Obesity in children, especially at a young age, can have detrimental long-term effects on their health and wellbeing. The phase IIIa SCALE Kids trial, led by Claudia Fox, MD, evaluated the efficacy of liraglutide (Saxenda) in reducing BMI in children aged 6 to Study Findings
The findings from the SCALE Kids trial demonstrated that children on once-daily 3-mg liraglutide lost 5.8% of BMI, compared to a 1.6% gain in the group receiving lifestyle intervention alone. This substantial reduction in BMI highlights the potential of liraglutide as an effective treatment option for young children with severe obesity who have failed to achieve significant weight loss through lifestyle therapy alone.
Therapeutic Options
Timothy Barrett, MB, PhD, and Julian Hamilton-Shield, MD, emphasized the importance of liraglutide as a therapeutic option for prepubertal children with severe obesity. The results of the trial provide much-needed evidence for the effects of a GLP-1 receptor agonist in this age group and suggest that liraglutide could complement healthy lifestyle interventions to promote sustainable weight loss and improve metabolic variables.
Comparison to Adolescents and Adults
The BMI standard-deviation score treatment difference observed in the SCALE Kids trial was nearly double that reported in the SCALE Teens trial, which led to FDA approval for liraglutide in adolescents aged 12 to 17. Prior to approval for teenagers, liraglutide was already approved for chronic weight management in adults, signaling its potential efficacy across different age groups.
The SCALE Kids trial enrolled children with a BMI in the 95th percentile or higher, with an average age of 10 years. The majority of participants had class 2 or class 3 obesity, highlighting the severity of their condition. Children who had failed to lose sufficient weight through lifestyle interventions were included in the study, reflecting the need for alternative treatment strategies for pediatric obesity.
The children in the liraglutide group underwent a dose escalation regimen, starting at 0.6 mg/day and increasing to 3.0 mg once daily or the maximum tolerated dose. This treatment regimen was combined with lifestyle interventions focusing on dietary counseling and physical activity promotion. The study also reported several secondary endpoints favoring liraglutide, including BMI reduction ≥10%, waist circumference change, and improvements in blood pressure and HbA1c levels.
Adverse Events and Long-Term Effects
Gastrointestinal adverse events were more common in the liraglutide group, with nausea, vomiting, and diarrhea being the most frequently reported side effects. It is crucial to monitor the potential effects of liraglutide on growth and puberty in pediatric patients, as long-term data on these aspects are still limited. The 3-year open-label extension phase of the trial aims to address these concerns and provide insights into the long-term impact of liraglutide in young children with obesity.
Overall, the findings of the SCALE Kids trial support the use of liraglutide as a promising therapeutic option for managing obesity in young children, underscoring the importance of early intervention and comprehensive treatment strategies in addressing pediatric obesity. Future research should focus on further evaluating the safety and efficacy of liraglutide in this vulnerable population to improve long-term health outcomes.
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