A Multiple Dose Study to Assess the Pharmacokinetics, Safety, and Tolerability of Tablet and Capsule Formulations of LY3502970 in Healthy Overweight and Obese Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 5
- 主要终点
- PK: Maximum Observed Concentration (Cmax) of LY3502970
研究概览
简要总结
The main purpose of this study is to evaluate how much LY3502970 gets into the bloodstream and how long it takes the body to eliminate when administered orally as tablet and capsule formulations along with effect of food on LY3502970 in healthy overweight and obese participants. The study will also evaluate the safety and tolerability of LY3502970 in these participants. The study is conducted in two parts (part A and B) and will last up to 135 days including the screening period.
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
- None
盲法说明
Part A open label. Part B double blinded (Investigator and Participant blinded).
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female participants who are overtly healthy as determined by medical evaluation
- •Participants with body mass index (BMI) of 27.0 kilograms per meter squared (kg/m²) or more
- •Participants with a stable body weight, with 5% or less body weight gain or loss
排除标准
- •Have any type of diabetes with hemoglobin A1c (HbA1c) level of 6.5% or greater or a fasting blood sugar over 120 milligram per deciliter (mg/dL)
- •Obesity induced by other endocrine disorders, such as Cushing's syndrome or Prader-Willi syndrome
- •Have known clinically significant gastric emptying abnormality
- •Have undergone bariatric surgery (for example: Lap-Band, Gastric Bypass)
- •Known self or family history (first-degree relative) of multiple endocrine neoplasia type 2A or type 2B, thyroid C-cell hyperplasia, or any form of thyroid cancer
- •Have significant previous or current history of comorbidities capable of significantly altering the absorption, metabolism, or elimination of drug
- •Have significant history of or currently have Major Depressive Disorder or psychiatric disorder within the last 2 years
结局指标
主要结局
PK: Maximum Observed Concentration (Cmax) of LY3502970
时间窗: Predose up to 92 days postdose
PK: Cmax of LY3502970
PK: Time to Maximum Observed Concentration (Tmax) of LY3502970
时间窗: Predose up to 92 days postdose
PK: Tmax of LY3502970
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time Zero to the 24 Hour Time Point (AUC[0-24]) of LY3502970
时间窗: Predose up to 92 days postdose
PK: AUC\[0-24\] of LY3502970
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to the 24 Hour Time Point (AUC[0-24]) of LY3502970 in Fasted State - Part A: Periods 1-9, 11 and Part B: Periods 12-13
时间窗: Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 20, and 24 hours post-dose on Day 7 of each treatment period in Part A: Periods 1-9, 11 and Part B: Periods 12-13
PK: AUC\[0-24\] of LY3502970 in fasted state
PK: Maximum Observed Concentration (Cmax) of LY3502970 in Fasted State - Part A: Periods 1-9, 11 and Part B: Periods 12-13
时间窗: Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 20, and 24 hours post-dose on Day 7 of each treatment period in Part A: Periods 1-9, 11 and Part B: Periods 12-13
PK: Cmax of LY3502970 in fasted state
PK: Time to Maximum Observed Concentration (Tmax) of LY3502970 in Fasted State - Part A: Periods 1-9, 11 and Part B: Periods 12-13
时间窗: Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 20, and 24 hours post-dose on Day 7 of each treatment period in Part A: Periods 1-9, 11 and Part B: Periods 12-13
PK: Tmax of LY3502970 in fasted state
次要结局
- PK: Tmax of LY3502970 in fed state(Predose up to 92 days postdose)
- PK: Cmax of LY3502970 in fed state(Predose up to 92 days postdose)
- PK: AUC[0-24] of LY3502970 in fed state(Predose up to 92 days postdose)
- PK: Area Under the Concentration Versus Time Curve From Time Zero to the 24 Hour Time Point (AUC[0-24]) of LY3502970 in Fed State - Part A: Period 10(Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 20, and 24 hours post-dose on Day 7 of Part A: Period 10 (Day 70))
- PK: Maximum Observed Concentration (Cmax) of LY3502970 in Fed State - Part A: Period 10(Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 20, and 24 hours post-dose on Day 7 of Part A: Period 10 (Day 70))
- PK: Time to Maximum Observed Concentration (Tmax) of LY3502970 in Fed State - Part A: Period 10(Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 20, and 24 hours post-dose on Day 7 of Part A: Period 10 (Day 70))