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Novo Nordisk A/S on Monday shared topline results from its STEP Young Phase 3 clinical trial evaluating once-weekly semaglutide in children aged 6 to under 12 with obesity.

The study achieved its primary endpoint, demonstrating a significantly higher reduction in body mass index (BMI) at week 68 among pediatric patients receiving semaglutide compared to those receiving a placebo.

STEP Young Trial Yields Significant BMI Reductions

At the start of the study, over 85% of participating children presented with severe obesity, categorized as class II or class III.

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By week 68, 40.4% of participants treated with once-weekly subcutaneous semaglutide were no longer classified as having obesity, bringing their BMI down to overweight or normal weight levels.

In contrast, 0% of the children in the placebo group achieved non-obese status.

The trial’s findings offer potential hope for an age bracket facing rising obesity rates alongside limited clinically evaluated or approved treatment choices when diet and exercise alone prove insufficient.

Both intervention arms in the study received ongoing lifestyle modifications, which included a reduced-calorie diet and increased physical activity.

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Safety Profile Aligns With Previous Studies

The safety and tolerability profile of semaglutide in the STEP Young trial aligned with findings from earlier adult and pediatric trials involving semaglutide and liraglutide.

Researchers identified no new safety issues, and the treatment raised no safety concerns regarding the growth or pubertal development of the young patients.

Image via Shutterstock

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