Effect of Liraglutide for Weight Management in Pubertal Adolescent Subjects With Obesity

Effect of Liraglutide for Weight Management in Pubertal Adolescent Subjects With Obesity. 56-week, Double-blind, Randomised, Parallel-group, Placebo-controlled Multi-national Trial Followed by a 26-week Period Off Study-drug

This trial is conducted globally. The aim of this trial is to investigate the effect of liraglutide for weight management in pubertal adolescent subjects with obesity.

Inclusion Criteria:

• Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
• Male or female, age 12 to less than 18 years at the time of signing informed consent and less than 18 years at date of randomisation
• BMI corresponding to equal to or above 30 kg/m^2 for adults by international cut-off points and equal or above the 95th percentile for age and sex (for diagnosis of obesity)
• Stable body weight during the previous 90 days before screening V2 (below 5 kg self-reported weight change)
• History of failing to lose sufficient weight with lifestyle modification as judged by the investigator and documented in subject's medical record

Exclusion Criteria:

• Pre-pubertal subjects (Tanner stage 1) at screening V2
• Type 1 diabetes mellitus (T1DM)
• Family or personal history of multiple endocrine neoplasia type 2 (MEN2)
• Medullary thyroid carcinoma (MTC)
• History of pancreatitis (acute or chronic)
• Subjects with secondary causes of obesity (i.e., hypothalamic, genetic or endocrine causes)
• Treatment with medications within 90 days before screening V2 that, based on the investigator's judgement, may cause significant weight change. This should also include treatment with any of the following medications: pramlintide, orlistat, zonisamide, topiramate, lorcaserin, phenteremine, bupropion, naltrexone, glucagon-like peptide-1 (GLP-1) receptor agonists, or metformin (used as treatment for obesity)
• Anti-diabetic treatment other than metformin
• History of major depressive disorder within 2 years before screening V2