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TerminatedNCT02227784ACCENTUATEUpdated Oct 8, 2019Results posted

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

A Phase 3 interventional study of Evacetrapib and Atorvastatin in Hyperlipidemia, sponsored by Eli Lilly and Company. Terminated at 64 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-10-08.

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

Why this study was terminated
Study termination due to program termination.
Phase
Phase 3
Study type
Interventional
Enrollment
366
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Hyperlipidemia
03

In context

Hyperlipidemias

821 studies on the registry are indexed under Hyperlipidemias; 105 are open to participants now.

This study's enrollment of 366 is above the median of 88 across 691 interventional studies indexed under Hyperlipidemias.

Browse Hyperlipidemias 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
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

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

Study arms

  • 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: Evacetrapib · Drug: Atorvastatin · Drug: Placebo

  • 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: Atorvastatin · Drug: Placebo

  • 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: Atorvastatin · Drug: Ezetimibe · Drug: Placebo

  • 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: Atorvastatin · Drug: Placebo

Interventions

  • DrugEvacetrapib

    Administered orally

    Also known as: LY2484595

  • DrugAtorvastatin

    Administered orally

  • DrugEzetimibe

    Administered orally

  • DrugPlacebo

    Administered orally

06

What researchers measure

Primary outcomes

  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.

    Time frame: Baseline, 3 Months

Secondary outcomes

  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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: Baseline, 3 Months

07

Results

Posted Mar 22, 2018
Limitations and caveats
Early termination was due to program termination.

Participant flow

Double-Blind Phase
Participant flow — Double-Blind Phase
MilestoneAtorvastatin + EvacetrapibAtorvastatin 40 mgAtorvastatin 80 mgAtorvastatin + EzetimibeAtorvastatin + Evacetrapib Open-Label (OLE)
Started12354621270
Completed833641880
Not completed401821390
Withdrew: Adverse event32130
Withdrew: Physician decision10010
Withdrew: Protocol violation00110
Withdrew: Sponsor decision341514320
Withdrew: Withdrawal by subject21520
Open-Label Extension Phase (OLE)
Participant flow — Open-Label Extension Phase (OLE)
MilestoneAtorvastatin + EvacetrapibAtorvastatin 40 mgAtorvastatin 80 mgAtorvastatin + EzetimibeAtorvastatin + Evacetrapib Open-Label (OLE)
Started0000248
Received at least 1 dose of study drug0000247
Completed00000
Not completed0000248
Withdrew: Adverse event00001
Withdrew: Death00001
Withdrew: Sponsor decision0000243
Withdrew: Withdrawal by subject00003

Outcome measures

PrimaryPercent 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.

Time frame:
Baseline, 3 Months
Reported as:
Median · percent
Percent Change From Baseline to 3 Months in Low-Density Lipoprotein Cholesterol (LDL-C)
percentAtorvastatin + EvacetrapibAtorvastatin 40 mgAtorvastatin 80 mgAtorvastatin + Ezetimibe
Percent Change From Baseline to 3 Months in Low-Density Lipoprotein Cholesterol (LDL-C)-33.44 (-34.47 to -32.41)0.04 (-1.01 to 1.09)-6.19 (-7.24 to -5.15)-27.30 (-28.33 to -26.27)
Statistical analysis
  • Atorvastatin + Evacetrapib vs Atorvastatin 40 mg · ANCOVA · p = <0.001 · Median difference (final values): -33.48 · 95% CI -44.4 to -23.3
  • Atorvastatin + Evacetrapib vs Atorvastatin 80 mg · ANCOVA · p = <0.001 · Median difference (final values): -27.24 · 95% CI -36.6 to -18.5
  • Atorvastatin + Evacetrapib vs Atorvastatin + Ezetimibe · ANCOVA · p = 0.045 · Median difference (final values): -6.14 · 95% CI -12.2 to -0.22
SecondaryPercent 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.

Time frame:
Baseline, 3 Months
Reported as:
Median · percent
Percent Change From Baseline to 3 Months in High-Density Lipoprotein Cholesterol (HDL-C)
percentAtorvastatin + EvacetrapibAtorvastatin 40 mgAtorvastatin 80 mgAtorvastatin + Ezetimibe
Percent Change From Baseline to 3 Months in High-Density Lipoprotein Cholesterol (HDL-C)125.39 (124.37 to 126.40)0.11 (-0.92 to 1.13)-6.10 (-7.12 to -5.07)-2.18 (-3.20 to -1.17)
Statistical analysis
  • Atorvastatin + Evacetrapib vs Atorvastatin 40 mg · Mixed Models Analysis · p = <0.001 · Median difference (final values): 125.28 · 95% CI 117.1 to 133.6
  • Atorvastatin + Evacetrapib vs Atorvastatin 80 mg · Mixed Models Analysis · p = <0.001 · Median difference (final values): 131.48 · 95% CI 123.5 to 139.5
  • Atorvastatin + Evacetrapib vs Atorvastatin + Ezetimibe · Mixed Models Analysis · p = <0.001 · Median difference (final values): 127.57 · 95% CI 120.1 to 135.0
SecondaryPercent 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.

Time frame:
Baseline, 3 Months
Reported as:
Median · percent
Percent Change From Baseline to 3 Months in Apolipoprotein AI (apoAI)
percentAtorvastatin + EvacetrapibAtorvastatin 40 mgAtorvastatin 80 mgAtorvastatin + Ezetimibe
Percent Change From Baseline to 3 Months in Apolipoprotein AI (apoAI)46.08 (45.07 to 47.09)-0.27 (-1.29 to 0.76)-6.14 (-7.16 to -5.12)-2.36 (-3.38 to -1.35)
Statistical analysis
  • Atorvastatin + Evacetrapib vs Atorvastatin 40 mg · ANCOVA · p = <0.001 · Median difference (final values): 46.35 · 95% CI 40.79 to 51.98
  • Atorvastatin + Evacetrapib vs Atorvastatin 80 mg · ANCOVA · p = <0.001 · Median difference (final values): 52.22 · 95% CI 47.12 to 57.33
  • Atorvastatin + Evacetrapib vs Atorvastatin + Ezetimibe · ANCOVA · p = <0.001 · Median difference (final values): 48.44 · 95% CI 43.82 to 52.86
SecondaryPercent 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.

Time frame:
Baseline, 3 Months
Reported as:
Median · percent
Percent Change From Baseline to 3 Months in Non-HDL-C
percentAtorvastatin + EvacetrapibAtorvastatin 40 mgAtorvastatin 80 mgAtorvastatin + Ezetimibe
Percent Change From Baseline to 3 Months in Non-HDL-C-31.42 (-32.44 to -30.40)-4.95 (-5.98 to -3.92)-9.40 (-10.44 to -8.37)-24.37 (-25.40 to -23.35)
Statistical analysis
  • Atorvastatin + Evacetrapib vs Atorvastatin 40 mg · Mixed Models Analysis · p = <0.001 · Median difference (final values): -26.47 · 95% CI -33.4 to -20.0
  • Atorvastatin + Evacetrapib vs Atorvastatin 80 mg · Mixed Models Analysis · p = <0.001 · Median difference (final values): -22.02 · 95% CI -28.4 to -15.9
  • Atorvastatin + Evacetrapib vs Atorvastatin + Ezetimibe · Mixed Models Analysis · p = <0.001 · Median difference (final values): -7.05 · 95% CI -11.5 to -2.68
SecondaryPercent 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.

Time frame:
Baseline, 3 Months
Reported as:
Median · percent
Percent Change From Baseline to 3 Months in Apolipoprotein B (apoB)
percentAtorvastatin + EvacetrapibAtorvastatin 40 mgAtorvastatin 80 mgAtorvastatin + Ezetimibe
Percent Change From Baseline to 3 Months in Apolipoprotein B (apoB)-22.96 (-23.98 to -22.96)0.21 (-0.82 to 1.24)-6.54 (-7.56 to -5.51)-18.84 (-19.86 to -17.82)
Statistical analysis
  • Atorvastatin + Evacetrapib vs Atorvastatin 40 mg · ANCOVA · p = <0.001 · Median difference (final values): -23.16 · 95% CI -30.00 to -16.5
  • Atorvastatin + Evacetrapib vs Atorvastatin 80 mg · ANCOVA · p = <0.001 · Median difference (final values): -16.42 · 95% CI -22.3 to -10.6
  • Atorvastatin + Evacetrapib vs Atorvastatin + Ezetimibe · ANCOVA · p = 0.062 · Median difference (final values): -4.11 · 95% CI -8.47 to 0.15
SecondaryPercent 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.

Time frame:
Baseline, 3 Months
Reported as:
Median · percent
Percent Change From Baseline to 3 Months in Cholesterol Efflux Capacity
percentAtorvastatin + EvacetrapibAtorvastatin 40 mgAtorvastatin + EzetimibeAtorvastatin 80 mg
Percent Change From Baseline to 3 Months in Cholesterol Efflux Capacity35.09 (34.07 to 36.11)-2.96 (-3.99 to -1.93)-7.03 (-8.06 to -6.00)-4.55 (-5.57 to -3.53)
Statistical analysis
  • Atorvastatin + Evacetrapib vs Atorvastatin 40 mg · ANCOVA · p = <0.001 · Median difference (final values): 38.05 · 95% CI 30.17 to 45.88
  • Atorvastatin + Evacetrapib vs Atorvastatin + Ezetimibe · ANCOVA · p = <0.001 · Median difference (final values): 42.12 · 95% CI 34.29 to 49.76
  • Atorvastatin + Evacetrapib vs Atorvastatin 80 mg · ANCOVA · p = <0.001 · Median difference (final values): 39.64 · 95% CI 33.20 to 46.08
SecondaryPercent 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.

Time frame:
Baseline, 3 Months
Reported as:
Median · percent
Percent Change From Baseline to 3 Months in Lipoprotein(a) (Lp[a])
percentAtorvastatin + EvacetrapibAtorvastatin 40 mgAtorvastatin 80 mgAtorvastatin + Ezetimibe
Percent Change From Baseline to 3 Months in Lipoprotein(a) (Lp[a])-28.73 (-29.77 to 27.69)4.45 (3.40 to 5.50)3.90 (2.86 to 4.95)13.42 (12.39 to 14.45)
Statistical analysis
  • Atorvastatin + Evacetrapib vs Atorvastatin 40 mg · ANCOVA · p = <0.001 · Median difference (final values): -33.18 · 95% CI -44.9 to -22.3
  • Atorvastatin + Evacetrapib vs Atorvastatin 80 mg · ANCOVA · p = <0.001 · Median difference (final values): -32.63 · 95% CI -44.0 to -21.8
  • Atorvastatin + Evacetrapib vs Atorvastatin + Ezetimibe · ANCOVA · p = <0.001 · Median difference (final values): -42.15 · 95% CI -50.9 to -33.4

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Atorvastatin + Evacetrapib Double-Blind (DB)—2/123 (1.6%)6/123 (4.9%)
Atorvastatin 40 mg DB—3/54 (5.6%)5/54 (9.3%)
Atorvastatin 80 mg DB—3/62 (4.8%)4/62 (6.5%)
Atorvastatin + Ezetimibe DB—3/127 (2.4%)5/127 (3.9%)
Atorvastatin + Evacetrapib Open-Label (OLE)—11/247 (4.5%)9/247 (3.6%)
Most frequent serious events
Showing 10 of 28
Most frequent serious events
EventAtorvastatin + Evacetrapib Double-Blind (DB)Atorvastatin 40 mg DBAtorvastatin 80 mg DBAtorvastatin + Ezetimibe DBAtorvastatin + Evacetrapib Open-Label (OLE)
Chronic sinusitisInfections and infestations0/1231/540/620/1270/247
Accidental overdoseInjury, poisoning and procedural complications0/1231/540/620/1270/247
Suicidal ideationPsychiatric disorders0/1231/540/620/1270/247
Acute respiratory failureRespiratory, thoracic and mediastinal disorders0/1231/540/620/1270/247
Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders0/1231/540/620/1271/247
Pulmonary embolismRespiratory, thoracic and mediastinal disorders0/1231/540/620/1270/247
Chest painGeneral disorders0/1230/541/620/1270/247
Non-cardiac chest painGeneral disorders0/1230/541/620/1271/247
Cerebrovascular accidentNervous system disorders0/1230/541/620/1270/247
Transient ischaemic attackNervous system disorders0/1230/541/620/1270/247
Most frequent other events
Most frequent other events
EventAtorvastatin + Evacetrapib Double-Blind (DB)Atorvastatin 40 mg DBAtorvastatin 80 mg DBAtorvastatin + Ezetimibe DBAtorvastatin + Evacetrapib Open-Label (OLE)
DiarrhoeaGastrointestinal disorders5/1234/541/623/1274/247
ArthralgiaMusculoskeletal and connective tissue disorders1/1231/544/622/1275/247

Baseline characteristics

Age, Continuous
Age, Continuous(years)Atorvastatin + EvacetrapibAtorvastatin 40 mgAtorvastatin 80 mgAtorvastatin + EzetimibeTotal
Mean63.2 ± 8.762.7 ± 9.361.7 ± 10.264.7 ± 8.963.4 ± 9.2
Sex: Female, Male
Sex: Female, Male(Participants)Atorvastatin + EvacetrapibAtorvastatin 40 mgAtorvastatin 80 mgAtorvastatin + EzetimibeTotal
Female38151853124
Male85394474242
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Atorvastatin + EvacetrapibAtorvastatin 40 mgAtorvastatin 80 mgAtorvastatin + EzetimibeTotal
Hispanic or Latino13391338
Not Hispanic or Latino1105153114328
Unknown or Not Reported00000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Atorvastatin + EvacetrapibAtorvastatin 40 mgAtorvastatin 80 mgAtorvastatin + EzetimibeTotal
American Indian or Alaska Native00112
Asian41016
Native Hawaiian or Other Pacific Islander00000
Black or African American198151456
White974446110297
More than one race31015
Unknown or Not Reported00000
Region of Enrollment
Region of Enrollment(Participants)Atorvastatin + EvacetrapibAtorvastatin 40 mgAtorvastatin 80 mgAtorvastatin + EzetimibeTotal
United States1235462127366
08

Study locations

64 sites
  • Heart Center Research, LLC
    Huntsville, Alabama 35801, United States
  • Desert Clinical Research
    Mesa, Arizona 85213, United States
  • Central Phoenix Med Clinic LLC
    Phoenix, Arizona 85020, United States
  • Advanced Clinical Research
    Carmichael, California 95608, United States
  • Tooraj Joseph Raoof M.D., Inc.
    Encino, California 91436, United States
  • Irvine Clinical Research Center
    Irvine, California 92618, United States
  • VA Long Beach Healthcare System
    Long Beach, California 90822, United States
  • Rancho Cucamonga Clinical
    Rancho Cucamonga, California 91730, United States
  • Encompass Clinical Research
    Spring Valley, California 91978, United States
  • University Clinical Investigators, Inc.
    Tustin, California 92780, United States
  • Diablo Clinical Research
    Walnut Creek, California 94598, United States
  • University of Colorado Health Sciences Center
    Aurora, Colorado 80045-2517, United States
  • Cardiac Research
    Colorado Springs, Colorado 80909, United States
  • ZASA Clinical Research
    Boynton Beach, Florida 33472, United States
  • Cardiology Research Assoc.
    Daytona Beach, Florida 32117, United States
  • Avail Clinical Research LLC
    DeLand, Florida 32720, United States
  • Alan Graff, MD, PA
    Fort Lauderdale, Florida 33308, United States
  • Nature Coast Clinical Research, LLC
    Inverness, Florida 34452, United States
  • Suncoast Research Group, LLC
    Miami, Florida 33135, United States
  • Progressive Medical Research
    Port Orange, Florida 32127, United States
  • Cardiology Partners Clinical Research Institute, LLC
    Wellington, Florida 33449, United States
  • Georgia Heart Specialists
    Covington, Georgia 30014, United States
  • United Osteoporosis Center
    Gainesville, Georgia 30501, United States
  • East West Medical Institute
    Honolulu, Hawaii 96814, United States
  • Solaris Clinical Research
    Meridian, Idaho 83646, United States
  • Northwest Heart Clinical Research, LLC
    Arlington Heights, Illinois 60005, United States
  • Cedar-Crosse Research Center
    Chicago, Illinois 60607, United States
  • Midwest CRC
    Crystal Lake, Illinois 60012, United States
  • Indiana Heart Physicians Inc
    Indianapolis, Indiana 46237, United States
  • Midwest Institute for Clinical Research
    Indianapolis, Indiana 46260, United States
  • Hutchinson Clinic
    Hutchinson, Kansas 67502, United States
  • Community Medical Associates
    Louisville, Kentucky 40205, United States
  • Grace Research
    Bossier City, Louisiana 71111, United States
  • Maryland Cardiovascular Specialists
    Baltimore, Maryland 21229, United States
  • Overlea Personal Physicians
    Baltimore, Maryland 21236, United States
  • Cape Cod Research Institute
    Hyannis, Massachusetts 02601, United States
  • ActivMed Practices & Research, Inc
    Methuen, Massachusetts 01844, United States
  • Medex Healthcare Research, Inc.
    Saint Louis, Missouri 63117, United States
  • Palm Research Center
    Las Vegas, Nevada 89128, United States
  • Heart and Vascular Center of New Brunswick LLC
    Somerset, New Jersey 08873, United States
  • Medex Healthcare Research, Inc.
    New York, New York 10036, United States
  • Saratoga Clinical Research LLC
    Saratoga Springs, New York 12866, United States
  • Buffalo Cardiology and Pulmonary Associates, P.C.
    Williamsville, New York 14221, United States
  • Asheville Cardiology Associates
    Asheville, North Carolina 28803, United States
  • Metrolina Internal Medicine, P.A.
    Charlotte, North Carolina 28204, United States
  • High Point Clinical Trials Center
    High Point, North Carolina 27265, United States
  • Boice Willis Clinic, PA
    Rocky Mount, North Carolina 27804, United States
  • PMG Research of Wilmington, LLC
    Wilmington, North Carolina 28401, United States
  • Lillestol Research LLC
    Fargo, North Dakota 58103, United States
  • Aventiv Research
    Columbus, Ohio 43213, United States
  • South Oklahoma Heart Research, LLC
    Oklahoma City, Oklahoma 73135, United States
  • Portland Preventive Cardiology, LLC
    Portland, Oregon 97225, United States
  • Partners in Clinical Research
    Cumberland, Rhode Island 02864, United States
  • PMG Research of Charleston, LLC
    Mount Pleasant, South Carolina 29464, United States
  • Black Hills Cardiovascular Research Group
    Rapid City, South Dakota 57701, United States
  • Holston Medical Group Clinical Research
    Kingsport, Tennessee 37660, United States
  • Northwest Houston Heart Center
    Tomball, Texas 77375-4536, United States
  • National Clinical Research - Richmond
    Richmond, Virginia 23294, United States
  • Northwest Clinical Research Center
    Bellevue, Washington 98007-4209, United States
  • Kootenai Heart Clinics, LLC
    Spokane, Washington 99204, United States
  • Clinical Investigation Specialists Inc
    Kenosha, Wisconsin 53142, United States
  • Research and Cardiovascular Corp.
    Ponce, 00717-1322, Puerto Rico
  • Clinical Research Puerto Rico, Inc.
    San Juan, 00909, Puerto Rico
  • GCM Medical Group PSC
    San Juan, 00909, Puerto Rico
09

References and documents

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 ↗

Individual participant data

Plan to share: 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.

Supporting information: Study protocol, Sap, Csr

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 8, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02227784
Lead sponsor
Eli Lilly and Company
Responsible party
Sponsor
First posted
Aug 28, 2014
Start date
Oct 2014
Primary completion
Dec 2015
Completion
Dec 2015
Results posted
Mar 22, 2018
Last update
Oct 8, 2019

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 ↗

Not currently enrolling

This study is terminated, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

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