Novo Nordisk said on Monday that its late-stage STEP Young trial found that 40.4% of children aged 6 to under 12 who received semaglutide were no longer classified as having obesity after 68 weeks, assuming full adherence to treatment. Semaglutide is the active ingredient in the company’s weight-loss drug Wegovy.
The STEP Young study enrolled 165 children between the ages of 6 and under 12. According to Novo Nordisk, more than 85% of participants entered the trial with severe obesity. The company said all patients involved in the study received lifestyle modification support throughout the 68-week trial period. These measures included a reduced-calorie diet and increased physical activity in addition to either semaglutide or placebo treatment.
Trial Demonstrates Greater Reduction in BMI Than Placebo
Novo Nordisk reported that the STEP Young trial met its primary endpoint. The company said the study demonstrated superior body mass index (BMI) reduction at week 68 among children receiving once-weekly subcutaneous semaglutide compared with those receiving placebo.
The findings also showed a difference in obesity status between the two groups. According to Novo Nordisk, 40.4% of children treated with semaglutide were no longer classified as having obesity after 68 weeks, assuming full adherence to treatment. In comparison, none of the participants in the placebo group moved below the obesity threshold under the same assumption.
Both groups in the study received the same diet and exercise support. The reported difference in outcomes was observed despite all participants receiving lifestyle interventions throughout the trial.
Safety Findings Consistent With Earlier Semaglutide Studies
Novo Nordisk said the overall safety and tolerability profile observed in STEP Young was consistent with findings previously reported in trials involving adults and adolescents treated with semaglutide.
The company also stated that it identified no new concerns involving growth or puberty during the study. These findings formed part of the safety observations reported from the pediatric trial population.
Commenting on the results, Martin Holst Lange, Novo Nordisk’s Chief Scientific Officer, said: “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.”
Results Released as GLP-1 Prescriptions Increase Among Children
The announcement comes as the use of GLP-1 weight-loss medicines among children under the age of 12 in the United States has increased. A study published on Friday found that prescriptions for GLP-1 weight-loss drugs in this age group have risen by more than 300-fold since 2019.
The study also noted that these medicines are not approved for children under 12. Novo Nordisk’s trial results add new clinical data from a population of children aged 6 to under 12 who were treated with semaglutide while also participating in structured lifestyle modification programs.
According to the company, the trial included dietary measures and increased physical activity for all participants, regardless of treatment assignment. After 68 weeks, the semaglutide group showed greater BMI reduction than the placebo group, while 40.4% of treated participants were no longer classified as having obesity, compared with none of those receiving placebo.
Novo Nordisk has reported positive results from its late-stage STEP Young trial evaluating once-weekly semaglutide in children aged 6 to under 12 living with obesity. The Phase 3 study met its primary endpoint, demonstrating a greater reduction in body mass index (BMI) compared with placebo after 68 weeks.
The Novo trial included 165 children, with more than 85% classified as having severe class II or III obesity at the beginning of the study. Participants received either once-weekly semaglutide or placebo alongside lifestyle interventions, including a reduced-calorie diet and increased physical activity.
Novo Reports Significant BMI Improvement
The Novo results showed that 40.4% of children receiving semaglutide were no longer classified as having obesity after 68 weeks, compared with 0% in the placebo group. The company said this means approximately two out of five treated children moved below the obesity threshold during the study period.
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