Compared with lifestyle intervention alone in adolescents with obesity, semaglutide 2.4 mg plus lifestyle intervention significantly reduced BMI at week 68 in the phase 3a STEP TEENS trial. Weight loss of at least 5% occurred in more patients on semaglutide 2.4 mg than with lifestyle interventions alone.
The double-blind, parallel-group, randomized, placebo-controlled trial included adolescents (12 to <18 years of age) with obesity or overweight and at least 1 weight-related coexisting condition. Compared with placebo at 68 weeks plus lifestyle intervention, the active therapy produced these changes in a primary endpoint of the percentage change in BMI from baseline to week 68: “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 weight loss of 5% or more, as 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). Reductions in body weight and improvement with respect to cardiometabolic risk factors (waist circumference and levels of glycated hemoglobin, 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.”