NCT06362265已完成1 期
A Single Dose Study to Evaluate the Pharmacokinetics of LY3209590 in Pediatric Participants With Type 2 Diabetes Mellitus
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 17
- 主要终点
- Pharmacokinetics (PK): Area Under the Plasma Concentration Versus Time Curve (AUC) of LY3209590
研究概览
简要总结
The main purpose of this study is to evaluate how much of LY3209590 gets into the blood stream after a single dose and how long it takes the body to remove it in pediatric participants with Type 2 Diabetes Mellitus (T2DM). The study will last for approximately 100 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with Type 2 Diabetes Mellitus (T2DM) for at least 3 months
- •Have Glycated hemoglobin (HbA1c) level of 6.5 percent (%) to 9.5% at screening
- •Have a body mass index equal to or less than 45.0 kilograms per square meter (kg/m²)
- •Participants are insulin naïve or have been without insulin treatment for at least 3 months prior to screening
排除标准
- •Have had a severe hypoglycemia in the past 6 months
- •Have a history of renal impairment
- •Have had a blood transfusion or severe blood loss within last 90 days
- •Have had a significant weight gain or loss of approximately 6% or more within 3 months prior to screening.
- •Have a history of an active or untreated malignancy
- •Are receiving or received systemic glucocorticoid therapy
- •Are currently enrolled in another clinical study trial involving medical research or have participated within the last 30 days in a clinical study involving an investigational product
研究组 & 干预措施
LY3209590
Experimental
LY3209590 administered subcutaneously (SC).
干预措施: LY3209590 (Drug)
结局指标
主要结局
Pharmacokinetics (PK): Area Under the Plasma Concentration Versus Time Curve (AUC) of LY3209590
时间窗: Predose up to 65 days post dose
PK: Maximum Observed Plasma Concentration (Cmax) of LY3209590
时间窗: Predose up to 65 days post dose
次要结局
- Change from Baseline in Fasting Glucose(Baseline, 65 days)
研究者
研究点 (17)
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