Allocation: Central randomisation using a web-based response system. Randomisation was stratified according to pubertal status and glycaemic status. Setting: 32 sites over five countries (Belgium, Mexico, Russia, Sweden and the USA). Intervention: All participants received lifestyle therapy. 125 were assigned to liraglutide and 126 assigned to the placebo group, receiving a volume matched equivalent. Patients: 251 participants, aged 12 to <18 years. All participants were obese (defined as body mass index (BMI) of 30 or more), stable body weight (self-reported change of less than 5 kg during the 90 days before screening) and poor response to lifestyle therapy alone. Primary outcomes: Change in baseline BMI SD score. Secondary: Reduction in BMI of at least 5% and 10% at week 56, change from baseline BMI, weight, waist circumference, blood pressure, waist:hip ratio, glucose metabolism, blood pressure and quality of life. Follow-up: Outcome was measured over a 56-week treatment period. There was a 26-week follow-up period after ceasing treatment. MAIN RESULTS The patients who were given liraglutide had a much greater decrease in their BMI at week 56, but then demonstrated a larger increase in weight after the intervention was stopped (weeks 56 to 82). CONCLUSION The use of liraglutide led to a significantly greater reduction in the BMI SD score than placebo, but has no longer-term benefits.
