Semaglutide became the first GLP-1 receptor agonist FDA-approved for pediatric weight management in December 2022, for adolescents aged 12 and older with a BMI at or above the 95th percentile for age and sex. Liraglutide holds a separate, earlier pediatric approval. Below is a review of the trial data behind these approvals, more recent meta-analytic evidence spanning younger ages, and what real-world data shows about how these approvals have translated into actual prescribing.
The approval trial: STEP TEENS
Semaglutide's adolescent approval rests on the Semaglutide Treatment Effect in People with obesity (STEP)-TEENS trial, a 68-week, double-blind, randomized, placebo-controlled trial in 201 adolescents aged 12–18 with a BMI at or above the 95th percentile, or the 85th percentile with at least one obesity-related comorbidity.[1] Participants were randomized 2:1 to subcutaneous semaglutide 2.4mg or placebo, both alongside lifestyle intervention.
Completion rates exceeded 95% in both study arms — notably high for a pediatric pharmacotherapy trial — and the trial tested the same highest FDA-approved weekly adult dose, which has not always been standard practice in earlier pediatric GLP-1 trials.[2]
Broader evidence across younger ages: the 2026 meta-analysis
A 2026 systematic review and meta-analysis in Pediatric Research pooled 11 randomized controlled trials covering 1,024 patients with obesity aged 6 to 19.[3] Compared with placebo, GLP-1 receptor agonists significantly reduced body weight (mean difference -4.32 kg, 95% CI -7.02 to -1.63), BMI z-score (MD -0.28, 95% CI -0.45 to -0.1), and waist circumference (MD -3.84 cm).
GLP-1 receptor agonists were recently approved for obesity treatment in children 12–17 years by both the FDA and the EMA. However, their effectiveness in younger pediatric patients remains uncertain.
That uncertainty is important: current FDA and EMA approvals are specifically for ages 12 and older. A separate trial of liraglutide in children 6 to under 12, published in NEJM in 2024, represents one of the few controlled data points below the currently approved age range, but a single trial in a younger cohort is a narrower evidence base than the adolescent approval rests on.[4]
Real-world prescribing: how approval has translated into use
A retrospective cohort study using the Epic Cosmos electronic health record dataset examined GLP-1 receptor agonist prescribing among 2,090,467 U.S. adolescents with obesity between January 2021 and July 2025.[5] Only 19,097 (0.9%) received at least one GLP-1 RA prescription during that window. Of those prescribed, mean age was 15.0±1.7 years, and 87.4% had severe obesity — meaning prescribing in practice has concentrated in more clinically severe cases rather than the broader BMI-eligible population.
The prevalent prescription rate rose from 0.12% shortly after semaglutide's December 2022 approval to 1.38% by July 2025; the incident (new-prescription) rate rose from 0.15% to 0.77% over the same window. Semaglutide rapidly overtook liraglutide in adolescent prescribing, and off-label tirzepatide prescribing has exceeded liraglutide prescribing since early 2025 — notable since tirzepatide does not currently carry a pediatric indication.[5]
The study also found demographic disparities in prescribing after adjustment for clinical factors — for example, male adolescents were significantly less likely to receive a prescription than female adolescents (adjusted OR 0.53, 95% CI 0.51–0.54) — raising access-equity questions independent of the clinical trial evidence itself.
Pediatric trials have not yet demonstrated hard cardiovascular outcome reductions, the way some adult trials (like SELECT) have. Current pediatric evidence relies on surrogate endpoints — BMI, weight, waist circumference — which is part of why insurance coverage indications for adolescents continue to lag behind adult coverage in practice.[6]
What's actively being studied now
Pediatric trials in children younger than 12 are underway, though clinicians in the field have expressed caution about prescribing expansion given the still-limited data on long-term effects on growing bodies.[7] Separately, a University of Virginia observational study (NCT06903923) is specifically examining bone metabolism in patients aged 12–21 undergoing GLP-1 receptor agonist therapy — a direct pediatric counterpart to the adult bone-density findings covered separately on this site — and is currently recruiting.[8]
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