In children aged 6 to <12 years with obesity, liraglutide (3.0 mg daily, combined with lifestyle interventions) significantly reduced BMI and body weight compared to placebo with lifestyle interventions, though it was associated with increased gastrointestinal side effects.
PICO Summary
Population:
Children aged 6 to <12 years with obesity (BMI ≥95th percentile), without monogenic or syndromic obesity, enrolled from diverse global sites.
Intervention:
Liraglutide, initiated at 0.6 mg daily and titrated to a maximum of 3.0 mg daily over 56 weeks, combined with lifestyle interventions (diet and physical activity guidance).
Comparison:
Placebo combined with lifestyle interventions.
Outcome:
• Efficacy: Liraglutide led to a mean BMI reduction of −5.8% compared to an increase of 1.6% with placebo, yielding an estimated treatment difference of −7.4% (P < 0.001). Additionally, 46% of participants on liraglutide achieved at least a 5% BMI reduction versus 9% with placebo.
• Safety and Tolerability: Gastrointestinal events were more frequent with liraglutide (80%) compared to placebo (54%), with nausea and vomiting as common side effects. Serious adverse events were rare but included vomiting and colitis in the liraglutide group.
Clinical Summary
Main Finding:
Liraglutide demonstrated a significant benefit in reducing BMI and body weight in children with obesity, surpassing placebo outcomes when combined with lifestyle interventions.
Clinical Relevance:
This study highlights liraglutide’s potential as a treatment option for childhood obesity where lifestyle interventions alone are insufficient. It underscores the importance of managing obesity early to prevent lifelong metabolic complications. However, gastrointestinal tolerability is a consideration, especially as adherence may be affected by side effects like nausea and vomiting.
Study Overview:
• Type of Study: Phase 3a, double-blind, randomised, placebo-controlled trial.
• Sample Size & Population: 82 children aged 6 to <12 years; 56 received liraglutide, and 26 received placebo.
• Intervention Duration & Doses: Liraglutide was administered daily for 56 weeks, starting at 0.6 mg and titrating up to 3.0 mg or maximum tolerated dose.
• Comparison: Placebo plus lifestyle interventions.
Outcomes:
• Primary Measure (BMI): Liraglutide led to a BMI reduction of −5.8%, with a significant −7.4% difference from placebo (P < 0.001).
• Secondary Measure (Body Weight): Mean body weight reduction of 1.6% with liraglutide compared to a 10.0% increase in the placebo group.
• Safety Profile: Common adverse events included gastrointestinal disturbances, particularly during dose escalation, resulting in a higher discontinuation rate in the liraglutide group compared to placebo.
Considerations:
While liraglutide is effective in reducing BMI in children with obesity, the high frequency of gastrointestinal side effects may impact its acceptability and long-term adherence. Further studies assessing the long-term effects on growth, pubertal development, and metabolic outcomes are warranted.
Reference:
Fox, C.K., et al. (2024). “Liraglutide for Children 6 to <12 Years of Age with Obesity — A Randomized Trial.” New England Journal of Medicine. doi:10.1056/NEJMoa2407379
Disclosure:
This article on Hormone Insight was created with both human and AI assistance. The human expert editor reviewed the article before publication to ensure accuracy, quality, and clarity.
