Liraglutide reduces BMI for young children with obesity

medwireNews: Liraglutide is more effective at reducing BMI than placebo in children with obesity aged between 6 and 11 years, the SCALE Kids trial investigators report. The phase 3a trial findings were presented at EASD 2024 in Madrid, Spain, and simultaneously published in The New England Journal of Medicine. The study included 82 children aged a mean of 10 years with an age- and sex-adjusted BMI in the 95th percentile or above, and a pubertal Tanner stage of 1–5. None of the participants had type 1 diabetes or a secondary cause of obesity, explain presenting author Claudia Fox (University of Minnesota Medical School, Minneapolis, USA) and co-authors. The children were randomly assigned to receive subcutaneous liraglutide 3.0 mg/day (n=56) or placebo (n=26) for 56 weeks plus lifestyle interventions encouraging adherence to a healthy diet and 60 min of moderate-to-intensive exercise per day, and then followed up for 26 weeks. The primary endpoint of the percentage change in BMI was –5.8% for the children given liraglutide compared with a 1.6% increase in controls, giving a significant estimated difference of –7.4 percentage points in favor of the glucagon-like peptide (GLP)-1 receptor agonist. Fox et al note that the treatment difference in BMI relative to placebo was “almost double that observed in the SCALE Teens trial” of liraglutide in adolescents, leading them to suggest that their findings “may imply advantages to treating obesity at younger ages.” They continue: “Our findings are consistent with evidence suggesting that lifestyle interventions may be more effective in younger children than in adolescents; however, the supporting evidence is not consistent.” In addition, the trial met the confirmatory secondary endpoints, with a mean percentage change in bodyweight of 1.6% with liraglutide versus 10.0% with placebo (significant estimated difference –8.4 percentage points) and a BMI reduction of at least 5% in 46.0% versus 9.0% of patients (significant adjusted odds ratio=6.3). “Although the trial was not powered to test superiority of secondary end points, liraglutide appeared to be superior to placebo with respect to changes in BMI and body weight,” the researchers comment. Other secondary endpoints favoring liraglutide versus placebo included the change from baseline in systolic and diastolic blood pressure (–3.4 and –4.2 mmHg differences, respectively) and the change in glycated hemoglobin (–0.1 percentage point difference) There was a comparable rate of adverse events (AEs) in the liraglutide- and placebo-treatment arms (89 vs 88%), but gastrointestinal AEs such as nausea, vomiting, and diarrhea were more common with the GLP-1 receptor agonist (80 vs 54%). Serious AEs occurred in 12% and 8% of the groups, respectively, and 11% of liraglutide-treated patients discontinued treatment because of AEs. Fox and co-authors also report “similar” changes in the liraglutide and placebo treatment groups with regard to height, height standard deviation score, bone age, and pubertal status over the study follow-up, which they believe “suggests that liraglutide had no apparent adverse effects on growth and development.” The researchers conclude: “Given the evidence that supports the safety and efficacy of obesity medications such as liraglutide for use in adolescents, the American Academy of Pediatrics Clinical Practice Guideline recommends offering obesity medications to adolescents at least 12 years of age with obesity, as adjuncts to lifestyle interventions, according to medication indications, risks, and benefits. “Such guidelines may change over time, as the evidence base for obesity medications in children increases.” Timothy Barrett (University of Birmingham, UK) and Julian Hamilton-Shield (University of Bristol, UK) write in an accompanying editorial that “it is reassuring that an open-label extension follow-up phase is ongoing to ensure that safety continues to be monitored.” They conclude that while further research is essential, obesity at an early age predicts obesity in adolescence and later life, and the current findings therefore “provide much-needed evidence for the effects of a GLP-1 receptor agonist in young children with obesity, offering a therapeutic option in prepubertal children with severe obesity as an adjunct to healthy lifestyle interventions.” medwireNews is an independent medical news service provided by Springer Healthcare Ltd. © 2024 Springer Healthcare Ltd, part of the Springer Nature Group EASD 2024; Madrid, Spain: 10–13 September N Engl J Med 2024; doi: 10.1056/NEJMoa2407379 N Engl J Med 2024; doi: 10.1056/NEJMe2410560

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Liraglutide reduces BMI for young children with obesity

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