Back to results

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

Primary Purpose

Hypercholesterolemia

Status

Terminated

Phase

Phase 3

Locations

Japan

Study Type

Interventional

Intervention

Evacetrapib

Ezetimibe

Atorvastatin

Placebo

About this trial

This is an interventional treatment trial for Hypercholesterolemia

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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).

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.
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.
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.
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 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Evacetrapib

Ezetimibe

Placebo

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Percent Change From Baseline to Week 12 in Low-Density Lipoprotein Cholesterol (LDL-C) Measured by Beta Quantification

The mixed-effects model for repeated measures (MMRM) was used for the Least Squares Mean (LS Mean) estimates at Week 12 for LDL-C adjusting for baseline as response variables, baseline measurement as a covariate, treatment, Visit (4,5,6, or 7), and treatment-by-visit interaction as fixed effects, and participant as a random effect.

Secondary Outcome Measures

Percent Change From Baseline to Week 12 in High-Density Lipoprotein Cholesterol (HDL-C)

The MMRM was used for the LS Mean estimates at Week 12 for HDL-C adjusting for baseline as response variables, baseline measurement as a covariate, treatment, visit, and treatment-by-visit interaction as fixed effects, and participant as a random effect, and treatment-by-visit interaction as fixed effects, and participant as a random effect.

Percent Change From Baseline to Week 12 in LDL-C (Direct)

The MMRM was used for the LS Mean estimates at Week 12 for LDL-C (direct) adjusting for baseline as response variables, baseline measurement as a covariate, treatment, visit, and treatment-by-visit interaction as fixed effects, and participant as a random effect.

Percent Change From Baseline to Week 12 in Non HDL-C

The MMRM was used for the LS Mean estimates at Week 12 for Non HDL-C adjusting for baseline as response variables, baseline measurement as a covariate, treatment, visit, and treatment-by-visit interaction as fixed effects, and participant as a random effect.

Percent Change From Baseline to Week 12 in Lipoprotein-a

The analysis of covariance (ANCOVA) model using last observation carried forward (LOCF) was applied to analyze percent changes from baseline.

Percent Change From Baseline to Week 12 in Apolipoprotein A-I

The ANCOVA model using last observation carried forward (LOCF) was applied to analyze percent changes from baseline.

Percent Change From Baseline to Week 12 in Apolipoprotein B

The ANCOVA model using last observation carried forward (LOCF) was applied to analyze percent changes from baseline.

Full Information

NCT ID

NCT02260648

First Posted

October 6, 2014

Last Updated

February 18, 2018

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT02260648

Brief Title

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

Official Title

A Double-Blind Efficacy and Safety Study of Evacetrapib in Combination With Atorvastatin 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

January 2015 (undefined)

Primary Completion Date

November 2015 (Actual)

Study Completion Date

November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Data Monitoring Committee

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

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

149 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Evacetrapib

Arm Type

Experimental

Arm Description

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

Arm Title

Ezetimibe

Arm Type

Active Comparator

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Evacetrapib

Other Intervention Name(s)

LY2484595

Intervention Description

Administered orally

Intervention Type

Drug

Intervention Name(s)

Ezetimibe

Intervention Description

Administered orally

Intervention Type

Drug

Intervention Name(s)

Atorvastatin

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

Time Frame

Baseline, Week 12

Secondary Outcome Measure Information:

Title

Percent Change From Baseline to Week 12 in High-Density Lipoprotein Cholesterol (HDL-C)

Description

Time Frame

Baseline, Week 12

Title

Percent Change From Baseline to Week 12 in LDL-C (Direct)

Description

Time Frame

Baseline, Week 12

Title

Percent Change From Baseline to Week 12 in Non HDL-C

Description

Time Frame

Baseline, Week 12

Title

Percent Change From Baseline to Week 12 in Lipoprotein-a

Description

The analysis of covariance (ANCOVA) model using last observation carried forward (LOCF) was applied to analyze percent changes from baseline.

Time Frame

Baseline, Week 12

Title

Percent Change From Baseline to Week 12 in Apolipoprotein A-I

Description

The ANCOVA model using last observation carried forward (LOCF) was applied to analyze percent changes from baseline.

Time Frame

Baseline, Week 12

Title

Percent Change From Baseline to Week 12 in Apolipoprotein B

Description

The ANCOVA model using last observation carried forward (LOCF) was applied to analyze percent changes from baseline.

Time Frame

Baseline, Week 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

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).

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

Hyogo

ZIP/Postal Code

650-0021

Country

Japan

Facility Name

City

Ibaragi

ZIP/Postal Code

311-3516

Country

Japan

Facility Name

City

Ibaraki

ZIP/Postal Code

311-4153

Country

Japan

Facility Name

City

Kyoto

ZIP/Postal Code

6150035

Country

Japan

Facility Name

City

Osaka

ZIP/Postal Code

530-0001

Country

Japan

Facility Name

City

Saitama

ZIP/Postal Code

350-1305

Country

Japan

Facility Name

City

Shizuoka

ZIP/Postal Code

424-0855

Country

Japan

Facility Name

City

Tokyo

ZIP/Postal Code

103-0028

Country

Japan

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs