Novo’s Wegovy shows benefit in young children

Pediatric doctor holding GLP-1 injection pen in clinic, illustrating positive Wegovy trial results in children

Key Points

01Phase 3 STEP Young trial tested weekly semaglutide in children 6 to under 12 with obesity
02At week 68, 40.4% of treated children were no longer classified as obese
03The trial met its primary endpoint with superior BMI reduction versus placebo
04Safety and growth findings were consistent with prior semaglutide studies

Semaglutide trial in young children with obesity

Novo Nordisk has released phase 3 data from the STEP Young trial, which evaluated once‑weekly semaglutide, marketed as Wegovy, in children aged 6 to under 12 with obesity. The study focused on children with high body mass index levels and included a large proportion with severe obesity at baseline.

More than 85% of participants entered the trial with class II or class III severe obesity. All children in the study received lifestyle modification support, consisting of a reduced‑calorie diet and increased physical activity, alongside either semaglutide or placebo.

Key efficacy results at 68 weeks

The STEP Young trial met its primary endpoint by demonstrating a superior percentage reduction in body mass index for semaglutide compared with placebo at week 68. This confirmed the treatment’s effectiveness in lowering BMI in this paediatric population over the study period.

At week 68, 40.4% of children treated with once‑weekly semaglutide were no longer classified as having obesity. This outcome was observed in the context of combined pharmacologic therapy and structured lifestyle intervention, while children in the placebo group did not achieve similar reclassification rates.

Dosing approach and safety profile

Dosing in the trial was weight‑based, with weekly semaglutide doses reported to range up to about 1.7 mg to 2.4 mg. This approach was used to tailor treatment to the body weight of each child within the study’s design.

Novo Nordisk reported that the overall safety and tolerability profile of semaglutide in STEP Young was consistent with previous paediatric and adult trials of the drug. Measures related to growth and pubertal development were described as consistent with earlier semaglutide experience, and no new safety concerns were identified in this younger age group.

Implications for paediatric obesity treatment

The results indicate that once‑weekly semaglutide, used together with lifestyle modification, can substantially reduce BMI in children aged 6 to under 12 living with obesity, including many with severe forms. The proportion of treated children who were no longer classified as obese after 68 weeks highlights a potential role for this therapy within broader paediatric obesity management strategies.

Key Takeaways

01Semaglutide delivered clinically meaningful BMI reductions beyond lifestyle changes alone in children 6 to under 12 with obesity.
02A notable share of treated children transitioned out of the obesity category over 68 weeks, despite high rates of severe obesity at baseline.
03The safety and growth data suggest semaglutide’s risk profile in young children is similar to prior paediatric and adult experience, with no new safety signals reported.

References