A Study to Evaluate the Safety and Efficacy of Ecnoglutide Tablets in Chinese Participants With Overweight or Obesity
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
注册 (估计的)
阶段
- 阶段2
联系人和位置
学习联系方式
- 姓名:Yao Li
- 电话号码:010-67889253
- 邮箱:ra@sciwindbio.com
学习地点
-
-
Henan
-
Luoyang、Henan、中国
- The First Affiliated Hospital of Henan University of Science & Technology
-
接触:
- Hongwei Jiang
- 电话号码:010-67889253
- 邮箱:ra@sciwindbio.com
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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.);
- Self-declaration of body weight change <5% within 3 months prior to informed consent;
Exclusion Criteria:
- Diagnosis of overweight or obesity due to endocrine disorders , such as Cushing's syndrome;
- 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.
- 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.
- 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.
- History of major gastrointestinal surgery (except cholecystectomy or appendectomy), or metabolic surgery, or plan to undergo major surgery during the study period;
- HbA1c ≥6.5% or fasting blood glucose ≥7.0 mmol/L, or OGTT 2-hour blood glucose ≥11.1 mmol/L, at screening;
- Clinical laboratory test results with clinical significance
学习计划
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
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
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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.