Pharmacists Must Consider Benefits and Risks for GLP-1 Medication for Pediatric Patients | ASHP Midyear 2025

There has been an alarming rise in pediatric obesity rates across the United States, which has necessitated an examination of treatment strategies. Lifestyle changes and metformin as a pharmacological adjunct have been considered first-line treatment, but with the introduction of glucagon-like peptide-1 (GLP-1) receptor agonists, these medications have the potential to treat obesity in pediatric patients. In a session at the American Society of Health-System Pharmacists, Kelly L. Matson, PharmD, BCPPS, clinical professor at the University of Rhode Island, and Norman E. Fenn, III, PharmD, BCPPS, BCPS, FASHP, clinical associate professor at Manchester University, compared and contrasted the use of GLP-1 agonists in children and adolescents.¹

Matson laid out the growing prevalence of the disease and the evidence supporting pharmacotherapy, and Fenn provided a cautionary, evidence-based critique focusing on the risks, costs, and long-term unknowns associated with these agents.

Overview of Overweight and Obesity in Pediatrics

The scale of pediatric obesity is substantial, affecting approximately 1 in 5 children in the US, which translates to about 15 million children. Matson noted that obesity prevalence, based on 2017 to 2020 data, increases with age, affecting 12.7% of children aged 2 to 5 years, 20.7% of those aged 6 to 11 years, and 22.2% of adolescents aged 12 to 19 years. This trend has been consistently rising over the last couple of decades.¹

“This translates to 1 in 5 children in the US having obesity,” Matson said. “If you're under the poverty level, you have a double chance of having obesity prevalence."

Furthermore, socioeconomic factors and race play a significant role, as Hispanic children (26.2%) and Black children (24.8%) exhibit higher rates than white (16.6%) and Asian (9%) children.

The gold standard for treatment remains intensive health and behavior and lifestyle treatment (IHBLT), defined as a formal, face-to-face, family-based program lasting at least 3 months to a year. IHBLT is the necessary mainstay of therapy because it provides proven improvements in weight management with less risk of developing an eating disorder.

However, adherence is challenging, Matson said. Studies show that 26 or more hours are needed to be efficacious, and 52 or more hours are most consistent with significant body mass index (BMI) reduction. Barriers like transportation issues, loss of school or work, difficulty maintaining the time commitment, and insurance coverage issues make IHBLT difficult to sustain.

Pharmacotherapy is always viewed as adjunctive to lifestyle efforts. The American Academy of Pediatrics (AAP) guidelines recommend considering pharmacotherapy for patients 12 years of age and older with a BMI greater than the 95th percentile. It can also be considered for patients with a BMI at or above the 85th percentile if they have at least 1 obesity-related condition. However, Fenn noted that the AAP guidelines are perceived as aggressive by some organizations, as they mention children as young as 2 years of age for intervention and tend to focus on weight instead of health. In contrast, the US Preventive Services Task Force recommends only referring children under 6 years of age to IHBLT, stating there is insufficient evidence to support or oppose other aspects of patient care.

Benefits and Considerations of GLP-1 Agonists

The use of GLP-1 agonists has grown dramatically. Currently, liraglutide and semaglutide are the 2 GLP-1 agents FDA-approved for pediatric weight loss in patients 12 and older. These agents should be considered when dietary measures and physical activity have been consistently attempted but have not resulted in sustained BMI reduction. They are indicated for patients with comorbidities such as prediabetes, type 2 diabetes, metabolic dysfunction-associated steatotic liver disease, or obstructive sleep apnea. Prescribing is concentrated among pediatric as well as nurse practitioners, Matson said.¹

Clinical trials have shown significant efficacy. The liraglutide study showed a statistically significant change in BMI at 56 weeks in adolescents between 12 and 17 years compared with placebo.² The SCALE Kids trial, involving younger children from 6 to 11 years, found the relative change in body weight was -5.8% compared with 1.6% in the placebo group.³

As for semaglutide, the STEP TEENS trial demonstrated powerful efficacy, with a change in BMI of -16.1% compared with a gain of 0.6% in the placebo group.⁴ Matson also highlighted that significant weight loss can positively impact emotional health and noted a patient who was able to discontinue her anxiety and depression medications after achieving weight loss with a GLP-1 agonist.

Risks and Critical Concerns of GLP-1 Agonists

Fenn emphasized the significant financial and safety challenges. The cost for GLP-1 agonist coverage is expected to reach 71.7 billion. Due to projected costs, it is anticipated that these agents will also not be covered by Medicare or Medicaid in 2026.¹

"If you lose insurance or it comes off your insurance? Well, you get charged $500 a month as a co-pay for this medication,” Fenn said.

Safety concerns are substantial, primarily due to common and sometimes severe gastrointestinal (GI) adverse effects (AEs), including gastroparesis, pancreatitis, intestinal blockage requiring surgery, and severe constipation. Since the doses used for weight loss are often higher than those used for T2D, an increase in AEs is expected.

Further, Fenn discussed weight returns when therapy stops. After discontinuing treatment, patients who had been on liraglutide regained weight at a faster rate than those in the placebo group.² In the semaglutide trial, BMI increased by almost 3% just 7 weeks after cessation.⁴

Fenn also voiced significant concerns about the lack of long-term data regarding the impact on growth, development, puberty, and fertility. Moreover, children with obesity have a higher-than-average risk for disordered eating, including self-induced emesis and misuse of laxatives/diet pills. Using appetite-restricting medications raises concerns about abuse or the development or worsening of eating disorders in this vulnerable population.¹

Fenn analyzed the trial data, pointing out that metformin has the greatest body of evidence for obesity management and is the first-line therapy for metabolically stable T2D in children, not GLP-1 agonists. He noted that many GLP-1 trials did not standardize the lifestyle modifications provided, making it difficult to determine the drug’s true effect. Furthermore, trials were small; one liraglutide study only had 201 completers out of 251 patients.² The clinical significance of the weight loss was often minor; for example, the difference in BMI change between liraglutide and placebo was only 1.58%.²

Fenn also highlighted potential bias in the STEP TEENS trial because the sponsor analyzed the data, performed site monitoring, and oversaw the entire trial.³ Dosing was also a concern, as the SCALE Kids trial studied children as young as six using the adult maximum dose (3 mg) of liraglutide, raising safety questions for growing patients.³

Conclusion

GLP-1 agonists represent a powerful pharmacological intervention for pediatric obesity, demonstrating significant efficacy in reducing BMI compared to placebo in clinical trials. However, both Fenn and Matson agree that these medications should be viewed as an adjunctive consideration within a comprehensive, patient-centered program that prioritizes IHBLT.¹

Pharmacists must exercise critical evaluation, balancing the impressive weight loss potential against the substantial financial barriers, the high risk of severe GI AEs, and the concerning lack of long-term data on growth and development. Given the certainty of weight regain upon cessation, pharmacists are key in counseling families that this treatment may require lifelong adherence and must be paired with foundational behavioral changes to ensure sustained positive health outcomes.

“We need to assess [a patient’s] medications,” Fenn said. “Look at everything else first before you decide to bite the bullet and go with these medications."

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REFERENCES

1. Sierra CM, Matson KL, Fenn NE. Is It Worth a Shot? A Pro/Con Debate About GLP-1 Agonist Use in Pediatric Patients. ASHP Midyear. December 7-10, 2025. Las Vegas, Nevada

2. Kelly AS, Auerbach P, Barrientos-Perez M, et al. A Randomized, Controlled Trial of Liraglutide for Adolescents with Obesity. N Engl J Med. 2020;382(22):2117-2128. doi:10.1056/NEJMoa1916038

3. Fox CK, Barrientos-Pérez M, Bomberg EM, et al. Liraglutide for Children 6 to <12 Years of Age with Obesity - A Randomized Trial. N Engl J Med. 2025;392(6):555-565. doi:10.1056/NEJMoa2407379

4. Weghuber D, Barrett T, Barrientos-Pérez M, et al. Once-Weekly Semaglutide in Adolescents with Obesity. N Engl J Med. 2022;387(24):2245-2257. doi:10.1056/NEJMoa2208601