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HyperlipidemiaPhase 3ACCENTUATENCT02227784

A Study of Evacetrapib (LY2484595) in Participants With High Cholesterol

A Phase 3 study testing Evacetrapib, Atorvastatin and Ezetimibe in people with Hyperlipidemia, run by Eli Lilly and Company at 64 sites in 2 countries.

Terminated

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

Official record
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Trial summary

The purpose of the ACCENTUATE study is to evaluate whether the study drug known as evacetrapib is effective in treating participants with high cholesterol and atherosclerotic cardiovascular disease (ASCVD) and/or diabetes. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hyperlipidemia
What is being tested?
Evacetrapib, Atorvastatin and Ezetimibe
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
366 participants
Where
64 sitesin 2 countries
Study dates
Oct 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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Must be treated with atorvastatin 40 mg/day for at least 30 days prior to screening
  • Have an LDL-C >70 mg/deciliter(dL) or non-HDL-C >100 mg/dL
  • Have screening triglycerides ≤400 mg/dL (≤4.5 millimoles/Liter)
  • Individuals with ASCVD and/or individuals with type 1 or type 2 diabetes

Who cannot join

  • Have a hemoglobin A1c (HbA1c) >9.5%
  • New York Heart Association (NYHA) class III or IV congestive heart failure
  • History of either a transient ischemic stroke or ischemic stroke <30 days
  • History of acute coronary syndrome (ACS) <30 days

Trial locations and contacts

64 sites in 2 countries.

64 sites in 2 countries

United States61 sites

  • Northwest Heart Clinical Research, LLC

    Arlington Heights, Illinois, 60005

  • Asheville Cardiology Associates

    Asheville, North Carolina, 28803

  • University of Colorado Health Sciences Center

    Aurora, Colorado, 80045-2517

  • Maryland Cardiovascular Specialists

    Baltimore, Maryland, 21229

  • Overlea Personal Physicians

    Baltimore, Maryland, 21236

  • Northwest Clinical Research Center

    Bellevue, Washington, 98007-4209

  • Grace Research

    Bossier City, Louisiana, 71111

  • ZASA Clinical Research

    Boynton Beach, Florida, 33472

  • Advanced Clinical Research

    Carmichael, California, 95608

  • Metrolina Internal Medicine, P.A.

    Charlotte, North Carolina, 28204

  • Cedar-Crosse Research Center

    Chicago, Illinois, 60607

  • Cardiac Research

    Colorado Springs, Colorado, 80909

  • Aventiv Research

    Columbus, Ohio, 43213

  • Georgia Heart Specialists

    Covington, Georgia, 30014

  • Midwest CRC

    Crystal Lake, Illinois, 60012

  • Partners in Clinical Research

    Cumberland, Rhode Island, 02864

  • Cardiology Research Assoc.

    Daytona Beach, Florida, 32117

  • Avail Clinical Research LLC

    DeLand, Florida, 32720

  • Tooraj Joseph Raoof M.D., Inc.

    Encino, California, 91436

  • Lillestol Research LLC

    Fargo, North Dakota, 58103

  • Alan Graff, MD, PA

    Fort Lauderdale, Florida, 33308

  • United Osteoporosis Center

    Gainesville, Georgia, 30501

  • High Point Clinical Trials Center

    High Point, North Carolina, 27265

  • East West Medical Institute

    Honolulu, Hawaii, 96814

  • Heart Center Research, LLC

    Huntsville, Alabama, 35801

  • Hutchinson Clinic

    Hutchinson, Kansas, 67502

  • Cape Cod Research Institute

    Hyannis, Massachusetts, 02601

  • Indiana Heart Physicians Inc

    Indianapolis, Indiana, 46237

  • Midwest Institute for Clinical Research

    Indianapolis, Indiana, 46260

  • Nature Coast Clinical Research, LLC

    Inverness, Florida, 34452

  • Irvine Clinical Research Center

    Irvine, California, 92618

  • Clinical Investigation Specialists Inc

    Kenosha, Wisconsin, 53142

  • Holston Medical Group Clinical Research

    Kingsport, Tennessee, 37660

  • Palm Research Center

    Las Vegas, Nevada, 89128

  • VA Long Beach Healthcare System

    Long Beach, California, 90822

  • Community Medical Associates

    Louisville, Kentucky, 40205

  • Solaris Clinical Research

    Meridian, Idaho, 83646

  • Desert Clinical Research

    Mesa, Arizona, 85213

  • ActivMed Practices & Research, Inc

    Methuen, Massachusetts, 01844

  • Suncoast Research Group, LLC

    Miami, Florida, 33135

  • PMG Research of Charleston, LLC

    Mt. Pleasant, South Carolina, 29464

  • Medex Healthcare Research, Inc.

    New York, New York, 10036

  • South Oklahoma Heart Research, LLC

    Oklahoma City, Oklahoma, 73135

  • Central Phoenix Med Clinic LLC

    Phoenix, Arizona, 85020

  • Progressive Medical Research

    Port Orange, Florida, 32127

  • Portland Preventive Cardiology, LLC

    Portland, Oregon, 97225

  • Rancho Cucamonga Clinical

    Rancho Cucamonga, California, 91730

  • Black Hills Cardiovascular Research Group

    Rapid City, South Dakota, 57701

  • National Clinical Research - Richmond

    Richmond, Virginia, 23294

  • Boice Willis Clinic, PA

    Rocky Mount, North Carolina, 27804

  • Saratoga Clinical Research LLC

    Saratoga Springs, New York, 12866

  • Heart and Vascular Center of New Brunswick LLC

    Somerset, New Jersey, 08873

  • Kootenai Heart Clinics, LLC

    Spokane, Washington, 99204

  • Encompass Clinical Research

    Spring Valley, California, 91978

  • Medex Healthcare Research, Inc.

    St Louis, Missouri, 63117

  • Northwest Houston Heart Center

    Tomball, Texas, 77375-4536

  • University Clinical Investigators, Inc.

    Tustin, California, 92780

  • Diablo Clinical Research

    Walnut Creek, California, 94598

  • Cardiology Partners Clinical Research Institute, LLC

    Wellington, Florida, 33449

  • Buffalo Cardiology and Pulmonary Associates, P.C.

    Williamsville, New York, 14221

  • PMG Research of Wilmington, LLC

    Wilmington, North Carolina, 28401

Other trials in United States

Puerto Rico3 sites

  • Research and Cardiovascular Corp.

    Ponce, 00717-1322

  • Clinical Research Puerto Rico, Inc.

    San Juan, 00909

  • GCM Medical Group PSC

    San Juan, 00909

Other trials in Puerto Rico

About this study

Official title: The Addition of Evacetrapib to Atorvastatin Compared to Placebo, High Intensity Atorvastatin, and Atorvastatin With Ezetimibe to Evaluate LDL-C Lowering in Patients With Primary Hyperlipidemia - The ACCENTUATE Study

The purpose of the ACCENTUATE study is to evaluate whether the study drug known as evacetrapib is effective in treating participants with high cholesterol and atherosclerotic cardiovascular disease (ASCVD) and/or diabetes.

Conditions
Hyperlipidemia
Being tested
Evacetrapib, Atorvastatin, Ezetimibe, Placebo
Medical subject headings
Hyperlipidemias

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

  • AtorvastatinDrug

    Administered orally

  • EzetimibeDrug

    Administered orally

  • PlaceboDrug

    Administered orally

Study groups in NCT02227784
Study groupRoleWhat they receive
Atorvastatin + EvacetrapibExperimentalAtorvastatin 40 milligrams (mg) orally once daily for 28 days during lead in period. Atorvastatin 40 mg plus evacetrapib 130 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
Receives: Drug: Evacetrapib; Drug: Atorvastatin; Drug: Placebo
Atorvastatin 80 mgActive comparatorAtorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 80 mg orally with placebo for blinding once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
Receives: Drug: Atorvastatin; Drug: Placebo
Atorvastatin + EzetimibeActive comparatorAtorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg plus ezetimibe 10 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
Receives: Drug: Atorvastatin; Drug: Ezetimibe; Drug: Placebo
Atorvastatin 40 mgActive comparatorAtorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
Receives: Drug: Atorvastatin; Drug: Placebo

What is being measured

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

  1. Percent Change From Baseline to 3 Months in Low-Density Lipoprotein Cholesterol (LDL-C)

    Change in LDL-C levels from baseline to the 3-month visit expressed as a percentage of the baseline levels. LDL-C was measured by beta quantification. Statistics are from analysis of covariance with log baseline measurement and treatment is included in the model. Least Square Means (LS means) and median differences were analyzed in log units and converted to standard units. Log Percent change from baseline response is the dependent variable.

    Measured: Baseline, 3 Months

Secondary outcomes (6)

  1. Percent Change From Baseline to 3 Months in High-Density Lipoprotein Cholesterol (HDL-C)

    Change in HDL-C levels from baseline to the 3-month visit expressed as a percentage of the baseline levels. LS medians and median differences were analyzed in log units and converted to standard units. Statistics are from mixed model repeated measures analysis with log baseline measurement, treatment, visit, and treatment by visit interaction included in the model. Log percent change from baseline response is the dependent variable. Within-participant repeated measures at multiple visits are modeled by a compound symmetry covariance structure.

    Measured: Baseline, 3 Months

  2. Percent Change From Baseline to 3 Months in Apolipoprotein AI (apoAI)

    Change in apoAI levels from baseline to the 3-month visit expressed as a percentage of the baseline levels. Statistics are from analysis of covariance with log baseline measurement and treatment is included in the model. LS means and median differences were analyzed in log units and converted to standard units. Log Percent change from baseline response is the dependent variable.

    Measured: Baseline, 3 Months

  3. Percent Change From Baseline to 3 Months in Non-HDL-C

    Change in Non-HDL-C levels from baseline to the 3-month visit expressed as a percentage of the baseline levels. LS medians and median differences were analyzed in log units and converted to standard units. Statistics are from mixed model repeated measures analysis with log baseline measurement, treatment, visit, and treatment by visit interaction included in the model. Log percent change from baseline response is the dependent variable. Within-participant repeated measures at multiple visits are modeled by a compound symmetry covariance structure.

    Measured: Baseline, 3 Months

  4. Percent Change From Baseline to 3 Months in Apolipoprotein B (apoB)

    Change in apoB levels from baseline to the 3-month visit expressed as a percentage of the baseline levels. Statistics are from analysis of covariance with log baseline measurement and treatment is included in the model. LS means and median differences were analyzed in log units and converted to standard units. Log Percent change from baseline response is the dependent variable.

    Measured: Baseline, 3 Months

  5. Percent Change From Baseline to 3 Months in Cholesterol Efflux Capacity

    Change in cholesterol efflux capacity from baseline to the 3-month visit expressed as a percentage of the baseline levels. Statistics are from analysis of covariance with log baseline measurement and treatment is included in the model. LS means and median differences were analyzed in log units and converted to standard units. Log Percent change from baseline response is the dependent variable.

    Measured: Baseline, 3 Months

  6. Percent Change From Baseline to 3 Months in Lipoprotein(a) (Lp[a])

    Change in Lp(a) levels from baseline to the 3-month visit expressed as a percentage of the baseline levels. Statistics are from analysis of covariance with log baseline measurement and treatment is included in the model. LS means and median differences were analyzed in log units and converted to standard units. Log Percent change from baseline response is the dependent variable.

    Measured: Baseline, 3 Months

Timeline

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

  1. First posted28 Aug 2014 (estimated)
  2. Study startOct 2014
  3. Primary completionDec 2015
  4. Study completionDec 2015

Why it stopped: Study termination due to program termination.

Resources

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
366 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02227784
Sponsor's protocol ID
14502
Other IDs
I1V-MC-EIBH
Acronym
ACCENTUATE
Status last verified
Sep 2019
First submitted
26 Aug 2014
Last updated
8 Oct 2019
Data monitoring committee
No
Individual data sharing
Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Publications

  • Nicholls SJ, Ray KK, Ballantyne CM, Beacham LA, Miller DL, Ruotolo G, Nissen SE, Riesmeyer JS; ACCENTUATE Investigators. Comparative effects of cholesteryl ester transfer protein inhibition, statin or ezetimibe on lipid factors: The ACCENTUATE trial. Atherosclerosis. 2017 Jun;261:12-18. doi: 10.1016/j.atherosclerosis.2017.04.008. Epub 2017 Apr 8.

    PubMed 28412650

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Evacetrapib, Atorvastatin and Ezetimibe in people with Hyperlipidemia, run by Eli Lilly and Company at 64 sites in 2 countries.

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 4 inclusion and 4 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 8 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 64 sites in United States, Puerto Rico. 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. 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 22 Mar 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 3 Months in Low-Density Lipoprotein Cholesterol (LDL-C) (time frame: Baseline, 3 Months). 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 NCT02227784, which also lists 1 linked publication.

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 8 Oct 2019.

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