Semaglutide With Lifestyle Interventions Shows Benefits for Adolescents With Obesity
The use of semaglutide for adolescents was included in recent pediatric guidelines, though there are few studies assessing the drug in this patient population.
Once weekly treatment with a 2.4 mg dosage of semaglutide and lifestyle intervention demonstrated greater reductions in body mass index (BMI) than lifestyle intervention alone for adolescents with obesity, according to results of a study published in The New England Journal of Medicine.1
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Semaglutide is a subcutaneous glucagon-like peptide-1 receptor agonist that has been used to treat obesity in adults.1 In the recent recommendations for pediatric obesity from the American Association of Pediatrics, the authors recommended the use of semaglutide for adolescents, though there have been only a few studies assessing the drug in this patient population.2
Investigators of the STEP TEENS study (NCT04102189) enrolled 201 adolescents, aged 12 to 17 years of age, who were obese with a BMI in the 95th percentile or higher, or overweight with a BMI in the 85th percentile or higher, and at least 1 weight-related comorbidity.1
Of the 201 individuals, 180 completed the treatment. All but one individual in the study had obesity.1
Study participants were randomly assigned in a 2:1 ratio, receiving either the once-weekly dose of subcutaneous semaglutide in the 2.4 mg dosage or the placebo, as well as lifestyle interventions for 68 weeks.1
The primary endpoint included the percentage change in BMI from baseline to week 68 and the secondary endpoint included weight loss of at least 5% at week 68.1
Investigators found that the mean change in BMI was a 16.1% reduction for those who were on semaglutide for 68 weeks and plus 0.6% for those who were on the placebo. At 68 weeks, it was also reported that approximately 73% of individuals on semaglutide had weight loss of 5% or more compared with only 18% on the placebo.1
The body weight reductions and improvements of risk factors for cardiovascular disease, including waist circumference, levels of glycated hemoglobin, and lipids, were greater for semaglutide than with the placebo at 62% and 42%, respectively.1
Investigators noted that the incidence of gastrointestinal adverse effects (AEs) was greater in the semaglutide group at 62% compared with the placebo group at 42%. Serious AEs were reported for 11% in the semaglutide group compared to 9% in the placebo group.1
Additionally, investigators reported that 5 individuals taking semaglutide experienced cholelithiasis, or gallstones, but no participants in the placebo group did.1
Investigators also noted that a longer treatment period would have been beneficial to determine the durability of the treatment over time. They also said that a longer follow-up period could have shown any impacts of treatment cessation, saying that between week 68 and 75 a small BMI regain is seen.1
Furthermore, investigators said that the result would have benefited from a larger trial population because the generalizability of the results are limited due to the fact that there were more female than male participants, there were small representations of racial and ethnic backgrounds, and there were few individuals with type 2 diabetes and overweight.1
References
1. Weghuber D, Barrett T, Barrientos-Pérez M, Gies I, et al. Once-weekly semaglutide in adolescents with obesity. N Engl J Med. 2022;387(24):2245-2257. doi:10.1056/NEJMoa2208601
2. Hampl SE, Hassink SG, Skinner AC, Armstrong SC, et al. Clinical practice guideline for the evaluation and treatment of children and adolescents with obesity. Pediatrics. 2023;151(2):e2022060640. doi:10.1542/peds.2022-060640
