Department of Pediatrics, Center for Pediatric Obesity Medicine, University of Minnesota, Minneapolis, Minnesota, USA.
Clinical Development, Medical & Regulatory Affairs, Novo Nordisk Inc., Plainsboro, New Jersey, USA.
Pediatr Obes. 2023 Sep;18(9):e13061. doi: 10.1111/ijpo.13061. Epub 2023 Jun 1.
As childhood obesity prevalence increases, determining which patients respond to anti-obesity medications would strengthen personalized approaches to obesity treatment. In the SCALE Teens trial among pubertal adolescents with obesity (NCT02918279), liraglutide 3.0 mg (or maximum tolerated dose) significantly reduced body mass index (BMI) standard deviation score on average versus placebo. That said, liraglutide effects on BMI reduction varied greatly among adolescents, similar to adults.
To identify post hoc characteristics predictive of achieving ≥5% and ≥10% BMI reductions at 56 weeks with liraglutide versus placebo in adolescents from the SCALE Teens trial.
Logistic regression analysis was performed in 251 adolescents treated with liraglutide (n = 125) or placebo (n = 126) for 56 weeks. Baseline characteristics (selected a priori) included sex, race, ethnicity, age, Tanner (pubertal) stage, glycemic status (hyperglycemia [type 2 diabetes/prediabetes] vs. normoglycemia), obesity category (Class II/III vs. I), severity of depression symptoms (Patient Health Questionnaire-9), and weight variability (weight fluctuations over time). The effects of early responder status (≥4% BMI reduction at week 16) on week 56 response were assessed using descriptive statistics.
Baseline characteristics did not affect achievement of ≥5% and ≥10% BMI reductions at week 56 in adolescents treated with liraglutide. Further, there was no association between weight variability and BMI reduction. Early liraglutide responders appeared to have greater BMI and body weight reductions at week 56 compared with early non-responders.
This secondary analysis suggests that adolescents with obesity may experience significant BMI reductions after 56 weeks of liraglutide treatment, regardless of their sex, race, ethnicity, age, pubertal stage, glycemic status, obesity category, severity of depression symptoms, or weight variability. Early response may predict greater week 56 response.
随着儿童肥胖症患病率的增加，确定哪些患者对减肥药物有反应将加强肥胖症治疗的个性化方法。在一项针对青春期肥胖青少年的 SCALE Teens 试验（NCT02918279）中，与安慰剂相比，利拉鲁肽 3.0mg（或最大耐受剂量）平均显著降低了体重指数（BMI）标准差评分。也就是说，利拉鲁肽对青少年 BMI 降低的影响差异很大，与成年人相似。
确定事后特征，以预测青少年接受利拉鲁肽与安慰剂治疗 56 周时，达到 BMI 降低≥5%和≥10%的可能性。
对接受利拉鲁肽（n=125）或安慰剂（n=126）治疗 56 周的 251 名青少年进行逻辑回归分析。基线特征（预先选择）包括性别、种族、民族、年龄、Tanner（青春期）阶段、血糖状态（高血糖[2 型糖尿病/糖尿病前期]与正常血糖）、肥胖类别（II/III 类与 I 类）、抑郁症状严重程度（患者健康问卷-9）和体重波动（随时间的体重波动）。使用描述性统计评估早期应答者状态（第 16 周 BMI 降低≥4%）对第 56 周反应的影响。
基线特征不影响青少年接受利拉鲁肽治疗后第 56 周达到≥5%和≥10%BMI 降低的可能性。此外，体重波动与 BMI 降低之间没有关联。与早期非应答者相比，早期利拉鲁肽应答者在第 56 周时 BMI 和体重减轻幅度更大。
这项二次分析表明，肥胖青少年在接受利拉鲁肽治疗 56 周后可能会显著降低 BMI，无论其性别、种族、民族、年龄、青春期阶段、血糖状态、肥胖类别、抑郁症状严重程度或体重波动如何。早期反应可能预测第 56 周更大的反应。
