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

September 25, 2019 updated by: Eli Lilly and Company

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
366

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • Ponce, Puerto Rico, 00717-1322
        • Research and Cardiovascular Corp.
      • San Juan, Puerto Rico, 00909
        • GCM Medical Group PSC
      • San Juan, Puerto Rico, 00909
        • Clinical Research Puerto Rico, Inc.
  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Heart Center Research, LLC
    • Arizona
      • Mesa, Arizona, United States, 85213
        • Desert Clinical Research
      • Phoenix, Arizona, United States, 85020
        • Central Phoenix Med Clinic LLC
    • California
      • Carmichael, California, United States, 95608
        • Advanced Clinical Research
      • Encino, California, United States, 91436
        • Tooraj Joseph Raoof M.D., Inc.
      • Irvine, California, United States, 92618
        • Irvine Clinical Research Center
      • Long Beach, California, United States, 90822
        • VA Long Beach Healthcare System
      • Rancho Cucamonga, California, United States, 91730
        • Rancho Cucamonga Clinical
      • Spring Valley, California, United States, 91978
        • Encompass Clinical Research
      • Tustin, California, United States, 92780
        • University Clinical Investigators, Inc.
      • Walnut Creek, California, United States, 94598
        • Diablo Clinical Research
    • Colorado
      • Aurora, Colorado, United States, 80045-2517
        • University of Colorado Health Sciences Center
      • Colorado Springs, Colorado, United States, 80909
        • Cardiac Research
    • Florida
      • Boynton Beach, Florida, United States, 33472
        • Zasa Clinical Research
      • Daytona Beach, Florida, United States, 32117
        • Cardiology Research Assoc.
      • DeLand, Florida, United States, 32720
        • Avail Clinical Research LLC
      • Fort Lauderdale, Florida, United States, 33308
        • Alan Graff, MD, PA
      • Inverness, Florida, United States, 34452
        • Nature Coast Clinical Research, LLC
      • Miami, Florida, United States, 33135
        • Suncoast Research Group, LLC
      • Port Orange, Florida, United States, 32127
        • Progressive Medical Research
      • Wellington, Florida, United States, 33449
        • Cardiology Partners Clinical Research Institute, LLC
    • Georgia
      • Covington, Georgia, United States, 30014
        • Georgia Heart Specialists
      • Gainesville, Georgia, United States, 30501
        • United Osteoporosis Center
    • Hawaii
      • Honolulu, Hawaii, United States, 96814
        • East West Medical Institute
    • Idaho
      • Meridian, Idaho, United States, 83646
        • Solaris Clinical Research
    • Illinois
      • Arlington Heights, Illinois, United States, 60005
        • Northwest Heart Clinical Research, LLC
      • Chicago, Illinois, United States, 60607
        • Cedar-Crosse Research Center
      • Crystal Lake, Illinois, United States, 60012
        • Midwest CRC
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Midwest Institute for Clinical Research
      • Indianapolis, Indiana, United States, 46237
        • Indiana Heart Physicians Inc
    • Kansas
      • Hutchinson, Kansas, United States, 67502
        • Hutchinson Clinic
    • Kentucky
      • Louisville, Kentucky, United States, 40205
        • Community Medical Associates
    • Louisiana
      • Bossier City, Louisiana, United States, 71111
        • Grace Research
    • Maryland
      • Baltimore, Maryland, United States, 21229
        • Maryland Cardiovascular Specialists
      • Baltimore, Maryland, United States, 21236
        • Overlea Personal Physicians
    • Massachusetts
      • Hyannis, Massachusetts, United States, 02601
        • Cape Cod Research Institute
      • Methuen, Massachusetts, United States, 01844
        • ActivMed Practices & Research, Inc
    • Missouri
      • Saint Louis, Missouri, United States, 63117
        • Medex Healthcare Research, Inc.
    • Nevada
      • Las Vegas, Nevada, United States, 89128
        • Palm Research Center
    • New Jersey
      • Somerset, New Jersey, United States, 08873
        • Heart and Vascular Center of New Brunswick LLC
    • New York
      • New York, New York, United States, 10036
        • Medex Healthcare Research, Inc.
      • Saratoga Springs, New York, United States, 12866
        • Saratoga Clinical Research LLC
      • Williamsville, New York, United States, 14221
        • Buffalo Cardiology and Pulmonary Associates, P.C.
    • North Carolina
      • Asheville, North Carolina, United States, 28803
        • Asheville Cardiology Associates
      • Charlotte, North Carolina, United States, 28204
        • Metrolina Internal Medicine, P.A.
      • High Point, North Carolina, United States, 27265
        • High Point Clinical Trials Center
      • Rocky Mount, North Carolina, United States, 27804
        • Boice Willis Clinic, PA
      • Wilmington, North Carolina, United States, 28401
        • PMG Research of Wilmington, LLC
    • North Dakota
      • Fargo, North Dakota, United States, 58103
        • Lillestol Research LLC
    • Ohio
      • Columbus, Ohio, United States, 43213
        • Aventiv Research
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73135
        • South Oklahoma Heart Research, LLC
    • Oregon
      • Portland, Oregon, United States, 97225
        • Portland Preventive Cardiology, LLC
    • Rhode Island
      • Cumberland, Rhode Island, United States, 02864
        • Partners in Clinical Research
    • South Carolina
      • Mount Pleasant, South Carolina, United States, 29464
        • PMG Research of Charleston, LLC
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Black Hills Cardiovascular Research Group
    • Tennessee
      • Kingsport, Tennessee, United States, 37660
        • Holston Medical Group Clinical Research
    • Texas
      • Tomball, Texas, United States, 77375-4536
        • Northwest Houston Heart Center
    • Virginia
      • Richmond, Virginia, United States, 23294
        • National Clinical Research - Richmond
    • Washington
      • Bellevue, Washington, United States, 98007-4209
        • Northwest Clinical Research Center
      • Spokane, Washington, United States, 99204
        • Kootenai Heart Clinics, LLC
    • Wisconsin
      • Kenosha, Wisconsin, United States, 53142
        • Clinical Investigation Specialists Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Atorvastatin + Evacetrapib
Atorvastatin 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.
Drug: Placebo
Administered orally
Drug: Evacetrapib
Administered orally
Other Names:
  • LY2484595
Drug: Atorvastatin
Administered orally
Active Comparator: Atorvastatin 80 mg
Atorvastatin 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.
Drug: Placebo
Administered orally
Drug: Atorvastatin
Administered orally
Active Comparator: Atorvastatin + Ezetimibe
Atorvastatin 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.
Drug: Placebo
Administered orally
Drug: Ezetimibe
Administered orally
Drug: Atorvastatin
Administered orally
Active Comparator: Atorvastatin 40 mg
Atorvastatin 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.
Drug: Placebo
Administered orally
Drug: Atorvastatin
Administered orally

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percent Change From Baseline to 3 Months in Low-Density Lipoprotein Cholesterol (LDL-C)
Time Frame: Baseline, 3 Months
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.
Baseline, 3 Months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percent Change From Baseline to 3 Months in High-Density Lipoprotein Cholesterol (HDL-C)
Time Frame: Baseline, 3 Months
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.
Baseline, 3 Months
Percent Change From Baseline to 3 Months in Apolipoprotein AI (apoAI)
Time Frame: Baseline, 3 Months
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.
Baseline, 3 Months
Percent Change From Baseline to 3 Months in Non-HDL-C
Time Frame: Baseline, 3 Months
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.
Baseline, 3 Months
Percent Change From Baseline to 3 Months in Apolipoprotein B (apoB)
Time Frame: Baseline, 3 Months
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.
Baseline, 3 Months
Percent Change From Baseline to 3 Months in Cholesterol Efflux Capacity
Time Frame: Baseline, 3 Months
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.
Baseline, 3 Months
Percent Change From Baseline to 3 Months in Lipoprotein(a) (Lp[a])
Time Frame: Baseline, 3 Months
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.
Baseline, 3 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eli Lilly and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 26, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 28, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 8, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 25, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 14502
  • I1V-MC-EIBH (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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