SCALE Kids
Trial question
What is the role of liraglutide in children with obesity?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
46.0% female
54.0% male
N = 82
82 patients (38 female, 44 male).
Inclusion criteria: children aged 6-12 years with obesity.
Key exclusion criteria: self-reported change in body weight > 5 kg within 90 days before screening; treatment with any medication for the indication of obesity within the past 90 days before screening; T1DM; secondary causes of obesity.
Interventions
N=56 liraglutide (subcutaneous dose of 3 mg once daily or maximum tolerated dose plus lifestyle intervention).
N=26 placebo (matching placebo plus lifestyle intervention).
Primary outcome
Mean reduction in body mass index at 56 weeks
5.8%
-1.6%
5.8 %
4.3 %
2.9 %
1.4 %
0.0 %
-1.4 %
-2.9 %
Liraglutide
Placebo
Significant
increase ▲
NNT = 13
Significantly greater reduction in mean BMI at 56 weeks (5.8% vs. -1.6%; MD 7.4, 95% CI 3.2 to 11.6).
Secondary outcomes
Significant increase in participants with ≥ 5% reduction in BMI at 52 weeks (46% vs. 9%; OR 6.3, 95% CI 1.4 to 28.8).
No significant difference in mean reduction in waist circumference at 52 weeks (2 cm vs. -1.3 cm; MD 3.4, 95% CI -2.7 to 9.4).
Safety outcomes
No significant difference in overall adverse events.
Significant difference in gastrointestinal adverse events (80% vs. 54%).
Conclusion
In children aged 6-12 years with obesity, liraglutide was superior to placebo with respect to mean reduction in BMI at 56 weeks.
Reference
Claudia K Fox, Margarita Barrientos-Pérez, Eric M Bomberg et al. Liraglutide for Children 6 to <12 Years of Age with Obesity - A Randomized Trial. N Engl J Med. 2025 Feb 6;392(6):555-565.
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