Department of Pediatrics and Center for Pediatric Obesity Medicine, University of Minnesota Medical School, Minneapolis, Minnesota, USA.
Division of Pediatric Endocrinology, Diabetes and Metabolism, Center for Pediatric Research in Obesity and Metabolism, University of Pittsburgh School of Medicine, UPMC Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania, USA.
Obesity (Silver Spring). 2023 Aug;31(8):2139-2149. doi: 10.1002/oby.23808. Epub 2023 Jul 9.
The aim of this study was to examine how improvement in BMI with the glucagon-like peptide-1 receptor agonist semaglutide translated to changes in BMI category in a post hoc analysis of the double-blind, phase 3a randomized controlled Semaglutide Treatment Effect in People with obesity (STEP) TEENS trial.
Adolescents with obesity received once-weekly subcutaneous semaglutide 2.4 mg or placebo plus lifestyle intervention, which comprised counseling in healthy nutrition and a goal of 60 minutes of moderate- to high-intensity physical activity per day. Achievement of an improvement in BMI category and attainment of normal-weight or overweight BMI by week 68 were analyzed using logistic regression models.
In the overall population, 44.9% of participants receiving semaglutide achieved weight reduction resulting in reclassification to a normal-weight or overweight BMI category versus 12.1% receiving placebo at week 68 (odds ratio: 22.7; 95% CI: 7.6-67.9). The proportion of semaglutide-treated participants in obesity class III decreased from 37.3% to 13.6% but increased with placebo. The odds ratio for achieving an improvement of at least one BMI category was significantly greater with semaglutide versus placebo (23.5; 95% CI: 9.9-55.5); an improvement of at least one BMI category was seen in 73.7% of participants receiving semaglutide compared with 19.0% of participants receiving placebo.
Semaglutide was highly effective in reducing BMI category. While on treatment, most trial participants' BMI improved by at least one category, and >40% reached a category below the obesity threshold.
本研究旨在通过对双盲、3a 期随机对照 Semaglutide 治疗肥胖症患者(STEP)TEENS 试验的事后分析,研究胰高血糖素样肽-1 受体激动剂司美格鲁肽改善体重指数(BMI)与 BMI 类别变化的关系。
肥胖青少年每周接受一次皮下注射司美格鲁肽 2.4mg 或安慰剂,同时进行生活方式干预,包括健康营养咨询和每天 60 分钟中高强度体力活动的目标设定。使用逻辑回归模型分析第 68 周时 BMI 类别改善的实现情况和达到正常体重或超重 BMI 的情况。
在总体人群中,与接受安慰剂的患者相比,接受司美格鲁肽治疗的患者中有 44.9%体重减轻,导致重新分类为正常体重或超重 BMI 类别,而接受安慰剂的患者只有 12.1%,第 68 周时的比值比为 22.7(95%置信区间:7.6-67.9)。肥胖 III 级的司美格鲁肽治疗参与者比例从 37.3%降至 13.6%,但安慰剂组则增加。与安慰剂相比,司美格鲁肽治疗组实现至少一个 BMI 类别改善的可能性显著更高(23.5;95%置信区间:9.9-55.5);接受司美格鲁肽治疗的参与者中有 73.7%改善了至少一个 BMI 类别,而接受安慰剂治疗的参与者中只有 19.0%。
司美格鲁肽对降低 BMI 类别非常有效。在治疗期间,大多数试验参与者的 BMI 至少改善了一个类别,超过 40%的参与者达到了肥胖阈值以下的类别。