A Dose-Escalation Treatment, Phase 1, Investigator- and Participant-Blind, Placebo-controlled Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of LY3457263 in Combination With Tirzepatide in Overweight or Obese Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 38
- 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 LY3457263 when administered in combination with tirzepatitide in overweight or obese participants. The study will also evaluate how much of LY3457263 gets into the blood stream and how long it takes the body to remove it in overweight or obese participants. The study will last up to approximately 11 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
- 20 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
- •Have a stable body weight and body mass index (BMI) within the range 27.0 to 45.0 kilograms per meter squared (kg/m²)
- •Male or female participants not of childbearing potential
排除标准
- •Have a mean sitting systolic blood pressure (BP) higher than 160 millimeters of mercury (mmHg) or a mean sitting diastolic BP higher than 90 mmHg from 3 measurements
- •Have an abnormal 12-lead electrocardiogram (ECG) at screening
- •Have type 1 or type 2 diabetes mellitus
研究组 & 干预措施
LY3457263 + Tirzepatide
LY3457263 administered subcutaneously (SC) in combination with tirzepatide given SC.
干预措施: LY3457263 (Drug)
LY3457263 + Tirzepatide
LY3457263 administered subcutaneously (SC) in combination with tirzepatide given SC.
干预措施: Tirzepatide (Drug)
Placebo + Tirzepatide
Placebo administered SC in combination with tirzepatide given SC.
干预措施: Tirzepatide (Drug)
Placebo + Tirzepatide
Placebo administered SC in combination with tirzepatide given 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: Baseline up to 11 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 LY3457263(Predose on Day 1 up to 43 days postdose)