A Randomized, Investigator- and Participant-blinded, Multiple-ascending Dose, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3549492 in Japanese Participants With Type 2 Diabetes Mellitus and Healthy Japanese Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 4
- 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 purpose of this study is to evaluate how well LY3549492 is tolerated and what side effects may occur in Japanese participants with Type 2 Diabetes Mellitus (T2D) and healthy Japanese participants. The study drug will be administered orally. Blood tests will be performed to check how much LY3549492 gets into the bloodstream and how long it takes the body to eliminate it.
The study will last up to approximately 19 weeks for both Part A (Cohorts 1-3) for multiple-ascending doses (MAD), and Part B (Cohorts 4-5) multiple-ascending doses (MAD), for a total of approximately 25 weeks, including screening.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants with T2DM for at least 6 months
- •With an HbA1c value:
- •equal to or greater than 7.0% and equal to or less than 10.0% at screening for participants treated with diet and exercise alone, OR
- •equal to or greater than 6.5% and equal to or less than 9.0% for participants prior to washout of antidiabetic medications
- •Have had a stable weight for the 3 months prior to screening. Stable weight is defined as less than 5% body weight change
- •Have safety laboratory test results within normal reference range for the population or investigative site, or results with acceptable deviations that are judged to be not clinically significant by the investigator. Laboratory tests may be repeated if there is a documented technical error, or once at the discretion of the investigator for any out-of-range results
排除标准
- •Have a known clinically significant gastric emptying abnormality
- •Have a 12-lead electrocardiogram (ECG) abnormality
- •Have an abnormal blood pressure or pulse rate
- •Have a significant history within the past 6 months or current evidence of comorbidities capable of altering the absorption, metabolism, or elimination of drug. Or constituting a risk when taking the study drug
- •Have a history of chronic medical conditions involving the heart, liver, or kidneys
研究组 & 干预措施
LY3549492 Part A
LY3549492 administered orally
干预措施: LY3549492 (Drug)
LY3549492 Part B
LY3549492 administered orally
干预措施: LY3549492 (Drug)
Placebo Part A
Placebo administered orally
干预措施: Placebo (Drug)
Placebo Part B
Placebo administered orally
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: Day 1 Through Day 127
A summary of TEAEs and SAEs regardless of causality, will be reported in the Reported Adverse Events module
次要结局
- PK: Maximum Concentration (Cmax) of LY3549492(Day 1 Through Day 127)
- Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3549492(Day 1 Through Day 127)
- Pharmacodynamic (PD): Part A: Change from Baseline in Hemoglobin A1c (HbA1c)(Day 1 Through Day 127)
- PD: Change from Baseline in Body Weight(Day 1 Through Day 127)