A Multiple Dose Titration Study in Participants With Obesity or Overweight to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3305677
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 3
- 主要终点
- Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
研究概览
简要总结
The main purpose of this study is to learn about the safety and tolerability of LY3305677 when given to participants with obesity or overweight. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. Each enrolled participant will receive injections of LY3305677 or placebo given just under the skin. For each participant, the study will last about approximately 28 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants who are overtly healthy as determined by medical evaluation
- •Participants with stable weight for 3 months and body mass index of 27.0 and 50.0 kilograms per square meter (kg/m²)
排除标准
- •Have history of type 1 diabetes mellitus or type 2 diabetes mellitus, ketoacidosis, or hyperosmolar state or coma
研究组 & 干预措施
Placebo
Placebo administered SC
干预措施: Placebo (Drug)
LY3305677
LY3305677 administered subcutaneously (SC)
干预措施: LY3305677 (Drug)
结局指标
主要结局
Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
时间窗: Baseline through Week 20
A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
次要结局
- Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3305677(Predose up to 72 hours postdose)
- PK: Area Under the Concentration Versus Time Curve (AUC) of LY3305677(Predose up to 72 hours postdose)
- Pharmacodynamics (PD): Percentage change in Body Weight(Baseline through Week 20)