NCT04447820已完成2 期
A Multicenter, Randomized, Open-Label, 4-Week Study to Investigate the Efficacy and Pharmacokinetic Profile of K-877-ER Once Daily Treatment Compared to K-877-IR Twice Daily Treatment in Adult Patients With Fasting Triglyceride Levels
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 12
- 主要终点
- Estimated Percentage Change in Fasting Triglyceride(s) (TG)
研究概览
简要总结
A study to evaluate the efficacy of K-877 extended release (ER) once daily (QD) compared to K-877 immediate release (IR) twice daily (BID).
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to provide written informed consent before any study-specific evaluation is performed
- •At screening, have a mean fasting TG level of ≥180 mg/dL and <550 mg/dL; at subsequent Qualification Period visits confirm fasting TG level of ≥200 mg/dL and <500 mg/dL
- •Able to meet all inclusion criteria outlined in clinical study protocol
排除标准
- •Require lipid-altering treatments other than study drugs, statins, ezetimibe, or PCSK9 inhibitors during the study
- •Known hypersensitivity or intolerance to fibrates or peroxisome proliferator-activated receptor alpha agonists
- •Meet any other exclusion criteria outlined in clinical study protocol
研究组 & 干预措施
K-877-ER Dose A
Experimental
K-877-ER dose A administered once daily
干预措施: K-877-ER (Dose A) (Drug)
K-877-ER Dose B
Experimental
K-877-ER dose B administered once daily
干预措施: K-877-ER (Dose B) (Drug)
K-877-IR
Experimental
K-877-IR administered twice daily.
干预措施: K-877-IR (Drug)
结局指标
主要结局
Estimated Percentage Change in Fasting Triglyceride(s) (TG)
时间窗: Baseline to Day 28
次要结局
- K-877 PK Parameters AUC (Tau)(Day 28)
- Percentage Change From Baseline to Day 28 in Low-density Lipoprotein Cholesterol (LDL-C)(Baseline to Day 28)
- Percentage Change From Baseline to Day 28 in Remnant Cholesterol(Baseline to Day 28)
- Percentage Change From Baseline to Day 28 in Total Cholesterol (TC)(Baseline to Day 28)
- Percentage Change From Baseline to Day 28 in Non-HDL-C(Baseline to Day 28)
- Percentage Change From Baseline to Day 28 in Free Fatty Acid (FFAs)(Baseline to Day 28)
- Percentage Change From Baseline to Day 28 in High-density Lipoprotein Cholesterol (HDL-C)(Baseline to Day 28)
- K-877 PK Parameters Cmax(Day 28)
研究者
研究点 (12)
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