Phase III study of Saxenda in adolescent obesity published in New England Journal of Medicine.- Novo Nordisk

Novo Nordisk announced that the New England Journal of Medicine published results of a phase III trial evaluating the investigational use of Saxenda (liraglutide) injection 3.0 mg in adolescents (aged 12– 18) with obesity. The study was accepted for presentation at ENDO 2020, the Endocrine Society's annual meeting in San Francisco, Calif., and will be published in a supplemental issue of the Journal of the Endocrine Society. In the trial, following 56 weeks of treatment, there was a difference in change in BMI (kg/m2) with adolescents in the Saxenda arm achieving a 4.29% reduction in BMI, compared to a 0.35% increase with placebo. In addition, 43.3% of adolescents treated with Saxenda had a 5%, or more, reduction in BMI at week 56 (compared to 18.7% on placebo) and 26.1% had a 10%, or more, reduction (compared to 8.1% with placebo). The study was a post-marketing requirement of the FDA under the Pediatric Research Equity Act (PREA) and the EMA in agreement with Paediatric Investigations Plan, both of which aim to ensure treatments are safe and effective for children and adolescents. Saxenda is currently indicated for chronic weight management in adults with a BMI of at least 30 kg/m2, or at least 27 kg/m2 with one or more weight-related comorbidities, as an adjunct to a reduced-calorie diet and increased physical activity.See: "A Randomized, Controlled Trial of Liraglutide for Adolescents with Obesity." Kelly A, Auerbach P, Barrientos-Perez M. New England Journal of Medicine. 2020; DOI: 10.1056/NEJMoa1916038