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

Phase 3

Terminated

• Conditions: Hypercholesterolemia
• Interventions: Drug: Evacetrapib; Drug: Placebo

• Registration Number: NCT02260635
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-10-06
• Study First Submitted QC: 2014-10-06
• Study First Posted: 2014-10-09
• Study Start: 2014-11
• Primary Completion: 2015-07
• Disposition First Submitted: 2015-09-03
• Disposition First Submitted QC: 2015-09-03
• Disposition First Posted: 2015-09-18
• Study Completion: 2015-12
• Status Verified: 2018-02
• Results First Submitted: 2018-02-18
• Results First Submitted QC: 2018-02-18
• Last Update Submitted: 2018-02-18
• Results First Posted: 2018-10-09
• Last Update Posted: 2018-10-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 54

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.

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	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.
Placebo	Evacetrapib	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.
Evacetrapib	Evacetrapib	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.

Primary Outcome Measures

Name	Time	Method
Percent Change From Baseline to Week 12 in Low-Density Lipoprotein Cholesterol (LDL-C) Measured by Beta Quantification	Baseline, Week 12	Least Square Mean (LS mean) using mixed model repeated measures (MMRM) adjusted for baseline, treatment, visit , and treatment\*visit, where the participant is a random effect.

Secondary Outcome Measures

Name	Time	Method
Percent Change From Baseline in Lipoprotein-a	Baseline, Week 12, Week 52	LS Mean from analysis of covariance (ANCOVA) model adjusted for baseline and treatment.
Percent Change From Baseline in Apolipoprotein A-I	Baseline, Week 12, Week 52	LS Mean from ANCOVA model adjusted for baseline and treatment.
Percent Change From Baseline in Apolipoprotein B	Baseline, Week 12, Week 52	LS Mean from ANCOVA model adjusted for baseline and treatment.
Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C)	Baseline, Week 12	LS mean using MMRM adjusted for baseline, treatment, visit , and treatment\*visit, where the participant is a random effect.
Percent Change From Baseline in LDL-C (Direct)	Baseline, Week 12	LS mean using MMRM adjusted for baseline, treatment, visit , and treatment\*visit, where the participant is a random effect.
Percent Change From Baseline in Non HDL-C	Baseline, Week 12	LS mean using MMRM adjusted for baseline, treatment, visit , and treatment\*visit, where the participant is a random effect.

Trial Locations

Locations (1)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.; 🇯🇵 Tokyo, Japan