A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of LY3819469 in Adults With Elevated Lipoprotein(a)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 320
- 试验地点
- 80
- 主要终点
- Percent Change From Baseline in Time Averaged Lipoprotein(a) [Lp(a)] Over Days 60-180
研究概览
简要总结
The main purpose of this study is to determine the efficacy and safety of LY3819469 in adults with elevated lipoprotein(a). The study will lasts about 20 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must be at least 40 years old at the time of signing the informed consent.
- •Participants with Lp(a) ≥175 nmol/L at screening, measured at the central laboratory
- •Participants on the following medications according to local practice must be on a stable regimen for at least 4 weeks prior to screening and randomization and expected to remain on a stable regimen through the end of the Treatment and Assessment Period:
- •lipid-lowering drugs
- •testosterone, estrogens, anti-estrogens, progestins, selective estrogen receptor modulators, or growth hormone
- •Have a body mass index within the range 18.5 to 40 kilogram/square meter (kg/m²), inclusive.
- •Male and/or Female
- •Males who agree to use highly effective/effective methods of contraception may participate in this trial.
- •Women not of childbearing potential (WNOCBP) may participate in this trial.
排除标准
- •Have a history or presence of an underlying disease, or surgical, physical, medical, or psychiatric condition that, in the opinion of the investigator, would potentially affect participant safety within the study or interfere with participating in or completing the study or with the interpretation of data.
- •Any of the following, or other events indicating unstable medical condition in the opinion of the investigator, within 3 months of randomization:
- •major surgery
- •coronary, carotid, or peripheral arterial revascularization
- •stroke or transient ischemic attack
- •myocardial infarction or unstable angina
- •acute limb ischemia
- •Have, in the 6 months prior to day 1, uncontrolled Type 1 or Type 2 diabetes.
- •Have uncontrolled hypertension
研究组 & 干预措施
400 mg LY3819469
Participants received 400 mg of LY3819469 on day 1 and day 180, administered as a SC injection.
干预措施: LY3819469 (Drug)
16 mg LY3819469
Participants received 16 milligrams (mg) of LY3819469 on day 1 and day 180, administered as a subcutaneous (SC) injection.
干预措施: LY3819469 (Drug)
96 mg LY3819469
Participants received 96 mg of LY3819469 on day 1 and day 180, administered as a SC injection.
干预措施: LY3819469 (Drug)
400 mg LY3819469 + Placebo
Participants received 400 mg of LY3819469 on day 1 and placebo on day 180, administered as a SC injection.
干预措施: LY3819469 (Drug)
400 mg LY3819469 + Placebo
Participants received 400 mg of LY3819469 on day 1 and placebo on day 180, administered as a SC injection.
干预措施: Placebo (Drug)
Placebo
Participants received placebo on day 1 and day 180, administered as a SC injection.
干预措施: Placebo (Drug)
结局指标
主要结局
Percent Change From Baseline in Time Averaged Lipoprotein(a) [Lp(a)] Over Days 60-180
时间窗: Baseline, Days 60 - 180
LPa levels were assessed using Immuno turbidimetric method. Percent change is calculated as: Percent Change=\[(Lp(a) at Time Point-Lp(a) at Baseline)/Lp(a) at Baseline\]×100 Least squares (LS) mean was determined using mixed model repeated measures (MMRM) model with log(Lp(a)) - log(Baseline) = log(Baseline) + Treatment + Time + Treatment\*Time (Type III sum of squares) as post-baseline measures. Result presented is after back-transformation. Variance-Covariance structure = Unstructured. Analyses included all participants having non-missing baseline and at least one non-missing post-baseline value of the response variable.
次要结局
- Percent Change From Baseline in Time Averaged Lp(a) Over Days 240-360(Baseline, Days 240 - 360)
- Percentage of Participants Achieving Lp(a) <125 and <75 Nanomole/Liter (Nmol/L) at Days 60, 180(Days 60, 180)
- Percentage of Participants Achieving Lp(a) <125 and <75 Nanomole/Liter (Nmol/L) at Days 240, 360, and 540(Days 240, 360, and 540)
- Percent Change From Baseline in Lp(a)(Baseline, Days 60, 180, 240, 360, and 540)
- Percent Change From Baseline in Apolipoprotein B (ApoB)(Baseline, Days 60, 180, 240, 360, and 540)
- Percent Change From Baseline in High-sensitivity C-reactive Protein (hsCRP)(Baseline, Days 60, 180, 240, 360, and 540)
- Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf]) of LY3819469(Day 1: 0.5 hours, 4-9 hours post-dose; Day 180: 24-36 hours post-dose)