GLP-1s for Pediatric Obesity: Wegovy’s Approval and Emerging Data

Last Updated: March 2026

The landscape of pediatric obesity management is evolving rapidly, with glucagon-like peptide-1 (GLP-1) receptor agonists emerging as powerful tools. In the pivotal STEP TEENS trial, adolescents aged 12 to less than 18 years treated with once-weekly semaglutide (Wegovy) achieved an average 16.1% reduction in body mass index (BMI) from baseline at week 68, a stark contrast to a 0.6% increase in the placebo group (New England Journal of Medicine, 2022) [1]. This significant outcome underpinned the FDA’s decision to expand Wegovy’s approval to include adolescents, marking a critical advancement in pharmaceutical interventions for younger populations grappling with obesity.

The rise in childhood and adolescent obesity rates presents a profound public health challenge. Data from the Centers for Disease Control and Prevention indicates that approximately 19.7% of children and adolescents aged 2-19 years in the United States have obesity [4]. This condition carries severe short- and long-term health implications, including an increased risk of type 2 diabetes, cardiovascular disease, non-alcoholic fatty liver disease, and certain cancers, often extending into adulthood. Traditional interventions, such as intensive lifestyle modifications involving diet and exercise, remain foundational. However, for many adolescents, these alone are insufficient to achieve sustainable weight loss and improve metabolic health. The introduction of GLP-1 agonists offers a new therapeutic avenue for a patient population with limited pharmacological options.

FDA Approvals: Semaglutide (Wegovy) and Liraglutide (Saxenda) for Adolescents

Two GLP-1 receptor agonists are currently FDA-approved for chronic weight management in adolescents aged 12 and older: liraglutide (Saxenda) and semaglutide (Wegovy). These approvals represent a significant paradigm shift, offering clinicians evidence-based pharmacological treatments to complement lifestyle interventions.

Wegovy (semaglutide): A Once-Weekly Option

Semaglutide, marketed as Wegovy, received FDA approval for chronic weight management in adolescents aged 12 years and older in December 2022. This approval was based primarily on the results of the STEP TEENS trial. Participants in the trial had an initial BMI at or above the 95th percentile for their age and sex, or a BMI at or above the 85th percentile with at least one weight-related comorbidity.

The trial demonstrated not only significant BMI reduction but also improvements in cardiometabolic risk factors. “The observed changes in body weight and BMI with semaglutide were sustained throughout the 68-week trial period,” according to the published study [1]. The median weight loss among adolescents receiving semaglutide was 14.7%, compared to a median weight gain of 2.7% in the placebo group [1]. Furthermore, a substantial proportion of adolescents on semaglutide achieved clinically meaningful weight loss. Specifically, 73.1% of participants in the semaglutide group achieved a BMI reduction of at least 5%, compared to only 10.5% in the placebo group [1].

The dosage for Wegovy in adolescents follows a similar titration schedule to adults, starting at 0.25 mg once weekly and gradually increasing over 16 weeks to a target dose of 2.4 mg once weekly, or the maximum tolerated dose. This allows for careful monitoring and management of potential side effects.

Saxenda (liraglutide): The First Daily GLP-1 for Teens

Liraglutide, marketed as Saxenda, was the first GLP-1 receptor agonist approved by the FDA for adolescents aged 12 years and older with obesity, receiving its indication in June 2020. This approval was supported by data from the phase 3 SCALE TEENS trial.

In the SCALE TEENS trial, adolescents with obesity who received liraglutide (up to 3.0 mg daily) showed an average reduction in BMI of 12.1% from baseline, compared to a 3.6% reduction with placebo, both groups in conjunction with lifestyle therapy [3]. A key finding was that 43.3% of participants on liraglutide achieved a reduction in BMI of at least 5%, versus 18.7% with placebo [3]. Similar to semaglutide, liraglutide is initiated at a low daily dose and gradually titrated up over several weeks to a target of 3.0 mg once daily, or the highest tolerated dose.

Other Pharmacological Options for Pediatric Obesity

While GLP-1s represent a significant advance, other pharmacological treatments are also approved for pediatric obesity, including phentermine-topiramate extended-release (Qsymia) for adolescents aged 12 and older. However, GLP-1 receptor agonists offer a distinct mechanism of action with established cardiometabolic benefits beyond weight loss, making them a particularly appealing class of medications for this population. Exenatide, another GLP-1, has shown some efficacy in studies but is not FDA-approved for pediatric weight management [4].

How GLP-1s Work in Adolescents

GLP-1 receptor agonists mimic the action of the naturally occurring gut hormone GLP-1, which plays a crucial role in regulating appetite and glucose metabolism. In adolescents, the mechanisms are largely similar to adults:

• Appetite Regulation: GLP-1 acts on receptors in the brain, particularly in the hypothalamus, to reduce hunger and increase feelings of fullness and satiety. This leads to decreased calorie intake.
• Gastric Emptying: GLP-1 slows down gastric emptying, meaning food stays in the stomach longer. This further contributes to satiety and can help reduce post-meal glucose spikes.
• Blood Sugar Control: While their primary indication in obesity is weight loss, GLP-1s also stimulate glucose-dependent insulin secretion and suppress glucagon secretion, contributing to improved glycemic control, which is particularly relevant for adolescents with obesity who are at risk for or have type 2 diabetes.

The impact of GLP-1s on the developing bodies of adolescents is a key area of ongoing research. While the trials have shown efficacy and a manageable safety profile over the study duration, long-term data regarding bone density, growth plates, and hormonal development are still accumulating.

Safety Profile and Side Effects in Adolescents

The safety profiles of semaglutide and liraglutide in adolescents are broadly consistent with those observed in adults, with gastrointestinal (GI) side effects being the most common.

Common Side Effects

• Nausea: This is the most frequently reported side effect for both semaglutide and liraglutide. It is often mild to moderate and tends to subside over time, particularly with gradual dose titration.
• Vomiting and Diarrhea: These are also common, contributing to discomfort and sometimes leading to treatment discontinuation if severe.
• Constipation: Less common than diarrhea but still reported.
• Abdominal Pain: Experienced by some patients.

In the STEP TEENS trial, treatment discontinuation due to adverse events occurred in 4.5% of the semaglutide group, primarily due to GI issues [1]. For liraglutide in the SCALE TEENS trial, 10% of participants discontinued treatment due to adverse events, mainly GI events [3].

Serious Adverse Events and Contraindications

Serious adverse events are rare but include pancreatitis and gallbladder-related issues (cholelithiasis, cholecystitis). Both semaglutide and liraglutide carry a Boxed Warning regarding the risk of thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), observed in rodent studies. Therefore, they are contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) [2, 5].

Monitoring for these rare but serious side effects is crucial. Regular follow-ups with healthcare providers are essential to manage side effects and assess overall treatment efficacy and safety in adolescents.

Comparing Approved GLP-1s for Pediatric Obesity

The two FDA-approved GLP-1 receptor agonists for pediatric obesity offer distinct advantages, primarily differing in their administration frequency.

This comparison highlights that while both drugs offer significant benefits, Wegovy’s once-weekly dosing schedule may offer a convenience advantage, potentially leading to better adherence for some adolescents and their families. The magnitude of BMI reduction observed in trials also suggests semaglutide may be more potent, though direct head-to-head trials in adolescents are not yet available.

Emerging Research and Future Directions

The field of GLP-1 therapy for pediatric obesity is dynamic, with ongoing research poised to further refine treatment strategies and expand options.

Broader Age Ranges and Newer Molecules

Clinical trials are actively investigating the use of GLP-1 receptor agonists in even younger children, exploring optimal dosing, safety, and efficacy in prepubertal populations. Additionally, newer multi-agonist drugs, such as tirzepatide (a GLP-1/GIP co-agonist), which has demonstrated superior weight loss efficacy in adults compared to semaglutide, are likely to be evaluated in pediatric trials. These newer molecules may offer even greater weight loss and metabolic improvements, but their specific risk-benefit profiles in children and adolescents will require rigorous evaluation.

Long-term Safety and Efficacy

While current trial data provide valuable insights over 68 weeks or a year, the long-term impact of GLP-1 therapy on growth, bone health, and the full spectrum of metabolic health in adolescents remains an active area of investigation. Understanding the duration of treatment required and the potential for weight regain upon cessation are critical questions for ongoing research.

Integration with Lifestyle and Behavioral Interventions

The American Academy of Pediatrics’ 2023 clinical practice guideline for the evaluation and treatment of childhood obesity emphasizes a comprehensive, individualized approach, recommending pharmacological treatment as an adjunct to intensive health behavior and lifestyle treatment [4]. Future research will likely focus on optimizing the integration of GLP-1 therapy with robust behavioral support, nutritional counseling, and physical activity programs to maximize outcomes and foster sustainable healthy habits.

Conclusion

The FDA approvals of semaglutide (Wegovy) and liraglutide (Saxenda) for adolescents aged 12 and older represent a pivotal moment in pediatric obesity management. These GLP-1 receptor agonists offer significant and clinically meaningful weight loss, alongside improvements in cardiometabolic markers, for a patient population in dire need of effective treatment options beyond lifestyle interventions alone. The robust data from trials like STEP TEENS underscore their efficacy and generally manageable safety profiles, primarily characterized by transient gastrointestinal side effects. As research continues to unfold, further clarifying long-term impacts and exploring newer molecules and expanded age ranges, GLP-1 therapies are set to play an increasingly central role in addressing the complex and pervasive challenge of pediatric obesity.

Sources

1. Weghofer, M. C., et al. “Once-Weekly Semaglutide in Adolescents with Obesity.” New England Journal of Medicine, vol. 387, no. 23, 2022, pp. 2203-2216. https://www.nejm.org/doi/full/10.1056/NEJMoa2208601
2. U.S. Food and Drug Administration. “Wegovy (semaglutide) injection Full Prescribing Information.” Revised December 2022. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215256s003lbl.pdf
3. Kelly, A. S., et al. “A Randomized, Controlled, Phase 3 Trial of Liraglutide for Adolescents with Obesity.” New England Journal of Medicine, vol. 382, no. 22, 2020, pp. 2117-2128. https://www.nejm.org/doi/full/10.1056/NEJMoa1916037
4. Hampl, S. E., et al. “Clinical Practice Guideline for the Evaluation and Treatment of Children and Adolescents With Obesity.” Pediatrics, vol. 151, no. 2, 2023, e2022060644. https://www.endocrine.org/news-and-advocacy/news-room/2023/pediatric-guideline-recommendations-for-evaluating-and-treating-childhood-obesity
5. U.S. Food and Drug Administration. “Saxenda (liraglutide) injection Full Prescribing Information.” Revised June 2020. [https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206103s008lbl.pdf](https://www.accessdata.fda.gov/drugsatfda_docs/label/2020