A Placebo-Controlled, Double-Blind, Randomized, Phase 2 Study to Evaluate the Effect of Obicetrapib 10 mg Daily in Combination With Ezetimibe 10 mg Daily as an Adjunct to High-Intensity Statin Therapy: The ROSE 2 Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 119
- 试验地点
- 16
- 主要终点
- Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Combination Treatment Group Compared With the Placebo Group [Friedewald]
研究概览
简要总结
This study will be a placebo-controlled, double-blind, randomized, phase 2 study to evaluate the efficacy, safety, and tolerability of obicetrapib 10 mg, both in combination with ezetimibe 10 mg and as monotherapy, as an adjunct to high-intensity statin therapy.
详细描述
This study will be a placebo-controlled, double-blind, randomized, phase 2 study to evaluate the efficacy, safety, and tolerability of obicetrapib 10 mg, both in combination with ezetimibe 10 mg and as monotherapy, 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, 10 mg obicetrapib monotherapy, or 10 mg obicetrapib + 10 mg ezetimibe combination therapy for a 12-week treatment period. After the treatment period, patients will continue for a 4-week safety 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; placebo capsule 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 Triglycerides < 400 mg/dL,
- •Treated with a high-intensity statin therapy
排除标准
- •BMI >= 40 kg/m2
- •Significant cardiovascular disease
- •HbA1c >= 10%
- •Uncontrolled hypertension
- •Active muscle disease
- •estimated glomerular filtration rate < 60 mL/min
- •Hepatic dysfunction
- •History of participation in any clinical trial evaluating obicetrapib
- •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 tablet and placebo capsule
干预措施: Obicetrapib placebo (Other)
Placebo
once-daily placebo tablet and placebo capsule
干预措施: Ezetimibe placebo (Other)
monotherapy
once-daily obicetrapib 10 mg tablet and placebo capsule
干预措施: Obicetrapib (Drug)
monotherapy
once-daily obicetrapib 10 mg tablet and placebo capsule
干预措施: Ezetimibe placebo (Other)
combination therapy
once-daily obicetrapib 10 mg tablet and ezetimibe 10 mg capsule
干预措施: Obicetrapib (Drug)
combination therapy
once-daily obicetrapib 10 mg tablet and ezetimibe 10 mg capsule
干预措施: Ezetimibe 10mg (Drug)
结局指标
主要结局
Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Combination Treatment Group Compared With the Placebo Group [Friedewald]
时间窗: 12-Weeks
Median percent change from Day 1 to Day 84 in Low-Density Lipoprotein Cholesterol (LDL-C) for the obicetrapib 10 mg + ezetimibe 10 mg combination treatment group compared with 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) for Combination Treatment Group Compared With the Placebo Group [Friedewald]
时间窗: 12-Weeks
LS Mean percent change from Day 1 to Day 84 in Low-Density Lipoprotein Cholesterol (LDL-C) for the obicetrapib 10 mg + ezetimibe 10 mg combination treatment group compared with 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) for Combination Treatment Group Compared With the Placebo Group [PUC]
时间窗: 12-Weeks
LS Mean percent change from Day 1 to Day 84 in Low-Density Lipoprotein Cholesterol (LDL-C) for the obicetrapib 10 mg + ezetimibe 10 mg combination treatment group compared with the placebo group. LDL-C level was measured by preparative ultracentrifugation (PUC).
Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Combination Treatment Group Compared With the Placebo Group [Friedewald]
时间窗: 12-weeks
Mean percent change from Day 1 to Day 84 in Low-Density Lipoprotein Cholesterol (LDL-C) for the obicetrapib 10 mg + ezetimibe 10 mg combination treatment group compared with 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) for Combination Treatment Group Compared With the Placebo Group [PUC]
时间窗: 12-Weeks
Mean percent change from Day 1 to Day 84 in Low-Density Lipoprotein Cholesterol (LDL-C) for the obicetrapib 10 mg + ezetimibe 10 mg combination treatment group compared with the placebo group. LDL-C level was measured by preparative ultracentrifugation (PUC).
Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Combination Treatment Group Compared With the Placebo Group [PUC]
时间窗: 12-Weeks
Median percent change from Day 1 to Day 84 in Low-Density Lipoprotein Cholesterol (LDL-C) for the obicetrapib 10 mg + ezetimibe 10 mg combination treatment group compared with the placebo group. LDL-C level was measured by preparative ultracentrifugation (PUC).
次要结局
- Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Obicetrapib 10 mg Monotherapy Compared With Placebo [PUC](12-Weeks)
- Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Obicetrapib 10 mg Monotherapy Compared With Placebo [PUC](12-Weeks)
- LS Mean Percent Change in Apolipoprotein-B (ApoB) for Obicetrapib 10 mg Monotherapy Compared With Placebo(12-Weeks)
- Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Obicetrapib 10 mg Monotherapy Compared With Placebo [Friedewald](12-Weeks)
- Median Percent Change in Apolipoprotein-B (ApoB) for Obicetrapib 10 mg Monotherapy Compared With Placebo(12-Weeks)
- Mean Percent Change in Apolipoprotein-B (ApoB) for Obicetrapib in Combination With Ezetimibe Compared to Placebo(12-weeks)
- Median Percent Change in Apolipoprotein-B (ApoB) for Obicetrapib in Combination With Ezetimibe Compared to Placebo(12-Weeks)
- Mean Percent Change in Apolipoprotein-B (ApoB) for Obicetrapib 10 mg Monotherapy Compared With Placebo(12-weeks)
- Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Obicetrapib 10 mg Monotherapy Compared With Placebo [Friedewald](12-weeks)
- LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Obicetrapib 10 mg Monotherapy Compared With Placebo [Friedewald](12-Weeks)
- LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Obicetrapib 10 mg Monotherapy Compared With Placebo [PUC](12-Weeks)
- LS Mean Percent Change in Apolipoprotein-B (ApoB) for Obicetrapib in Combination With Ezetimibe Compared to Placebo(12-Weeks)