Back to resultsA Study of Evacetrapib (LY2484595) in Japanese Participants With Primary Hypercholesterolemia
Primary Purpose
Hypercholesterolemia
Status
Terminated
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Evacetrapib
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hypercholesterolemia
Eligibility 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).
Sites / Locations
- 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.
- 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.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Evacetrapib
Placebo
Arm 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.
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.
Outcomes
Primary Outcome Measures
Percent Change From Baseline to Week 12 in Low-Density Lipoprotein Cholesterol (LDL-C) Measured by Beta Quantification
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
Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C)
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)
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
LS mean using MMRM adjusted for baseline, treatment, visit , and treatment*visit, where the participant is a random effect.
Percent Change From Baseline in Lipoprotein-a
LS Mean from analysis of covariance (ANCOVA) model adjusted for baseline and treatment.
Percent Change From Baseline in Apolipoprotein A-I
LS Mean from ANCOVA model adjusted for baseline and treatment.
Percent Change From Baseline in Apolipoprotein B
LS Mean from ANCOVA model adjusted for baseline and treatment.
Full Information
NCT ID
NCT02260635
First Posted
October 6, 2014
Last Updated
February 18, 2018
Sponsor
Eli Lilly and Company
1. Study Identification
Unique Protocol Identification Number
NCT02260635
Brief Title
A Study of Evacetrapib (LY2484595) in Japanese Participants With Primary Hypercholesterolemia
Official Title
A Double-Blind Efficacy and Safety Study of Evacetrapib Followed by an Open-Label Extension in Japanese Patients With Primary Hypercholesterolemia
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Terminated
Why Stopped
Study termination due to insufficient efficacy.
Study Start Date
November 2014 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Evacetrapib
Arm Type
Experimental
Arm 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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Evacetrapib
Other Intervention Name(s)
LY2484595
Intervention Description
Administered orally
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered orally
Primary Outcome Measure Information:
Title
Percent Change From Baseline to Week 12 in Low-Density Lipoprotein Cholesterol (LDL-C) Measured by Beta Quantification
Description
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.
Time Frame
Baseline, Week 12
Secondary Outcome Measure Information:
Title
Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C)
Description
LS mean using MMRM adjusted for baseline, treatment, visit , and treatment*visit, where the participant is a random effect.
Time Frame
Baseline, Week 12
Title
Percent Change From Baseline in LDL-C (Direct)
Description
LS mean using MMRM adjusted for baseline, treatment, visit , and treatment*visit, where the participant is a random effect.
Time Frame
Baseline, Week 12
Title
Percent Change From Baseline in Non HDL-C
Description
LS mean using MMRM adjusted for baseline, treatment, visit , and treatment*visit, where the participant is a random effect.
Time Frame
Baseline, Week 12
Title
Percent Change From Baseline in Lipoprotein-a
Description
LS Mean from analysis of covariance (ANCOVA) model adjusted for baseline and treatment.
Time Frame
Baseline, Week 12, Week 52
Title
Percent Change From Baseline in Apolipoprotein A-I
Description
LS Mean from ANCOVA model adjusted for baseline and treatment.
Time Frame
Baseline, Week 12, Week 52
Title
Percent Change From Baseline in Apolipoprotein B
Description
LS Mean from ANCOVA model adjusted for baseline and treatment.
Time Frame
Baseline, Week 12, Week 52
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
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.
City
Osaka
ZIP/Postal Code
530-0001
Country
Japan
Facility Name
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.
City
Tokyo
ZIP/Postal Code
103-0028
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
A Study of Evacetrapib (LY2484595) in Japanese Participants With Primary Hypercholesterolemia
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