NCT02300233已完成3 期
The COMPASS Study: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of ISIS 304801 Administered Subcutaneously to Patients With Hypertriglyceridemia
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Percent Change in Fasting Triglycerides (TG) From Baseline to Month 3
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of volanesorsen given for 26 weeks in participants with Hypertriglyceridemia.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Body mass index (BMI) ≤ 45 kg/m2
- •Fasting Triglycerides (TG) ≥ 500 mg/dL (≥ 5.7 mmol/L) at Screening.
- •If on statin or fibrate, participants must be on stable, labeled dose for at least 3 months prior to screening. Participants not receiving these drugs within 4 weeks prior to screening are also eligible.
排除标准
- •Type 1 diabetes mellitus
- •Newly diagnosed type 2 diabetes mellitus (within 12 weeks of screening) or HbA1c ≥ 9.0% at Screening
- •Acute pancreatitis within 3 months of screening
- •Acute Coronary Syndrome within 6 months of screening
- •Major surgery within 3 months of screening
- •Prior exposure to ISIS 304801
- •Have any other conditions in the opinion of the investigator which could interfere with the participant participating in or completing the study
研究组 & 干预措施
Placebo
Placebo Comparator
Volanesorsen-matching placebo administered subcutaneously once-weekly for 26 weeks.
干预措施: Placebo (Drug)
Volanesorsen 300 mg weekly
Experimental
Volanesorsen 300 mg administered subcutaneously once-weekly for 26 weeks.
干预措施: Volanesorsen (Drug)
Volanesorsen 300 mg biweekly, post Week 13
Experimental
Volanesorsen 300 mg administered subcutaneously once-weekly for 13 weeks, then bi-weekly for 13 weeks.
干预措施: Volanesorsen (Drug)
结局指标
主要结局
Percent Change in Fasting Triglycerides (TG) From Baseline to Month 3
时间窗: Baseline to 3 months
次要结局
- Absolute Change in Fasting TG From Baseline to Month 3(Baseline to 3 months)
- Percent Change in High-density Lipoprotein-cholesterol (HDL-C) From Baseline(Baseline to 3 months)
- Treatment Response Rate Defined as Participants With Fasting TG ≥ 40% Reduction From Baseline at Month 3(Baseline to 3 months)
- Treatment Response Rate Defined as Participants With Fasting TG < 150 mg/dL Reduction From Baseline at Month 3(Baseline to 3 months)
- Change From Baseline in Homeostasis Model Assessment-estimated Insulin Resistance (HOMA-IR)(Baseline to 3 and 6 months)
- Change From Baseline in Glycated Hemoglobin (HbA1c) in Type 2 Diabetes Mellitus (T2DM) Participants(Baseline to 3 and 6 months)
研究者
研究点 (1)
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