创作:orchid 审核:szx 03月02日
  • 纳入1961名肥胖成年人,进行68周的每周一次皮下注射2.4mg索马鲁肽或安慰剂治疗;
  • 68周后,索马鲁肽组体重平均降低15.3kg(14.9%),安慰剂组降低2.6kg(2.4%);
  • 第68周,索马鲁肽组体重减少5%以上、10%以上及15%以上的比例分别为86.4%、69.1%及50.5%,显著高于对照组的31.5%、12.0%、4.9%;
  • 索马鲁肽显著降低腰围、BMI、血脂、血糖和血压等心血管代谢疾病风险因素,并改善生活质量;
  • 一些参与者出现短暂的轻中度恶心和腹泻等副作用。
New England Journal of Medicine上发表的一项随机双盲安慰剂对照临床试验,对近2000名肥胖成年人进行68周的干预,每周皮下注射一次索马鲁肽或安慰剂,结果发现,索马鲁肽可持续安全有效地降低体重,并可改善腰围、血脂、血糖、血压等心血管疾病风险因素,同时可提高生活质量。

Once-Weekly Semaglutide in Adults with Overweight or Obesity



02-10, Article

Abstract & Authors:展开

Background: Obesity 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. Methods: In 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. Results: The 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<0.001). More participants in the semaglutide group than in the placebo group achieved weight reductions of 5% or more (1047 participants [86.4%] vs. 182 [31.5%]), 10% or more (838 [69.1%] vs. 69 [12.0%]), and 15% or more (612 [50.5%] vs. 28 [4.9%]) at week 68 (P<0.001 for all three comparisons of odds). The change in body weight from baseline to week 68 was -15.3 kg in the semaglutide group as compared with -2.6 kg in the placebo group (estimated treatment difference, -12.7 kg; 95% CI, -13.7 to -11.7). Participants who received semaglutide had a greater improvement with respect to cardiometabolic risk factors and a greater increase in participant-reported physical functioning from baseline than those who received placebo. Nausea and diarrhea were the most common adverse events with semaglutide; they were typically transient and mild-to-moderate in severity and subsided with time. More participants in the semaglutide group than in the placebo group discontinued treatment owing to gastrointestinal events (59 [4.5%] vs. 5 [0.8%]). Conclusions: In participants with overweight or obesity, 2.4 mg of semaglutide once weekly plus lifestyle intervention was associated with sustained, clinically relevant reduction in body weight. (Funded by Novo Nordisk; STEP 1 number, NCT03548935).

First Authors:
John P H Wilding

Correspondence Authors:
Robert F Kushner

All Authors:
John P H Wilding,Rachel L Batterham,Salvatore Calanna,Melanie Davies,Luc F Van Gaal,Ildiko Lingvay,Barbara M McGowan,Julio Rosenstock,Marie T D Tran,Thomas A Wadden,Sean Wharton,Koutaro Yokote,Niels Zeuthen,Robert F Kushner,STEP Study Group