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

Lilly

Status and phase: Terminated; Phase 3

Conditions: Hypercholesterolemia

Treatments: Drug: Atorvastatin; Drug: Evacetrapib; Drug: Ezetimibe; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02260648

I1V-JE-EIBG (Other Identifier)

14501

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 when administered in combination with atorvastatin for 12 weeks in Japanese participants with primary hypercholesterolemia.

Enrollment: 149 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Must be treated with atorvastatin 10 mg/day for at least 30 days prior to study initiation.

• Japanese outpatients who are diagnosed with primary hypercholesterolemia with LDL-C levels (measured by a direct method) 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
  • Category II: 140 mg/dL≤LDL-C
  • Category III: 120 mg/dL≤LDL-C
  • Secondary prevention: 100 mg/dL≤LDL-C

• 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 homozygous 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 conditions < 90 days prior to study initiation

  • acute coronary syndrome (unstable angina, acute myocardial infarction)
  • symptomatic peripheral arterial disease
  • invasive treatment of carotid artery disease
  • ischemic stroke or transient ischemic attack (TIA)
  • intracranial hemorrhage

• History of abdominal aortic aneurysm.

• Participants with a history of intolerance/hypersensitivity to ezetimibe or statins.

• 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 (OTC) 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 (except for atorvastatin 10 mg), ezetimibe, bile acid sequestrant, eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). Participants taking probucol, fibrate or nicotinic agents within 8 weeks before study initiation are excluded from the study.

• Have been exposed to cholesteryl ester transfer protein (CETP) inhibitors (for example, anacetrapib or dalcetrapib).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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149 participants in 3 patient groups, including a placebo group

Evacetrapib

Experimental group

Description:

130 milligrams (mg) evacetrapib and 10 mg atorvastatin administered PO once a day for 12 weeks.

Treatment:

Drug: Atorvastatin

Drug: Evacetrapib

Ezetimibe

Active Comparator group

Description:

10 mg ezetimibe and 10 mg atorvastatin administered PO once a day for 12 weeks as a reference arm.

Treatment:

Drug: Atorvastatin

Drug: Ezetimibe

Placebo

Placebo Comparator group

Description:

Placebo and 10 mg atorvastatin administered PO once a day for 12 weeks.

Treatment:

Drug: Atorvastatin

Drug: Placebo