Summary:
In 82 children aged 6 to <12 years with obesity (BMI ≥95th percentile), without monogenic or syndromic causes, liraglutide titrated to max 3.0 mg daily for 56 weeks plus lifestyle intervention reduced BMI by 5.8% vs 1.6% increase with placebo (difference -7.4%, P<0.001), body weight -1.6% vs +10.0%, and 46% achieved ≥5% BMI reduction vs 9% compared to matching placebo plus identical lifestyle intervention, with common GI adverse events (80% vs 54%) including nausea and vomiting.
| PICO | Description |
|---|---|
| Population | 82 children aged 6 to <12 years with obesity (BMI ≥95th percentile). |
| Intervention | Liraglutide 0.6-3.0 mg daily for 56 weeks + lifestyle intervention. |
| Comparison | Matching placebo + identical lifestyle intervention. |
| Outcome | BMI -5.8% vs +1.6%. Weight -1.6% vs +10.0%. GI AEs 80% vs 54%. |
Liraglutide for Childhood Obesity
RCT · obesity, ages 6 to <12 · 56 weeks
Liraglutide reduced BMI by 7.4 percentage points versus placebo over 56 weeks, the first drug to show meaningful benefit in children aged 6 to <12. GI side effects were common.
Clinical Context
Childhood obesity has tripled over 4 decades. Lifestyle interventions achieve modest results; pharmacotherapy has been largely absent from pediatric management.
Clinical Pearls
1. Compare to Placebo Trajectory: Placebo group gained 10% weight; treatment difference is ~12% trajectory modification.
2. BMI Reduction Despite Growth Is Significant: Children still growing in height makes BMI reduction meaningful.
3. GI Tolerability Is a Real Concern: 80% experienced GI side effects; careful titration needed.
4. Daily Injection Is a Barrier: Once-weekly formulations may offer advantages if approved.
Practical Application
Consider when lifestyle insufficient after 3-6 months, BMI ≥95th with comorbidities or ≥99th percentile. Monitor growth and development.
Study Limitations
Small sample (82 children). 56-week duration. High GI adverse event rate. Long-term effects unknown.
Bottom Line
Liraglutide produces meaningful BMI reduction in children 6-11, providing first pharmacological option when lifestyle intervention alone insufficient.
Source: Fox CK, et al. “Liraglutide for Children 6 to <12 Years with Obesity." NEJM, 2024. Read article