A Single-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3875383 in Healthy Participants and Participants With Hypertriglyceridemia
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 41
- 试验地点
- 1
- 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
The main purpose of this study is to determine the tolerability and side effects related to LY3875383 given as a single injection under the skin to healthy participants and participants with elevated triglyceride (TG) levels.The study will also assess how fast LY3875383 gets into the blood stream and how long the body takes to get rid of it. Each enrolled participant will receive a single dose of either LY3875383 or placebo.The study will be conducted in four parts (A, B, C and D) and may last up to approximately 28 to 56 weeks including screening.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •All participants:
- •Have a body mass index (BMI) between 18.5 and 40 kilograms per square meter (kg/m²), inclusive.
- •Males who agree to follow contraceptive requirements, or women not of childbearing potential (WNOCBP).
- •Healthy participants (Part A):
- •Participants must be overtly healthy, as determined by medical evaluation.
- •For Part B:
- •Participants must be first-generation Japanese, defined as the participant's biological parents, and all of the participant's biological grandparents must be of exclusive Japanese descent and born in Japan.
- •Hypertriglyceridemia participants (Parts C and D):
- •For Part C:
- •Have history of very high triglyceride (lipid) level 500 mg/dL ≤ TG <2000 mg/dL, which needs to be further confirmed at screening.
- •Participants must be on a lipid-modifying diet and can be on stable lipid-lowering drugs (LLDs) for at least 8 weeks before screening and plan to continue the same throughout the study duration.
- •For Part D:
- •Have history of high triglyceride (lipid) level between 150 mg/dL and 500 mg/dL inclusive at pre-screening or based on medical history and confirmed at screening and Low-density lipoprotein cholesterol (LDL-C) level of ≥40 mg/dL.
- •Participants must be on a stable moderate or high-intensity dose of a statin for at least 8 weeks before screening and plan to continue the same medication and dose throughout the study duration.
排除标准
- •All participants:
- •Participants must not be currently participating in or completed a clinical trial within the last 30 days
- •Have donated blood of more than 500 mL within the previous 3 months
- •Have one of the following viral infections: hepatitis B virus, hepatitis C virus or human immunodeficiency virus (HIV).
- •Participants must not be heavy alcohol drinkers or cigarette smokers.
- •For Part C: Have active pancreatitis within the last 6 months
研究组 & 干预措施
LY3875383 (Part A)
Single-ascending doses of LY3875383 administered subcutaneously (SC).
干预措施: LY3875383 (Drug)
LY3875383 (Part B)
Single doses of LY3875383 administered SC.
干预措施: LY3875383 (Drug)
LY3875383 (Part C)
Single doses of LY3875383 administered SC.
干预措施: LY3875383 (Drug)
LY3875383 (Part D)
Single doses of LY3875383 administered SC.
干预措施: LY3875383 (Drug)
Placebo (Part A)
Placebo administered SC.
干预措施: Placebo (Drug)
Placebo (Part B)
Placebo administered SC.
干预措施: Placebo (Drug)
Placebo (Part C)
Placebo administered SC.
干预措施: Placebo (Drug)
Placebo (Part D)
Placebo administered SC.
干预措施: Placebo (Drug)
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: Baseline through Week 53
A summary of TEAEs and SAEs, regardless of causality, will be reported in the Reported Adverse Events module
次要结局
- Pharmacokinetics (PK):Area Under the Concentration Versus Time Curve (AUC) of LY3875383(Predose up to Day 8 post dose)
- PK: Maximum Observed Concentration (Cmax) of LY3875383(Predose up to Day 8 post dose)
- Part C and D only: Pharmacodynamics (PD): Percentage Change from Baseline in Fasting Triglyceride (TG)(Baseline through up to Week 53)
- Part D only: PD: Percentage Change from Baseline in Fasting Non-High-Density Lipoprotein Cholesterol (HDL-C)(Baseline through Week 53)