Phase II Trial of Liraglutide (Saxenda(R), Novo Nordisk) in Adolescents with Obesity After Sleeve Gastrectomy: A Pilot Open-Label Study

This trial was an open-label Phase II non-randomized pilot study conducted at the NIH Clinical Center to investigate the efficacy of daily subcutaneous injection of liraglutide, a glucagon-like peptide-1 (GLP1) analogue to promote reduction of body mass index in adolescents who continued to have obesity 1 year or more after vertical sleeve gastrectomy (SG). We hypothesized that administration of liraglutide would be associated with reduction in BMI. Primary objective was: To determine the effect size for the change in BMI of liraglutide 3.0 mg at 16 weeks. Secondary objectives were: 1. To study the effects of liraglutide on change in mean BMI and fat mass. 2. To compare the effects of liraglutide on BMI and fat mass in participants who had a poor initial response to SG vs. those with a typical post-SG weight loss (?20% BMI reduction at BMI nadir). Liraglutide treatment for 16 weeks was associated with a mean BMI reduction of 4.3% in adolescents and young adults who had previously undergone SG, quantitatively similar to results obtained in adolescents with obesity who had not undergone bariatric surgery after 16 and 56 weeks of liraglutide.