A Study of Evacetrapib (LY2484595) in Japanese Participants With Primary Hypercholesterolemia

Lilly

Status and phase: Terminated; Phase 3

Conditions: Hypercholesterolemia

Treatments: Drug: Placebo; Drug: Evacetrapib

Study type: Interventional

Funder types: Industry

Identifiers

NCT02260635

14503

I1V-JE-EIBI (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 54 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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54 participants in 2 patient groups, including a placebo group

Evacetrapib

Experimental group

Description:

130 milligrams (mg) evacetrapib given orally (PO) once a day for 12 weeks. Participants begin open label extension (130 mg evacetrapib given orally once a day for 40 weeks) after week 12.

Treatment:

Drug: Evacetrapib

Placebo

Placebo Comparator group

Description:

Placebo given PO once a day for 12 weeks. Participants begin open label extension (130 mg evacetrapib given PO once a day for 40 weeks) after week 12.

Treatment:

Drug: Evacetrapib

Drug: Placebo