NCT01529424已完成2 期
A Randomized, Double-Blind, Placebo-Controlled, Dose Response, Phase 2 Study of ISIS 304801 Administered Subcutaneously to Patients With Severe or Uncontrolled Hypertriglyceridemia
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 89
- 试验地点
- 7
- 主要终点
- VLDL apoC-III
研究概览
简要总结
The purpose of this study is to evaluate the dose/response pharmacodynamic effects of ISIS ApoC-III Rx vs. Placebo on fasting total apoC-III levels.
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
- •Severe hypertriglyceridemia
排除标准
- •HbA1c >/=9.0%, type 1 diabetes, or history of outpatient insulin use for more than 2 weeks in the last year
- •Body mass index (BMI) >40 kg/m2
- •History of bariatric surgery or currently on weight loss drugs
- •Use of oral contraceptives or hormone replacement therapy or statins unless stable for 3 months prior to dosing
- •Group 1 and 2 patients: Use of systemic corticosteroids, fibrates, niacin, fish oil or other products containing omega-3 fatty acids within 6 weeks of dosing. Group 3 patients: unable to discontinue use of systemic corticosteroids at least 6 weeks prior to dosing ; use of niacin, fish oil, or other products containing omega-3 fatty acids unless on a stable well controlled dose for at least 30 days prior to screening that is not anticipated to change during the study period. Group 4 patients: unable to discontinue use of systemic corticosteroids at least 6 weeks prior to dosing; use of fibrates niacin, fish oil, or other products containing omega-3 fatty acids unless on a stable well controlled dose for at least 30 days prior to screening that is not anticipated to change during the study period.
- •Use of topical corticosteroids, anticoagulants, or drugs or dietary supplements with potential lipid-altering effects unless dose is stable and well controlled for 30 days prior to dosing
- •Any Screening laboratory values that are out of allowed reference ranges
- •Inability to comply with protocol or study procedures
- •Any other significant illness or condition that may adversely affect the subjects participation in the study
研究组 & 干预措施
Group 2b
Experimental
Post-prandial assessment
干预措施: ISIS apoC-III Rx (Drug)
Group 1
Experimental
Non-extensive PK/non post-prandial
干预措施: Placebo (Drug)
Group 1
Experimental
Non-extensive PK/non post-prandial
干预措施: ISIS apoC-III Rx (Drug)
Group 2a
Experimental
Extensive PK
干预措施: ISIS apoC-III Rx (Drug)
Group 2a
Experimental
Extensive PK
干预措施: Placebo (Drug)
Group 2b
Experimental
Post-prandial assessment
干预措施: Placebo (Drug)
Group 3
Experimental
Stable dose of fibrate
干预措施: ISIS apoC-III Rx (Drug)
Group 3
Experimental
Stable dose of fibrate
干预措施: Placebo (Drug)
Group 4
Experimental
Fredrickson Type 1 dyslipidemia
干预措施: ISIS apoC-III Rx (Drug)
结局指标
主要结局
VLDL apoC-III
时间窗: 92 Days
The effect of treatment with ISIS ApoC-III Rx or Placebo on fasting total apoC-III levels.
次要结局
未报告次要终点
研究者
研究点 (7)
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