location: USA

ACE: angiotensin‐converting enzyme; ALT: alanine transaminase; AST: aspartate transaminase; BMI: body mass index; CVD: cardiovascular disease; HbA1c: glycated haemoglobin; HOMA‐IR: homeostasis model assessment‐insulin resistance; IOTF: International Obesity Task Force; SD: standard deviation; GFR: glomerular filtration rate; min: minute; MRI: magnetic resonance imaging; PK: pharmacokinetics; PCOS: polycystic ovary syndrome; SDS: standard deviation score; WHO: World Health Organization.