Dyslipidemia Clinical Trial
Official title:
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
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.
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. ;
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