NCT02260648

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
149

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2015

Shorter than P25 for phase_3

Geographic Reach
1 country

8 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 6, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 9, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
2.9 years until next milestone

Results Posted

Study results publicly available

October 9, 2018

Completed
Last Updated

October 9, 2018

Status Verified

February 1, 2018

Enrollment Period

10 months

First QC Date

October 6, 2014

Results QC Date

February 18, 2018

Last Update Submit

February 18, 2018

Conditions

Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline, Week 12

Secondary Outcomes (6)

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

    Baseline, Week 12

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

    Baseline, Week 12

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

    Baseline, Week 12

  • Percent Change From Baseline to Week 12 in Lipoprotein-a

    Baseline, Week 12

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

    Baseline, Week 12

  • +1 more secondary outcomes

Study Arms (3)

Evacetrapib

EXPERIMENTAL

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

Drug: EvacetrapibDrug: Atorvastatin

Ezetimibe

ACTIVE COMPARATOR

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

Drug: EzetimibeDrug: Atorvastatin

Placebo

PLACEBO COMPARATOR

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

Drug: AtorvastatinDrug: Placebo

Interventions

EvacetrapibDRUG

Administered orally

Also known as: LY2484595
Evacetrapib
EzetimibeDRUG

Administered orally

Ezetimibe
AtorvastatinDRUG

Administered orally

EvacetrapibEzetimibePlacebo
PlaceboDRUG

Administered orally

Placebo

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

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.

Hyōgo, 650-0021, Japan

Location

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.

Ibaraki, 311-3516, Japan

Location

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.

Ibaraki, 311-4153, Japan

Location

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.

Kyoto, 6150035, Japan

Location

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, 530-0001, Japan

Location

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.

Saitama, 350-1305, Japan

Location

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.

Shizuoka, 424-0855, Japan

Location

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, 103-0028, Japan

Location

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

evacetrapibEzetimibeAtorvastatin

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

AzetidinesAzetinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrrolesAzolesHeptanoic AcidsFatty AcidsLipids

Limitations and Caveats

The study was terminated prematurely due to insufficient efficacy of the I1V-MC-EIAN (NCT01687998) study.

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
800-545-5979

Study Officials

  • 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

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2014

First Posted

October 9, 2014

Study Start

January 1, 2015

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

October 9, 2018

Results First Posted

October 9, 2018

Record last verified: 2018-02

Locations

JP(8)