A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 513 in Participants With Obesity
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Amgen
- 入组人数
- 82
- 试验地点
- 23
- 主要终点
- Number of Participants With Treatment-emergent Adverse Events (TEAE)
研究概览
简要总结
The primary objective of this study is to assess the safety and tolerability of AMG 513 after single and multiple doses.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants in the study will be males and females 18 to 65 years of age at the time of signing the informed consent with a body mass index (BMI) of 30.0 kg/m^2 to 40.0 kg/m^2 for Part A and BMI of 27.0 kg/m^2 to 40.0 kg/m^2 for Part B.
- •Females enrolled must be of non-childbearing potential.
排除标准
- •History and/or clinical evidence of diabetes mellitus, including hemoglobin A1c ≥ 6.5% and/or a fasting glucose of ≥ 126 mg/dL (7 mmol/L) at screening.
- •Triglycerides ≥ 5.65 mmol/L (i.e., 500 mg/dL) at screening.
研究组 & 干预措施
Single Ascending Dose (SAD) in Participants with Obesity (Part A)
In Part A participants will enroll into SAD cohorts and will be randomized to receive AMG 513 or placebo subcutaneously (SC) or intravenously (IV).
干预措施: Placebo (Drug)
Multiple Ascending Dose (MAD) in Participants with Overweight or Obesity (Part B)
In Part B participants will enroll into MAD cohorts and will be randomized to receive AMG 513 or placebo SC.
干预措施: Placebo (Drug)
Single Ascending Dose (SAD) in Participants with Obesity (Part A)
In Part A participants will enroll into SAD cohorts and will be randomized to receive AMG 513 or placebo subcutaneously (SC) or intravenously (IV).
干预措施: AMG 513 (Drug)
Multiple Ascending Dose (MAD) in Participants with Overweight or Obesity (Part B)
In Part B participants will enroll into MAD cohorts and will be randomized to receive AMG 513 or placebo SC.
干预措施: AMG 513 (Drug)
结局指标
主要结局
Number of Participants With Treatment-emergent Adverse Events (TEAE)
时间窗: Approximately 178 days (Part A) and 225 days (Part B)
Number of Participants With Treatment-emergent Adverse Events (TEAE)
时间窗: Day 1 up to approximately 150 days after last dose
次要结局
- Maximum Observed Drug Concentration (Cmax) of AMG 513(Day 1 up to Day 57)
- Time to Cmax (Tmax) of AMG 513(Day 1 up to Day 57)
- Area Under the Concentration-time Curve (AUC) of AMG 513(Day 1 up to Day 57)
- Maximum Observed Drug Concentration (Cmax) of AMG 513(Day 1 up to approximately 150 days after last dose)
- Time to Cmax (Tmax) of AMG 513(Day 1 up to approximately 150 days after last dose)
- Area Under the Concentration-time Curve (AUC) of AMG 513(Day 1 up to approximately 150 days after last dose)