EUCTR2015‐001628‐45‐SE.

Trial name or title	A study with lifestyle intervention and study medication once weekly or lifestyle intervention and placebo in adolescents with obesity to explore differences between groups with regard to change in BMI
Methods	Type of trial: interventional; randomised controlled trial Allocation: randomised Intervention model: parallel assignment Masking: double blind Primary purpose: treatment
Participants	Condition: obesity in adolescents Enrolment: 44 Inclusion criteria: signed informed consent prior to any trial‐specific procedures males or females aged 10 to 18 years and 7 months obesity (BMI SDS > 2.0 or age‐adapted BMI > 30 kg/m2), according to WHO not sexually active or usage of adequate contraception. Female participants must also have negative pregnancy tests. Methods that can achieve a failure rate of less than 1% per year (Pearl index < 1), when used consistently and correctly, are considered as highly effective birth control methods. Such methods include: combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, transdermal progestogen‐only hormonal contraception associated with inhibition of ovulation: oral, injectable, implantable intrauterine device intrauterine hormone‐releasing system bilateral tubal occlusion vasectomised partner sexual abstinence (if refraining from heterosexual intercourse during the entire period of risk associated with the trial treatments. The reliability of sexual abstinence needs to be evaluated in relation to the preferred and usual lifestyle of the participant) ability to understand and comply with the requirements of the trial Exclusion criteria: known syndromal obesity, such as Prader‐Willi syndrome, Laurence‐Moon syndrome or Bardet‐Biedl syndrome pregnancy or lactation indigestion‐causing diseases severe gastrointestinal disease total or partial gastric or small intestine resection type 1 or type 2 diabetes mellitus kidney disease (acute or chronic, according to physician (creatinine/urea/cystatin‐C for Schwartz calculation) hypo‐/hyperthyroidism, unless under stable treatment severe vitamin D insufficiency, unless under stable treatment abnormal QT interval clinically significant abnormal laboratory values, e.g. triglycerides > 400 mg/dL (Salzburg) or > 4.5 mmol/L (Uppsala), amylase > 300 U/L (Salzburg) or > 5.1 µkat/L (Uppsala), lipase > 180 U/L (Salzburg) or > 15 µkat/L (Uppsala) or calcitonin > 11.7 pg/mL (Salzburg) or > 3.4 pmol/L (Uppsala) for females and > 17 pg/mL (Salzburg) or > 5.0 pmol/L (Uppsala) for males severe depression, severe anxiety or other psychiatric disorder referred to or undergoing special treatment, as judged by the investigator severe sleep apnoea (defined clinically) chronic diseases, as judged by the investigator metformin treatment within 3 months prior to screening or concomitant medication influencing blood glucose (e.g. metformin and acarbose), influencing other parameters of metabolic syndrome (e.g. orlistat) or interfering with the investigational medicinal product steroid treatment (oral or injected) concomitant medication addressing attention disorders antidepressants that can lead to weight gain, as judged by the investigator hypersensitivity to exenatide or to any of the excipients pacemaker or metal implant that may interfere with MRI claustrophobia current or prior (within 3 months) participation in another clinical trial involving an investigational medicinal product a personal or family history of medullary thyroid carcinoma a personal or family history of multiple endocrine neoplasia syndrome type 2
Interventions	Intervention: exenatide + lifestyle intervention Comparator: placebo + lifestyle intervention
Outcomes	Primary outcome: BMI SDS (according to WHO) Secondary outcomes: adverse events, vital signs (blood pressure and pulse), electrocardiogram, tympanic body temperature, glucose, clinical chemistry, haematology and urinalysis endpoints of insulin secretion and sensitivity derived from oral glucose tolerance test glucagon levels at specified time points triglycerides, high‐density lipoprotein, low‐density lipoprotein, total cholesterol, free fatty acids, apolipoproteins, uric acid and blood pressure highly sensitive C‐reactive protein bioimpedance assessments to calculate total and regional body composition and MRI assessments of abdominal adipose tissue, organ fat characteristics and morphology (volume of visceral and abdominal subcutaneous adipose tissue and liver fat content) waist, hip, upper thigh and neck circumference, waist‐to‐hip ratio, sagittal abdominal diameter and skinfold calipre assessments of body fat standardised BMI interdisciplinary adiposity evaluation kit (AD‐EVA), sleeping habits questionnaire, self‐efficacy and outcome expectations questionnaire, food frequency questionnaire, regular meals questionnaire, portion size questionnaire, walking test (6 min), physical activity questionnaire and physical activity assessed by accelerometry U‐alpha1‐microglobulin (protein HC)/creatinine and estimated GFR according to Schwartz formula AST), ALT), gamma‐glutamyl transpeptidase, lactate dehydrogenase and bilirubin
Starting date	Trial start date: not given Trial completion date: not given
Contact information	Responsible party/principal investigator: Peter Bergsten, Department of Medical Cell Biology Uppsala University
Study identifier	EudraCT Number: 2015‐001628‐45
Official title	A parallel, double‐blinded, randomized, 6 months, two arms trial with lifestyle intervention and exenatide 2 mg once weekly or lifestyle intervention and placebo in adolescents with obesity to explore differences between groups with regard to change in BMI SDS (according to WHO)
Stated purpose of study	Quote: "To compare the change from baseline to the 6 months visit at the end of treatment, between lifestyle intervention + exenatide 2 mg once weekly and lifestyle intervention + placebo, in BMI SDS (according to WHO) for adolescents with obesity"
Notes	Trial registered on 27 July 2015. Trial status: ongoing (when identified). Trial sponsor: Department of Medical Cell Biology Uppsala University. Monetary or material support provided by: European Commission's Seventh Framework Programme (FP7) project Beta_JUDO (grant 279153). Country: Sweden