Nature Reviews Gastroenterology & Hepatology ( IF 45.9 ) Pub Date : 2024-10-15 , DOI: 10.1038/s41575-024-01010-2 Eleni Kotsiliti
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).
中文翻译:
利拉鲁肽治疗肥胖儿童
一项 IIIa 期试验在 82 名肥胖儿童 (6 至 <12 岁) 中测试了胰高血糖素样肽 1 受体激动剂利拉鲁肽的安全性和有效性。儿童被随机分配 (2:1) 接受每日剂量 3 mg 利拉鲁肽(或最大耐受剂量)或安慰剂,并遵循生活方式干预。
治疗持续 56 周,随访 26 周。在第 56 周,达到主要终点,即体重指数 (BMI) 相对于基线的百分比变化:利拉鲁肽组,平均 BMI 百分比变化为 -5.8%,而安慰剂组为 1.6%(95% CI -11.6 至 -3.2,P < 0.001)。 次要终点是 BMI 降低至少 5%,在接受利拉鲁肽治疗的儿童中有 46% 和安慰剂组有 9% 的儿童中观察到 (校正比值比 6.3,95% CI 1.4-28.8,P = 0.02)。