A Placebo-Controlled, Double-Blind, Randomized, Phase 2 Dose-Finding Study to Evaluate the Effect of Obicetrapib as an Adjunct to Stable Statin Therapy in Japanese Subjects.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 10
- 主要终点
- Mean Percent Change in 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 in Japanese patients to evaluate the efficacy, safety, and tolerability of obicetrapib as an adjunct to stable 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 stable statin therapy in Japanese patients. The screening period for this study will take up to 2-weeks. Afterwards, patients will be randomized to placebo, 2.5 mg obicetrapib, 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 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 tablet made to resemble active product
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 stable statin therapy; Atorvastatin 20/40 or Simvastatin 10/20
排除标准
- •BMI > or =35 kg/m2
- •Significant cardiovascular disease
- •HbA1c > 10%
- •Uncontrolled hypertension
- •Active muscle disease
- •GFR < 60 ml/min
- •Hepatic dysfunction
- •Existing CETP deficiency
- •History of Homozygous Familial Hypercholerstrolemia
- •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: Placebo (Drug)
2.5 mg Obicetrapib
once-daily Obicetrapib
干预措施: Obicetrapib (Drug)
5 mg Obicetrapib
once-daily Obicetrapib
干预措施: Obicetrapib (Drug)
10 mg Obicetrapib
once-daily Obicetrapib
干预措施: Obicetrapib (Drug)
结局指标
主要结局
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. 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).
LS Mean Percent Change in 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. 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).
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
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).
次要结局
- Mean Percent Change in Apolipoprotein B (ApoB)(8 Weeks)
- Median Percent Change in Apolipoprotein B (ApoB)(8 Weeks)
- LS Mean Percent Change in Apolipoprotein B (ApoB)(8 Weeks)
- 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)
- LS Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C)(8 Weeks)