Semaglutide removes 40% of compliant children from the obesity circle - Sarmad
Novo Nordisk announced today the preliminary results of the Phase 3 STEP Young study, which evaluated once-weekly semaglutide treatment alongside a low-calorie diet and increased physical activity in children aged 6 to under 12 years living with obesity.
Obesity rates are rising in this age group, which lacks clinically tested and approved therapeutic options when lifestyle changes are insufficient.
At the start of the study, more than 85% of participating children were classified as having severe obesity, Class II or III (equivalent to an adult body mass index [BMI] of 35 for Class II and 40 for Class III).
The study met its primary endpoint, with results showing a greater reduction in BMI in the semaglutide group compared to the placebo group after 68 weeks.
Results also showed that 40.4% of the semaglutide group were no longer classified as living with obesity after 68 weeks, compared to 0.0% in the placebo group.
This means that semaglutide helped reduce BMI to normal or overweight classification levels in one in five children, compared to 0.0% in the placebo group.
Both groups underwent lifestyle changes throughout the study period, including adherence to a low-calorie diet and increased physical activity.
Dr. Ania M. Jastreboff, MD, PhD, Professor of Medicine (Endocrinology) and Pediatrics (Pediatric Endocrinology) at Yale University and Director of the Yale Obesity Research Center (Y-Weight), stated: “Childhood obesity is a matter of concern due to its short- and long-term health impacts, including the high likelihood of obesity persisting into adulthood and the increased risk of obesity-related complications emerging at an early age.”
Most children participating in the STEP Young study were classified as having severe obesity (Class II or III) at baseline; however, semaglutide treatment contributed to a reduction in BMI to below the obesity threshold in approximately 40% of children after about one year of treatment.
Children living with obesity are at risk of cardiovascular disease, as well as depression, eating disorders, and bullying. Studies have shown that their quality of life may be comparable to that of children undergoing cancer treatment.
Without effective intervention, the risk of childhood obesity may persist into adulthood, where obesity-related complications may emerge at an earlier age and with greater severity, potentially leading to a significant reduction in life expectancy.
An estimated 177 million children aged 5 to 19 were living with obesity in 2025, and this number is projected to rise to 228 million by 2040.
Martin Holst Lang, Executive Vice President and Chief Scientific Officer, and Head of Research and Development at Novo Nordisk, said: “For children living with obesity and their families, health challenges can begin at an early age and may have lifelong health impacts. As pioneers in pediatric obesity medications, we are optimistic about the positive results of the STEP Young study and the potential of semaglutide to help children living with obesity who require medical supervision alongside lifestyle changes better manage their weight and address obesity. This could contribute to preventing severe health risks in later stages of life.
Overall, the safety and tolerability findings observed in the STEP Young study were consistent with those from Novo Nordisk’s previous studies in children and adults on semaglutide and liraglutide treatment, with no new safety concerns identified. Furthermore, no safety concerns related to growth during puberty and adolescence were identified.”
