Is a weekly semaglutide injection a safe and effective way for obese adolescents to lose weight?
Semaglutide helps adolescents lose a clinically significant amount of weight. Whether that weight loss persists when the medication is discontinued is unknown, and there was a concerning increase in episodes of acute cholelithiasis, a known adverse effect of the drug. It is not clear whether the risk of acute cholelithiasis (also seen a study of patients taking dulaglutide) is caused by the medication or is a function of rapid weight loss.
Plan de l'etude:
Randomized controlled trial (single-blinded)
Semaglutide is a GLP-1 agonist that has been shown to help adults lose weight. These researchers recruited adolescents (12 to < 18 years of age) who were obese (body mass index [BMI] > 95th percentile) or overweight (BMI > 85th percentile) with at least one risk factor. After a 12-week run-in period during which the 200 participants received lifestyle counseling, they were randomized in a 2-to-1 ratio to receive semaglutide subcutaneously once weekly or matching placebo. The dose started at 0.25 mg and was escalated as tolerated to a maximum dose of 2.4 mg during the first 16 weeks. The groups were balanced at the start of the study and the analysis was by intention to treat. All participants and their families received lifestyle education throughout the trial. All but 1 participant was obese, with a mean pretreatment BMI of 37.7 in the semaglutide group and 35.7 in the placebo group. Only 5 patients were lost to follow-up or withdrew by the end of the 68-week trial. The primary outcome was percentage change in BMI, which was significantly greater in the semaglutide group (-16.1% vs +0.6%; P < .001). Significantly more patients in the semaglutide group had reductions of at least 5% of their body weight (73% vs 18%; number needed to treat [NNT] = 2), of at least 10% (62% vs 8%; NNT = 2), and of at least 20% (37% vs 3%; NNT = 3). Quality-of-life scores improved, especially for the physical comfort domain. Gastrointestinal complaints were more common with semaglutide, and 5 patients in the treatment group had cholelithiasis (1 also had cholecystitis) compared with none in the placebo group. Withdrawals due to adverse events were similar between groups.
Mark H. Ebell, MD, MS
University of Georgia