美国明尼苏达大学医学院Claudia K. Fox团队研究了利拉鲁肽治疗6至12岁肥胖儿童的对BMI的改善效果。2024年9月10日出版的《新英格兰医学杂志》发表了这项成果。

目前尚无药物被批准用于治疗12岁以下儿童的非单基因、非综合征性肥胖。尽管利拉鲁肽的使用已被证明可以诱导肥胖成年人和青少年减肥，但其在儿童中的安全性和有效性尚未得到证实。

这项3a期临床试验包括56周的治疗期和26周的随访期，研究组以2:1的比例将肥胖儿童（6至<12岁）随机分配到每天一次皮下注射利拉鲁肽3.0mg（或最大耐受剂量）或安慰剂，再加上生活方式干预。主要终点是体重指数（BMI；体重（公斤）除以身高（米）的平方）的百分比变化。验证性次要终点是体重百分比变化，以及BMI至少降低5%。

共有82名参与者接受了随机分组；利拉鲁肽组56例，安慰剂组26例。在第56周，利拉鲁肽组和安慰剂组的BMI与基线相比的平均百分比变化分别为-5.8%和1.6%，估计差异为-7.4个百分点（95%置信区间[CI]，-11.6至-3.2；P<0.001）。利拉鲁肽组和安慰剂组的体重平均百分比变化分别为1.6%和10.0%，估计差异为-8.4个百分点（95%CI，-13.4至-3.3；P=0.001），利拉鲁肽组46%的参与者和安慰剂组9%的参与者的BMI至少降低了5%（调整后的比值比，6.3[95%CI，1.4至28.8]；P=0.02）。利拉鲁肽组和安慰剂组分别有89%和88%的参与者发生不良事件。利拉鲁肽组胃肠道不良事件更常见（80%对54%）；利拉鲁肽组和安慰剂组分别有12%和8%的参与者报告了严重不良事件。

研究结果表明，在肥胖儿童（6至<12岁）中，利拉鲁肽治疗56周加上生活方式干预比安慰剂加生活方式干预更能显著降低BMI。

附：英文原文

Title: Liraglutide for Children 6 to <12 Years of Age with Obesity — A Randomized Trial

Author: Claudia K. Fox, Margarita Barrientos-Pérez, Eric M. Bomberg, John Dcruz, Inge Gies, Nina M. Harder-Lauridsen, Muhammad Yazid Jalaludin, Kushal Sahu, Petra Weimers, Thomas Zueger, Silva Arslanian

Issue&Volume: 2024-09-10

Abstract:

BACKGROUND

No medications are currently approved for the treatment of nonmonogenic, nonsyndromic obesity in children younger than 12 years of age. Although the use of liraglutide has been shown to induce weight loss in adults and adolescents with obesity, its safety and efficacy have not been established in children.

METHODS

In this phase 3a trial, which consisted of a 56-week treatment period and a 26-week follow-up period, we randomly assigned children (6 to <12 years of age) with obesity, in a 2:1 ratio, to receive either once-daily subcutaneous liraglutide at a dose of 3.0 mg (or the maximum tolerated dose) or placebo, plus lifestyle interventions. The primary end point was the percentage change in the body-mass index (BMI; the weight in kilograms divided by the square of the height in meters). The confirmatory secondary end points were the percentage change in body weight and a reduction in BMI of at least 5%.

RESULTS

A total of 82 participants underwent randomization; 56 were assigned to the liraglutide group and 26 to the placebo group. At week 56, the mean percentage change from baseline in BMI was 5.8% with liraglutide and 1.6% with placebo, representing an estimated difference of 7.4 percentage points (95% confidence interval [CI], 11.6 to 3.2; P<0.001). The mean percentage change in body weight was 1.6% with liraglutide and 10.0% with placebo, representing an estimated difference of 8.4 percentage points (95% CI, 13.4 to 3.3; P=0.001), and a reduction in BMI of at least 5% occurred in 46% of participants in the liraglutide group and in 9% of participants in the placebo group (adjusted odds ratio, 6.3 [95% CI, 1.4 to 28.8]; P=0.02). Adverse events occurred in 89% and 88% of participants in the liraglutide and placebo groups, respectively. Gastrointestinal adverse events were more common in the liraglutide group (80% vs. 54%); serious adverse events were reported in 12% and 8% of participants in the liraglutide and placebo groups, respectively.

CONCLUSIONS

Among children (6 to <12 years of age) with obesity, treatment with liraglutide for 56 weeks plus lifestyle interventions resulted in a greater reduction in BMI than placebo plus lifestyle interventions.

DOI: NJ202409100000011

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2407379