Lofton Holly F, Maranga Gabrielle, Hold Robert, Fielding George, Youn Heekoung, Gujral Akash, Heffron Sean, Fielding Christine
Division of Bariatric Surgery, NYU Grossman School of Medicine, New York, New York; Division of Internal Medicine, NYU Grossman School of Medicine, New York, New York.
Division of Bariatric Surgery, NYU Grossman School of Medicine, New York, New York.
Surg Obes Relat Dis. 2025 Feb;21(2):135-145. doi: 10.1016/j.soard.2024.08.037. Epub 2024 Sep 10.
Bariatric surgery, such as Roux-en-Y gastric bypass (RYGB) remains the gold standard for treating obesity. Most people regain weight from postsurgery nadir.
Liraglutide 3.0 mg is approved for weight management. This study will examine the effects on liraglutide 3.0 mg on weight regain post-RYGB.
University Hospital, United States.
A 56-week, double-blind, placebo-controlled study was conducted in 132 subjects, who achieved ≥25% total body weight loss (TBWL) status-post-RYGB and regained ≥10% TBWL after reaching nadir weight (NW). Subjects 18-120 months post-RYGB were randomized to receive liraglutide 3.0 mg/d (n = 89) or placebo (n = 43) with lifestyle counseling regularly for 56 weeks. The co-primary endpoints were the proportion of subjects losing at least 5%, 10%, and 15% TBWL and achieving weight lower than their NW.
53.4% of the placebo group and 65% of the liraglutide group completed the trial due to Severe acute respiratory syndrome coronavirus 2 pandemic. The change in %TBWL from baseline to 56-weeks was -8.8 (8.5, -29.2 to 9.7) and 1.1 (3.5, -7.9 to 5.99) in the liraglutide and placebo groups, respectively. 76% and 17% of subjects achieved ≥5% TBWL at 56 weeks in the liraglutide and placebo groups, respectively; 51% and 26.0% of the liraglutide group achieved ≥10% and ≥15% TBWL, respectively. None of the placebo group lost ≥10% TBWL. Twenty-one percent of subjects receiving liraglutide surpassed postoperative NW. No subjects on placebo met this goal. Nonserious adverse events occurred in 41.6% of subjects on liraglutide. Serious adverse events (SAE) occurred less often on liraglutide.
Liraglutide was significantly more effective than placebo in treating weight regain that occurs post-RYGB without increased SAE.
减肥手术，如Roux-en-Y胃旁路术（RYGB）仍是治疗肥胖症的金标准。大多数人会从术后体重最低点开始体重反弹。
利拉鲁肽3.0毫克已被批准用于体重管理。本研究将探讨利拉鲁肽3.0毫克对RYGB术后体重反弹的影响。
美国大学医院。
对132名受试者进行了一项为期56周的双盲、安慰剂对照研究，这些受试者在RYGB术后实现了全身体重减轻（TBWL）≥25%，并在达到最低体重（NW）后体重反弹≥10%TBWL。RYGB术后18至120个月的受试者被随机分为接受利拉鲁肽3.0毫克/天（n = 89）或安慰剂（n = 43），并定期接受生活方式咨询，为期56周。共同主要终点是体重减轻至少5%、10%和15%TBWL并达到低于其NW体重的受试者比例。
由于严重急性呼吸综合征冠状病毒2大流行，安慰剂组53.4%和利拉鲁肽组65%的受试者完成了试验。利拉鲁肽组和安慰剂组从基线到56周时%TBWL的变化分别为-8.8（8.5，-29.2至9.7）和1.1（3.5，-7.9至5.99）。利拉鲁肽组和安慰剂组分别有76%和17%的受试者在56周时体重减轻≥5%TBWL；利拉鲁肽组分别有51%和26.0%的受试者体重减轻≥10%和≥15%TBWL。安慰剂组中没有受试者体重减轻≥10%TBWL。接受利拉鲁肽治疗的受试者中有21%超过了术后NW。安慰剂组中没有受试者达到这一目标。利拉鲁肽组41.6%的受试者发生了非严重不良事件。利拉鲁肽组发生严重不良事件（SAE）的频率较低。
在治疗RYGB术后发生的体重反弹方面，利拉鲁肽比安慰剂显著更有效，且未增加SAE。
