HypercholesterolemiaPhase 3NCT02260635

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

A Phase 3 study testing Evacetrapib in people with Hypercholesterolemia, run by Eli Lilly and Company at 2 sites in Japan.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Hypercholesterolemia
What is being tested?: Evacetrapib
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 54 participants
Where: 2 sitesJapan
Study dates: Nov 2014to Dec 2015
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Show all 13Show fewer

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).

Trial locations and contacts

2 sites in 1 country.

Japan2 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
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

Other trials in Japan

About this study

Official title: A Double-Blind Efficacy and Safety Study of Evacetrapib Followed by an Open-Label Extension in Japanese Patients With Primary Hypercholesterolemia

Conditions: Hypercholesterolemia
Being tested: Evacetrapib, Placebo
Medical subject headings: Hypercholesterolemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

EvacetrapibDrug
Also called LY2484595
Administered orally
PlaceboDrug
Administered orally

Study groups in NCT02260635
Study group	Role	What they receive
Evacetrapib	Experimental	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. Receives: Drug: Evacetrapib
Placebo	Placebo comparator	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. Receives: Drug: Evacetrapib; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline, Week 12

Secondary outcomes (6)

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.
Measured: Baseline, Week 12
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.
Measured: Baseline, Week 12
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.
Measured: Baseline, Week 12
Percent Change From Baseline in Lipoprotein-a
LS Mean from analysis of covariance (ANCOVA) model adjusted for baseline and treatment.
Measured: Baseline, Week 12, Week 52
Percent Change From Baseline in Apolipoprotein A-I
LS Mean from ANCOVA model adjusted for baseline and treatment.
Measured: Baseline, Week 12, Week 52
Percent Change From Baseline in Apolipoprotein B
LS Mean from ANCOVA model adjusted for baseline and treatment.
Measured: Baseline, Week 12, Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2014Dec 2015

First posted9 Oct 2014 (estimated)
Study startNov 2014
Primary completionJul 2015
Study completionDec 2015

Why it stopped: Study termination due to insufficient efficacy.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 54 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02260635
Sponsor's protocol ID: 14503
Other IDs: I1V-JE-EIBI
Status last verified: Feb 2018
First submitted: 6 Oct 2014
Last updated: 9 Oct 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
Active, not recruitingObservational study
Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
Familial Hypercholesterolaemia
Not yet recruiting
Penn Family Screening for Familial Hypercholesterolemia (NHLBI R33) Trial 3
Familial Hypercholesterolemia

All Hypercholesterolemia trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-Blind Efficacy and Safety Study of Evacetrapib Followed by an Open-Label Extension in Japanese Patients With Primary Hypercholesterolemia
ClinicalTrials.gov ID: NCT02260635
Acronym / sponsor ID: 14503
Conditions: Hypercholesterolemia
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Study termination due to insufficient efficacy.
Enrolment: 54 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Nov 2014
Primary completion: Jul 2015 (actual)
Study completion: Dec 2015 (actual)
First posted: 9 Oct 2014 (estimated)
Results: Posted 9 Oct 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Evacetrapib	Experimental	Drug: Evacetrapib130 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	Placebo comparator	Drug: Evacetrapib, Drug: PlaceboPlacebo 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.

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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.)
Have triglycerides (TG) ≤400 mg/dL.
Have HDL-C <100 mg/dL.

Key exclusion criteria (13 listed)

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:
Have systolic blood pressure (SBP) >160 millimeters of mercury (mm Hg) or diastolic blood pressure (DBP) >100 mm Hg.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
EvacetrapibAlso: LY2484595Administered orally	Drug	Evacetrapib, Placebo
PlaceboAdministered orally	Drug	Placebo

Primary outcome

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.

6 secondary outcomes

Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C)
Time frame: Baseline, Week 12
Percent Change From Baseline in LDL-C (Direct)
Time frame: Baseline, Week 12
Percent Change From Baseline in Non HDL-C
Time frame: Baseline, Week 12
Percent Change From Baseline in Lipoprotein-a
Time frame: Baseline, Week 12, Week 52
Percent Change From Baseline in Apolipoprotein A-I
Time frame: Baseline, Week 12, Week 52
Percent Change From Baseline in Apolipoprotein B
Time frame: Baseline, Week 12, Week 52

Results and safety

Results posted to the registry on 9 Oct 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Evacetrapib	27	26
Placebo	27	25

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

Time frame: Baseline, Week 12. Least squares mean (Standard Error). Unit: percent change in LDL-C

Measure	Evacetrapib n = 26	Placebo n = 25
Value	-34.27 (3.908)	0.00 (3.984)

Population analysed: All randomized participants receiving at least 1 dose of study drug with evaluable LDL-C values measured by beta quantification at baseline, and at least 1 post-baseline measurement.

6 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Evacetrapib Double Blind Treatment Period	0 of 27 (0%)	5 of 27 (18.5%)	Not reported
Placebo Double Blind Treatment Period	0 of 26 (0%)	7 of 26 (26.9%)	Not reported
Evacetrapib Open Label Extension	0 of 26 (0%)	6 of 26 (23.1%)	Not reported
Placebo/Evacetrapib Open Label Extension	0 of 25 (0%)	4 of 25 (16%)	Not reported

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

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Hypercholesterolemia

Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
Active, not recruitingObservational study
Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
Familial Hypercholesterolaemia
Not yet recruiting
Penn Family Screening for Familial Hypercholesterolemia (NHLBI R33) Trial 3
Familial Hypercholesterolemia

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Evacetrapib in people with Hypercholesterolemia, run by Eli Lilly and Company at 2 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 9 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change From Baseline to Week 12 in Low-Density Lipoprotein Cholesterol (LDL-C) Measured by Beta Quantification (time frame: Baseline, Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02260635.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2018.