Young children with obesity have historically faced challenges in achieving significant and sustainable reductions in their body mass index (BMI) through lifestyle intervention alone. However, the phase IIIa SCALE Kids trial has shed light on the potential benefits of adding liraglutide (Saxenda) to the treatment regimen of these children. The trial, led by Claudia Fox, MD, of the University of Minnesota Medical School, showed that children ages 6 to under 12 years who received once-daily 3-mg liraglutide experienced a notable reduction in BMI compared to those on lifestyle intervention alone.
Weight Loss Results and Clinical Significance
By week 56 of the trial, children in the liraglutide group lost 5.8% of their BMI, while those in the placebo group gained 1.6% with lifestyle intervention alone. This translates to an estimated difference of -7.4% between the two groups. Notably, a significantly higher proportion of children in the liraglutide group (46%) lost at least 5% of their BMI compared to the placebo group (9%). Furthermore, the average body weight change was 1.6% with liraglutide compared to 10% with placebo. These findings underscore the potential of liraglutide as an adjunct therapy to lifestyle intervention in addressing obesity in young children.
Timothy Barrett, MB, PhD, and Julian Hamilton-Shield, MD, emphasized the importance of these results in offering a therapeutic option for prepubertal children with severe obesity. The improvement in the BMI standard-deviation score among children taking liraglutide indicates the potential for positive metabolic effects, such as enhanced insulin sensitivity and reduced hepatic steatosis. This is particularly significant given the lack of approved medications for pediatric obesity, except in rare cases of monogenic or syndromic obesity.
The treatment difference in the BMI standard-deviation score observed in the SCALE Kids trial exceeds that reported in the SCALE Teens trial for adolescents aged 12 to 17. Notably, liraglutide had previously received FDA approval for chronic weight management in adults and for the treatment of type 2 diabetes at a lower dose. The findings from SCALE Kids offer valuable insights into the efficacy of liraglutide in a younger population with obesity.
The SCALE Kids trial enrolled children with a BMI in the 95th percentile or higher, with a significant proportion presenting with class 2 or class 3 obesity. The trial involved a 56-week treatment period with liraglutide and a subsequent 26-week off-treatment period. In addition to BMI reduction, several secondary endpoints favored liraglutide, including changes in waist circumference, blood pressure, and HbA1c levels. However, gastrointestinal adverse events were more common in the liraglutide group, with nausea, vomiting, and diarrhea being among the most frequently reported side effects.
Future Directions and Long-Term Monitoring
While the initial results of the trial are promising, the long-term effects of liraglutide in young children with obesity remain to be fully elucidated. The 3-year, open-label extension phase of the trial aims to provide further insights into the sustained benefits and safety profile of liraglutide in this population. Monitoring for effects on growth and puberty is crucial, although no concerning signals were observed during the trial period. Continued research is needed to establish the role of liraglutide as part of a comprehensive approach to managing childhood obesity.
The SCALE Kids trial represents a significant advancement in the field of pediatric obesity management by demonstrating the potential benefits of liraglutide in reducing BMI and improving metabolic parameters in young children. The findings highlight the importance of considering pharmacological interventions in conjunction with lifestyle modifications to address the complex challenges associated with childhood obesity. Ongoing research will further inform clinical practice and help optimize the care of children struggling with obesity.