An Exploratory Study of Single-Dose and Multiple-Doses IBI3042 in Healthy, Overweight, or Obese Participants
2026年8月31日 更新者：Hongwei Jiang
An Exploratory Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single-Dose IBI3042 in Healthy or Overweight Participants and Multiple-Dose IBI3042 in Overweight or Obese Participants
The goal of this study is to learn about the safety and tolerability of IBI3042, an investigational oral drug that activates the glucagon-like peptide-1 (GLP-1) receptor. The study will also assess how IBI3042 moves through the body and explore its effects on body weight and related measures. Researchers will evaluate whether single and multiple oral doses of IBI3042 can be administered with acceptable safety and tolerability.
The study has two parts. In Part A, healthy or overweight participants will receive a single oral dose of IBI3042 or placebo. In Part B, overweight or obese participants will receive multiple oral doses of IBI3042 or placebo over 29 days. Participants will be assigned to different dose groups, and dose escalation will be guided by safety, tolerability, and available drug concentration data from earlier groups.
Participants will undergo safety assessments and blood sampling during the study. These assessments will include medical examinations, vital signs, laboratory tests, and electrocardiograms. In Part B, researchers will also assess changes in body weight, body mass index, waist circumference, and other metabolic measures.
研究概览
研究类型
介入性
注册 (估计的)
94
阶段
- 阶段1
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
- 姓名：Hongwei Jiang
- 电话号码：+86-0379-64830815
- 邮箱：jianghw@haust.edu.cn
学习地点
-
-
Hennan
-
Luoyang、Hennan、中国
- The First Affiliated Hospital of Henan University of Science and Technology
-
接触：
- Caie Wang
- 电话号码：+86-0379-64830815
- 邮箱：245454618@qq.com
-
-
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
接受健康志愿者
是的
描述
Inclusion Criteria:
- Aged 18 to 55 years, inclusive.
- For Part A: BMI ≥20 and<28 kg/m^2 and body weight ≥50 kg.
- For Part B: BMI ≥24 and ≤40 kg/m^2, with stable body weight during the 3 months prior to screening.
- Female participants of childbearing potential and male participants with female partners of childbearing potential must agree to use highly effective contraception during the study and for 90 days after the last dose.
- Able and willing to comply with study procedures and voluntarily provide written informed consent.
Exclusion Criteria:
- Known or suspected hypersensitivity to any component of the study drug or to GLP-1 receptor agonists.
- History of diabetes or abnormal glycemic parameters at screening.
- Personal or family history of thyroid C-cell carcinoma or multiple endocrine neoplasia syndrome type 2 (MEN 2A or 2B), or calcitonin ≥20 ng/L at screening.
- History of acute or chronic pancreatitis, or clinically significant pancreatic enzyme elevation at screening.
- Use of medications that may significantly affect gastrointestinal motility, appetite, or drug absorption within 3 months prior to screening.
- Clinically significant hematologic, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurologic disease that may increase study-related risk or interfere with study assessments.
- Clinically significant abnormalities in physical examination or laboratory tests at screening.
- History of malignancy within 5 years, except for basal cell or squamous cell skin cancer.
- Use of prescription or over-the-counter medications, dietary supplements, or herbal medicines within 2 weeks or 5 half-lives prior to screening, except as permitted by the protocol.
- Participation in another drug or medical device clinical study within 3 months prior to screening or within 5 half-lives of the investigational drug, as applicable.
- Any other condition that, in the investigator's opinion, makes the participant unsuitable for participation in the study.
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：顺序分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：IBI3042 treatment Group
|
IBI3042 is an investigational oral drug administered as single or multiple doses according to the study protocol.
|
|
实验性的：Placebo Control Group
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Matching oral placebo is administered as single or multiple doses according to the study protocol.
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Number of Participants With Adverse Events (Part A)
大体时间：Through study completion, an average of 29 days.
|
Through study completion, an average of 29 days.
|
|
Number of Participants With Abnormal Physical Examination Findings (Part A)
大体时间：Through study completion, an average of 29 days.
|
Through study completion, an average of 29 days.
|
|
Number of Participants With Clinically Significant Abnormal Vital Signs (Part A)
大体时间：Through study completion, an average of 29 days.
|
Through study completion, an average of 29 days.
|
|
Number of Participants With Clinically Significant Abnormal Laboratory Tests (Part A)
大体时间：Through study completion, an average of 29 days.
|
Through study completion, an average of 29 days.
|
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Number of Participants With Clinically Significant Abnormal Twelve-Lead Electrocardiogram Readings (Part A)
大体时间：Through study completion, an average of 29 days.
|
Through study completion, an average of 29 days.
|
|
Number of Participants With Adverse Events (Part B)
大体时间：Through study completion, an average of 57 days.
|
Through study completion, an average of 57 days.
|
|
Number of Participants With Abnormal Physical Examination Findings (Part B)
大体时间：Through study completion, an average of 57 days.
|
Through study completion, an average of 57 days.
|
|
Number of Participants With Clinically Significant Abnormal Vital Signs (Part B)
大体时间：Through study completion, an average of 57 days.
|
Through study completion, an average of 57 days.
|
|
Number of Participants With Clinically Significant Abnormal Laboratory Tests (Part B)
大体时间：Through study completion, an average of 57 days.
|
Through study completion, an average of 57 days.
|
|
Number of Participants With Clinically Significant Abnormal Twelve-Lead Electrocardiogram Readings (Part B)
大体时间：Through study completion, an average of 57 days.
|
Through study completion, an average of 57 days.
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Area under the blood concentration-time curve (AUC) (Part A)
大体时间：Through study completion, an average of 29 days.
|
Through study completion, an average of 29 days.
|
|
Peak Plasma Concentration (Cmax) (Part A)
大体时间：Through study completion, an average of 29 days.
|
Through study completion, an average of 29 days.
|
|
Time to Reach Peak Plasma Concentration (Tmax) (Part A)
大体时间：Through study completion, an average of 29 days.
|
Through study completion, an average of 29 days.
|
|
Apparent Clearance (CL/F) (Part A)
大体时间：Through study completion, an average of 29 days.
|
Through study completion, an average of 29 days.
|
|
Apparent Volume of Distribution (Vz/F) (Part A)
大体时间：Through study completion, an average of 29 days.
|
Through study completion, an average of 29 days.
|
|
Terminal Half-Life (T1/2) (Part A)
大体时间：Through study completion, an average of 29 days.
|
Through study completion, an average of 29 days.
|
|
Area Under the Plasma Concentration-Time Curve (AUC) (Part B)
大体时间：Through study completion, an average of 57 days.
|
Through study completion, an average of 57 days.
|
|
Peak Plasma Concentration (Cmax) (Part B)
大体时间：Through study completion, an average of 57 days.
|
Through study completion, an average of 57 days.
|
|
Time to Reach Peak Plasma Concentration (Tmax) (Part B)
大体时间：Through study completion, an average of 57 days.
|
Through study completion, an average of 57 days.
|
|
Apparent Clearance (CL/F) (Part B)
大体时间：Through study completion, an average of 57 days.
|
Through study completion, an average of 57 days.
|
|
Apparent Volume of Distribution (Vz/F) (Part B)
大体时间：Through study completion, an average of 57 days.
|
Through study completion, an average of 57 days.
|
|
Terminal Half-Life (T1/2) (Part B)
大体时间：Through study completion, an average of 57 days.
|
Through study completion, an average of 57 days.
|
|
Changes in body weight from baseline (Part B)
大体时间：Through study completion, an average of 57 days.
|
Through study completion, an average of 57 days.
|
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Percentage change in body weight from baseline (Part B)
大体时间：Through study completion, an average of 57 days.
|
Through study completion, an average of 57 days.
|
|
Percentage change in waist circumference from baseline (Part B)
大体时间：Through study completion, an average of 57 days.
|
Through study completion, an average of 57 days.
|
|
Percentage change in body mass index (BMI) from baseline (Part B)
大体时间：Through study completion, an average of 57 days.
|
Through study completion, an average of 57 days.
|
|
Body Mass Index (BMI) change from baseline (Part B)
大体时间：Through study completion, an average of 57 days.
|
Through study completion, an average of 57 days.
|
|
Changes in waist circumference from baseline (Part B)
大体时间：Through study completion, an average of 57 days.
|
Through study completion, an average of 57 days.
|
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。
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9月2日
初级完成 (估计的)
2027年3月20日
研究完成 (估计的)
2027年5月2日
研究注册日期
首次提交
2026年8月31日
首先提交符合 QC 标准的
2026年8月31日
首次发布 (实际的)
2026年9月3日
研究记录更新
最后更新发布 (实际的)
2026年9月3日
上次提交的符合 QC 标准的更新
2026年8月31日
最后验证
2026年8月1日
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.