Efficacy, Safety and Pharmacokinetics of Semaglutide 1.7 mg for Obesity Treatment in Adolescents: A Model‐Informed Drug Development Approach
Authors' conclusion
PK/PD and safety modelling indicated 1.7 mg semaglutide provides comparable exposure, tolerability and meaningful BMI reduction in adolescents versus adults and versus 2.4 mg. These results supported approval of 1.7 mg for adolescents ≥ 12 years in the November 2024 Wegovy label, obviating a dedicated adolescent 1.7-mg placebo trial.
Study context
- Population
- Adolescents with obesity (STEP TEENS, N = 201) and adults (STEP studies, ≈3100 participants)N = 201 adolescents
- Comparison
- Semaglutide 1.7 mg vs 2.4 mg in adolescents, and adolescents vs adults
- Outcome
- Mean BMI change in adolescents (modelled)
Methodological detailspharmacokinetic and pharmacodynamic modelling, pooled STEP TEENS Phase 3 and adult STEP Phases 2-3 data
- Pharmacokinetic and pharmacodynamic modelling
- Pooled STEP TEENS Phase 3 and adult STEP Phases 2-3 data
Main finding
As reported in the abstract
1.7 mg
−15.2
mean · %
2.4 mg
−17.4
mean · %
P < 0.01
Further findings
Modelled semaglutide concentrations, adolescents vs adults · 68 weeks
- Similar between adolescents and adults; body weight was the main covariate influencing exposure
Predicted proportions achieving ≥ 5%, ≥ 10% and ≥ 15% BMI reductions
- Similar across populations and doses
Safety
Gastrointestinal adverse event (AE) profiles (predicted)
- Similar across populations and doses
Original publication
Efficacy, Safety and Pharmacokinetics of Semaglutide 1.7 mg for Obesity Treatment in Adolescents: A Model‐Informed Drug Development Approach. Diabetes Obes Metab. Published 30 March 2026. doi:10.
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