Novo Nordisk reported positive results from its late-stage STEP Young trial for semaglutide in children aged 6 to under 12. Semaglutide serves as the active ingredient in the weight-loss drug Wegovy.
The study found that 40.4% of children treated with semaglutide were no longer obese. This result was recorded after 68 weeks of treatment. Zero participants in the placebo group reached the same outcome.
All trial participants received counseling on lifestyle modifications, including reduced-calorie diets and increased physical activity. The trial met its primary endpoint by demonstrating a superior reduction in body mass index (BMI) for the weekly injection group.
The safety profile for semaglutide in this age group remained consistent with previous trials in adolescents and adults. No new safety concerns were identified during the study. These results allow Novo Nordisk to seek regulatory approval for Wegovy's use in this younger demographic.