A Phase I Study to Evaluate Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Characteristics of Single-Dose IBI3042 in Healthy Participants and Multiple-Dose IBI3042 in Overweight or Obese Participants
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 104
- 试验地点
- 2
- 主要终点
- Number of Participants With Adverse Events (Part A)
研究概览
简要总结
This is a Phase 1 study of IBI3042, an investigational oral medicine being developed as a potential treatment for overweight and obesity. The study has two parts. Part A will evaluate single doses of IBI3042 in healthy adults. Part B will evaluate repeated doses for 13 weeks in adults with overweight or obesity. The main goal is to assess the safety and tolerability of IBI3042. The study will also evaluate how IBI3042 is processed in the body and explore its effects on body weight and other metabolic measures. Some participants will receive placebo, and some Part B groups will also receive orforglipron for comparison.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 18 to 55 years, inclusive.
- •For Part A: BMI ≥20 and <30 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.
排除标准
- •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.
研究组 & 干预措施
Investigational Drug: IBI3042 (Part A)
IBI3042,oral. Corresponding dose regimen according to study cohort.
干预措施: IBI3042 (Drug)
Investigational Drug: IBI3042 (Part B)
IBI3042,oral. Corresponding dose regimen according to study cohort.
干预措施: IBI3042 (Drug)
Matching Placebo (Part B)
Placebo matching to IBI3042, oral. Corresponding dose regimen according to study cohort.
干预措施: Matching Placebo (Drug)
Orforglipron (Part B)
Orforglipron, oral. Corresponding dose regimen according to study cohort.
干预措施: Orforglipron (Drug)
Matching Placebo (Part A)
Placebo matching to IBI3042, oral. Corresponding dose regimen according to study cohort.
干预措施: Matching Placebo (Drug)
结局指标
主要结局
Number of Participants With Adverse Events (Part A)
时间窗: through study completion, an average of 29 days
Number of subjects with Adverse Event
Number of Participants With Abnormal Physical Examination Findings (Part A)
时间窗: through study completion, an average of 29 days
Number of participants with at least one clinically significant abnormal finding in physical examination. Physical examination includes general appearance, respiratory tract, cardiovascular, abdominal, skin, head and neck (ear, eye, nose, throat) , lymph node, thyroid, musculoskeletal (spine and extremities), and neurological assessments. Anogenital examination may be omitted as permitted per protocol.
Number of Participants With Clinically Significant Abnormal Vital Signs (Part A)
时间窗: through study completion, an average of 29 day
Number of participants with at least one clinically significant abnormal vital sign，including body temperature, pulse, respiratory rate and blood pressure.
Number of Participants With Clinically Significant Abnormal Laboratory Tests (Part A)
时间窗: through study completion, an average of 29 days
Number of participants with at least one clinically significant abnormal laboratory finding. Laboratory tests including blood routine, blood Biochemistry (including blood lipids), coagulation routine, urine routine, calcitonin, glycated hemoglobin (HbA1c), infection-related immunology tests, thyroid function tests, pregnancy test, serum follicle-stimulating hormone (FSH) .
Number of Participants With Clinically Significant Abnormal Twelve?Lead Electrocardiogram Readings (Part A)
时间窗: through study completion,an average of 29 days
Number of participants with at least one clinically significant abnormal finding on resting 12?lead electrocardiogram (ECG). Participants shall lie supine for at least 5 minutes prior to ECG acquisition and remain supine during ECG recording. Evaluated ECG parameters include RR interval, PR interval, heart rate, QT interval, and QTcF (QTcF=QT/RR\^0.33).
Number of Participants With Adverse Events (Part B)
时间窗: through study completion, an average of 113 days
Number of subjects with Adverse Event
Number of Participants With Abnormal Physical Examination Findings (Part B)
时间窗: through study completion, an average of 113 days
Number of participants with at least one clinically significant abnormal finding in physical examination. Physical examination includes general appearance, respiratory tract, cardiovascular, abdominal, skin, head and neck (ear, eye, nose, throat), lymph node, thyroid, musculoskeletal (spine and extremities), and neurological assessments. Anogenital examination may be omitted as permitted per protocol.
Number of Participants With Clinically Significant Abnormal Vital Signs (Part B)
时间窗: through study completion, an average of 113 days
Number of participants with at least one clinically significant abnormal vital sign, including body temperature, pulse, respiratory rate and blood pressure.
Number of Participants With Clinically Significant Abnormal Laboratory Tests (Part B)
时间窗: through study completion, an average of 113 days
Number of participants with at least one clinically significant abnormal laboratory finding. Laboratory tests include blood routine, blood biochemistry (including blood lipids), coagulation routine, urine routine, calcitonin, glycated hemoglobin (HbA1c), infection?related immunology tests, thyroid function tests, pregnancy test, serum follicle?stimulating hormone (FSH).
Number of Participants With Clinically Significant Abnormal Twelve?Lead Electrocardiogram Readings (Part B)
时间窗: through study completion, an average of 113 days
Number of participants with at least one clinically significant abnormal finding on resting 12?lead electrocardiogram (ECG). Participants shall lie supine for at least 5 minutes prior to ECG acquisition and remain supine during ECG recording. Evaluated ECG parameters include RR interval, PR interval, heart rate, QT interval, and QTcF (QTcF=QT/RR\^0.33).
次要结局
- Peak Plasma Concentration (Cmax) (Part A)(through study completion,an average of 29 days)
- Time to Reach Peak Plasma Concentration (Tmax) (Part A)(through study completion,an average of 29 days)
- Apparent Clearance (CL/F) (Part A)(through study completion,an average of 29 days)
- Apparent Volume of Distribution (Vz/F) (Part A)(through study completion,an average of 29 days)
- Area Under the Plasma Concentration?Time Curve (AUC) (Part A)(through study completion,an average of 29 days)
- Terminal Half-Life (T1/2) (Part A)(through study completion,an average of 29 days)
- Area Under the Plasma Concentration?Time Curve (AUC) (Part B)(through study completion, an average of 113 days)
- Peak Plasma Concentration (Cmax) (Part B)(through study completion, an average of 113 days)
- Time to Reach Peak Plasma Concentration (Tmax) (Part B)(through study completion, an average of 113 days)
- Apparent Clearance (CL/F) (Part B)(through study completion, an average of 113 days)
- Apparent Volume of Distribution (Vz/F) (Part B)(through study completion, an average of 113 days)
- Terminal Half-Life (T1/2) (Part B)(through study completion, an average of 113 days)
- Absolute and Percent Change From Baseline in Body Weight (Part B)(through study completion, an average of 113 days)
- Absolute and Percent Change From Baseline in Body Mass Index (BMI) (Part B)(through study completion, an average of 113 days)
- Absolute and Percent Change From Baseline in Waist Circumference (Part B)(through study completion, an average of 113 days)