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一项旨在了解索马鲁肽如何帮助体重超过健康体重范围的人的研究 (STEP12)

2026年4月24日 更新者：Novo Nordisk A/S

索马鲁肽 2.4 mg 每周一次对超重和肥胖成人的疗效和安全性

这项研究将探讨索马鲁肽的研究剂量如何帮助体重超标的人减肥。 这项研究将比较服用索马鲁肽的人和服用“模拟”药物（安慰剂）的人的体重减轻情况。 研究将持续约1年。 参与者将在诊所进行 12 次就诊，并通过电话与研究医生或工作人员进行 3 次远程就诊。

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

242

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 中国
    • Beijing Municipality
      • Beijing、Beijing Municipality、中国、100730
        • Beijing Hospital
    • Chongqing Municipality
      • Chongqing、Chongqing Municipality、中国、404000
        • Chongqing University Three Gorges Hospital
    • Fujian
      • Fuzhou、Fujian、中国、350001
        • Fujian Medical University Union Hospital-Endocrinology
    • Guangdong
      • Huizhou、Guangdong、中国、516001
        • Huizhou Central People's Hospital-Endocrinology
    • Hebei
      • Hengshui、Hebei、中国、053000
        • Hengshui People's Hospital (Harrison International Peace Hospital)-Endocrinology
    • Hubei
      • Shiyan、Hubei、中国、442008
        • Shiyan Taihe Hospital (Affiliated Hospital of Hubei University of Medicine)-Endocrinology
    • Jiangsu
      • Changzhou、Jiangsu、中国、213003
        • Changzhou No.2 People's Hospital, Yanghu Branch
      • Nanjing、Jiangsu、中国、210011
        • The Second Affiliated Hospital of Nanjing Medical University_Nanjing
      • Nanjing、Jiangsu、中国、210011
        • The Second Affiliated Hospital of Nanjing Medical University-Endocrinology
      • Zhenjiang、Jiangsu、中国、212001
        • The Affiliated Hospital of Jiangsu University-Endocrinology
    • Jilin
      • Changchun、Jilin、中国、130061
        • The First Bethune hospital of Jilin University-Endocrinology
    • Qinghai
      • Xining、Qinghai、中国、810007
        • Qinghai Provincial People's Hospital
    • Shandong
      • Jinan、Shandong、中国、250013
        • Jinan Central Hospital
    • Shanghai Municipality
      • Shanghai、Shanghai Municipality、中国、201200
        • Shanghai Pudong New Area People's Hospital-Endocrinology
      • Shanghai、Shanghai Municipality、中国、200240
        • Shanghai Fifth People's Hospital-Endocrinology
      • Shanghai、Shanghai Municipality、中国、200336
        • Tongren Hospital Shanghai Jiao Tong University School of Medicine
  • 台湾
      • Chiayi City、台湾、600
        • Ditmanson Medical Foundation Chia-Yi Christian Hospital
      • Taichung、台湾、404
        • China Medical University Hospital
      • Tainan、台湾、704
        • National Cheng Kung University Hospital
      • Taipei、台湾、110
        • Taipei Medical University Hospital
      • Taipei、台湾、100
        • National Taiwan University Hospital_main

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

纳入标准：

  • 签署知情同意书时年龄大于或等于 18 岁。
  • 体重指数 (BMI) 大于或等于 24 且小于 28 千克每平方米 (kg/m^2)，且存在至少一种与体重相关的并发症（已治疗或未治疗）：2 型糖尿病 (T2D) 、高血压、血脂异常、阻塞性睡眠呼吸暂停或心血管疾病或 BMI 大于或等于 28 且大于 30 kg/m^2，筛查时有或没有与体重相关的并发症。
  • 至少有过一次自我报告的减肥饮食努力失败的历史。

对于筛选时患有 T2D 的参与者：

- 在筛查日前 180 天以上被诊断患有 T2D

用以下任一方法治疗：

  • 单独饮食和运动或根据当地情况与 1-3 种市售口服抗糖尿病药物（二甲双胍、α 葡萄糖苷酶、磺酰脲类 (SU)、格列奈类、钠-葡萄糖共转运蛋白 2 抑制剂 (SGLT2i) 或格列酮作为单药或联合用药）联合使用标签。
  • 筛选前，口服抗糖尿病药物治疗应稳定（相同药物或活性成分、剂量和给药频率）至少 60 天
  • 中心实验室在筛选时测得的糖化血红蛋白 (HbA1c) 小于或等于 10.0%（小于或等于 86 毫摩尔每摩尔 [mmol/mol]）。

排除标准：

  • 无论医疗记录如何，筛查前 90 天内自我报告的体重变化大于 5 公斤 (kg)。
  • 在筛查前的过去 90 天内接受过任何针对肥胖指征的药物治疗。
  • 个人或一级亲属有多发性内分泌肿瘤 2 型或甲状腺髓样癌病史。

对于筛选时没有 T2D 的参与者：

- 实验室测量的 HbA1c 大于或等于 6.5% (48 mmol/mol)。

对于筛选时患有 T2D 的参与者：

  • 肾功能损害，估计肾小球滤过率 (eGFR) 值低于每分钟每 1.73 平方米 30 毫升 (mL/min/1.73 m^2) 根据慢性肾病流行病学协作 (CKD-EPI) 肌酐方程，由中心实验室在筛查时根据肾病改善全球成果 (KDIGO) 2012 年分类定义。
  • 不受控制且可能不稳定的糖尿病视网膜病变或黄斑病变。 通过筛选前 90 天内或筛选与随机分组之间进行的眼底检查进行验证。 除非使用指定用于非散瞳检查的数字眼底摄影相机，否则需要药理学散瞳。

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
实验性的：索马鲁肽 2.4 毫克 (mg)
参与者将每周接受一次皮下 (s.c) 注射索马鲁肽，持续 44 周。
药品：索马鲁肽
每周一次皮下注射索马鲁肽，每四周逐渐增加剂量，直至达到 2.4 mg 索马鲁肽的维持剂量。
安慰剂比较：安慰剂
参与者将每周接受一次皮下 (s.c) 安慰剂注射，持续 44 周。
药品：安慰剂
安慰剂每周一次皮下注射，剂量递增，每四周一次，直至达到相当于 2.4 mg 的安慰剂维持剂量。

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Change in Body Weight (%)
大体时间：Baseline (week 0), end of treatment (week 44)
Percentage change in body weight from baseline (week 0) to end of treatment (week 44) is presented.
Baseline (week 0), end of treatment (week 44)
Number of Participants Who Achieved Body Weight Reduction Greater Than or Equal to (≥) 5% (Yes/No)
大体时间：At end of treatment (week 44)
Number of participants who achieved ≥5% body weight reduction at the end of treatment (week 44) is presented. In the reported data, 'Yes' infers the number of participants who have achieved greater than or equal to 5% weight reduction, whereas 'No' infers the number of participants who have not achieved greater than or equal to 5% weight reduction.
At end of treatment (week 44)

次要结果测量

结果测量
措施说明
大体时间
Number of Participants Who Achieved Body Weight Reduction ≥ 10% (Yes/No)
大体时间：At end of treatment (week 44)
Number of participants who achieved ≥10% body weight reduction at the end of treatment (week 44) is presented. In the reported data, 'Yes' infers the number of participants who have achieved greater than or equal to 10% weight reduction, whereas 'No' infers the number of participants who have not achieved greater than or equal to 10% weight reduction.
At end of treatment (week 44)
Change in Waist Circumference
大体时间：Baseline (week 0), end of treatment (week 44)
Change in waist circumference from baseline (week 0) to end of treatment (week 44) is presented.
Baseline (week 0), end of treatment (week 44)
Change in Body Weight (kg)
大体时间：Baseline (week 0), end of treatment (week 44)
Change in body weight in kilogram (kg) from baseline (week 0) to end of treatment (week 44) is presented.
Baseline (week 0), end of treatment (week 44)
Change in Body Mass Index
大体时间：Baseline (week 0), end of treatment (week 44)
Change in body mass index from baseline (week 0) to end of treatment (week 44) is presented.
Baseline (week 0), end of treatment (week 44)
Change in Waist-height Ratio (WtHR)
大体时间：Baseline (week 0), end of treatment (week 44)
Change in waist-height ratio (WtHR) from baseline (week 0) to end of treatment (week 44) is presented.
Baseline (week 0), end of treatment (week 44)
Change in Systolic Blood Pressure
大体时间：Baseline (week 0), end of treatment (week 44)
Change in systolic blood pressure from baseline (week 0) to end of treatment (week 44) is presented.
Baseline (week 0), end of treatment (week 44)
Change in Diastolic Blood Pressure
大体时间：Baseline (week 0), end of treatment (week 44)
Change in diastolic blood pressure from baseline (week 0) to end of treatment (week 44) is presented
Baseline (week 0), end of treatment (week 44)
Change in Total Cholesterol (mmol/L) - Ratio to Baseline
大体时间：Baseline (week 0), end of treatment (week 44)
Change in total cholesterol measured in millimoles per liter (mmol/L) from baseline (week 0) to end of treatment (week 44) is presented as ratio to baseline.
Baseline (week 0), end of treatment (week 44)
Change in High Density Lipoprotein (HDL) Cholesterol (mmol/L) - Ratio to Baseline
大体时间：Baseline (week 0), end of treatment (week 44)
Change in high density lipoprotein (HDL) cholesterol measured in mmol/L from baseline (week 0) to end of treatment (week 44) is presented as ratio to baseline.
Baseline (week 0), end of treatment (week 44)
Change in Low Density Lipoprotein (LDL) Cholesterol (mmol/L) - Ratio to Baseline
大体时间：Baseline (week 0), end of treatment (week 44)
Change in low density lipoprotein (LDL) cholesterol measured in mmol/L from baseline (week 0) to end of treatment (week 44) is presented as ratio to baseline.
Baseline (week 0), end of treatment (week 44)
Change in Very Low-Density Lipoproteins (VLDL) Cholesterol (mmol/L) - Ratio to Baseline
大体时间：Baseline (week 0), end of treatment (week 44)
Change in VLDL cholesterol measured in mmol/L from baseline (week 0) to end of treatment (week 44) is presented as ratio to baseline.
Baseline (week 0), end of treatment (week 44)
Change in Triglycerides (mmol/L) - Ratio to Baseline
大体时间：Baseline (week 0), end of treatment (week 44)
Change in triglycerides measured in mmol/L from baseline (week 0) to end of treatment (week 44) is presented as ratio to baseline.
Baseline (week 0), end of treatment (week 44)
Change in Free Fatty Acids (mmol/L) - Ratio to Baseline
大体时间：Baseline (week 0), end of treatment (week 44)
Change in free fatty acids measured in mmol/L from baseline (week 0) to end of treatment (week 44) is presented as ratio to baseline.
Baseline (week 0), end of treatment (week 44)
Change in High Sensitivity C-Reactive Protein (hsCRP) - Ratio to Baseline
大体时间：Baseline (week 0), end of treatment (week 44)
Change in high sensitivity C-Reactive Protein (hsCRP) measured in milligram per litre (mg/L) from baseline (week 0) to end of treatment (week 44) is presented as ratio to baseline.
Baseline (week 0), end of treatment (week 44)
Change in HbA1c (%)
大体时间：Baseline (week 0), end of treatment (week 44)
Change in glycosylated haemoglobin (HbA1c) in percentage from baseline (week 0) to end of treatment (week 44) is presented.
Baseline (week 0), end of treatment (week 44)
Change in HbA1c (mmol/Mol)
大体时间：Baseline (week 0), end of treatment (week 44)
Change in HbA1c measured in millimoles per mole (mmol/mol) from baseline (week 0) to end of treatment (week 44) is presented.
Baseline (week 0), end of treatment (week 44)
Change in Fasting Plasma Glucose (mg/dL)
大体时间：Baseline (week 0), end of treatment (week 44)
Change in fasting plasma glucose (FPG) measured in milligrams per deciliter (mg/dL) from baseline (week 0) to end of treatment (week 44) is presented.
Baseline (week 0), end of treatment (week 44)
Change in Fasting Plasma Glucose (mmol/L)
大体时间：Baseline (week 0), end of treatment (week 44)
Change in FPG measured in mmol/L from baseline (week 0) to end of treatment (week 44) is presented.
Baseline (week 0), end of treatment (week 44)
Number of Treatment Emergent Adverse Events (TEAEs)
大体时间：From baseline (week 0) to end of study (week 49)
Number of TEAEs from baseline (week 0) to end of study (week 49) is presented. An adverse event is any untoward medical occurrence in a clinical trial participant that is temporally associated with the use of an investigational medicinal product (IMP), whether or not considered related to the IMP.
From baseline (week 0) to end of study (week 49)
Number of Serious Adverse Events (SAEs)
大体时间：From baseline (week 0) to end of study (week 49)
Number of SAEs from baseline (week 0) to end of study (week 49) is presented. A serious adverse event (SAE) is any untoward medical occurrence that fulfils at least one of following criteria: results in death; is life-threatening; requires inpatient or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is congenital anomaly/birth defect; important medical event.
From baseline (week 0) to end of study (week 49)
Change in Pulse
大体时间：Baseline (week 0), end of treatment (week 44)
Change in pulse from baseline (week 0) to end of treatment (week 44) is presented.
Baseline (week 0), end of treatment (week 44)
Number of Clinically Significant Hypoglycaemic Episodes (Level 2) Less Than (<) 3.0 mmol/L Confirmed by Blood Glucose (BG) Meter - Participants With Type 2 Diabetes (T2D)
大体时间：From baseline (week 0) to end of study (week 49)
Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L) confirmed by BG meter for participants with T2D from baseline (week 0) to end of study (week 49) is presented. Clinically significant hypoglycaemia (level 2) is defined as plasma glucose value of less than 3.0 mmol/L (54 mg/dL) confirmed by BG meter.
From baseline (week 0) to end of study (week 49)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Novo Nordisk A/S

调查人员

  • 研究主任：Clinical Transparency (dept. 2834)、Novo Nordisk A/S

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2023年9月15日

初级完成 (实际的)

2025年4月2日

研究完成 (实际的)

2025年5月7日

研究注册日期

首次提交

2023年9月11日

首先提交符合 QC 标准的

2023年9月11日

首次发布 (实际的)

2023年9月18日

研究记录更新

最后更新发布 (实际的)

2026年5月18日

上次提交的符合 QC 标准的更新

2026年4月24日

最后验证

2026年4月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • NN9536-4706
  • U1111-1273-4538 (其他标识符：World Health Organization (WHO))

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

根据诺和诺德在novonordisktrials.com上的披露承诺

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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