jRCT2071240136招募中不适用
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 (J3H-JE-GZNG )
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 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
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Basic Science
- 盲法
- Double Blind
入排标准
- 年龄范围
- 18age old over 至 70age old under（—）
- 性别
- All
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
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
未报告次要终点
研究者
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