Can Wegovy (semaglutide) be used in individuals less than 18 years old?

From the Guidelines

Wegovy (semaglutide) should not be used in individuals less than 18 years old outside of clinical trials or without explicit approval from regulatory authorities, as its safety and efficacy in this age group have not been established. The use of pharmacotherapy in children and adolescents with obesity is limited in clinical practice, and there is a lack of well-controlled studies and long-term data on the efficacy and safety of pharmacotherapy in children, as noted in a 2023 study 1. Currently, orlistat and liraglutide 3.0 mg are approved for use in adolescents (>12 years) in several Asian countries, but there is no mention of Wegovy (semaglutide) being approved for use in individuals less than 18 years old 1. Some key points to consider when treating adolescents with obesity include:

• Pharmacotherapy should be considered only if lifestyle modification has been ineffective or the patient has severe complications, and even then, only as an adjunct to behavioral change 1.
• Treatment should be evaluated after 12 weeks at the maximum dose and pharmacotherapy discontinued if BMI or BMI z-score reduction is <4% 1.
• Clinical studies on orlistat plus lifestyle modification suggest that adolescents may experience 0.55–0.8 kg/m2 reduction in BMI, but mild to moderate gastrointestinal (GI) adverse events are more common with orlistat than placebo 1. Given the lack of evidence supporting the use of Wegovy (semaglutide) in individuals less than 18 years old, it is essential to prioritize the safety and well-being of this age group and avoid using this medication without proper approval and monitoring.

From the FDA Drug Label

8.4 Pediatric Use Safety and efficacy of OZEMPIC have not been established in pediatric patients (younger than 18 years). The FDA drug label does not support the use of Wegovy (semaglutide) in individuals less than 18 years old, as safety and efficacy have not been established in pediatric patients. 2

From the Research

Use of Wegovy in Individuals Less Than 18 Years Old

• The use of Wegovy (semaglutide) in individuals less than 18 years old has been studied in a clinical trial 3.
• This trial, known as the STEP TEENS trial, enrolled adolescents (12 to <18 years of age) with obesity or overweight and at least one weight-related coexisting condition.
• Participants were randomly assigned to receive once-weekly subcutaneous semaglutide (at a dose of 2.4 mg) or placebo for 68 weeks, plus lifestyle intervention.
• The results of the trial showed that semaglutide was effective in reducing body mass index (BMI) and body weight in adolescents with obesity, with a mean change in BMI from baseline to week 68 of -16.1% with semaglutide and 0.6% with placebo.

Safety and Efficacy

• The trial also evaluated the safety and efficacy of semaglutide in adolescents, and found that the incidence of gastrointestinal adverse events was greater with semaglutide than with placebo (62% vs. 42%) 3.
• However, the trial concluded that once-weekly treatment with a 2.4-mg dose of semaglutide plus lifestyle intervention resulted in a greater reduction in BMI than lifestyle intervention alone in adolescents with obesity.

Comparison to Other Studies

• Other studies have evaluated the use of semaglutide in adults with overweight or obesity, and have found it to be effective in reducing body weight and improving cardiometabolic risk factors 4, 5, 6, 7.
• However, the use of semaglutide in individuals less than 18 years old is not as well-studied, and more research is needed to fully understand its safety and efficacy in this population.