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Semaglutide in patients with overweight or obesity and chronic kidney disease without diabetes: a randomized double-blind placebo-controlled clinical trial
Nature Medicine ( IF 58.7 ) Pub Date : 2024-10-25 , DOI: 10.1038/s41591-024-03327-6
Ellen M. Apperloo, Jose L. Gorriz, Maria Jose Soler, Secundino Cigarrán Guldris, Josep M. Cruzado, Maria Jesús Puchades, Marina López-Martínez, Femke Waanders, Gozewijn D. Laverman, Annemarie van der Aart-van der Beek, Klaas Hoogenberg, André P. van Beek, Jacobien Verhave, Sofia B. Ahmed, Roland E. Schmieder, Christoph Wanner, David Z. I. Cherney, Niels Jongs, Hiddo J. L. Heerspink

Semaglutide reduces albuminuria and the risk of kidney disease progression in patients with type 2 diabetes and chronic kidney disease (CKD). We conducted a randomized placebo-controlled double-blind clinical trial in adults with CKD (estimated glomerular filtration rate (eGFR) ≥25 ml min−1 1.73 m2 and urine albumin-to-creatinine ratio (UACR) ≥30 and <3,500 mg g−1) and body mass index ≥27 kg m2. Participants were randomized to semaglutide 2.4 mg per week or placebo. The primary endpoint was percentage change from baseline in UACR at week 24. Safety was monitored throughout. Overall, 125 participants were screened, of whom 101 were randomized to semaglutide (n = 51) or placebo (n = 50). Mean age was 55.8 (s.d. 12) years; 40 participants (39.6%) were female; median UACR was 251 mg g−1 (interquartile range 100, 584); mean eGFR was 65.0 (s.d. 25) ml min−1 1.73 m2; and mean body mass index was 36.2 (s.d. 5.6) kg m2. Chronic glomerulonephritis (n = 25) and hypertensive CKD (n = 27) were the most common CKD etiologies. Treatment for 24 weeks with semaglutide compared to placebo reduced UACR by −52.1% (95% confidence interval −65.5, −33.4; P < 0.0001). Gastrointestinal adverse events were more often reported with semaglutide (n = 30) than with placebo (n = 15). Semaglutide treatment for 24 weeks resulted in a clinically meaningful reduction in albuminuria in patients with overweight/obesity and non-diabetic CKD. ClinicalTrials.gov registration: NCT04889183.



中文翻译:


索马鲁肽治疗超重或肥胖和无糖尿病的慢性肾病患者:一项随机双盲安慰剂对照临床试验



索马鲁肽可降低 2 型糖尿病和慢性肾病 (CKD) 患者的白蛋白尿和肾脏疾病进展的风险。我们在患有 CKD 的成人中进行了一项随机安慰剂对照双盲临床试验 (估计肾小球滤过率 (eGFR) ≥25 ml min-1、1.73 m-2 和尿白蛋白与肌酐比值 (UACR) ≥30 和 <3,500 mg g-1)和体重指数 ≥27 kg m-2。参与者被随机分配到每周 2.4 mg 的 semaglutide 组或安慰剂组。主要终点是第 24 周时 UACR 相对于基线的百分比变化。全程监控安全。总体而言,筛选了 125 名参与者,其中 101 名被随机分配到索马鲁肽组 (n = 51) 或安慰剂组 (n = 50)。平均年龄为 55.8 (s.d. 12) 岁;40 名参与者 (39.6%) 为女性;中位 UACR 为 251 mg g-1 (四分位距 100, 584);平均 eGFR 为 65.0 (s.d. 25) ml min-1 1.73 m-2;平均体重指数为 36.2 (s.d. 5.6) kg m-2。慢性肾小球肾炎 (n = 25) 和高血压性 CKD (n = 27) 是最常见的 CKD 病因。与安慰剂相比,用 semaglutide 治疗 24 周使 UACR 降低了 -52.1%(95% 置信区间 -65.5,-33.4;P < 0.0001).semaglutide (n = 30) 比安慰剂 (n = 15) 更常报告胃肠道不良事件。索马鲁肽治疗 24 周导致超重/肥胖和非糖尿病 CKD 患者的白蛋白尿有临床意义的减少。ClinicalTrials.gov 注册:NCT04889183。

更新日期:2024-10-26
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