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In children (6 to <12 years of age) suffering from obesity, Liraglutide combined with lifestyle interventions effectively reduces body mass index.
A phase 3a randomized trial has revealed that the combination of Liraglutide and lifestyle interventions is highly useful to decrease body mass index (BMI) in obese children. This study sought to determine Liraglutide's safety and efficacy for treating nonmonogenic, nonsyndromic obesity in kids younger than 12 years, addressing a critical gap as no medications are currently authorized for this population.
Researchers enrolled 82 obesity-affected children. Volunteers were randomly divided in a 2:1 ratio to get either once-daily subcutaneous Liraglutide (up to 3.0 mg) or placebo, along with lifestyle adjustments. The trial consisted of a 56-week treatment phase. This was followed by a 26-week follow-up phase. Primary endpoints encompassed percentage alteration in BMI, while secondary endpoints measured body weight changes and a BMI reduction of at least 5%.
At week 56, those receiving Liraglutide achieved a remarkable mean BMI reduction of −5.8%, compared to a 1.6% increase in the placebo group, resulting in a significant difference of −7.4 percentage points. Similarly, body weight changes favored Liraglutide, with a modest 1.6% increase versus a substantial 10.0% gain in the placebo group, yielding a difference of −8.4 percentage points. Notably, 46% of Liraglutide-treated volunteers achieved a BMI reduction of at least 5%, compared to just 9% in the placebo group (adjusted odds ratio: 6.3).
In both groups, adverse events occurred at similar rates (89% with Liraglutide vs. 88% with placebo). However, gastrointestinal events such as nausea and vomiting were more prevalent in the Liraglutide group (80% vs. 54%). Severe side effects occurred in 12% of Liraglutide recipients compared to 8% in the placebo recipients. This trial establishes Liraglutide as a promising intervention for tackling obesity in children, demonstrating prominent reductions in BMI when combined with lifestyle changes.
The New England Journal of Medicine
Liraglutide for Children 6 to <12 Years of Age with Obesity — A Randomized Trial
Fox CK et al.
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