Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IBI362 in Overweight or Obese Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Number of treatment adverse events
研究概览
简要总结
This trial is conducted in China. The aim of this trial is to investigate Safety, Tolerability, PK and PD for Multiple Doses of IBI362 in Overweight or Obese Male and Female Subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have stable body weight for the past 12 weeks prior to screening
- •Have a body mass index (BMI) ≥24 kilograms per meter squared (kg/m²) with complication, or BMI≥28 kg/m²,inclusive at screening
- •Willing and agreeable to commit to the duration of the study and undergo study procedures as instructed by the clinic staff
排除标准
- •Have a diagnosis of type 2 diabetes
- •Have received prescription drugs or over the counter drugs that promote weight loss in the past 3 months prior to screening
- •Previous treatment with a GLP-1 (glucagon-like peptide 1) receptor agonists or GCG(glucagon)receptor agonists before.
- •Surgical treatment for obesity
- •Past or current chronic or idiopathic pancreatitis, or any of the following: -amylase or lipase above 2 times UNR (upper normal range), triglycerides above 500 mg/dL
- •Have other medical conditions or medical history that make participation in the study unsafe or which may interfere in the interpretation of the results of the study
- •Unwilling to comply with smoking and alcohol restrictions during the study
研究组 & 干预措施
IBI362
Participants received dose 1 level of IBI362 administered as multiple subcutaneous doses.
Participants received dose 2 level of IBI362 administered as multiple subcutaneous doses.
Participants received dose 3 level of IBI362 administered as multiple subcutaneous doses.
Participants received dose 4 level of IBI362 administered as multiple subcutaneous doses.
Participants received dose 5 level of IBI362 administered as multiple subcutaneous doses.
干预措施: IBI362 (Drug)
placebo
Participants received matching placebo dose regiments by subcutaneous injection
干预措施: Placebo (Drug)
结局指标
主要结局
Number of treatment adverse events
时间窗: From the time of first dosing (Day 1 ) until completion of the post treatment follow-up visit (20 week)
The relationship of each adverse event to the investigational product was assessed by the investigator.
次要结局
- Number of Participants With Anti-IBI362 Antibodies(From the time of first dosing (Day 1 )until comletion of the post treatment follow-up visit (20 week))
- Evaluate the C-peptide of IBI362 in overweight or obesity subjects;(From the first dose (Day 1 ) of study drug until 12 week)
- Change in body weight from baseline(Baseline (Day 1 ) and 12 week for groups)
- Evaluate the Peak Plasma Concentration (Cmax) of IBI362 in overweight or obesity subjects;(From the first dose (Day 1 ) of study drug until 12 week)
- Evaluate the Fasting Blood Glucose (FBG ) of IBI362 in overweight or obesity subjects;(From the first dose (Day 1 ) of study drug until 12 week)
- Evaluate the Glucagon of IBI362 in overweight or obesity subjects;(From the first dose (Day 1 ) of study drug until 12 week)
- Evaluate the Insulin of IBI362 in overweight or obesity subjects;(From the first dose (Day 1 ) of study drug until 12 week)
- Evaluate the Area under the plasma concentration versus time curve (AUC) of IBI362 in overweight or obesity subjects;(From the first dose (Day 1 ) of study drug until 12 week)