A phase IIIa trial tested the safety and efficacy of liraglutide, a glucagon-like peptide 1 receptor agonist, in 82 children (6 to <12 years) with obesity. The children were randomly assigned (2:1) to receive a daily dose of 3 mg liraglutide (or the maximum tolerated dose) or placebo and follow lifestyle interventions.
The treatment lasted 56 weeks with a 26-week follow-up. In week 56, the primary endpoint was reached, which was the percentage change in body mass index (BMI) from baseline: in the liraglutide group, mean BMI percentage change was –5.8% versus 1.6% in the placebo group (95% CI –11.6 to –3.2, P < 0.001). The secondary endpoint was a BMI reduction of at least 5% and was observed in 46% of the children who received liraglutide and 9% of the children in the placebo group (adjusted odds ratio 6.3, 95% CI 1.4–28.8, P = 0.02).
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