Once-Weekly Semaglutide in Adults with Overweight or Obesity
Once-Weekly Semaglutide in Adults with Overweight or Obesity
复制标题
DOI：
10.1056/nejmoa2032183
复制
发表时间：
2021-03-18
影响因子：
158.5
通讯作者：
Kushner, Robert F.
中科院分区：
文献类型：
--
作者：
Wilding, John P. H.;Batterham, Rachel L.;Kushner, Robert F.
肥胖是一个全球性的健康挑战，几乎没有药物选择。肥胖成年人是否可以通过每周一次剂量为2.4 mg的semaglutide作为生活方式干预的辅助治疗来实现体重减轻尚未得到证实。我们招募了1961名成年人，（重量（公斤）除以身高（米）的平方）30或更大（≥ 27例，患有≥ 1种体重相关共存疾病），无糖尿病，并以2：1的比例将其随机分配至每周一次皮下semaglutide（剂量为2.4 mg）或安慰剂治疗68周，加生活方式干预。共同主要终点为体重变化百分比和体重减轻至少5%。主要被估量（反映临床试验目的的治疗效果的精确描述）评估效果，而不管治疗中止或补救干预。Semaglutide组从基线至第68周体重的平均变化为-14.9%，而安慰剂组为-2.4%，估计治疗差异为-12.4个百分点（95%置信区间[CI]，-13.4至-11.5; P
BACKGROUNDObesity is a global health challenge with few pharmacologic options. Whether adults with obesity can achieve weight loss with once-weekly semaglutide at a dose of 2.4 mg as an adjunct to lifestyle intervention has not been confirmed.METHODSIn this double-blind trial, we enrolled 1961 adults with a body-mass index (the weight in kilograms divided by the square of the height in meters) of 30 or greater (>= 27 in persons with >= 1 weight-related coexisting condition), who did not have diabetes, and randomly assigned them, in a 2:1 ratio, to 68 weeks of treatment with once-weekly subcutaneous semaglutide (at a dose of 2.4 mg) or placebo, plus lifestyle intervention. The coprimary end points were the percentage change in body weight and weight reduction of at least 5%. The primary estimand (a precise description of the treatment effect reflecting the objective of the clinical trial) assessed effects regardless of treatment discontinuation or rescue interventions.RESULTSThe mean change in body weight from baseline to week 68 was -14.9% in the semaglutide group as compared with -2.4% with placebo, for an estimated treatment difference of -12.4 percentage points (95% confidence interval [CI], -13.4 to -11.5; P