A Phase 1, Double-Blind, Randomized, Placebo-Controlled, Study to Evaluate the Safety and Tolerability of LY3537021 When Combined With GLP-1 Receptor Agonist in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 47
- 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 LY3537021 when administered in combination with glucagon-like peptide (GLP-1) receptor agonist called liraglutide in treatment-naïve healthy participants. The study will include 2 parts. The study will last up to 16 and 22 weeks for part A and B, respectively which includes a screening period of 6 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
- 21 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants who are overtly healthy as determined through medical evaluation
- •Participants with body weight at least 55 kilograms (kg) and body mass index (BMI) of 23.0 to 40.0 kilograms per meter squared (kg/m²)
- •Males, or females who are not of childbearing potential.
- •Capable of giving signed informed consent form
- •Have blood pressure of less than 150/90 millimeters of mercury (mm Hg) and pulse rate of less than 100 beats per minute (bpm) (supine)
排除标准
- •Have a significant history of current disorders capable of significantly altering the absorption, metabolism or elimination of drugs
- •History of malignancy within 5 years prior to screening
- •Have evidence of significant active psychiatric disorder(s)
- •Have undergone any form of bariatric surgery
- •Have an abnormality in the 12-lead electrocardiogram (ECG)
- •Are females who are lactating
研究组 & 干预措施
Liraglutide + Placebo (Part A)
Liraglutide administered SC followed by liraglutide in combination with placebo given SC.
干预措施: Liraglutide (Drug)
LY3537021 + Liraglutide (Part A)
Liraglutide administered subcutaneously (SC) followed by liraglutide in combination with LY3537021 given SC.
干预措施: LY3537021 (Drug)
LY3537021 + Liraglutide (Part A)
Liraglutide administered subcutaneously (SC) followed by liraglutide in combination with LY3537021 given SC.
干预措施: Liraglutide (Drug)
Liraglutide + Placebo (Part A)
Liraglutide administered SC followed by liraglutide in combination with placebo given SC.
干预措施: Placebo (Drug)
LY3537021 + Liraglutide & Placebo + Liraglutide (Part B)
LY3537021 administered SC followed by liraglutide administered SC in treatment period 1.
Placebo administered SC followed by liraglutide administered SC in treatment period 2.
干预措施: LY3537021 (Drug)
LY3537021 + Liraglutide & Placebo + Liraglutide (Part B)
LY3537021 administered SC followed by liraglutide administered SC in treatment period 1.
Placebo administered SC followed by liraglutide administered SC in treatment period 2.
干预措施: Liraglutide (Drug)
LY3537021 + Liraglutide & Placebo + Liraglutide (Part B)
LY3537021 administered SC followed by liraglutide administered SC in treatment period 1.
Placebo administered SC followed by liraglutide administered SC in treatment period 2.
干预措施: Placebo (Drug)
Placebo + Liraglutide & LY3537021 + Liraglutide Part B)
Placebo administered SC followed by liraglutide administered SC in treatment period 1.
LY3537021 administered SC followed by liraglutide administered SC in treatment period 2.
干预措施: LY3537021 (Drug)
Placebo + Liraglutide & LY3537021 + Liraglutide Part B)
Placebo administered SC followed by liraglutide administered SC in treatment period 1.
LY3537021 administered SC followed by liraglutide administered SC in treatment period 2.
干预措施: Liraglutide (Drug)
Placebo + Liraglutide & LY3537021 + Liraglutide Part B)
Placebo administered SC followed by liraglutide administered SC in treatment period 1.
LY3537021 administered SC followed by liraglutide administered SC in treatment period 2.
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 Week 22
A summary of TEAEs and SAEs, regardless of causality, will be reported in the Reported Adverse Events module
次要结局
未报告次要终点