A Single-Dose and Multiple-Ascending Dose Study of LY4086940 in Healthy Participants and Participants With Overweight or Obesity, With or Without Type 2 Diabetes
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 219
- 试验地点
- 8
- 主要终点
- Number of Participants with One or More Serious Adverse Events (SAE) 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, tolerability of LY4086940 and how it is processed in the body.
Participation in Part A of the study will last about 10 weeks and may include up to 6 visits. Participation in Parts B, C, D will last approximately 15 weeks and may include up to 10 visits. Participation in Part E will last approximately 7 weeks and may include up to 12 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
- •Have no significant body weight change for the 3 months prior to screening
- •Part A and Part E:
- •Are considered healthy
- •Have a body mass index (BMI) of 22 to 35 kilograms per square meter (kg/m2) at screening
- •Have a BMI of 27 to 45 kg/m2 at screening
- •Have a BMI of 25 to 45 kg/m2 at screening
- •Have type 2 diabetes
- •Have hemoglobin A1C (HbA1c) ≥6.5% and ≤10.5% at screening
- •Have a BMI of 27 to 45 kg/m2 at screening
排除标准
- •Have had an acute cardiovascular condition within the past 6 months prior to screening
- •Have liver disease or pancreatitis
- •Have used medications for weight loss within the 3 months prior to screening
- •Parts A, B, C, E:
- •Have any form of diabetes
- •Have type 1 diabetes
研究组 & 干预措施
Part A: Placebo Multiple Dose (Healthy Participants)
Participants will receive placebo orally for 3 days
干预措施: Placebo (Drug)
Part A: LY4086940 Multiple Dose (Healthy Participants)
Participants will receive LY4086940 orally for 3 days
干预措施: LY4086940 (Drug)
Part B: LY4086940 Multiple Dose (Participants with Overweight or Obesity)
Participants will receive LY4086940 orally for 4 weeks
干预措施: LY4086940 (Drug)
Part A: Placebo Single Dose (Healthy Participants)
Participants will receive a single dose of placebo orally
干预措施: Placebo (Drug)
Part C: Placebo Multiple Dose (Japanese/Chinese Participants with Overweight or Obesity
Participants will receive placebo orally for 4 weeks
干预措施: Placebo (Drug)
Part D: LY4086940 Multiple Dose (Participants with Type 2 Diabetes with Overweight or Obesity)
Participants will receive LY4086940 orally for 4-6 weeks
干预措施: LY4086940 (Drug)
Part D: Placebo Multiple Dose (Participants with Type 2 Diabetes with Overweight or Obesity)
Participants will receive placebo orally for 4-6 weeks
干预措施: Placebo (Drug)
Part E (Open-Label): LY4086940 Single Dose (Healthy Participants)
Participants will receive a single dose of LY4086940 intravenously (IV)
干预措施: LY4086940 (Drug)
Part A: LY4086940 Single Dose (Healthy Participants)
Participants will receive a single dose of LY4086940 orally
干预措施: LY4086940 (Drug)
Part B: Placebo Multiple Dose (Participants with Overweight or Obesity)
Participants will receive placebo orally for 4 weeks
干预措施: Placebo (Drug)
Part C: LY4086940 Multiple Dose (Japanese/Chinese Participants with Overweight or Obesity)
Participants will receive LY4086940 orally for 4 weeks
干预措施: LY4086940 (Drug)
结局指标
主要结局
Number of Participants with One or More Serious Adverse Events (SAE) Considered by the Investigator to be Related to Study Drug Administration
时间窗: Baseline up to Week 9
次要结局
- Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY4086940(Predose up to Day 64)
- PK: Area Under the Concentration Versus Time Curve (AUC) of LY4086940(Predose up to Day 64)