Semaglutide versus placebo in individuals with poor weight loss after bariatric surgery: a double-blinded, randomized, placebo-controlled trial.

Here a double-blinded, randomized (1:1), placebo-controlledtrial using semaglutide 2.4 mg weekly (BARI-STEP) recruited adult participants at least 1 year after gastric bypass or sleeve gastrectomy with a suboptimal clinical response, defined as less than 20% weight loss from surgery.

这里进行了一项双盲、随机（1:1）、安慰剂对照试验，使用每周2.4毫克的司美格鲁肽（BARI-STEP），招募了至少在胃旁路或袖状胃切除术后1年以上的成年参与者，其临床反应不佳，定义为手术后体重减轻少于20%。

This was an adjunct to lifestyle intervention with a 500-kcal daily energy deficit.

这是对生活方式干预的补充，每天有500千卡的能量赤字。

The primary outcome was percentage weight loss after 68-week treatment on an intention-to-treatanalysis.

主要结果是在68周治疗后，按意向治疗分析的体重百分比减轻。

Seventy participants (mean (s.d.) age = 47.3 (10.3) years, 58 (82.9%) female and 12 (17.1%) male) were randomized to receive 2.4 mg semaglutide (n = 35) or placebo (n = 35).

共有70名参与者（平均年龄（标准差）= 47.3（10.3）岁，女性58人（82.9%），男性12人（17.1%））被随机分配接受2.4毫克的司美格鲁肽（n = 35）或安慰剂（n = 35）。

The intention-to-treatsample included 63 participants.

意向性治疗样本包括63名参与者。

Estimated change in mean (s.d.) percentage weight loss from baseline to week 68 was -18.0 (9.2) with semaglutide 2.4 mg (n = 34) versus +0.4 (7.0) with placebo (n = 29).

从基线到第68周，使用2.4毫克司美格鲁肽的平均（标准差）体重百分比减轻估计为-18.0（9.2），而安慰剂组为+0.4（7.0）（司美格鲁肽组n=34，安慰剂组n=29）。

The mean adjusted treatment difference in percentage body weight change for semaglutide 2.4 mg versus placebo was -19.18 (95% confidence interval-23.4 to -14.8; P < 0.001).

司美格鲁肽2.4毫克与安慰剂相比，平均调整后的体重百分比变化差异为-19.18（95%置信区间-23.4至-14.8；P<0.001）。

Adverse events (AEs) were consistent with the known safety and tolerability profile of semaglutide, with no new safety concerns for the post-bariatric population.

不良事件(AEs)与司美格鲁肽已知的安全性和耐受性特征一致，对于接受过减肥手术的人群没有新的安全问题。

There were eight serious AEs, one suspected unexpected serious adverse reaction and no treatment-related deaths.

有八例严重不良事件，一例疑似意外严重不良反应，没有与治疗相关的死亡事件。

BARI-STEP demonstrates that in people with a suboptimal clinical response after MBS, semaglutide results in substantial and clinically significant body weight reduction along with improvement in metabolic parameters and quality of life, compared to placebo.

BARI-STEP 显示，在接受 MBS 后临床反应不佳的人群中，与安慰剂相比，司美格鲁肽能显著且具有临床意义地减轻体重，同时改善代谢参数和生活质量。

These findings suggest that semaglutide 2.4 mg is a safe and effective treatment option for this patient population.

这些发现表明，对于这一患者群体，司美格鲁肽 2.4 mg 是一种安全且有效的治疗选择。

ClinicalTrials.gov: NCT05073835 .

ClinicalTrials.gov: NCT05073835 .