Methods
In this double-blind, parallel-group, randomized, placebo-controlled trial, we enrolled adolescents (aged 12 to <18 years) with obesity (body mass index [BMI] at the 95th percentile or higher) or overweight (BMI at the 85th percentile or higher) and at least one co-existing weight-related condition. Participants were randomized 2:1 to receive subcutaneous semaglutide once weekly (at a dose of 2.4 mg) or placebo for 68 weeks, plus lifestyle intervention. The primary endpoint was percent change in BMI from baseline at week 68. the secondary confirmatory endpoint was weight loss of at least 5% at week 68.
Results
A total of 201 participants were randomized and 180 (90%) completed treatment. All but one of the participants had obesity. The mean change in BMI from baseline to week 68 was -16.1% with semaglutide and 0.6% with placebo (estimated difference, -16.7 percentage points, 95% confidence interval [CI], −20.3 to −13.2; P<0.001). At week 68, a total of 95 of 131 participants (73%) in the semaglutide group had a weight loss of 5% or more, compared with 11 of 62 participants (18%) in the placebo group (estimated odds ratio, 14.0 ; 95% CI, 6.3 to 31.0, P<0.001). Weight reduction and improvement in cardiometabolic risk factors (waist circumference and glycated hemoglobin levels, lipids [except high-density lipoprotein cholesterol]and alanine aminotransferase) were greater with semaglutide than with placebo. The incidence of gastrointestinal adverse events was greater with semaglutide than with placebo (62% vs. 42%). Five participants (4%) in the semaglutide group and no participants in the placebo group had cholelithiasis. Serious adverse events were reported in 15 of 133 participants (11%) in the semaglutide group and in 6 of 67 participants (9%) in the placebo group.
conclusions
Among obese adolescents, once-weekly treatment with semaglutide 2.4 mg plus lifestyle intervention resulted in a greater reduction in BMI than lifestyle intervention alone. (Funded by Novo Nordisk, STEP TEENS ClinicalTrials.gov number, NCT04102189.)
