Liraglutide Efficacious, Safe for Children Aged 6 to
By Elana Gotkine HealthDay Reporter
THURSDAY, Sept. 12, 2024 -- Liraglutide plus lifestyle intervention is efficacious for children aged 6 to <12 years with obesity, according to a study published online Sept. 10 in the New England Journal of Medicine to coincide with the European Association for the Study of Diabetes Congress, held Sept. 9 to 13 in Madrid.
Claudia K. Fox, M.D., from the University of Minnesota Medical School in Minneapolis, and colleagues conducted a phase 3a trial consisting of a 56-week treatment period and a 26-week follow-up period to examine the safety and efficacy of liraglutide in children aged 6 to <12 years. Participants were randomly assigned to receive once-daily subcutaneous liraglutide or placebo (56 and 26, respectively) plus lifestyle interventions.
The researchers found that at week 56, the mean percentage change from baseline in body mass index (BMI) was −5.8 and 1.6 percent with liraglutide and placebo, respectively, representing an estimated difference of −7.4 percentage points. The mean percentage change in body weight was 1.6 and 10.0 percent with liraglutide and placebo, respectively, representing an estimated difference of −8.4 percentage points. A reduction in BMI of at least 5 percent occurred in 46 and 9 percent in the liraglutide and placebo groups, respectively (adjusted odds ratio, 6.3). In the liraglutide and placebo groups, adverse events occurred in 89 and 88 percent; gastrointestinal adverse events occurred in 80 and 54 percent; and serious adverse events were reported in 12 and 8 percent, respectively.
"In this trial, liraglutide was superior to placebo with regard to the percentage change from baseline in BMI and body weight," the authors write.
The study was funded by Novo Nordisk and the authors disclosed ties to the pharmaceutical industry.
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Posted September 2024
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