Novo Nordisk announced positive results from its STEP Young trial, where 40.4% of children aged 6 to under 12 treated with semaglutide were no longer classified as obese after 68 weeks, alongside lifestyle modifications. The trial met its primary endpoint for BMI reduction.
The trial results suggest a potential new medical treatment option for childhood obesity, a growing public health concern, and indicate a significant increase in the use of GLP-1 drugs among young children, even before formal approval for that age group.
Novo Nordisk announced on Monday that its late-stage STEP Young trial showed that 40.4% of children aged 6 to under 12 treated with semaglutide, the active ingredient in its Wegovy weight-loss drug, were no longer classified as having obesity after 68 weeks, assuming full adherence to the treatment. All participants received lifestyle modification, including a reduced-calorie diet and increased physical activity, throughout the trial.
Martin Holst Lange, Novo Nordisk's Chief Scientific Officer, expressed encouragement with the positive results, highlighting semaglutide's potential for children with obesity who require medical treatment alongside lifestyle changes. The trial successfully met its primary endpoint, demonstrating a superior reduction in body mass index at week 68 for the group receiving once-weekly subcutaneous semaglutide compared to the placebo group. The drug's overall safety and tolerability were found to be consistent with findings from trials involving adults and adolescents.
This development comes as a study published on Friday revealed that prescriptions for GLP-1 weight-loss drugs among U.S. children under 12 have surged more than 300-fold since 2019, despite the drugs not being approved for this age group.