A randomized, phase 3 trial found that liraglutide at 3.0 mg is safe and effective for treating obesity in children aged 6 to <12 years. The study, presented at the European Association for the Study of Diabetes (EASD) 2024 Annual Meeting in Madrid, is the first to examine liraglutide's safety and efficacy in this pediatric population.

Key findings from the SCALE Kids study included:

• Mean body mass index (BMI) change was -5.8% for liraglutide vs +1.6% for placebo (estimated treatment difference [ETD] = -7.4%; 95% confidence interval [CI] = -11.6 to -3.2; P=.0005)
• Mean body weight change was +1.6% for liraglutide vs +10.0% for placebo (ETD = -8.4%; 95% CI = -13.4 to -3.3; P=.0011)
• BMI reduction of ≥ 5% was seen in 46.2% of liraglutide recipients vs 8.7% of placebo recipients (odds ratio = 6.3; 95% CI = 1.4-28.8; P=.0183).

The multicenter, placebo-controlled trial enrolled 82 children (53.7% male) with obesity (BMI ≥ 95th percentile). At baseline, participants had a mean age of 10 years, a mean BMI of 31.0 kg/m2, and a mean body weight of 70.2 kg. More than half of participants (54.9%) had at least one obesity-related complication.

Participants were randomized 2:1 to receive daily subcutaneous injections of liraglutide (3 mg or maximum tolerated dose; n=56) or placebo (n=26) for 56 weeks. All children received individualized counseling on diet and physical activity.

Adverse events were common in both groups, with gastrointestinal toxicity being the most frequently reported side effect. Serious adverse events occurred in 12.5% of the liraglutide group and 7.7% of the placebo group. Treatment discontinuation due to adverse events was observed in 10.7% of liraglutide recipients and no placebo recipients.

Further research is needed to evaluate long-term outcomes and potential impacts on obesity-related complications in this age group. 

The lead study author received research support for serving as a site principal investigator for trials sponsored by Novo Nordisk and Eli Lilly, paid directly to her institution.  This study was funded by Novo Nordisk, the manufacturer of liraglutide.