A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY4060874 in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 121
- 试验地点
- 2
- 主要终点
- Number of Participants With One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
研究概览
简要总结
The purpose of this study is to evaluate safety and tolerability of LY4060874 in healthy participants.
Study participation may last up to 22 weeks and up to approximately 18 study visits.
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
- •Are overtly healthy as determined by medical evaluation, including medical history and physical examination.
- •Have a body mass index in the range of 20 to 29.9 kilogram per meter squared (kg/m²), inclusive, at screening.
- •To qualify as Chinese for this study, all 4 of the participant's biological grandparents must be of exclusive Chinese descent and born in China.
- •To qualify as a participant of first-generation Japanese origin, the participant, the participant's biological parents, and all the participants' biological grandparents must be of exclusive Japanese descent and born in Japan.
排除标准
- •Have a history of or have been diagnosed with Type 1 or Type 2 diabetes mellitus.
- •Have hemoglobin A1c (HbA1c) > 6.4% or 46 millimoles/mole (mmol/mol) at screening.
- •Have taken approved, including over the counter (OTC) or prescribed, medication or investigational medication for weight loss, including GLP-1 receptor agonists, within the previous 3 months of study screening.
- •Have had surgical treatment for obesity.
- •Are actively participating in a weight loss program or intend to initiate an intensive diet and/or exercise program during the study.
研究组 & 干预措施
LY4060874 (Part A Intravenous)
Single ascending dose of LY4060874 administered intravenously (IV).
干预措施: LY4060874 (Drug)
Placebo (SC)
Placebo administered SC in Part A, B, and C.
干预措施: Placebo (Drug)
Placebo (IV)
Placebo administered IV in Part A.
干预措施: Placebo (Drug)
LY4060874 (Part B Chinese)
Multiple ascending doses of LY4060874 administered SC in Chinese participants.
干预措施: LY4060874 (Drug)
LY4060874 (Part C Japanese)
Multiple ascending doses of LY4060874 administered SC in Japanese participants.
干预措施: LY4060874 (Drug)
LY4060874 (Part A Subcutaneous)
Single ascending dose of LY4060874 administered subcutaneously (SC).
干预措施: LY4060874 (Drug)
LY4060874 (Part B)
Multiple ascending doses of LY4060874 administered SC.
干预措施: LY4060874 (Drug)
结局指标
主要结局
Number of Participants With One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
时间窗: Baseline up to 22 Weeks
Number of participants with one or more TEAEs and SAEs.
次要结局
- Pharmacokinetics (PK): Area Under the Concentration Versus Time (AUC) of LY4060874(PK: Part A: Baseline up to 13 weeks; Part B and C: Baseline up to 18 weeks)
- PK: Maximum Observed Concentration of LY4060874(PK: Part A: Baseline up to 13 weeks; Part B and C: Baseline up to 18 weeks)