A Placebo-Controlled, Double-Blind, Randomized, Phase 2 Dose-Finding Study to Evaluate the Effect of Obicetrapib as an Adjunct to High-Intensity Statin Therapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 19
- 主要终点
- LS Mean Percent Change Iin Low-Density Lipoprotein Cholesterol (LDL-C) [Friedewald]
研究概览
简要总结
This study will be a placebo-controlled, double-blind, randomized, phase 2 dose-finding study to evaluate the efficacy, safety, and tolerability of obicetrapib as an adjunct to high-intensity statin therapy.
详细描述
This study will be a placebo-controlled, double-blind, randomized, phase 2 dose-finding study to evaluate the efficacy, safety, and tolerability of obicetrapib as an adjunct to high-intensity statin therapy. The screening period for this study will take up to 2-weeks. Afterwards patients will be randomized to placebo, 5 mg obicetrapib or 10 mg obicetrapib for an 8-week treatment period. After the treatment period, patients will continue for a 4-week safety follow-up and a 15-week PK follow-up.
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 tablet made to resemble active
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •LDL-C > 70 mg/dL and TG < 400 mg/dL,
- •Treated with a high-intensity statin therapy
排除标准
- •BMI > 40 kg/m
- •Significant cardiovascular disease
- •HbA1c > 10%
- •Uncontrolled hypertension
- •Active muscle disease
- •GFR < 60 ml/min
- •Hepatic dysfunction
- •History of malignancy
- •Alcohol abuse
- •Treatment with investigational product
- •Treatment with PCSK9
- •Clinically significant condition
- •Known CETP inhibitor allergy
研究组 & 干预措施
Placebo
once-daily placebo
干预措施: Obicetrapib (Drug)
obicetrapib 5 mg
once-daily obicetrapib
干预措施: Obicetrapib (Drug)
obicetrapib 10 mg
once-daily obicetrapib
干预措施: Obicetrapib (Drug)
结局指标
主要结局
LS Mean Percent Change Iin Low-Density Lipoprotein Cholesterol (LDL-C) [Friedewald]
时间窗: 8-Weeks
LS mean percent change from Day 1 to Day 56 in Low-Density Lipoprotein Cholesterol (LDL-C) for each obicetrapib group compared to the placebo group. \[Friedewald\] LDL-C was calculated using the Friedewald equation unless TG ≥400 mg/dL or LDL-C ≤50 mg/dL; if TG ≥400 mg/dL or LDL-C ≤50 mg/dL, then LDL-C level was measured directly by preparative ultracentrifugation (PUC),
Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [PUC]
时间窗: 8-Weeks
Mean Percent change from Day 1 to Day 56 in Low-Density Lipoprotein Cholesterol (LDL-C) for each obicetrapib group compared to the placebo group. LDL-C level was measured by preparative ultracentrifugation (PUC).
Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [Friedewald]
时间窗: 8-weeks
Mean percent change from Day 1 to Day 56 in Low-Density Lipoprotein Cholesterol (LDL-C) for each obicetrapib group compared to the placebo group.LDL-C was calculated using the Friedewald equation unless TG ≥400 mg/dL or LDL-C ≤50 mg/dL; if TG ≥400 mg/dL or LDL-C ≤50 mg/dL, then LDL-C level was measured directly by preparative ultracentrifugation (PUC),
Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [Friedewald]
时间窗: 8-Weeks
Median Percent change from Day 1 to Day 56 in Low-Density Lipoprotein Cholesterol (LDL-C) for each obicetrapib group compared to the placebo group. \[Friedewald\] LDL-C was calculated using the Friedewald equation unless TG ≥400 mg/dL or LDL-C ≤50 mg/dL; if TG ≥400 mg/dL or LDL-C ≤50 mg/dL, then LDL-C level was measured directly by preparative ultracentrifugation (PUC),
Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [PUC]
时间窗: 8-Weeks
Median Percent change from Day 1 to Day 56 in Low-Density Lipoprotein Cholesterol (LDL-C) for each obicetrapib group compared to the placebo group. LDL-C level was measured by preparative ultracentrifugation (PUC).
LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [PUC]
时间窗: 8-Weeks
LS Mean Percent change from Day 1 to Day 56 in Low-Density Lipoprotein Cholesterol (LDL-C) for each obicetrapib group compared to the placebo group. LDL-C level was measured directly by preparative ultracentrifugation (PUC).
次要结局
- Mean Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)(8-weeks)
- Median Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)(8-Weeks)
- LS Mean Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)(8-Weeks)
- Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C)(8-weeks)
- Median Percent Change in High-density Lipoprotein Cholesterol (HDL-C)(8-Weeks)
- Mean Percent Change in Apolipoprotein B (ApoB)(8-Weeks)
- LS Mean Percent Change in Apolipoprotein B (ApoB)(8-Weeks)
- Median Percent Change in Apolipoprotein B (ApoB)(8-Week)
- LS Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C)(8-Weeks)