A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3841136 in Healthy and Overweight Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 148
- 试验地点
- 1
- 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 LY3841136 in healthy and overweight participants. Blood tests will be performed to check how much LY3841136 gets into the bloodstream and how long it takes the body to eliminate it. This is a 2-part study and may last up to 14 and 28 weeks for each participant and may include 7 and 19 visits in parts A and B, 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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male participants who agree to use highly effective/effective methods of contraception and female participants not of childbearing potential
- •Have had a stable weight for the last 3 months
- •Have a body mass index (BMI) in the range of 18.5 to 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)
排除标准
- •Are women who are lactating
- •Have known allergies to related compounds of LY3841136 or any components of the formulation
- •Have a history of significant atopy (severe or multiple allergic manifestations), or clinically significant multiple or severe drug allergies, or severe posttreatment hypersensitivity reactions
- •Have been diagnosed with Type 1 or Type 2 diabetes mellitus
- •Have a history of chronic medical conditions involving the heart, liver, or kidneys
研究组 & 干预措施
LY3841136 (Part A)
Single ascending doses of LY3841136 administered subcutaneously (SC).
干预措施: LY3841136 (Drug)
LY3841136 (Part B)
Multiple ascending doses of LY3841136 administered SC.
干预措施: LY3841136 (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 14 weeks (Part A) & 28 weeks (Part B)
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
- PK: Maximum Observed Concentration (Cmax) of LY3841136(Predose through week 14 (Part A) & week 28 (Part B))
- Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3841136(Predose through week 14 (Part A) & week 28 (Part B))
- Pharmacodynamics (PD): Change From Baseline in Body Weight(Predose through week 28)