A Phase 1, Randomized, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety, Tolerability, and PK of LY3541105 Following Single Doses in Healthy/Overweight Participants and Multiple Doses in Overweight Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 205
- 试验地点
- 2
- 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 evaluate the safety and tolerability of LY3541105 in healthy and overweight participants. Blood tests will be performed to check how much LY3541105 gets into the bloodstream and how long it takes the body to eliminate it. The study will also evaluate the effects of LY3541105 on body weight and assess safety and tolerability of LY3541105. This is a 3-part study and may last up to 15, 26 and 24 weeks for each participant and may include up to 7, 15 and 16 visits in parts A, B and C, respectively.
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
- 21 Years 至 65 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
- •Male participants who agree to refrain from sperm donation and to use contraceptive methods and female participants not of childbearing potential
- •Have a body mass index (BMI) in the range of greater than or equal to (>/=) 18.5 to less than (<) 32 kilogram per square meter (kg/m²), both inclusive (in Part A) or a BMI in the range of >/=27 to <40 kg/m², both inclusive (in Part B and C)
- •Have had a stable weight for the last 3 months
排除标准
- •Have history of diabetes (except gestational diabetes) or current diagnosis of diabetes
- •Clinically significant abnormal electrocardiogram (ECG) at screening, as judged by the Investigator
- •Have history or current evidence of a clinically significant cardiovascular condition
研究组 & 干预措施
Placebo (Part C)
Placebo administered SC.
干预措施: Placebo (Drug)
LY3541105 (Part A)
Single ascending doses of LY3541105 administered subcutaneously (SC).
干预措施: LY3541105 (Drug)
LY3541105 (Part B)
Multiple ascending doses of LY3541105 administered SC.
干预措施: LY3541105 (Drug)
LY3541105 (Part C)
Escalating doses of LY3541105 administered SC.
干预措施: LY3541105 (Drug)
Placebo (Part A)
Placebo administered SC.
干预措施: Placebo (Drug)
Placebo (Part B)
Placebo administered SC.
干预措施: Placebo (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: Predose up to 26 weeks
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): Area Under the Concentration Versus Time Curve (AUC) of LY3541105(Predose through day 43 (Part A) & day 78 (Part B))
- PK: Time of Maximum observed Concentration (Tmax) of LY3541105(Predose through day 43 (Part A) & day 78 (Part B))
- PK: Maximum Observed Concentration (Cmax) of LY3541105(Predose through day 43 (Part A) & day 78 (Part B))
- Pharmacodynamics (PD): Absolute and Percentage Change from Baseline in Body Weight(Predose through week 26 (Part B Only))