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
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)
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.
Inclusion Criteria:
• Diagnosed with Low High Density Lipoprotein Cholesterol (HDL-C) or hypercholesterolemia, after diet lead-in/washout of lipid therapies
Exclusion Criteria:
Fayetteville, Arkansas 72703, United States
San Diego, California 92128, United States
Spring Valley, California 91978, United States
Vista, California 92083, United States
Golden, Colorado 80401, United States
Brandon, Florida 33511, United States
Jacksonville, Florida 32216, United States
Longwood, Florida 32779, United States
Ponte Vedra, Florida 32081, United States
Indianapolis, Indiana 46254, United States
Waterloo, Iowa 50702, United States
Wichita, Kansas 67708, United States
Lexington, Kentucky 40504, United States
Auburn, Maine 04210, United States
Baltimore, Maryland 21209, United States
Picayune, Mississippi 39466, United States
Edison, New Jersey 08817, United States
Endwell, New York 13760, United States
Cary, North Carolina 27518, United States
Charlotte, North Carolina 28209, United States
Greensboro, North Carolina 27408, United States
Hickory, North Carolina 28601, United States
Raleigh, North Carolina 27609, United States
Salisbury, North Carolina 28144, United States
Wilmington, North Carolina 28401, United States
Winston-Salem, North Carolina 27103, United States
Philadelphia, Pennsylvania 19152, United States
Red Lion, Pennsylvania 17356, United States
Yardley, Pennsylvania 19067, United States
Greer, South Carolina 29651, United States
Mt. Pleasant, South Carolina 29464, United States
Simpsonville, South Carolina 29681, United States
Bristol, Tennessee 37620, United States
Kingsport, Tennessee 37660, United States
Dallas, Texas 75231, United States
Houston, Texas 77030, United States
Tacoma, Washington 98405, United States
Oregon, Wisconsin 53575, United States
Ballerup Municipality, 2750, Denmark
Vejle, 7100, Denmark
Berlin, 12627, Germany
Bochum, 44787, Germany
Leipzig, 04103, Germany
Amsterdam, 1105 AZ, Netherlands
Breda, 4811 VL, Netherlands
Eindhoven, 5611 NJ, Netherlands
Geleen, 6160 BB, Netherlands
Groningen, 9711 SG, Netherlands
Leiderdorp, 2352 RA, Netherlands
Rotterdam, 3021 HC, Netherlands
Zoetermeer, 2724 EK, Netherlands
Gdynia, 81-572, Poland
Warsaw, 02-777, Poland
Wroclaw, 50-088, Poland
Reading, Berkshire RG2 7AG, United Kingdom
Chorley, Lancashire PR 7 7NA, United Kingdom
Liverpool, Merseyside L22 0LG, United Kingdom
Glasgow, Scotland G81 2DR, United Kingdom