Phase III data from Novo Nordisk's STEP Young trial show that once-weekly semaglutide (Wegovy, Ozempic, Rybelsus) reduced body mass index (BMI) in children aged 6 to under 12 with obesity, with 40.4% of treated children no longer classified as having obesity at week 68, compared with none in the placebo group. The result matters because no pharmacotherapy is currently approved for general, non-syndromic obesity in this age group, leaving lifestyle modification as the only standard-of-care option for millions of children globally.

The randomised, double-blind, placebo-controlled trial enrolled 165 children, more than 85% of whom had class II or III severe obesity at baseline. Both arms received lifestyle modification throughout. Children received a maximum dose of 1.7 mg or 2.4 mg once-weekly subcutaneous semaglutide, determined by body weight at enrolment. The trial met its primary endpoint of superior BMI reduction at week 68. Novo Nordisk said safety and tolerability were consistent with prior pediatric and adult semaglutide trials, with no new safety signals and no concerns related to growth or pubertal development. Full numerical results are expected at ObesityWeek 2026 in November.

Semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist that reduces appetite and food intake by mimicking the endogenous incretin hormone GLP-1. The molecule is already approved in the US as Wegovy for chronic weight management in adults and adolescents aged 12 and older, including cardiovascular risk reduction in certain adults with established CVD, and as Ozempic for type 2 diabetes. The FDA approval of Wegovy HD (semaglutide 7.2 mg) in March 2026 extended the adult obesity indication to a higher-dose formulation, and Novo Nordisk's own STEP Young trial was conducted as a post-marketing requirement under its existing regulatory programme.

The 6-to-under-12 age group has been a regulatory blind spot. Rhythm Pharmaceuticals' Imcivree (setmelanotide), a melanocortin-4 receptor agonist, holds FDA approval for obesity in children aged 6 and older, but only for rare genetic syndromes — POMC, PCSK1, or LEPR deficiency and Bardet-Biedl syndrome — covering a small fraction of children with obesity. Novo Nordisk's own Saxenda (liraglutide), a daily GLP-1 receptor agonist, is approved for adolescents aged 12 and older but not for younger children, and published Phase III data from the SCALE Kids trial in this younger age group have not yet resulted in a regulatory filing. Semaglutide's once-weekly dosing contrasts with liraglutide's daily injection, a distinction likely to influence adherence and prescriber preference in a pediatric population.

Spot something wrong? Report an issue with this article