Novo Nordisk Initiates Phase III Clinical Trial of Semaglutide for Weight Management in Children and Adolescents

On February 13, Novo Nordisk registered a Phase III clinical trial (STEP Young) on the ClinicalTrials.gov website to evaluate the weight-loss effects and safety of semaglutide in children and adolescents.

This study is a randomized, double-blind, placebo-controlled clinical trial expected to enroll 210 overweight patients aged 6 years and above but under 18. The trial group includes two subgroups: one consists of overweight children aged 6 years and above but under 12, and the other consists of overweight adolescents aged above 12 but under 18. Patients in both subgroups will receive a 16-week escalating dose regimen of semaglutide (0.25mg for the first 4 weeks, 0.5mg from weeks 5-8, 1.0mg from weeks 9-12, and 1.7mg from weeks 13-16), followed by an 88-week maintenance treatment with 2.4mg of semaglutide, combined with a low-calorie diet and exercise for weight management.

The primary endpoint of the study is the change in Body Mass Index (BMI) in the pediatric group, while secondary endpoints include changes in weight improvement indicators for both the pediatric and adolescent groups, as well as safety metrics. Novo Nordisk expects the study to begin on July 7, 2023, and be completed by November 7, 2025.

Previously, Novo Nordisk announced the results of the Phase III weight-loss study (STEP TEENS) of semaglutide in overweight adolescents aged 12-17 in November 2022. The results showed that at week 68 of treatment, the BMI of patients in the semaglutide group decreased by 16.1% from baseline, compared to only a 0.6% decrease in the placebo group. In addition, 73% (95/131) of patients in the semaglutide group lost more than 5% of their body weight, while this proportion was 18% in the placebo group (see details: ).

References

[1] https://clinicaltrials.gov/ct2/show/NCT05726227?draw=2&rank=15

[2] Once-Weekly Semaglutide in Adolescents with Obesity. N Engl J Med. 2022;387(24):2245-2257.

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