A Phase 1, Multicenter, Parallel-Design, Single-Dose, Open-Label Study to Evaluate the Pharmacokinetics and Safety of LY3537031 in Participants With Normal Renal Function and Participants With Renal Impairment
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 8
- 主要终点
- PK: Maximum Concentration (Cmax) of LY3537031
研究概览
简要总结
The purpose of this study is to assess the amount of LY3537031 that reaches the bloodstream and the time it takes for the body to get rid of it when given to participants with renal (kidney) impairment and to healthy participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Have a body weight of 55 kilogram (kg) or more and body mass index (BMI) within the range 19.0 to 40.0 kilogram per square meter (kg/m²), inclusive
- •Have no significant history of spontaneous or ethanol-induced hypoglycemia
- •Additional Inclusion Criteria for Healthy Participants in Control Group:
- •Are healthy as determined by medical history, physical examination, and other screening procedures, with normal renal function, assessed by estimated glomerular filtration rate (eGFR) of at least 90 milliliter per minute (mL/min) at screening
- •Have glycated hemoglobin (HbA1c) less than or equal to 6.5% at screening
- •Additional Inclusion Criteria for Participants with Severe Renal Impairment or with End-Stage Renal Disease (ESRD):
- •Have stable severe renal impairment, assessed by eGFR less than 30 mL/min at screening, who have been on stable hemodialysis schedule for at least 3 months prior to planned dosing
- •Have acceptable blood pressure and pulse rate
- •If participants have Type 2 Diabetes Mellitus (T2DM), they must have a HbA1c equal to or less than 11.5% at the screening visit
排除标准
- •Have a history of chronic liver disease, acute or chronic hepatitis, including a history of autoimmune hepatitis, any evidence for hepatic impairments
- •Have a current, functional renal transplant. Non-functional renal allografts may be allowed
- •Have a diagnosis or history of malignant disease within 5 years before screening (some exceptions are allowed)
- •Have a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome Type 2
研究组 & 干预措施
LY3537031 (Group 1)
LY3537031 administered subcutaneously (SC) in a control group of participants with normal renal function
干预措施: LY3537031 (Drug)
LY3537031 (Groups 2-3)
LY3537031 administered SC in groups of participants with impaired renal function
干预措施: LY3537031 (Drug)
LY3537031 (Group 3)
LY3537031 administered SC in a group of participants with end-stage renal disease (ESRD) on hemodialysis
干预措施: LY3537031 (Drug)
结局指标
主要结局
PK: Maximum Concentration (Cmax) of LY3537031
时间窗: Predose on day 1 up to week 8 post dose
PK: Cmax of LY3537031
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3537031
时间窗: Predose on day 1 up to week 8 post dose
PK: AUC of LY3537031
次要结局
未报告次要终点