Novo's Semaglutide Hits Phase III Endpoint in Children with Obesity

Novo Nordisk has reported positive results from the STEP Young Phase III trial, a randomised, double-blind, placebo-controlled, multicountry study in 165 children aged 6 to 12 with obesity, where weekly semaglutide was added to low-calorie diet and increased physical activity and titrated to 1.7 mg or 2.4 mg by baseline weight. At week 68, semaglutide produced a significantly greater BMI reduction than placebo, and 40.4% of treated children were no longer classified as obese versus 0% on placebo. Safety and tolerability were consistent with prior adolescent and adult semaglutide data.

The unmet need is structural: childhood obesity carries cardiovascular risk factors, depression, eating-disorder risk, and bullying-related burden where quality of life can rival that of paediatric cancer patients, and without intervention it tracks strongly into adulthood, accelerating complications and shortening lifespan, with global 5 to 19-year-old obesity prevalence estimated at 177 million in 2025 and projected at 228 million by 2040.

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