NCT07225556进行中（未招募）1 期
A Phase 1, Randomized, Placebo-Controlled, Single Ascending Dose-Escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY4167586 in Participants With Obesity or Overweight Who Are Otherwise Healthy
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Number and Incidence of Serious Adverse Events (SAEs)
研究概览
简要总结
The purpose of this study is to look at how safe and well-tolerated LY4167586 is in participants with obesity or overweight who are otherwise healthy. Blood tests will be performed to check how much LY4167586 gets into the bloodstream and how long it takes the body to eliminate it following a single administration. Participation in the study will last approximately 7 months.
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
- •Participant must be 21 for Singapore site
- •Have a body mass index (BMI) between 27.0 kilogram per square meter (kg/m²) and 35.0 kg/m², inclusive
- •Have had a self-reported stable weight for 3 months prior to screening (less than approximately 5 percent [%] body weight change)
排除标准
- •Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal (GI), endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs, or of constituting a risk when taking the study drug, or of interfering with the interpretation of data.
- •Is an individual of childbearing potential (IOCBP)
研究组 & 干预措施
LY4167586 (Cohort B)
Experimental
LY4167586 administered intravenously (IV)
干预措施: LY4167586 (Drug)
LY4167586 (Cohorts A1 to A6)
Experimental
LY4167586 administered subcutaneously (SC)
干预措施: LY4167586 (Drug)
Placebo (Cohorts A1 to A6)
Placebo Comparator
Placebo administered SC
干预措施: Placebo (Drug)
结局指标
主要结局
Number and Incidence of Serious Adverse Events (SAEs)
时间窗: Baseline to study completion (up to 29 weeks)
A summary of SAEs regardless of causality, will be reported in the Reported Adverse Events module
次要结局
- Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax)(Predose on Day 1 through end of the Follow-up Period (Week 25))
- PK: Time of Maximum Drug Concentration (tmax)(Predose on Day 1 through end of the Follow-up Period (Week 25))
- PK: Area Under the Concentration Versus Time Curve (AUC)(Predose on Day 1 through end of the Follow-up Period (Week 25))
研究者
研究点 (2)
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