A Study of LY2484595 in Patients With High LDL-C or Low HDL-C
- Conditions
- Dyslipidemia
- Interventions
- Drug: Placebo for LY2484595Drug: Placebo for Statins
- Registration Number
- NCT01105975
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 398
• Diagnosed with Low High Density Lipoprotein Cholesterol (HDL-C) or hypercholesterolemia, after diet lead-in/washout of lipid therapies
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 10 mg Rosuvastatin monotherapy Placebo for LY2484595 - 100 mg LY2484595 monotherapy Placebo for Statins - 100 mg LY2484595 + 10 mg Rosuvastatin LY2484595 - 30 milligram (mg) LY2484595 monotherapy Placebo for Statins - 20 mg Atorvastatin monotherapy Placebo for LY2484595 - 40 mg Simvastatin monotherapy Placebo for LY2484595 - 100 mg LY2484595 + 40 mg Simvastatin LY2484595 - 100 mg LY2484595 monotherapy LY2484595 - Placebo Placebo for Statins - 30 milligram (mg) LY2484595 monotherapy LY2484595 - 500 mg LY2484595 monotherapy LY2484595 - 500 mg LY2484595 monotherapy Placebo for Statins - Placebo Placebo for LY2484595 - 100 mg LY2484595 + 20 mg Atorvastatin LY2484595 - 100 mg LY2484595 + 20 mg Atorvastatin Atorvastatin - 100 mg LY2484595 + 10 mg Rosuvastatin Rosuvastatin - 20 mg Atorvastatin monotherapy Atorvastatin - 40 mg Simvastatin monotherapy Simvastatin - 100 mg LY2484595 + 40 mg Simvastatin Simvastatin - 10 mg Rosuvastatin monotherapy Rosuvastatin -
- Primary Outcome Measures
Name Time Method Percent Change From Baseline to 12 Weeks Endpoint in High Density Lipoprotein Cholesterol (HDL-C) With LY2484595 in Combination With Atorvastatin and Atorvastatin Monotherapy 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 Baseline, Week 12 Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.
- Secondary Outcome Measures
Name Time Method Percent Change From Baseline to 12 Weeks Endpoint in High Density Lipoprotein Cholesterol (HDL-C) With LY2484595 and Placebo 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 Simvastatin or Rosuvastatin and Simvastatin/Rosuvastatin Monotherapy 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 Plasma Cholesteryl Ester Transfer Protein (CETP) Activity 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 Plasma Cholesteryl Ester Transfer Protein (CETP) Mass Baseline, Week 12 Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.
Change From Baseline to 12 Weeks Endpoint in Serum Sodium 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 and Placebo Baseline, Week 12 Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.
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 Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.
Change From Baseline to 18 Weeks Endpoint in EuroQoL Questionnaire - 5 Dimensions (EQ-5D) Score Baseline up to Week 18 EQ-5D is a health-related, quality-of-life instrument. It allows participants to rate their health state in 5 domains: mobility, self-care, usual activities, pain/discomfort, and mood. A single score 1 -3 is generated for each domain, with 1=no problem and 3= extreme problems. The outcome ratings on the 5 domains are mapped to a single index through an algorithm. The index ranges 0-1, with the higher score indicating a better health state perceived by the participants. 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 High Density Lipoprotein Cholesterol (HDL-C) With LY2484595 in Combination With Simvastatin or Rosuvastatin and Simvastatin/Rosuvastatin Monotherapy Baseline, Week 12 Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.
Change From Baseline to 12 Weeks Endpoint in Blood Pressure (BP) Baseline, Week 12 Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.
Change From Baseline to 12 Weeks Endpoint in Serum Potassium Baseline, Week 12 Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.
The Number of Episodes of Rashes at Any Time From Baseline Through Week 12 Baseline through Week 12 All rash cases were adjudicated by a central dermatologist blinded to treatment assignment according to a study-specific Clinical Events Committee (CEC) charter. Rash events were assessed according to clinical relevance (high risk, low risk, not a relevant dermatosis, or insufficient documentation for determination). A participant could be reported in multiple categories.
Change From Baseline to 12 Weeks Endpoint in Serum Aldosterone Baseline, Week 12 Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.
Change From Baseline to 12 Weeks Endpoint in Plasma Renin Activity Baseline, Week 12 Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.
Trial Locations
- Locations (1)
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
🇬🇧Birmingham, United Kingdom