Efficacy, Safety and Pharmacokinetics of Semaglutide 1.7 mg for Obesity Treatment in Adolescents: A Model-Informed Drug Development Approach
Strathe A, Bomberg EM, Jensch G, Kildegaard J, Harder-Lauridsen NM, Weghuber D, Overgaard RV
Summary
This Novo Nordisk study used model-informed drug development to evaluate whether semaglutide 1.7 mg provides comparable exposure and efficacy in adolescents with obesity versus the approved 2.4 mg dose. Modelled results showed the 1.7 mg dose achieved mean BMI reduction of -15.2% versus -17.4% for 2.4 mg, with similar GI adverse event profiles across populations. These results supported the November 2024 Wegovy label expansion to include 1.7 mg for adolescents ≥12 years of age.
Clinical Significance
This study validates the use of a lower semaglutide maintenance dose in adolescents with obesity, expanding treatment options for a population with limited pharmacologic choices. The comparable efficacy profile at 1.7 mg may improve tolerability and adherence in younger patients, and the MIDD approach demonstrates how computational modeling can accelerate pediatric label expansions without requiring dedicated placebo-controlled trials.
Key Findings:
- Semaglutide pharmacokinetics were similar between adolescents and adults, with body weight as the main covariate
- 1.7 mg dose showed comparable BMI reduction to 2.4 mg (-15.2% vs -17.4%) in adolescents
- GI adverse event profiles were similar across populations and doses
- Supported regulatory approval of Wegovy 1.7 mg for adolescents ≥12 years
Clinical Takeaway: For prescribers treating adolescent obesity, the 1.7 mg semaglutide dose offers an effective alternative to 2.4 mg with potentially improved tolerability.
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