Novo Nordisk Trial Shows 40.4% of Obese Children Under 12 No Longer Obese After 68 Weeks on Wegovy

Novo Nordisk on Monday released results from a late-stage clinical trial showing that its weight-loss drug Wegovy demonstrated clear efficacy in children aged 6 to under 12 with obesity. Among participants who fully adhered to the treatment regimen, 40.4% of those receiving Wegovy were no longer classified as obese after 68 weeks of treatment. The trial, named STEP Young, included lifestyle intervention for all participants throughout the study period, comprising a calorie-controlled diet and increased physical activity. At baseline, most participating children had body mass index levels in the severe obesity range.

Novo Nordisk said the trial met its primary endpoint, with the once-weekly subcutaneous Wegovy treatment group showing a significantly greater reduction in body mass index at week 68 compared with the placebo group. Wegovy's active ingredient is semaglutide. The company added that the drug's overall safety and tolerability profile was consistent with findings from previous trials in adults and adolescents, with no safety concerns identified regarding growth or pubertal development. Earlier studies had already shown that Wegovy can help older children lose weight; this trial is the first to evaluate the drug's effect in younger children.

Childhood obesity rates in the United States have reached their highest level on record, with approximately one in five children and adolescents affected. When lifestyle intervention is insufficient to control obesity, clinically validated and approved treatment options for this population remain limited. A study published last Friday showed that since 2019, prescriptions for GLP-1 class weight-loss drugs among U. S. children under 12 have increased more than 300-fold, even though these medications are not yet approved for this age group.