NCT03397121已完成3 期
Placebo-Controlled, Double-Blind, Randomized Trial to Evaluate the Effect of 300 mg of Inclisiran Sodium Given as Subcutaneous Injections in Subjects With Heterozygous Familial Hypercholesterolemia (HeFH) and Elevated Low-Density Lipoprotein Cholesterol (LDL-C).
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
- 482
- 试验地点
- 45
- 主要终点
- Time-adjusted Percent Change in LDL-C From Baseline After Day 90 and up to Day 540
研究概览
简要总结
This is a Phase III, placebo-controlled, double-blind, randomized study in participants with HeFH and elevated LDL-C to evaluate the efficacy, safety, and tolerability of subcutaneous (SC) injection(s) of inclisiran. The study will be multicenter and international.
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, Care Provider)
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
- •Participants may be included if they meet all of the following inclusion criteria prior to randomization:
- •Male or female participants ≥18 years of age.
- •History of HeFH with a diagnosis of HeFH by genetic testing; and/or a documented history of untreated LDL-C of >190 mg/dL, and a family history of familial hypercholesterolemia, elevated cholesterol or early heart disease that may indicate familial hypercholesterolemia.
- •Serum LDL-C ≥2.6 millimoles (mmol)/liter (L) (≥100 mg/dL) at screening.
- •Fasting triglyceride <4.52 mmol/L (<400 mg/dL) at screening.
- •Participants on statins should be receiving a maximally tolerated dose.
- •Participants not receiving statins must have documented evidence of intolerance to all doses of at least 2 different statins.
- •Participants on lipid-lowering therapies (such as a statin and/or ezetimibe) should be on a stable dose for ≥30 days before screening with no planned medication or dose change during study participation.
排除标准
- •Participants will be excluded from the study if any of the following exclusion criteria apply immediately prior to randomization:
- •New York Heart Association (NYHA) class IV heart failure.
- •Uncontrolled cardiac arrhythmia
- •Uncontrolled severe hypertension
- •Active liver disease
- •Females who are pregnant or nursing, or who are of childbearing potential and unwilling to use at least 2 methods of highly effective contraception (failure rate less than 1% per year) (combined oral contraceptives, barrier methods, approved contraceptive implant, long-term injectable contraception, or intrauterine device) for the entire duration of the study. Exemptions from this criterion:
- •Women >2 years postmenopausal (defined as 1 year or longer since last menstrual period) AND more than 55 years of age.
- •Postmenopausal women (as defined above) and less than 55 years of age with a negative pregnancy test within 24 hours of randomization.
- •Women who are surgically sterilized at least 3 months prior to enrollment.
- •Males who are unwilling to use an acceptable method of birth control during the entire study period (condom with spermicide).
- •Treatment with other investigational products or devices within 30 days or 5 half-lives of the screening visit, whichever is longer.
- •Treatment (within 90 days of screening) with monoclonal antibodies directed towards PCSK
- •The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
研究组 & 干预措施
Inclisiran
Experimental
Inclisiran sodium 300 milligrams (mg) will be administered as a SC injection on Day 1, Day 90 then every 6 months.
干预措施: Inclisiran (Drug)
Placebo
Placebo Comparator
Placebo will be administered as SC injections of saline solution on Day 1, Day 90 then every 6 months.
干预措施: Placebo (Drug)
结局指标
主要结局
Time-adjusted Percent Change in LDL-C From Baseline After Day 90 and up to Day 540
时间窗: Baseline, Day 90
Assessments performed at Baseline, Day 90, Day 540, time-adjusted percent change at Day 90 reported
Percent Change in LDL-C From Baseline To Day 510
时间窗: Baseline, Day 510
次要结局
- Percentage Change in Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) From Baseline to Day 510(Baseline, Day 510)
- Percentage Change in Total Cholesterol From Baseline to Day 510(Baseline, Day 510)
- Absolute Change in LDL-C From Baseline to Day 510(Baseline, Day 510)
- Time-adjusted Absolute Change in LDL-C From Baseline After Day 90 and up to Day 540(Baseline, Day 90)
- Percent Change in Apolipoprotein B (Apo-B) From Baseline To Day 510(Baseline, Day 510)
- Percent Change in Non-high-density Lipoprotein (HDL)-C From Baseline To Day 510(Baseline, Day 510)
研究者
研究点 (45)
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