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A Study to Evaluate the Safety and Efficacy of Ecnoglutide Tablets in Chinese Participants With Overweight or Obesity

2026年11月4日 更新者:Hangzhou Sciwind Biosciences Co., Ltd.

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Study to Evaluate the Safety and Efficacy of Oral Ecnoglutide Tablets in Chinese Participants With Overweight or Obesity

The aim of the study is to evaluate the safety and efficacy of oral ecnoglutide tablets in Chinese participants with overweight or obesity

研究概览

详细说明

In this study, eligible participants will be randomized to one of the four cohorts to receive either oral ecnoglutide tablet or placebo for up to 24 weeks, including a dose escalation period.

研究类型

介入性

注册 (估计的)

180

阶段

  • 阶段2

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。

学习联系方式

学习地点

    • Henan
      • Luoyang、Henan、中国
        • The First Affiliated Hospital of Henan University of Science & Technology
        • 接触:

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

18年 至 65年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. At the time of informed consent, BMI≥28.0 kg/m^2 regardless of comorbidities, or 24.0kg/m^2≤BMI<28.0 kg/m^2 with at least one of the comorbidities (prediabetes, hypertension, dyslipidemia, fatty liver, obstructive sleep apnea syndrome, weight-bearing joint pain, etc.);
  2. Self-declaration of body weight change <5% within 3 months prior to informed consent;

Exclusion Criteria:

  1. Diagnosis of overweight or obesity due to endocrine disorders , such as Cushing's syndrome;
  2. Diagnosis of other endocrine disorders with clinical significance, including but not limited to hyperthyroidism or hypothyroidism, thyroid nodules (imaging shows C-TIRADS≥ class 4A), Medullary thyroid carcinoma, or personal or family history of type 2 multiple endocrine tumor syndrome (MEN2), etc.
  3. Diagnosis of cardiovascular or cerebrovascular diseases with clinical significance within 6 months prior to screening, including but not limited to myocardial infarction, coronary angioplasty or bypass surgery, valvular heart disease or valve repair, unstable angina, transient ischemic attack, acute stroke, acute coronary syndrome, congestive heart failure classified as New York Heart Association class III or IV, clinically significant arrhythmias requiring treatment, and cerebrovascular accidents, etc.
  4. Diagnosis of gastrointestinal diseases with clinical significance within 6 months prior to screening, including but not limited to inflammatory bowel disease, active ulcers, irritable bowel syndrome, celiac disease, dyspepsia, clinical gastric emptying abnormalities (such as pyloric obstruction), etc.
  5. History of major gastrointestinal surgery (except cholecystectomy or appendectomy), or metabolic surgery, or plan to undergo major surgery during the study period;
  6. HbA1c ≥6.5% or fasting blood glucose ≥7.0 mmol/L, or OGTT 2-hour blood glucose ≥11.1 mmol/L, at screening;
  7. Clinical laboratory test results with clinical significance

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:oral ecnoglutide dose 1

once daily from week1 to week 8, then once weekly from week 9 to week 24

oral tablet

实验性的:oral ecnoglutide dose 2

once daily from week1 to week 8, then once weekly from week 9 to week 24

oral tablet

实验性的:oral ecnoglutide dose 3

once daily from week1 to week 12, then once weekly from week 13 to week 24

oral tablet

安慰剂比较:Placebo

once daily from week1 to week 8 or week 12, then once weekly from week 9 or week 13 to week 24

oral tablet

实验性的:oral ecnoglutide dose 4

once daily from week1 to week 12, then once weekly from week 13 to week 24

oral tablet

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Percentage Change in Body Weight
大体时间:Baseline, week 24
Baseline, week 24

次要结果测量

结果测量
措施说明
大体时间
Percentage of Participants with ≥5% of Body Weight Loss
大体时间:Baseline, week 24
Baseline, week 24
Percentage of Participants with ≥10% of Body Weight Loss
大体时间:Baseline, week 24
Baseline, week 24
Percentage of Participants with ≥15% of Body Weight Loss
大体时间:Baseline, week 24
Baseline, week 24
Absolute Change in Body Weight
大体时间:Baseline, week 24
Baseline, week 24
Change in Body Mass Index (BMI)
大体时间:Baseline, week 24
Baseline, week 24
Change in blood pressure
大体时间:Baseline, week 24
Baseline, week 24
Change in other body measurements
大体时间:Baseline, week 24

Body measurements include neck circumference, waist circumference, hip circumference

Baseline, week 24
Change in lipid profile
大体时间:Baseline, week 24

Include triglicerides, LDL-C, HDL-C, total cholesterol

Baseline, week 24
Change in fasting blood glucose (FBG)
大体时间:Baseline, week 24
Baseline, week 24
Change in HbA1c
大体时间:Baseline, week 24
Baseline, week 24
Change in fasting insulin
大体时间:Baseline, week 24
Baseline, week 24
Change in blood uric acid
大体时间:Baseline, week 24
Baseline, week 24
Change in liver enzymes
大体时间:Baseline, week 24

include ALT and AST

Baseline, week 24
Adverse events
大体时间:Week 1 to week 28 (EOS)
Week 1 to week 28 (EOS)
Plasma Concentration of Ecnoglutide
大体时间:Week 1 to week 28 (EOS)
Week 1 to week 28 (EOS)

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。

调查人员

  • 首席研究员:Hongwei Jiang、The First Affiliated Hospital of Henan University of Science and Technology

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 (估计的)

2026年11月10日

初级完成 (估计的)

2027年9月3日

研究完成 (估计的)

2028年1月28日

研究注册日期

首次提交

2026年10月28日

首先提交符合 QC 标准的

2026年11月4日

首次发布 (实际的)

2026年11月10日

研究记录更新

最后更新发布 (实际的)

2026年11月10日

上次提交的符合 QC 标准的更新

2026年11月4日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

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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