A Multiple-Dose Study in Participants With Type 2 Diabetes Mellitus to Investigate the Safety, Tolerability, Pharmacokinetics,and Pharmacodynamics of LY3502970
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 12
- 主要终点
- Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug
研究概览
简要总结
The main purpose of this study is to learn more about the safety of LY3502970 and any side effects that might be associated with it. Blood tests will be done to measure how much LY3502970 is in the bloodstream, how long it takes the body to eliminate it, and how it affects blood sugar. Participation could last up to 18 weeks and may include up to 14 visits (including three overnight stays) in the study center.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 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
- 否
入选标准
- •Have type 2 diabetes mellitus (T2DM) for at least 6 months
- •Have a glycated hemoglobin (HbA1c) value at screening of greater than or equal to (≥)7.0 percent (%) and less than or equal to (≤)10.5% and are treated with diet and exercise alone or a stable dose of metformin for at least 3 months prior to screening
- •Have a body weight of ≥45 kilograms (kg) and have a body mass index of 18.5 to 45 kilograms per square meter (kg/m²), inclusive
- •Have had a stable body weight for the 3 months prior to screening (less than [<]5% body weight change)
- •Males and females (not considered woman of childbearing potential)
排除标准
- •Have type 1 diabetes mellitus, latent autoimmune diabetes in adults or have had an episode of ketoacidosis or hyperosmolar state requiring hospitalization in the 6 months prior to screening
- •Have had any of the following within the past 6 months prior to screening: myocardial infarction, unstable angina, coronary artery bypass graft, percutaneous coronary intervention (diagnostic angiograms are permitted), transient ischemic attack, cerebrovascular accident or decompensated congestive heart failure, or currently have New York Health Association Class III or IV heart failure
- •Show evidence of hepatitis B, and/or positive hepatitis B surface antigen
- •Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies
- •Any glucose-lowering medications other than metformin within 3 months prior to screening
研究组 & 干预措施
LY3502970
3, 6, 9, 12, 15, 21, 27, 36 and 45 milligrams (mg) LY3502970 administered orally.
干预措施: LY3502970 (Drug)
Placebo
Placebo administered orally.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug
时间窗: Baseline through Follow-up (up to Day 105)
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
次要结局
- PK: Area Under the Concentration Versus Time Curve of LY3502970(Day 1 through Day 84: Predose up to 96 hours postdose)
- Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3502970(Day 1 through Day 84: Predose up to 96 hours postdose)
- Pharmacodynamics (PD): Change from Baseline to Week 12 in Fasting Plasma Glucose (FPG)(Baseline, Week 12)
- PD: Change from Baseline to Week 12 in Fasting Insulin(Baseline, Week 12)