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TerminatedNCT02260635Updated Oct 9, 2018Results posted

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

A Phase 3 interventional study of Evacetrapib and Placebo in Hypercholesterolemia, sponsored by Eli Lilly and Company. Terminated at 2 sites in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2018-10-09.

Sponsored by Eli Lilly and Company · Phase 3, Interventional, and Treatment

Why this study was terminated
Study termination due to insufficient efficacy.
Phase
Phase 3
Study type
Interventional
Enrollment
54
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Hypercholesterolemia
03

In context

Hypercholesterolemia

1,238 studies on the registry are indexed under Hypercholesterolemia; 110 are open to participants now.

This study's enrollment of 54 is below the median of 100 across 992 interventional studies indexed under Hypercholesterolemia.

Browse Hypercholesterolemia studies →

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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).
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
54 participants (actual)

Study arms

  • 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

  • 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 · Drug: Placebo

Interventions

  • DrugEvacetrapib

    Administered orally

    Also known as: LY2484595

  • DrugPlacebo

    Administered orally

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline, Week 12

Secondary outcomes

  1. 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.

    Time frame: Baseline, Week 12

  2. 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.

    Time frame: Baseline, Week 12

  3. 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.

    Time frame: Baseline, Week 12

  4. Percent Change From Baseline in Lipoprotein-a

    LS Mean from analysis of covariance (ANCOVA) model adjusted for baseline and treatment.

    Time frame: Baseline, Week 12, Week 52

  5. Percent Change From Baseline in Apolipoprotein A-I

    LS Mean from ANCOVA model adjusted for baseline and treatment.

    Time frame: Baseline, Week 12, Week 52

  6. Percent Change From Baseline in Apolipoprotein B

    LS Mean from ANCOVA model adjusted for baseline and treatment.

    Time frame: Baseline, Week 12, Week 52

07

Results

Posted Oct 9, 2018
Limitations and caveats
The study was terminated prematurely due to anticipated Inefficient efficacy of the I1V-MC-EIAN (NCT01687998) study, therefore Week 52 data is not available.

Participant flow

Double-Blind Treatment Period
Participant flow — Double-Blind Treatment Period
MilestoneEvacetrapibPlacebo
Started2727
Received at least one dose of study drug2726
Completed2625
Not completed12
Withdrew: Failure to meet randomization criteria12
Open-Label Extension
Participant flow — Open-Label Extension
MilestoneEvacetrapibPlacebo
Started2625
Received at least one dose of study drug2625
Completed00
Not completed2625
Withdrew: Study termination2525
Withdrew: Withdrawal by subject10

Outcome measures

PrimaryPercent 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.

Time frame:
Baseline, Week 12
Reported as:
Least squares mean · percent change in LDL-C
Percent Change From Baseline to Week 12 in Low-Density Lipoprotein Cholesterol (LDL-C) Measured by Beta Quantification
percent change in LDL-CEvacetrapibPlacebo
Percent Change From Baseline to Week 12 in Low-Density Lipoprotein Cholesterol (LDL-C) Measured by Beta Quantification-34.27 ± 3.9080.00 ± 3.984
SecondaryPercent 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.

Time frame:
Baseline, Week 12
Reported as:
Least squares mean · percent change of HDL-C
Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C)
percent change of HDL-CEvacetrapibPlacebo
Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C)123.57 ± 6.697-0.45 ± 6.805
SecondaryPercent 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.

Time frame:
Baseline, Week 12
Reported as:
Least squares mean · percent change of LDL-C direct
Percent Change From Baseline in LDL-C (Direct)
percent change of LDL-C directEvacetrapibPlacebo
Percent Change From Baseline in LDL-C (Direct)-33.86 ± 3.1630.22 ± 3.226
SecondaryPercent 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.

Time frame:
Baseline, Week 12
Reported as:
Least squares mean · percent change in non HDL-C
Percent Change From Baseline in Non HDL-C
percent change in non HDL-CEvacetrapibPlacebo
Percent Change From Baseline in Non HDL-C-26.48 ± 3.171-0.03 ± 3.237
SecondaryPercent Change From Baseline in Lipoprotein-a

LS Mean from analysis of covariance (ANCOVA) model adjusted for baseline and treatment.

Time frame:
Baseline, Week 12, Week 52
Reported as:
Least squares mean · percent change in Lipoprotein-a
Percent Change From Baseline in Lipoprotein-a
percent change in Lipoprotein-aEvacetrapibPlacebo
Week 12-35.71 ± 6.5743.54 ± 5.532
Week 52NA ± NANA ± NA
SecondaryPercent Change From Baseline in Apolipoprotein A-I

LS Mean from ANCOVA model adjusted for baseline and treatment.

Time frame:
Baseline, Week 12, Week 52
Reported as:
Least squares mean · percent change in Apolipoprotein A-I
Percent Change From Baseline in Apolipoprotein A-I
percent change in Apolipoprotein A-IEvacetrapibPlacebo
Week 1249.1 ± 3.44-2.5 ± 3.51
Week 52NA ± NANA ± NA
SecondaryPercent Change From Baseline in Apolipoprotein B

LS Mean from ANCOVA model adjusted for baseline and treatment.

Time frame:
Baseline, Week 12, Week 52
Reported as:
Least squares mean · percent change in Apolipoprotein B
Percent Change From Baseline in Apolipoprotein B
percent change in Apolipoprotein BEvacetrapibPlacebo
Week 12-29.0 ± 2.65-1.3 ± 2.70
Week 52NA ± NANA ± NA

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Evacetrapib Double Blind Treatment Period—0/27 (0%)5/27 (18.5%)
Placebo Double Blind Treatment Period—0/26 (0%)7/26 (26.9%)
Evacetrapib Open Label Extension—0/26 (0%)6/26 (23.1%)
Placebo/Evacetrapib Open Label Extension—0/25 (0%)4/25 (16%)
Most frequent other events
Showing 10 of 19
Most frequent other events
EventEvacetrapib Double Blind Treatment PeriodPlacebo Double Blind Treatment PeriodEvacetrapib Open Label ExtensionPlacebo/Evacetrapib Open Label Extension
NasopharyngitisInfections and infestations2/273/263/261/25
Conjunctivitis allergicEye disorders0/270/260/261/25
Seasonal allergyImmune system disorders0/270/260/261/25
Musculoskeletal stiffnessMusculoskeletal and connective tissue disorders0/270/260/261/25
HypoaesthesiaNervous system disorders0/270/260/261/25
Wisdom teeth removalSurgical and medical procedures0/270/260/261/25
DiarrhoeaGastrointestinal disorders1/271/260/260/25
VomitingGastrointestinal disorders0/270/261/260/25
Acute sinusitisInfections and infestations0/270/261/260/25
InfluenzaInfections and infestations1/271/260/260/25

Baseline characteristics

All randomized participants.

Age, Continuous
Age, Continuous(years)EvacetrapibPlaceboTotal
Mean52.2 ± 10.1953.3 ± 10.1352.8 ± 10.08
Sex: Female, Male
Sex: Female, Male(Participants)EvacetrapibPlaceboTotal
Female71017
Male201737
Race (NIH/OMB)
Race (NIH/OMB)(Participants)EvacetrapibPlaceboTotal
American Indian or Alaska Native000
Asian272754
Native Hawaiian or Other Pacific Islander000
Black or African American000
White000
More than one race000
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(Participants)EvacetrapibPlaceboTotal
Japan272754
08

Study locations

2 sites
  • 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
  • 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
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 9, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02260635
Lead sponsor
Eli Lilly and Company
Responsible party
Sponsor
First posted
Oct 9, 2014
Start date
Nov 2014
Primary completion
Jul 2015
Completion
Dec 2015
Results posted
Oct 9, 2018
Last update
Oct 9, 2018

Study contacts

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)
study director · Eli Lilly and Company

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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