A Study of Evacetrapib (LY2484595) in Japanese Participants With Primary Hypercholesterolemia
A Study of Evacetrapib (LY2484595) in Japanese Participants With Primary Hypercholesterolemia
The main purpose of this study is to evaluate the efficacy and safety of the study drug known
 as evacetrapib in Japanese participants with primary hypercholesterolemia. The double blind
 treatment period will last for 12 weeks and the open-label extension period will last for an
 additional 40 weeks.
Inclusion Criteria:

 -  Japanese outpatients who are diagnosed with primary hypercholesterolemia with LDL-C
 levels (measured by a direct method at baseline) that meet the following criteria.
 (Participant categories are based on the definition in Japan Atherosclerosis Society
 2012 guidelines.)

 -  Category I: 160 mg/deciliter (dL)≤LDL-C<200 mg/dL

 -  Category II: 140 mg/dL≤LDL-C<175 mg/dL

 -  Category III: 120 mg/dL≤LDL-C<150 mg/dL

 -  Have triglycerides (TG) ≤400 mg/dL.

 -  Have HDL-C <100 mg/dL.

 Exclusion Criteria:

 -  Participants on LDL apheresis or plasma apheresis.

 -  Participants with secondary hypercholesterolemia or familial hypercholesterolemia.

 -  Any planned angiography. If angiography is planned, participants may be screened and
 enrolled after all such planned procedures are completed.

 -  History of any of the following any conditions:

 -  Stable angina or acute coronary syndrome (unstable angina, myocardial
 infarction), old myocardial infarction or a coronary revascularization procedure
 including stent placement, or symptomatic carotid artery disease

 -  peripheral arterial disease

 -  ischemic stroke or transient ischemic attack (TIA)

 -  intracranial hemorrhage

 -  abdominal aortic aneurysm

 -  Have systolic blood pressure (SBP) >160 millimeters of mercury (mm Hg) or diastolic
 blood pressure (DBP) >100 mm Hg.

 -  Have a hemoglobin A1c ≥8.4% (National Glycohemoglobin Standardization Program).

 -  During the study period, participants who plan to use, are likely to require, or
 unwilling or unable to stop with adequate washout any prescription, over the counter
 medication, supplements or health foods with the intent to treat serum lipids (LDL-C,
 HDL-C, TG) including but not limited to these classes of drugs: statin, ezetimibe,
 bile acid sequestrant, eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA).
 Participants taking probucol, fibrate or nicotinic agents within 8 weeks before
 screening are excluded from the study.

 -  Have been exposed to cholesteryl ester transfer protein inhibitors (e.g., anacetrapib
 or dalcetrapib).