A Phase 2 Efficacy and Safety Study of LY2484595 Alone and in Combination With Atorvastatin, Simvastatin, and Rosuvastatin in Patients With Hypercholesterolemia or Low HDL-C
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 398
- 试验地点
- 1
- 主要终点
- Percent Change From Baseline to 12 Weeks Endpoint in High Density Lipoprotein Cholesterol (HDL-C) With LY2484595 in Combination With Atorvastatin and Atorvastatin Monotherapy
研究概览
简要总结
The primary purpose of your participation in this study is to help answer the following research question(s)
- Whether LY2484595 in combination with a statin drug (atorvastatin, simvastatin or rosuvastatin; currently used to treat abnormal fat or cholesterol in blood) improves the blood fat profile more than statins alone.
- Whether LY2484595 alone improves blood fats profile compared to sugar pills.
- Whether LY2484595 interferes with break down or functioning of statins.
- Whether LY2484595 has any side effects that would not support testing it in future studies.
详细描述
Patients will be stratified according to baseline levels of serum triglycerides (<150 or greater than or equal to 150 milligram/deciliter (mg/dL), HDL-C (<45 or greater than or equal to 45 mg/dL for men; <50 or greater than or equal to 50 mg/dL for women), and region (United States or Europe). After a diet lead-in and prior therapy washout phase, subjects meeting all entry criteria will be randomized to one of 10 double-blind treatment groups for a 12 week treatment phase. After randomization, patients will self-administer the study drugs once a day with a low fat meal as their first meal of the day.
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)
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
- •Diagnosed with Low High Density Lipoprotein Cholesterol (HDL-C) or hypercholesterolemia, after diet lead-in/washout of lipid therapies
排除标准
- •History of coronary heart disease, or hardening of the arteries, or heart does not pump sufficiently well
- •Hypertension or high blood pressure that is not under control or your study physician does not consider the electrical activity of heart (Electrocardiogram [ECG]) to be compatible with participation in the study
- •History of a bad skin rash, a prior rash due to a drug or a history of chronic skin disorder (such as psoriasis or eczema)
- •Intolerance to certain lipid modifying drugs (including statins and Cholesteryl Ester Transfer Protein (CETP) inhibitors)
- •Not willing to stop taking prescription or over the counter drugs you use to control fats in your blood (like fish oil, niacin or statin) or pills to decrease your weight, including herbs
- •Not willing to follow the diet (low-fat) that the study physician will recommend
- •Have disease of liver, kidneys, muscles or other organs of body, a serious infection or cancer, or abnormal laboratory tests that study physician does not consider compatible with participation in the study
- •Breastfeeding woman or a woman who can still become pregnant, but are not willing to use a valid birth control measure to prevent pregnancies
研究组 & 干预措施
30 milligram (mg) LY2484595 monotherapy
干预措施: LY2484595 (Drug)
30 milligram (mg) LY2484595 monotherapy
干预措施: Placebo for Statins (Drug)
100 mg LY2484595 monotherapy
干预措施: LY2484595 (Drug)
100 mg LY2484595 monotherapy
干预措施: Placebo for Statins (Drug)
500 mg LY2484595 monotherapy
干预措施: LY2484595 (Drug)
500 mg LY2484595 monotherapy
干预措施: Placebo for Statins (Drug)
Placebo
干预措施: Placebo for LY2484595 (Drug)
Placebo
干预措施: Placebo for Statins (Drug)
20 mg Atorvastatin monotherapy
干预措施: Atorvastatin (Drug)
20 mg Atorvastatin monotherapy
干预措施: Placebo for LY2484595 (Drug)
100 mg LY2484595 + 20 mg Atorvastatin
干预措施: LY2484595 (Drug)
100 mg LY2484595 + 20 mg Atorvastatin
干预措施: Atorvastatin (Drug)
40 mg Simvastatin monotherapy
干预措施: Simvastatin (Drug)
40 mg Simvastatin monotherapy
干预措施: Placebo for LY2484595 (Drug)
100 mg LY2484595 + 40 mg Simvastatin
干预措施: LY2484595 (Drug)
100 mg LY2484595 + 40 mg Simvastatin
干预措施: Simvastatin (Drug)
10 mg Rosuvastatin monotherapy
干预措施: Rosuvastatin (Drug)
10 mg Rosuvastatin monotherapy
干预措施: Placebo for LY2484595 (Drug)
100 mg LY2484595 + 10 mg Rosuvastatin
干预措施: LY2484595 (Drug)
100 mg LY2484595 + 10 mg Rosuvastatin
干预措施: Rosuvastatin (Drug)
结局指标
主要结局
Percent Change From Baseline to 12 Weeks Endpoint in High Density Lipoprotein Cholesterol (HDL-C) With LY2484595 in Combination With Atorvastatin and Atorvastatin Monotherapy
时间窗: Baseline, Week 12
Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.
Percent Change From Baseline to 12 Weeks Endpoint in Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 in Combination With Atorvastatin and Atorvastatin Monotherapy
时间窗: Baseline, Week 12
Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.
次要结局
- Percent Change From Baseline to 12 Weeks Endpoint in High Density Lipoprotein Cholesterol (HDL-C) With LY2484595 and Placebo(Baseline, Week 12)
- Percent Change From Baseline to 12 Weeks Endpoint in Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 in Combination With Simvastatin or Rosuvastatin and Simvastatin/Rosuvastatin Monotherapy(Baseline, Week 12)
- Percent Change From Baseline to 12 Weeks Endpoint in Plasma Cholesteryl Ester Transfer Protein (CETP) Activity(Baseline, Week 12)
- Percent Change From Baseline to 12 Weeks Endpoint in Plasma Cholesteryl Ester Transfer Protein (CETP) Mass(Baseline, Week 12)
- Change From Baseline to 12 Weeks Endpoint in Serum Sodium(Baseline, Week 12)
- Percent Change From Baseline to 12 Weeks Endpoint in Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 and Placebo(Baseline, Week 12)
- Pharmacokinetics - LY2484595 Area Under the Concentration-Time Curve (AUC) at Steady-State(Baseline up to 12 weeks)
- Change From Baseline to 12 Weeks Endpoint in Serum Bicarbonate(Baseline, Week 12)
- Change From Baseline to 18 Weeks Endpoint in EuroQoL Questionnaire - 5 Dimensions (EQ-5D) Score(Baseline up to Week 18)
- Percent Change From Baseline to 12 Weeks Endpoint in High Density Lipoprotein Cholesterol (HDL-C) With LY2484595 in Combination With Simvastatin or Rosuvastatin and Simvastatin/Rosuvastatin Monotherapy(Baseline, Week 12)
- Change From Baseline to 12 Weeks Endpoint in Blood Pressure (BP)(Baseline, Week 12)
- Change From Baseline to 12 Weeks Endpoint in Serum Potassium(Baseline, Week 12)
- The Number of Episodes of Rashes at Any Time From Baseline Through Week 12(Baseline through Week 12)
- Change From Baseline to 12 Weeks Endpoint in Serum Aldosterone(Baseline, Week 12)
- Change From Baseline to 12 Weeks Endpoint in Plasma Renin Activity(Baseline, Week 12)