Each month, the OMA Pediatric Committee reviews a pediatric-focused obesity research update to help keep you up to date about the latest findings. This month’s update addresses once-weekly semaglutide in adolescents with obesity.
Once-Weekly Semaglutide in Adolescents with Obesity
This article summarizes the findings of the STEP (Semaglutide Treatment Effect in People with obesity) TEEN clinical trial to evaluate once weekly semaglutide in adolescents. Read the full article.
In the adult population, the STEP (Semaglutide Treatment Effect in People with obesity) trials led to the FDA approval of semaglutide in the use of weight loss in adults with or without diabetes. Given the prevalence of severe obesity in children and adolescents, the STEP TEENS trial is timely.
In this double-blinded, parallel group, randomized, placebo-controlled trial, adolescents were enrolled if they had obesity or overweight with a weight related comorbidity. After a screening process, participants enrolled in a three-month lifestyle intervention. If still eligible after lifestyle intervention, the participants were then randomized at a 2:1 ratio of treatment with semaglutide vs. placebo for a total of 68 weeks. In the treatment group, semaglutide dosing was increased monthly until they reached 2.4 mg or to the dose that was tolerated without adverse side effects. After completion of the treatment period, there was a seven-week period when participants did not receive semaglutide or placebo. The STEP TEENS trial had a 90% completion rate with 180 adolescents.
The results in the STEP TEENS trial were very similar to the (adult) STEP results. In participants who received semaglutide, their mean change in BMI at completion was -16.1% compared with 0.6% in the placebo group. Almost three-quarters of the treatment group (73%) experienced at least 5% of body weight loss while; in contrast, only 18% placebo group experienced a similar amount. The side effect profile of GI symptoms were similar to adult studies with 62% of participants taking semaglutide and 42% in the placebo group experiencing nausea, vomiting and diarrhea.
In conclusion, the STEP TEENS trial demonstrated efficacy of once-weekly semaglutide 2.4 mg plus lifestyle intervention in reducing BMI when compared to lifestyle intervention only. It also showed that most participants experienced at least 5% body weight loss, which can significantly reduce the progression of obesity-related comorbidities.
Find more resources, curated by OMA’s Pediatric Committee, on our Pediatric Resources page. There you’ll find additional article reviews on various topics related to obesity as well as public resources for clinicians and families.