A Single and Multiple-Ascending Dose Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetics of LY3938577 in Healthy Participants and Participants With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 3
- 主要终点
- Part A: Number of Participants With Clinically Significant Changes in Safety Laboratory Parameters
研究概览
简要总结
The main purpose of this study is to assess the safety and tolerability of a single dose of LY3938577 in healthy participants and participants with Type 2 Diabetes Mellitus (T2DM) (Part A) and multiple doses of LY3938577 in participants with T2DM (Part B). The study will last approximately 6 weeks for Part A and approximately 10 weeks for Part B respectively.
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
- 是
入选标准
- •Male and female participants who are overtly healthy as determined by medical evaluation (Part A)
- •Participants with T2DM diagnosed greater than 1 year before enrollment (Part A and Part B)
- •Have a body mass index within the range of 18.5 to less than or equal to (<=) 32 kilograms per square meter (kg/m²) for healthy participants and 18.5 to 40 kg/m² for T2DM participants.
- •Male or female participants of nonchildbearing potential
排除标准
- •Have proliferative retinopathy or maculopathy and/or severe neuropathy
- •Have been treated with sulfonylurea, thiazolidinedione, alpha-glucosidase inhibitor, glucagon-like peptide-1 receptor agonist or Insulin within the previous 3 months
- •Have received chronic systemic glucocorticoid therapy in the past 3 months
- •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
LY3938577 (Part A)
LY3938577 administered Subcutaneously (SC).
干预措施: LY3938577 (Drug)
Placebo (Part A)
Placebo administered SC.
干预措施: Placebo (Drug)
Insulin degludec (Part A)
Insulin degludec administered SC.
干预措施: Insulin degludec (Drug)
LY3938577 (Part B)
LY3938577 administered SC.
干预措施: LY3938577 (Drug)
Insulin degludec (Part B)
Insulin degludec administered SC.
干预措施: Insulin degludec (Drug)
结局指标
主要结局
Part A: Number of Participants With Clinically Significant Changes in Safety Laboratory Parameters
时间窗: Baseline up to 16 days
Part A: Number of Participants With Clinically Significant Changes in Vital Signs
时间窗: Baseline up to 16 days
Part B: Number of participants with one or more Adverse Event (s) (AEs), and Serious Adverse Event(s) (SAEs) considered by the investigator to be related to study drug administration
时间窗: Baseline up to 44 days
A summary of AEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module.
Part B: Number of Participants With Clinically Significant Changes in Safety Laboratory Parameters
时间窗: Baseline up to 44 days
Part A: Number of participants with one or more Adverse Event (s) (AEs), and Serious Adverse Event(s) (SAEs) considered by the investigator to be related to study drug administration
时间窗: Baseline up to 16 days
A summary of AEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module.
Part A: Incidence of Hypoglycemia
时间窗: Baseline up to 16 days
Part B: Incidence of Hypoglycemia
时间窗: Baseline up to 44 days
Part B: Number of Participants With Clinically Significant Changes in Vital Signs
时间窗: Baseline up to 44 days
次要结局
- Part A and Part B: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC)(Part A: Predose up to 16 Days and Part B: Predose up to 44 Days)