• Claudia K Fox, Margarita Barrientos-Pérez, Eric M Bomberg, John Dcruz, Inge Gies, Nina M Harder-Lauridsen, Muhammad Yazid Jalaludin, Kushal Sahu, Petra Weimers, Thomas Zueger, Silva Arslanian, and SCALE Kids Trial Group.
• From the Center for Pediatric Obesity Medicine (C.K.F., E.M.B.) and the Division of Endocrinology (E.M.B.), Department of Pediatrics, University of Minnesota Medical School, Minneapolis; Pediatric Endocrinology, Hospital Ángeles Puebla, Puebla City, Mexico (M.B.-P.); Novo Nordisk Global Business Services, Bangalore, India (J.D., K.S.); the Division of Pediatric Endocrinology, Department of Pediatrics, Universitair Ziekenhuis Brussel, Brussels (I.G.); Novo Nordisk, Søborg, Denmark (N.M.H.-L., P.W.); the Department of Paediatrics, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia (M.Y.J.); the Department of Endocrinology, Diabetes and Metabolic Diseases, Kantonsspital Olten, Olten, and the Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital, Bern University Hospital, University of Bern, Bern - both in Switzerland (T.Z.); and the Center for Pediatric Research in Obesity and Metabolism, Division of Pediatric Endocrinology, Metabolism, and Diabetes Mellitus, University of Pittsburgh Medical Center Children's Hospital of Pittsburgh, University of Pittsburgh School of Medicine, Pittsburgh (S.A.).
• N. Engl. J. Med. 2024 Sep 10.

BackgroundNo medications are currently approved for the treatment of nonmonogenic, nonsyndromic obesity in children younger than 12 years of age. Although the use of liraglutide has been shown to induce weight loss in adults and adolescents with obesity, its safety and efficacy have not been established in children.MethodsIn this phase 3a trial, which consisted of a 56-week treatment period and a 26-week follow-up period, we randomly assigned children (6 to <12 years of age) with obesity, in a 2:1 ratio, to receive either once-daily subcutaneous liraglutide at a dose of 3.0 mg (or the maximum tolerated dose) or placebo, plus lifestyle interventions. The primary end point was the percentage change in the body-mass index (BMI; the weight in kilograms divided by the square of the height in meters). The confirmatory secondary end points were the percentage change in body weight and a reduction in BMI of at least 5%.ResultsA total of 82 participants underwent randomization; 56 were assigned to the liraglutide group and 26 to the placebo group. At week 56, the mean percentage change from baseline in BMI was -5.8% with liraglutide and 1.6% with placebo, representing an estimated difference of -7.4 percentage points (95% confidence interval [CI], -11.6 to -3.2; P<0.001). The mean percentage change in body weight was 1.6% with liraglutide and 10.0% with placebo, representing an estimated difference of -8.4 percentage points (95% CI, -13.4 to -3.3; P = 0.001), and a reduction in BMI of at least 5% occurred in 46% of participants in the liraglutide group and in 9% of participants in the placebo group (adjusted odds ratio, 6.3 [95% CI, 1.4 to 28.8]; P = 0.02). Adverse events occurred in 89% and 88% of participants in the liraglutide and placebo groups, respectively. Gastrointestinal adverse events were more common in the liraglutide group (80% vs. 54%); serious adverse events were reported in 12% and 8% of participants in the liraglutide and placebo groups, respectively.ConclusionsAmong children (6 to <12 years of age) with obesity, treatment with liraglutide for 56 weeks plus lifestyle interventions resulted in a greater reduction in BMI than placebo plus lifestyle interventions. (Funded by Novo Nordisk; SCALE Kids ClinicalTrials.gov number, NCT04775082.).Copyright © 2024 Massachusetts Medical Society.

12 keywords...

hide…