A Single-Ascending and Repeat-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3561774
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 5
- 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 Administration
研究概览
简要总结
This is a 3-part study. In Parts A and B, the main purpose is to evaluate the safety and tolerability of the study drug known as LY3561774 in participants with dyslipidemia (high blood fat levels). How the body processes the study drug and the effect of the study drug on blood fat levels will also be investigated. Part C will mainly evaluate the safety and tolerability of LY3561774 as well as how the body processes the study drug in Japanese participants. The study may last up 52, 56 and 28 weeks for each participant in Parts A, B and C, respectively. There are up to 22, 26 and 16 visits in Parts A, B and C, 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For Parts A and B, have a fasting triglyceride (TG) level greater than or equal to (≥) 150 milligram/deciliter (mg/dL) and less than 500 mg/dL, as well as low density lipoprotein cholesterol (LDL-C) level greater than or equal to (≥) 70 mg/dL
- •For Part C, participants should be first-generation Japanese origin.
- •Have a body mass index (BMI) of 18.5 to 40.0 kilograms per square meter (kg/m²)
- •Male participants must agree to adhere to contraception restrictions and female participants must not be able to get pregnant
排除标准
- •Have taken any prescription medications that are for lowering serum TGs within the past 2 months (use of statins is allowed if the dose has been stable for 8 weeks)
- •Have Type 1 diabetes
- •Are currently participating in or completed a clinical trial within the last 30 days
- •Are heavy alcohol drinkers or heavy cigarette smokers
- •Have donated blood of more than 500 millilitres (mL) in the last 3 months
研究组 & 干预措施
LY3561774 (Part A)
Single ascending doses of LY3561774 administered subcutaneously (SC).
干预措施: LY3561774 (Drug)
LY3561774 (Part B)
Repeat doses of LY3561774 administered SC.
干预措施: LY3561774 (Drug)
LY3561774 (Part C)
Single doses of LY3561774 administered SC in Japanese Participants.
干预措施: LY3561774 (Drug)
Placebo (Part A, B & C)
Placebo administered SC.
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 Administration
时间窗: Baseline up to Week 53
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
- Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time Zero to the Last Measurable Concentration (AUC[0-tlast]) of LY3561774(Predose through Day 8)
- PK: Maximum Observed Drug Concentration (Cmax) of LY3561774(Predose through Day 8)
- PD: Change From Baseline in Fasting Triglyceride (TG) and low-density lipoprotein cholesterol (LDL-C)(Predose through Week 53)
- PK: Time of Maximum Observed Concentration (Tmax) of LY3561774(Predose through Day 8)