A Placebo-Controlled, Double-Blind, Randomized, Phase 3 Study to Evaluate the Effect of Obicetrapib 10 mg and Ezetimibe 10 mg Fixed Dose Combination Daily on Top of Maximally Tolerated Lipid-Modifying Therapy in Participants With Heterozygous Familial Hypercholesterolemia (HeFH) and/or Atherosclerotic Cardiovascular Disease (ASCVD) or Multiple ASCVD Risk Factors
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 407
- 试验地点
- 45
- 主要终点
- Effect of Fixed-Dose Combination (FDC) Compared to Placebo on LDL-C
研究概览
简要总结
The study is a placebo-controlled, double-blind, randomized, phase 3 study in participants with heterozygous familial hypercholesterolemia (HeFH) and/or atherosclerotic cardiovascular disease (ASCVD) or multiple ASCVD risk factors to evaluate the efficacy, safety and tolerability of obicetrapib 10mg and ezetimibe 10mg fixed dose combination as an adjunct to diet and maximally tolerated lipid-lowering therapy.
详细描述
This study will be a placebo-controlled, double-blind, randomized, phase 3 study in participants with heterozygous familial hypercholesterolemia (HeFH) and/or atherosclerotic cardiovascular disease (ASCVD) or multiple ASCVD risk factors to evaluate the efficacy, safety, and tolerability of obicetrapib as an adjunct to diet and maximally tolerated lipid-lowering therapy. The screening period for this study will take up to 14 days. Afterwards patients will be randomized 1:1:1:1 to Obicetrapib 10 mg and ezetimibe 10 mg fixed dose combination, obicetrapib 10 mg, ezetimibe 10 mg or placebo for a 84 day treatment period. After the treatment period, patients will have an end of study follow-up visit.
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)
盲法说明
placebo tablets made to resemble active; placebo capsule made to resemble active
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
- •Have underlying HeFH and/or a history of ASCVD or multiple ASCVD risk factors
- •On maximally tolerated lipid-modifying therapy as an adjunct to a diet and lifestyle modifications
- •LDL-C ≥ 70 mg/dL
- •Triglycerides < 500
- •Estimated glomerular filtration rate ≥ 15 mL/min/1.73 m2
排除标准
- •History of New York Heart Association (NYHA) class III or IV heart failure of left ventricular ejection fraction <30%
- •Hospitalized for heart failure within the last 5 years
- •Myocardial infarction, stroke, non-elective coronary revascularization or hospitalization for unstable angina or chest pain in the last 3 months
- •Uncontrolled severe hypertension
- •Diagnosis of homozygous FH
- •Liver disease
- •HbA1c ≥ 10.0% or fasting glucose ≥ 270 mg/dL
- •Thyroid-stimulating hormone >1.5 x upper limit of normal (ULN)
- •History of malignancy
- •Creatinine kinase (CK) >3 X ULN
- •Alcohol abuse
- •Treatment with investigational product
- •Treatment with gemfibrozil or ezetimibe
- •Previous participation in a trial evaluating obicetrapib
- •Known allergy to study drugs, placebo or excipients in study drugs of placebo
- •Other condition that would interfere with the conduct of the study
研究组 & 干预措施
Combination Therapy
once-daily obicetrapib 10 mg and ezetimibe 10 mg fixed dose combination tablet, placebo tablet, placebo capsule
干预措施: Ezetimibe Placebo (Other)
Combination Therapy
once-daily obicetrapib 10 mg and ezetimibe 10 mg fixed dose combination tablet, placebo tablet, placebo capsule
干预措施: Combination Therapy (Combination Product)
Combination Therapy
once-daily obicetrapib 10 mg and ezetimibe 10 mg fixed dose combination tablet, placebo tablet, placebo capsule
干预措施: Obicetrapib Placebo (Other)
Monotherapy obicetrapib
once-daily obicetrapib 10 mg, placebo tablet, placebo capsule
干预措施: Monotherapy obicetrapib (Drug)
Monotherapy obicetrapib
once-daily obicetrapib 10 mg, placebo tablet, placebo capsule
干预措施: Combination Therapy placebo (Other)
Monotherapy obicetrapib
once-daily obicetrapib 10 mg, placebo tablet, placebo capsule
干预措施: Ezetimibe Placebo (Other)
Monotherapy ezetimibe
once-daily ezetimibe 10 mg capsule, 2 placebo tablets
干预措施: Monotherapy ezetimibe (Drug)
Monotherapy ezetimibe
once-daily ezetimibe 10 mg capsule, 2 placebo tablets
干预措施: Combination Therapy placebo (Other)
Monotherapy ezetimibe
once-daily ezetimibe 10 mg capsule, 2 placebo tablets
干预措施: Obicetrapib Placebo (Other)
Placebo
once-daily placebo tablets (2), placebo capsule
干预措施: Combination Therapy placebo (Other)
Placebo
once-daily placebo tablets (2), placebo capsule
干预措施: Obicetrapib Placebo (Other)
Placebo
once-daily placebo tablets (2), placebo capsule
干预措施: Ezetimibe Placebo (Other)
结局指标
主要结局
Effect of Fixed-Dose Combination (FDC) Compared to Placebo on LDL-C
时间窗: 84 Days
LS mean percent change in low-density lipoprotein cholesterol (LDL-C) from baseline to Day 84 in the obicetrapib 10 mg/ezetimibe 10 mg fixed-dose combination (FDC) group compared to the placebo group. LDL-C level was measured by preparative ultracentrifugation (PUC).
Effect of Fixed Dose Combination (FDC) Compared to Ezetimibe Monotherapy on LDL-C
时间窗: 84 Days
LS mean percent change in low-density lipoprotein cholesterol (LDL-C) from baseline to Day 84 in the obicetrapib 10 mg/ezetimibe 10 mg fixed-dose combination (FDC) group compared to the ezetimibe monotherapy 10 mg group. LDL-C level was measured by preparative ultracentrifugation (PUC).
Effect of Fixed Dose Combination (FDC) Compared to Obicetrapib Monotherapy on LDL-C
时间窗: 84 Days
LS mean percent change in low-density lipoprotein cholesterol (LDL-C) from baseline to Day 84 in the obicetrapib 10 mg/ezetimibe 10 mg fixed-dose combination (FDC) group compared to the obicetrapib monotherapy 10 mg group. LDL-C level was measured by preparative ultracentrifugation (PUC).
Effect of Obicetrapib Monotherapy Compared to Placebo on LDL-C
时间窗: 84 Days
LS mean percent change in low-density lipoprotein cholesterol (LDL-C) from baseline to Day 84 in the obicetrapib 10 mg group compared to the placebo group. LDL-C level was measured by preparative ultracentrifugation (PUC).
次要结局
- Effect of Fixed Dose Combination (FDC) Compared to Placebo on Non-HDL-C(84 Days)
- Effect of Fixed Dose Combination (FDC) Compared to Placebo on Apolipoprotein B (ApoB)(84 Days)
- Effect of Obicetrapib Monotherapy Compared to Placebo on Non-HDL-C(84 Days)
- Effect of Obicetrapib Monotherapy Compared to Placebo on Apolipoprotein B (ApoB)(84 Days)
- Effect of Fixed-Dose Combination (FDC) Compared to Ezetimibe Monotherapy on Non-HDL-C(84 Days)
- Effect of Fixed-Dose Combination (FDC) Compared to Ezetimibe Monotherapy on Apolipoprotein B (ApoB)(84 Days)
- Effect of Fixed-Dose Combination (FDC) Compared to Obicetrapib Monotherapy on Non-HDL-C(84 Days)
- Effect of Fixed-Dose Combination (FDC) Compared to Obicetrapib Monotherapy on Apolipoprotein B (ApoB)(84 Days)