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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02260635
Recruitment Status : Terminated (Study termination due to insufficient efficacy.)
First Posted : October 9, 2014
Results First Posted : October 9, 2018
Last Update Posted : October 9, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Drug: Evacetrapib Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind Efficacy and Safety Study of Evacetrapib Followed by an Open-Label Extension in Japanese Patients With Primary Hypercholesterolemia
Study Start Date : November 2014
Actual Primary Completion Date : July 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Drug: Evacetrapib
Administered orally
Other Name: LY2484595

Placebo Comparator: 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.
Drug: Evacetrapib
Administered orally
Other Name: LY2484595

Drug: Placebo
Administered orally




Primary Outcome Measures :
  1. Percent Change From Baseline to Week 12 in Low-Density Lipoprotein Cholesterol (LDL-C) Measured by Beta Quantification [ Time Frame: 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 :
  1. Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) [ Time Frame: Baseline, Week 12 ]
    LS mean using MMRM adjusted for baseline, treatment, visit , and treatment*visit, where the participant is a random effect.

  2. Percent Change From Baseline in LDL-C (Direct) [ Time Frame: Baseline, Week 12 ]
    LS mean using MMRM adjusted for baseline, treatment, visit , and treatment*visit, where the participant is a random effect.

  3. Percent Change From Baseline in Non HDL-C [ Time Frame: Baseline, Week 12 ]
    LS mean using MMRM adjusted for baseline, treatment, visit , and treatment*visit, where the participant is a random effect.

  4. Percent Change From Baseline in Lipoprotein-a [ Time Frame: Baseline, Week 12, Week 52 ]
    LS Mean from analysis of covariance (ANCOVA) model adjusted for baseline and treatment.

  5. Percent Change From Baseline in Apolipoprotein A-I [ Time Frame: Baseline, Week 12, Week 52 ]
    LS Mean from ANCOVA model adjusted for baseline and treatment.

  6. Percent Change From Baseline in Apolipoprotein B [ Time Frame: Baseline, Week 12, Week 52 ]
    LS Mean from ANCOVA model adjusted for baseline and treatment.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02260635


Locations
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Japan
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.
Osaka, Japan, 530-0001
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, 103-0028
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02260635    
Other Study ID Numbers: 14503
I1V-JE-EIBI ( Other Identifier: Eli Lilly and Company )
First Posted: October 9, 2014    Key Record Dates
Results First Posted: October 9, 2018
Last Update Posted: October 9, 2018
Last Verified: February 2018
Additional relevant MeSH terms:
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Evacetrapib
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents