Novo Nordisk has announced that 40.4% of obese children treated with semaglutide were no longer classified as having obesity at week 68, compared with none of those treated with placebo.
Nordisk released the first results from the STEP Young phase 3 trial, evaluating once-weekly semaglutide in combination with a reduced-calorie diet and increased physical activity in children aged 6 to under 12 years old with obesity. Obesity prevalence is growing in this age group, for whom there are limited clinically tested and approved treatments available when lifestyle modifications are not sufficient.
At baseline, more than 85% of the children had either class II or III severe obesity (corresponding to a BMI above or equal to 35 and 40 in adults, respectively). The trial met its primary endpoint demonstrating superior BMI reduction at week 68 in the group taking semaglutide compared with the placebo group. This means that semaglutide helped two out of five of the children reduce their BMI to a normal weight or overweight classification compared with none of the children in the placebo group. Both groups received lifestyle modification throughout the trial, including reduced-calorie diet and increased physical activity.
Particularly concerning
“Childhood obesity is particularly concerning due to both immediate and enduring impacts on health, including a strong predilection to adult obesity and increased risk for the early emergence of obesity-related complications,” said Ania M Jastreboff, MD, PhD, Professor of Medicine (Endocrinology) and Pediatrics (Pediatric Endocrinology) at the Yale and Director of the Yale Obesity Research Center (Y-Weight).
“Most of the children in the STEP Young trial were classified as having severe (class II or III) obesity at baseline, yet treatment with semaglutide resulted in a BMI percentile category below the obesity threshold in approximately 40% of the children within about a year of treatment.”
Children living with obesity experience cardiovascular disease risk factors, alongside depression, eating disorders, and bullying, with studies showing that their quality of life is comparable to children undergoing cancer treatment.1-3 Without effective intervention, childhood obesity strongly tracks into adulthood1, where obesity-related complications emerge earlier and more severely,1-3 substantially shortening life expectancy. An estimated 177 million children aged 5 to 19 were living with obesity in 2025, and this figure is projected to rise to 228 million by 2040.
Health challenges can begin early
"For children living with obesity and their families, health challenges can begin early and affect wellbeing throughout life,” said Martin Holst Lange, executive vice president, chief scientific officer and head of Research & Development at Novo Nordisk.
“As a pioneer in paediatric obesity medicine, we are encouraged by the positive STEP Young results and semaglutide’s potential to help children living with obesity who need medical treatment, alongside lifestyle changes, to better manage their obesity. This may prevent serious health risks later in life.”
The overall safety and tolerability of semaglutide observed in STEP Young were consistent with previous Novo Nordisk paediatric and adult trials with semaglutide and liraglutide, and no new safety concerns were identified. Furthermore, no safety concerns were identified for growth or pubertal development.
Detailed STEP Young results will be presented at The Obesity Society’s annual meeting ObesityWeek 2026, November 14 to 17 in Washington DC, US.--TradeArabia News Service
