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CompletedNCT01105975Updated Mar 22, 2018Results posted

A Study of LY2484595 in Patients With High LDL-C or Low HDL-C

A Phase 2 interventional study of LY2484595 and Atorvastatin in Dyslipidemia, sponsored by Eli Lilly and Company. Completed at 59 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-03-22.

Sponsored by Eli Lilly and Company · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
398
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The primary purpose of your participation in this study is to help answer the following research question(s)

  • Whether LY2484595 in combination with a statin drug (atorvastatin, simvastatin or rosuvastatin; currently used to treat abnormal fat or cholesterol in blood) improves the blood fat profile more than statins alone.
  • Whether LY2484595 alone improves blood fats profile compared to sugar pills.
  • Whether LY2484595 interferes with break down or functioning of statins.
  • Whether LY2484595 has any side effects that would not support testing it in future studies.
Read the detailed description

Patients will be stratified according to baseline levels of serum triglycerides (\<150 or greater than or equal to 150 milligram/deciliter (mg/dL), HDL-C (\<45 or greater than or equal to 45 mg/dL for men; \<50 or greater than or equal to 50 mg/dL for women), and region (United States or Europe). After a diet lead-in and prior therapy washout phase, subjects meeting all entry criteria will be randomized to one of 10 double-blind treatment groups for a 12 week treatment phase. After randomization, patients will self-administer the study drugs once a day with a low fat meal as their first meal of the day.

02

Conditions studied

  • Dyslipidemia

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Keywords

  • Dyslipidemias
  • Mixed dyslipidemia
  • Hypercholesterolemia
  • Atherosclerosis
  • Atorvastatin
  • Simvastatin
  • Rosuvastatin
  • Metabolic Diseases
  • Antilipemic Agents
  • Enzyme Inhibitors
  • Anticholesteremic Agents
  • Cholesteryl Ester Transfer Protein Inhibitors
  • Cholesteryl Ester
  • Lipid Metabolism Disorders
03

In context

Dyslipidemias

1,073 studies on the registry are indexed under Dyslipidemias; 158 are open to participants now.

This study's enrollment of 398 is above the median of 99 across 842 interventional studies indexed under Dyslipidemias.

Browse Dyslipidemias 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

  • Diagnosed with Low High Density Lipoprotein Cholesterol (HDL-C) or hypercholesterolemia, after diet lead-in/washout of lipid therapies

Exclusion criteria

Exclusion Criteria:

  • History of coronary heart disease, or hardening of the arteries, or heart does not pump sufficiently well
  • Hypertension or high blood pressure that is not under control or your study physician does not consider the electrical activity of heart (Electrocardiogram [ECG]) to be compatible with participation in the study
  • History of a bad skin rash, a prior rash due to a drug or a history of chronic skin disorder (such as psoriasis or eczema)
  • Intolerance to certain lipid modifying drugs (including statins and Cholesteryl Ester Transfer Protein (CETP) inhibitors)
  • Not willing to stop taking prescription or over the counter drugs you use to control fats in your blood (like fish oil, niacin or statin) or pills to decrease your weight, including herbs
  • Not willing to follow the diet (low-fat) that the study physician will recommend
  • Have disease of liver, kidneys, muscles or other organs of body, a serious infection or cancer, or abnormal laboratory tests that study physician does not consider compatible with participation in the study
  • Breastfeeding woman or a woman who can still become pregnant, but are not willing to use a valid birth control measure to prevent pregnancies
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
398 participants (actual)

Study arms

  • Experimental
    30 milligram (mg) LY2484595 monotherapy

    Drug: LY2484595 · Drug: Placebo for Statins

  • Experimental
    100 mg LY2484595 monotherapy

    Drug: LY2484595 · Drug: Placebo for Statins

  • Experimental
    500 mg LY2484595 monotherapy

    Drug: LY2484595 · Drug: Placebo for Statins

  • Placebo comparator
    Placebo

    Drug: Placebo for LY2484595 · Drug: Placebo for Statins

  • Active comparator
    20 mg Atorvastatin monotherapy

    Drug: Atorvastatin · Drug: Placebo for LY2484595

  • Experimental
    100 mg LY2484595 + 20 mg Atorvastatin

    Drug: LY2484595 · Drug: Atorvastatin

  • Active comparator
    40 mg Simvastatin monotherapy

    Drug: Simvastatin · Drug: Placebo for LY2484595

  • Experimental
    100 mg LY2484595 + 40 mg Simvastatin

    Drug: LY2484595 · Drug: Simvastatin

  • Active comparator
    10 mg Rosuvastatin monotherapy

    Drug: Rosuvastatin · Drug: Placebo for LY2484595

  • Experimental
    100 mg LY2484595 + 10 mg Rosuvastatin

    Drug: LY2484595 · Drug: Rosuvastatin

Interventions

  • DrugLY2484595

    Administered daily by mouth for 12 weeks

  • DrugAtorvastatin

    Administered daily by mouth for 12 weeks

  • DrugSimvastatin

    Administered daily by mouth for 12 weeks

  • DrugRosuvastatin

    Administered daily by mouth for 12 weeks

  • DrugPlacebo for LY2484595

    Administered daily by mouth for 12 weeks

  • DrugPlacebo for Statins

    Administered daily by mouth for 12 weeks

06

What researchers measure

Primary outcomes

  1. Percent Change From Baseline to 12 Weeks Endpoint in High Density Lipoprotein Cholesterol (HDL-C) With LY2484595 in Combination With Atorvastatin and Atorvastatin Monotherapy

    Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.

    Time frame: Baseline, Week 12

  2. Percent Change From Baseline to 12 Weeks Endpoint in Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 in Combination With Atorvastatin and Atorvastatin Monotherapy

    Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.

    Time frame: Baseline, Week 12

Secondary outcomes

  1. Percent Change From Baseline to 12 Weeks Endpoint in High Density Lipoprotein Cholesterol (HDL-C) With LY2484595 and Placebo

    Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.

    Time frame: Baseline, Week 12

  2. Percent Change From Baseline to 12 Weeks Endpoint in Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 and Placebo

    Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.

    Time frame: Baseline, Week 12

  3. Percent Change From Baseline to 12 Weeks Endpoint in High Density Lipoprotein Cholesterol (HDL-C) With LY2484595 in Combination With Simvastatin or Rosuvastatin and Simvastatin/Rosuvastatin Monotherapy

    Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.

    Time frame: Baseline, Week 12

  4. Percent Change From Baseline to 12 Weeks Endpoint in Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 in Combination With Simvastatin or Rosuvastatin and Simvastatin/Rosuvastatin Monotherapy

    Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.

    Time frame: Baseline, Week 12

  5. Pharmacokinetics - LY2484595 Area Under the Concentration-Time Curve (AUC) at Steady-State

    Time frame: Baseline up to 12 weeks

  6. Percent Change From Baseline to 12 Weeks Endpoint in Plasma Cholesteryl Ester Transfer Protein (CETP) Activity

    Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.

    Time frame: Baseline, Week 12

  7. Percent Change From Baseline to 12 Weeks Endpoint in Plasma Cholesteryl Ester Transfer Protein (CETP) Mass

    Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.

    Time frame: Baseline, Week 12

  8. The Number of Episodes of Rashes at Any Time From Baseline Through Week 12

    All rash cases were adjudicated by a central dermatologist blinded to treatment assignment according to a study-specific Clinical Events Committee (CEC) charter. Rash events were assessed according to clinical relevance (high risk, low risk, not a relevant dermatosis, or insufficient documentation for determination). A participant could be reported in multiple categories.

    Time frame: Baseline through Week 12

  9. Change From Baseline to 12 Weeks Endpoint in Blood Pressure (BP)

    Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.

    Time frame: Baseline, Week 12

  10. Change From Baseline to 12 Weeks Endpoint in Serum Aldosterone

    Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.

    Time frame: Baseline, Week 12

  11. Change From Baseline to 12 Weeks Endpoint in Plasma Renin Activity

    Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.

    Time frame: Baseline, Week 12

  12. Change From Baseline to 12 Weeks Endpoint in Serum Potassium

    Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.

    Time frame: Baseline, Week 12

  13. Change From Baseline to 12 Weeks Endpoint in Serum Sodium

    Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.

    Time frame: Baseline, Week 12

  14. Change From Baseline to 12 Weeks Endpoint in Serum Bicarbonate

    Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.

    Time frame: Baseline, Week 12

  15. Change From Baseline to 18 Weeks Endpoint in EuroQoL Questionnaire - 5 Dimensions (EQ-5D) Score

    EQ-5D is a health-related, quality-of-life instrument. It allows participants to rate their health state in 5 domains: mobility, self-care, usual activities, pain/discomfort, and mood. A single score 1 -3 is generated for each domain, with 1=no problem and 3= extreme problems. The outcome ratings on the 5 domains are mapped to a single index through an algorithm. The index ranges 0-1, with the higher score indicating a better health state perceived by the participants. LS Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.

    Time frame: Baseline up to Week 18

07

Results

Posted Mar 22, 2018

Participant flow

Participant flow — Overall Study
Milestone30 mg LY2484595 Monotherapy100 mg LY2484595 Monotherapy500 mg LY2484595 MonotherapyPlacebo20 mg Atorvastatin Monotherapy100 mg LY2484595 + 20 mg Atorvastatin40 mg Simvastatin Monotherapy100 mg LY2484595 + 40 mg Simvastatin10 mg Rosuvastatin Monotherapy100 mg LY2484595 + 10 mg Rosuvastatin
Started40394238413542404041
Took at least one dose of study drug40384038413541403941
Completed35343236353034333432
Not completed55102658769
Withdrew: Adverse event2151012414
Withdrew: Withdrawal by subject2220412103
Withdrew: Lost to follow-up1001100010
Withdrew: Physician decision0000002000
Withdrew: Protocol violation0220111122
Withdrew: Abnormal lab/electrocardiogram result0010021120

Outcome measures

PrimaryPercent Change From Baseline to 12 Weeks Endpoint in High Density Lipoprotein Cholesterol (HDL-C) With LY2484595 in Combination With Atorvastatin and Atorvastatin Monotherapy

Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.

Time frame:
Baseline, Week 12
Reported as:
Least squares mean · percent change of mg/dL
Percent Change From Baseline to 12 Weeks Endpoint in High Density Lipoprotein Cholesterol (HDL-C) With LY2484595 in Combination With Atorvastatin and Atorvastatin Monotherapy
percent change of mg/dL20 mg Atorvastatin Monotherapy100 mg LY2484595 + 20 mg Atorvastatin
Percent Change From Baseline to 12 Weeks Endpoint in High Density Lipoprotein Cholesterol (HDL-C) With LY2484595 in Combination With Atorvastatin and Atorvastatin Monotherapy1.4 ± 5.779.9 ± 6.0
Statistical analysis
  • 20 mg Atorvastatin Monotherapy vs 100 mg LY2484595 + 20 mg Atorvastatin · mixed model repeated measures (MMRM) · p = <0.001 · Mean difference (final values): 78.5 · 90% CI 64.9 to 92.1
PrimaryPercent Change From Baseline to 12 Weeks Endpoint in Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 in Combination With Atorvastatin and Atorvastatin Monotherapy

Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.

Time frame:
Baseline, Week 12
Reported as:
Least squares mean · percent change of mg/dL
Percent Change From Baseline to 12 Weeks Endpoint in Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 in Combination With Atorvastatin and Atorvastatin Monotherapy
percent change of mg/dL20 mg Atorvastatin Monotherapy100 mg LY2484595 + 20 mg Atorvastatin
Percent Change From Baseline to 12 Weeks Endpoint in Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 in Combination With Atorvastatin and Atorvastatin Monotherapy-33.6 ± 3.0-47.6 ± 3.2
Statistical analysis
  • 20 mg Atorvastatin Monotherapy vs 100 mg LY2484595 + 20 mg Atorvastatin · mixed model repeated measures (MMRM) · p = 0.002 · Mean difference (final values): -13.9 · 90% CI -21.2 to -6.7
SecondaryPercent Change From Baseline to 12 Weeks Endpoint in High Density Lipoprotein Cholesterol (HDL-C) With LY2484595 and Placebo

Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.

Time frame:
Baseline, Week 12
Reported as:
Least squares mean · percent change of mg/dL
Percent Change From Baseline to 12 Weeks Endpoint in High Density Lipoprotein Cholesterol (HDL-C) With LY2484595 and Placebo
percent change of mg/dL30 mg LY2484595 Monotherapy100 mg LY2484595 Monotherapy500 mg LY2484595 MonotherapyPlacebo
Percent Change From Baseline to 12 Weeks Endpoint in High Density Lipoprotein Cholesterol (HDL-C) With LY2484595 and Placebo53.6 ± 5.694.6 ± 5.7128.8 ± 5.8-3.0 ± 5.6
Statistical analysis
  • 30 mg LY2484595 Monotherapy vs Placebo · mixed model repeated measures (MMRM) · p = <0.001 · Mean difference (final values): 56.7 · 90% CI 43.6 to 69.8
  • 100 mg LY2484595 Monotherapy vs Placebo · mixed model repeated measures (MMRM) · p = <0.001 · Mean difference (final values): 97.6 · 90% CI 84.5 to 110.8
  • 500 mg LY2484595 Monotherapy vs Placebo · mixed model repeated measures (MMRM) · p = <0.001 · Mean difference (final values): 131.9 · 90% CI 118.5 to 145.2
SecondaryPercent Change From Baseline to 12 Weeks Endpoint in Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 and Placebo

Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.

Time frame:
Baseline, Week 12
Reported as:
Least squares mean · percent change of mg/dL
Percent Change From Baseline to 12 Weeks Endpoint in Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 and Placebo
percent change of mg/dL30 mg LY2484595 Monotherapy100 mg LY2484595 Monotherapy500 mg LY2484595 MonotherapyPlacebo
Percent Change From Baseline to 12 Weeks Endpoint in Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 and Placebo-13.6 ± 3.0-22.3 ± 3.0-35.9 ± 3.13.9 ± 3.0
Statistical analysis
  • 30 mg LY2484595 Monotherapy vs Placebo · mixed model repeated measures (MMRM) · p = <0.001 · Mean difference (final values): -17.6 · 90% CI -24.6 to -10.5
  • 100 mg LY2484595 Monotherapy vs Placebo · mixed model repeated measures (MMRM) · p = <0.001 · Mean difference (final values): -26.2 · 90% CI -33.2 to -19.2
  • 500 mg LY2484595 Monotherapy vs Placebo · mixed model repeated measures (MMRM) · p = <0.001 · Mean difference (final values): -39.8 · 90% CI -47.0 to -32.7
SecondaryPercent Change From Baseline to 12 Weeks Endpoint in High Density Lipoprotein Cholesterol (HDL-C) With LY2484595 in Combination With Simvastatin or Rosuvastatin and Simvastatin/Rosuvastatin Monotherapy

Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.

Time frame:
Baseline, Week 12
Reported as:
Least squares mean · percent change of mg/dL
Percent Change From Baseline to 12 Weeks Endpoint in High Density Lipoprotein Cholesterol (HDL-C) With LY2484595 in Combination With Simvastatin or Rosuvastatin and Simvastatin/Rosuvastatin Monotherapy
percent change of mg/dL40 mg Simvastatin Monotherapy100 mg LY2484595 + 40 mg Simvastatin10 mg Rosuvastatin Monotherapy100 mg LY2484595 + 10 mg Rosuvastatin
Percent Change From Baseline to 12 Weeks Endpoint in High Density Lipoprotein Cholesterol (HDL-C) With LY2484595 in Combination With Simvastatin or Rosuvastatin and Simvastatin/Rosuvastatin Monotherapy7.3 ± 5.586.6 ± 5.75.5 ± 5.794.0 ± 5.7
Statistical analysis
  • 40 mg Simvastatin Monotherapy vs 100 mg LY2484595 + 40 mg Simvastatin · mixed model repeated measures (MMRM) · p = <0.001 · Mean difference (final values): 79.3 · 90% CI 66.2 to 92.4
  • 10 mg Rosuvastatin Monotherapy vs 100 mg LY2484595 + 10 mg Rosuvastatin · mixed model repeated measures (MMRM) · p = <0.001 · Mean difference (final values): 88.5 · 90% CI 75.2 to 101.8
SecondaryPercent Change From Baseline to 12 Weeks Endpoint in Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 in Combination With Simvastatin or Rosuvastatin and Simvastatin/Rosuvastatin Monotherapy

Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.

Time frame:
Baseline, Week 12
Reported as:
Least squares mean · percent change of mg/dL
Percent Change From Baseline to 12 Weeks Endpoint in Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 in Combination With Simvastatin or Rosuvastatin and Simvastatin/Rosuvastatin Monotherapy
percent change of mg/dL40 mg Simvastatin Monotherapy100 mg LY2484595 + 40 mg Simvastatin10 mg Rosuvastatin Monotherapy100 mg LY2484595 + 10 mg Rosuvastatin
Percent Change From Baseline to 12 Weeks Endpoint in Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 in Combination With Simvastatin or Rosuvastatin and Simvastatin/Rosuvastatin Monotherapy-34.9 ± 3.0-46.1 ± 3.1-38.8 ± 3.0-52.3 ± 3.0
Statistical analysis
  • 40 mg Simvastatin Monotherapy vs 100 mg LY2484595 + 40 mg Simvastatin · mixed model repeated measures (MMRM) · p = 0.009 · Mean difference (final values): -11.2 · 90% CI -18.3 to -4.2
  • 10 mg Rosuvastatin Monotherapy vs 100 mg LY2484595 + 10 mg Rosuvastatin · mixed model repeated measures (MMRM) · p = 0.002 · Mean difference (final values): -13.5 · 90% CI -20.6 to -6.4
SecondaryPharmacokinetics - LY2484595 Area Under the Concentration-Time Curve (AUC) at Steady-State
Time frame:
Baseline up to 12 weeks
Reported as:
Geometric mean · nanograms*hour/milliliter (ng*h/mL)
Pharmacokinetics - LY2484595 Area Under the Concentration-Time Curve (AUC) at Steady-State
nanograms*hour/milliliter (ng*h/mL)30 mg LY2484595 Monotherapy100 mg LY2484595 Monotherapy500 mg LY2484595 Monotherapy100 mg LY2484595 + 20 mg Atorvastatin100 mg LY2484595 + 40 mg Simvastatin100 mg LY2484595 + 10 mg Rosuvastatin
Pharmacokinetics - LY2484595 Area Under the Concentration-Time Curve (AUC) at Steady-State2300 ± 39.45900 ± 39.419700 ± 39.45500 ± 39.45620 ± 39.45960 ± 39.4
SecondaryPercent Change From Baseline to 12 Weeks Endpoint in Plasma Cholesteryl Ester Transfer Protein (CETP) Activity

Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.

Time frame:
Baseline, Week 12
Reported as:
Least squares mean · percent change of picomoles/mL/minute
Percent Change From Baseline to 12 Weeks Endpoint in Plasma Cholesteryl Ester Transfer Protein (CETP) Activity
percent change of picomoles/mL/minute30 mg LY2484595 Monotherapy100 mg LY2484595 Monotherapy500 mg LY2484595 MonotherapyPlacebo20 mg Atorvastatin Monotherapy100 mg LY2484595 + 20 mg Atorvastatin40 mg Simvastatin Monotherapy100 mg LY2484595 + 40 mg Simvastatin10 mg Rosuvastatin Monotherapy100 mg LY2484595 + 10 mg Rosuvastatin
Percent Change From Baseline to 12 Weeks Endpoint in Plasma Cholesteryl Ester Transfer Protein (CETP) Activity-49.48 ± 3.75-70.80 ± 3.89-89.10 ± 4.0012.12 ± 3.75-0.01 ± 3.81-72.00 ± 4.01-2.23 ± 3.80-64.64 ± 3.86-7.19 ± 3.80-73.24 ± 3.96
SecondaryPercent Change From Baseline to 12 Weeks Endpoint in Plasma Cholesteryl Ester Transfer Protein (CETP) Mass

Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.

Time frame:
Baseline, Week 12
Reported as:
Least squares mean · percent change of micrograms/mL (mcg/mL)
Percent Change From Baseline to 12 Weeks Endpoint in Plasma Cholesteryl Ester Transfer Protein (CETP) Mass
percent change of micrograms/mL (mcg/mL)30 mg LY2484595 Monotherapy100 mg LY2484595 Monotherapy500 mg LY2484595 MonotherapyPlacebo20 mg Atorvastatin Monotherapy100 mg LY2484595 + 20 mg Atorvastatin40 mg Simvastatin Monotherapy100 mg LY2484595 + 40 mg Simvastatin10 mg Rosuvastatin Monotherapy100 mg LY2484595 + 10 mg Rosuvastatin
Percent Change From Baseline to 12 Weeks Endpoint in Plasma Cholesteryl Ester Transfer Protein (CETP) Mass63.94 ± 5.5492.27 ± 5.59136.66 ± 5.830.58 ± 5.51-11.8 ± 5.4862.98 ± 5.87-11.14 ± 5.5065.92 ± 5.63-16.58 ± 5.6264.08 ± 5.81
SecondaryThe Number of Episodes of Rashes at Any Time From Baseline Through Week 12

All rash cases were adjudicated by a central dermatologist blinded to treatment assignment according to a study-specific Clinical Events Committee (CEC) charter. Rash events were assessed according to clinical relevance (high risk, low risk, not a relevant dermatosis, or insufficient documentation for determination). A participant could be reported in multiple categories.

Time frame:
Baseline through Week 12
Reported as:
Number · events
The Number of Episodes of Rashes at Any Time From Baseline Through Week 12
events30 mg LY2484595 Monotherapy100 mg LY2484595 Monotherapy500 mg LY2484595 MonotherapyPlacebo20 mg Atorvastatin Monotherapy100 mg LY2484595 + 20 mg Atorvastatin40 mg Simvastatin Monotherapy100 mg LY2484595 + 40 mg Simvastatin10 mg Rosuvastatin Monotherapy100 mg LY2484595 + 10 mg Rosuvastatin
High Risk (HR)- Angioedema0000001000
HR - Insufficient Documentation for Determination0000000001
Low Risk0000000102
Not a Relevant Dermatoses4530126401
Insufficient Documentation for Determination0000000000
SecondaryChange From Baseline to 12 Weeks Endpoint in Blood Pressure (BP)

Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.

Time frame:
Baseline, Week 12
Reported as:
Least squares mean · millimeters of mercury (mmHg)
Change From Baseline to 12 Weeks Endpoint in Blood Pressure (BP)
millimeters of mercury (mmHg)30 mg LY2484595 Monotherapy100 mg LY2484595 Monotherapy500 mg LY2484595 MonotherapyPlacebo20 mg Atorvastatin Monotherapy100 mg LY2484595 + 20 mg Atorvastatin40 mg Simvastatin Monotherapy100 mg LY2484595 + 40 mg Simvastatin10 mg Rosuvastatin Monotherapy100 mg LY2484595 + 10 mg Rosuvastatin
Diastolic BP1.1 ± 1.10.8 ± 1.11.2 ± 1.21.6 ± 1.10.2 ± 1.11.2 ± 1.2-1.5 ± 1.12.3 ± 1.22.2 ± 1.1-0.1 ± 1.1
Systolic BP4.4 ± 1.84.3 ± 1.81.4 ± 1.82.8 ± 1.70.2 ± 1.72.1 ± 1.90.0 ± 1.72.3 ± 1.80.0 ± 1.83.8 ± 1.8
SecondaryChange From Baseline to 12 Weeks Endpoint in Serum Aldosterone

Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.

Time frame:
Baseline, Week 12
Reported as:
Least squares mean · nanogram/deciliter (ng/dL)
Change From Baseline to 12 Weeks Endpoint in Serum Aldosterone
nanogram/deciliter (ng/dL)30 mg LY2484595 Monotherapy100 mg LY2484595 Monotherapy500 mg LY2484595 MonotherapyPlacebo20 mg Atorvastatin Monotherapy100 mg LY2484595 + 20 mg Atorvastatin40 mg Simvastatin Monotherapy100 mg LY2484595 + 40 mg Simvastatin10 mg Rosuvastatin Monotherapy100 mg LY2484595 + 10 mg Rosuvastatin
Change From Baseline to 12 Weeks Endpoint in Serum Aldosterone-0.5 ± 0.91.0 ± 0.9-0.3 ± 0.9-1.0 ± 0.9-1.0 ± 0.90.4 ± 0.90.0 ± 0.9-1.7 ± 0.9-2.5 ± 0.90.0 ± 0.9
SecondaryChange From Baseline to 12 Weeks Endpoint in Plasma Renin Activity

Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.

Time frame:
Baseline, Week 12
Reported as:
Least squares mean · nanograms/milliliter/hour (ng/mL/h)
Change From Baseline to 12 Weeks Endpoint in Plasma Renin Activity
nanograms/milliliter/hour (ng/mL/h)30 mg LY2484595 Monotherapy100 mg LY2484595 Monotherapy500 mg LY2484595 MonotherapyPlacebo20 mg Atorvastatin Monotherapy100 mg LY2484595 + 20 mg Atorvastatin40 mg Simvastatin Monotherapy100 mg LY2484595 + 40 mg Simvastatin10 mg Rosuvastatin Monotherapy100 mg LY2484595 + 10 mg Rosuvastatin
Change From Baseline to 12 Weeks Endpoint in Plasma Renin Activity-0.06 ± 0.34-0.11 ± 0.34-0.58 ± 0.35-0.30 ± 0.34-0.58 ± 0.34-0.26 ± 0.37-0.16 ± 0.340.00 ± 0.34-0.86 ± 0.33-0.29 ± 0.35
SecondaryChange From Baseline to 12 Weeks Endpoint in Serum Potassium

Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.

Time frame:
Baseline, Week 12
Reported as:
Least squares mean · milliequivalents/Liter
Change From Baseline to 12 Weeks Endpoint in Serum Potassium
milliequivalents/Liter30 mg LY2484595 Monotherapy100 mg LY2484595 Monotherapy500 mg LY2484595 MonotherapyPlacebo20 mg Atorvastatin Monotherapy100 mg LY2484595 + 20 mg Atorvastatin40 mg Simvastatin Monotherapy100 mg LY2484595 + 40 mg Simvastatin10 mg Rosuvastatin Monotherapy100 mg LY2484595 + 10 mg Rosuvastatin
Change From Baseline to 12 Weeks Endpoint in Serum Potassium-0.04 ± 0.050.01 ± 0.05-0.02 ± 0.05-0.08 ± 0.050.09 ± 0.050.08 ± 0.050.03 ± 0.050.02 ± 0.05-0.07 ± 0.05-0.05 ± 0.05
SecondaryChange From Baseline to 12 Weeks Endpoint in Serum Sodium

Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.

Time frame:
Baseline, Week 12
Reported as:
Least squares mean · milliequivalents/Liter
Change From Baseline to 12 Weeks Endpoint in Serum Sodium
milliequivalents/Liter30 mg LY2484595 Monotherapy100 mg LY2484595 Monotherapy500 mg LY2484595 MonotherapyPlacebo20 mg Atorvastatin Monotherapy100 mg LY2484595 + 20 mg Atorvastatin40 mg Simvastatin Monotherapy100 mg LY2484595 + 40 mg Simvastatin10 mg Rosuvastatin Monotherapy100 mg LY2484595 + 10 mg Rosuvastatin
Change From Baseline to 12 Weeks Endpoint in Serum Sodium0.3 ± 0.40.3 ± 0.40.5 ± 0.40.1 ± 0.41.3 ± 0.40.6 ± 0.40.8 ± 0.40.9 ± 0.40.5 ± 0.40.3 ± 0.4
SecondaryChange From Baseline to 12 Weeks Endpoint in Serum Bicarbonate

Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.

Time frame:
Baseline, Week 12
Reported as:
Least squares mean · milliequivalents/Liter
Change From Baseline to 12 Weeks Endpoint in Serum Bicarbonate
milliequivalents/Liter30 mg LY2484595 Monotherapy100 mg LY2484595 Monotherapy500 mg LY2484595 MonotherapyPlacebo20 mg Atorvastatin Monotherapy100 mg LY2484595 + 20 mg Atorvastatin40 mg Simvastatin Monotherapy100 mg LY2484595 + 40 mg Simvastatin10 mg Rosuvastatin Monotherapy100 mg LY2484595 + 10 mg Rosuvastatin
Change From Baseline to 12 Weeks Endpoint in Serum Bicarbonate0.40 ± 0.360.60 ± 0.360.51 ± 0.370.27 ± 0.360.10 ± 0.360.58 ± 0.381.04 ± 0.350.58 ± 0.370.78 ± 0.361.25 ± 0.37
SecondaryChange From Baseline to 18 Weeks Endpoint in EuroQoL Questionnaire - 5 Dimensions (EQ-5D) Score

EQ-5D is a health-related, quality-of-life instrument. It allows participants to rate their health state in 5 domains: mobility, self-care, usual activities, pain/discomfort, and mood. A single score 1 -3 is generated for each domain, with 1=no problem and 3= extreme problems. The outcome ratings on the 5 domains are mapped to a single index through an algorithm. The index ranges 0-1, with the higher score indicating a better health state perceived by the participants. LS Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.

Time frame:
Baseline up to Week 18
Reported as:
Least squares mean · units on a scale
Change From Baseline to 18 Weeks Endpoint in EuroQoL Questionnaire - 5 Dimensions (EQ-5D) Score
units on a scale30 mg LY2484595 Monotherapy100 mg LY2484595 Monotherapy500 mg LY2484595 MonotherapyPlacebo20 mg Atorvastatin Monotherapy100 mg LY2484595 + 20 mg Atorvastatin40 mg Simvastatin Monotherapy100 mg LY2484595 + 40 mg Simvastatin10 mg Rosuvastatin Monotherapy100 mg LY2484595 + 10 mg Rosuvastatin
Change From Baseline to 18 Weeks Endpoint in EuroQoL Questionnaire - 5 Dimensions (EQ-5D) Score0.008 ± 0.0140.002 ± 0.0140.012 ± 0.014-0.001 ± 0.014-0.002 ± 0.014-0.006 ± 0.014-0.001 ± 0.014-0.001 ± 0.0130.014 ± 0.014-0.047 ± 0.013

Adverse events

Non-serious events are listed at a 2% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
30 mg LY2484595 Monotherapy—0/40 (0%)22/40 (55%)
100 mg LY2484595 Monotherapy—0/38 (0%)25/38 (65.8%)
500 mg LY2484595 Monotherapy—1/40 (2.5%)21/40 (52.5%)
Placebo—0/38 (0%)23/38 (60.5%)
20 mg Atorvastatin Monotherapy—0/41 (0%)29/41 (70.7%)
100 mg LY2484595 + 20 mg Atorvastatin—1/35 (2.9%)22/35 (62.9%)
40 mg Simvastatin Monotherapy—1/41 (2.4%)29/41 (70.7%)
100 mg LY2484595 + 40 mg Simvastatin—0/40 (0%)27/40 (67.5%)
10 mg Rosuvastatin Monotherapy—0/39 (0%)31/39 (79.5%)
100 mg LY2484595 + 10 mg Rosuvastatin—1/41 (2.4%)27/41 (65.9%)
30 mg LY2484595 Monotherapy Follow-Up—0/40 (0%)7/40 (17.5%)
100 mg LY2484595 Monotherapy Follow-Up—0/38 (0%)4/38 (10.5%)
500 mg LY2484595 Monotherapy Follow-Up—1/40 (2.5%)6/40 (15%)
Placebo Follow-Up—1/38 (2.6%)8/38 (21.1%)
20 mg Atorvastatin Monotherapy Follow-Up—0/41 (0%)6/41 (14.6%)
100 mg LY2484595 + 20 mg Atorvastatin Follow-Up—0/35 (0%)8/35 (22.9%)
40 mg Simvastatin Monotherapy Follow-Up—0/41 (0%)7/41 (17.1%)
100 mg LY2484595 + 40 mg Simvastatin Follow-Up—0/40 (0%)4/40 (10%)
10 mg Rosuvastatin Monotherapy Follow-Up—0/39 (0%)6/39 (15.4%)
100 mg LY2484595 + 10 mg Rosuvastatin Follow-Up—0/41 (0%)5/41 (12.2%)
Most frequent serious events
Most frequent serious events
Event30 mg LY2484595 Monotherapy100 mg LY2484595 Monotherapy500 mg LY2484595 MonotherapyPlacebo20 mg Atorvastatin Monotherapy100 mg LY2484595 + 20 mg Atorvastatin40 mg Simvastatin Monotherapy100 mg LY2484595 + 40 mg Simvastatin10 mg Rosuvastatin Monotherapy100 mg LY2484595 + 10 mg Rosuvastatin30 mg LY2484595 Monotherapy Follow-Up100 mg LY2484595 Monotherapy Follow-Up500 mg LY2484595 Monotherapy Follow-UpPlacebo Follow-Up20 mg Atorvastatin Monotherapy Follow-Up100 mg LY2484595 + 20 mg Atorvastatin Follow-Up40 mg Simvastatin Monotherapy Follow-Up100 mg LY2484595 + 40 mg Simvastatin Follow-Up10 mg Rosuvastatin Monotherapy Follow-Up100 mg LY2484595 + 10 mg Rosuvastatin Follow-Up
Coronary artery diseaseCardiac disorders0/400/380/400/380/411/350/410/400/390/410/400/380/400/380/410/350/410/400/390/41
InfluenzaInfections and infestations0/400/380/400/380/410/350/410/400/390/410/400/380/401/380/410/350/410/400/390/41
BursitisMusculoskeletal and connective tissue disorders0/400/380/400/380/410/350/410/400/390/410/400/381/400/380/410/350/410/400/390/41
Anal cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/400/381/400/380/410/350/410/400/390/410/400/380/400/380/410/350/410/400/390/41
Metastases to lymph nodesNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/400/381/400/380/410/350/410/400/390/410/400/380/400/380/410/350/410/400/390/41
FallInjury, poisoning and procedural complications0/400/380/400/380/410/351/410/400/390/410/400/380/400/380/410/350/410/400/390/41
Hip fractureInjury, poisoning and procedural complications0/400/380/400/380/410/350/410/400/391/410/400/380/400/380/410/350/410/400/390/41
Upper limb fractureInjury, poisoning and procedural complications0/400/380/400/380/410/351/410/400/390/410/400/380/400/380/410/350/410/400/390/41
Most frequent other events
Showing 10 of 227
Most frequent other events
Event30 mg LY2484595 Monotherapy100 mg LY2484595 Monotherapy500 mg LY2484595 MonotherapyPlacebo20 mg Atorvastatin Monotherapy100 mg LY2484595 + 20 mg Atorvastatin40 mg Simvastatin Monotherapy100 mg LY2484595 + 40 mg Simvastatin10 mg Rosuvastatin Monotherapy100 mg LY2484595 + 10 mg Rosuvastatin30 mg LY2484595 Monotherapy Follow-Up100 mg LY2484595 Monotherapy Follow-Up500 mg LY2484595 Monotherapy Follow-UpPlacebo Follow-Up20 mg Atorvastatin Monotherapy Follow-Up100 mg LY2484595 + 20 mg Atorvastatin Follow-Up40 mg Simvastatin Monotherapy Follow-Up100 mg LY2484595 + 40 mg Simvastatin Follow-Up10 mg Rosuvastatin Monotherapy Follow-Up100 mg LY2484595 + 10 mg Rosuvastatin Follow-Up
NasopharyngitisInfections and infestations2/403/381/406/384/416/354/414/409/393/411/400/381/402/380/410/350/410/401/390/41
NauseaGastrointestinal disorders0/400/383/401/381/413/351/412/401/394/411/400/380/400/380/410/350/410/400/390/41
HeadacheNervous system disorders2/400/380/401/384/410/350/412/402/393/410/400/380/400/380/410/351/410/400/390/41
DiarrhoeaGastrointestinal disorders0/402/383/401/381/412/351/412/402/392/411/400/380/400/381/410/350/410/401/390/41
ArthralgiaMusculoskeletal and connective tissue disorders0/401/382/400/383/412/350/413/401/392/410/400/380/400/380/410/350/410/400/390/41
RashSkin and subcutaneous tissue disorders1/402/381/400/380/410/352/413/400/391/410/400/380/400/380/410/350/410/400/390/41
FlatulenceGastrointestinal disorders0/400/380/402/380/410/351/411/400/393/410/400/380/400/380/410/350/410/400/390/41
Upper respiratory tract infectionInfections and infestations0/400/380/400/381/411/353/412/400/391/410/400/380/400/380/411/350/410/401/391/41
Blood pressure systolic increasedInvestigations0/400/380/400/380/411/350/410/400/393/410/400/380/400/380/410/350/410/400/390/41
DizzinessNervous system disorders0/402/380/400/380/411/350/412/400/393/410/400/380/400/380/410/350/410/400/390/41

Baseline characteristics

Age, Continuous
Age, Continuous(years)30 mg LY2484595 Monotherapy100 mg LY2484595 Monotherapy500 mg LY2484595 MonotherapyPlacebo20 mg Atorvastatin Monotherapy100 mg LY2484595 + 20 mg Atorvastatin40 mg Simvastatin Monotherapy100 mg LY2484595 + 40 mg Simvastatin10 mg Rosuvastatin Monotherapy100 mg LY2484595 + 10 mg RosuvastatinTotal
Mean58.5 ± 11.158.5 ± 9.258.8 ± 12.255.2 ± 10.557.8 ± 11.357.4 ± 11.861.3 ± 10.058.4 ± 9.057.4 ± 12.659.7 ± 10.158.3 ± 10.8
Sex: Female, Male
Sex: Female, Male(Participants)30 mg LY2484595 Monotherapy100 mg LY2484595 Monotherapy500 mg LY2484595 MonotherapyPlacebo20 mg Atorvastatin Monotherapy100 mg LY2484595 + 20 mg Atorvastatin40 mg Simvastatin Monotherapy100 mg LY2484595 + 40 mg Simvastatin10 mg Rosuvastatin Monotherapy100 mg LY2484595 + 10 mg RosuvastatinTotal
Female23222120261829251323220
Male17161918151712152618173
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)30 mg LY2484595 Monotherapy100 mg LY2484595 Monotherapy500 mg LY2484595 MonotherapyPlacebo20 mg Atorvastatin Monotherapy100 mg LY2484595 + 20 mg Atorvastatin40 mg Simvastatin Monotherapy100 mg LY2484595 + 40 mg Simvastatin10 mg Rosuvastatin Monotherapy100 mg LY2484595 + 10 mg RosuvastatinTotal
Hispanic or Latino232322211119
Not Hispanic or Latino27282926292529302534282
Unknown or Not Reported1179910810913692
Race (NIH/OMB)
Race (NIH/OMB)(Participants)30 mg LY2484595 Monotherapy100 mg LY2484595 Monotherapy500 mg LY2484595 MonotherapyPlacebo20 mg Atorvastatin Monotherapy100 mg LY2484595 + 20 mg Atorvastatin40 mg Simvastatin Monotherapy100 mg LY2484595 + 40 mg Simvastatin10 mg Rosuvastatin Monotherapy100 mg LY2484595 + 10 mg RosuvastatinTotal
American Indian or Alaska Native00000000000
Asian10000000001
Native Hawaiian or Other Pacific Islander00000000000
Black or African American514112203120
White33363536393339393540365
More than one race11111001107
Unknown or Not Reported00000000000
Region of Enrollment
Region of Enrollment(Participants)30 mg LY2484595 Monotherapy100 mg LY2484595 Monotherapy500 mg LY2484595 MonotherapyPlacebo20 mg Atorvastatin Monotherapy100 mg LY2484595 + 20 mg Atorvastatin40 mg Simvastatin Monotherapy100 mg LY2484595 + 40 mg Simvastatin10 mg Rosuvastatin Monotherapy100 mg LY2484595 + 10 mg RosuvastatinTotal
United States22232222231821232222218
Poland222021120416
Denmark12981010912111110102
Germany211121012011
Netherlands225545624439
United Kingdom01200111017
Weight
Weight(kilogram)30 mg LY2484595 Monotherapy100 mg LY2484595 Monotherapy500 mg LY2484595 MonotherapyPlacebo20 mg Atorvastatin Monotherapy100 mg LY2484595 + 20 mg Atorvastatin40 mg Simvastatin Monotherapy100 mg LY2484595 + 40 mg Simvastatin10 mg Rosuvastatin Monotherapy100 mg LY2484595 + 10 mg RosuvastatinTotal
Mean84.6 ± 23.279.9 ± 18.382.6 ± 20.689.3 ± 18.581.4 ± 16.487.4 ± 22.479.6 ± 15.484.5 ± 16.785.7 ± 19.482.2 ± 18.083.6 ± 19.0
Body Mass Index (BMI)
Body Mass Index (BMI)(kilogram/square meter (kg/m²))30 mg LY2484595 Monotherapy100 mg LY2484595 Monotherapy500 mg LY2484595 MonotherapyPlacebo20 mg Atorvastatin Monotherapy100 mg LY2484595 + 20 mg Atorvastatin40 mg Simvastatin Monotherapy100 mg LY2484595 + 40 mg Simvastatin10 mg Rosuvastatin Monotherapy100 mg LY2484595 + 10 mg RosuvastatinTotal
Mean29.8 ± 7.827.6 ± 5.729.0 ± 5.629.8 ± 6.128.8 ± 5.130.0 ± 7.528.3 ± 5.029.9 ± 5.328.3 ± 4.228.4 ± 5.329.0 ± 5.8
High-Density Lipoprotein Cholesterol (HDL-C)
High-Density Lipoprotein Cholesterol (HDL-C)(milligram/deciliter (mg/dL))30 mg LY2484595 Monotherapy100 mg LY2484595 Monotherapy500 mg LY2484595 MonotherapyPlacebo20 mg Atorvastatin Monotherapy100 mg LY2484595 + 20 mg Atorvastatin40 mg Simvastatin Monotherapy100 mg LY2484595 + 40 mg Simvastatin10 mg Rosuvastatin Monotherapy100 mg LY2484595 + 10 mg RosuvastatinTotal
Mean54.7 ± 12.057.0 ± 14.154.7 ± 16.353.0 ± 11.853.9 ± 17.055.7 ± 18.257.3 ± 16.253.7 ± 13.653.5 ± 15.257.8 ± 18.155.1 ± 15.3

2 further baseline measures are reported on the registry.

08

Study locations

59 sites
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    Fayetteville, Arkansas 72703, United States
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    San Diego, California 92128, United States
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    Spring Valley, California 91978, United States
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    Vista, California 92083, United States
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    Golden, Colorado 80401, United States
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    Brandon, Florida 33511, United States
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    Jacksonville, Florida 32216, United States
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    Longwood, Florida 32779, United States
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    Ponte Vedra, Florida 32081, United States
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    Indianapolis, Indiana 46254, United States
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    Waterloo, Iowa 50702, United States
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    Wichita, Kansas 67708, United States
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    Lexington, Kentucky 40504, United States
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    Auburn, Maine 04210, United States
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    Baltimore, Maryland 21209, United States
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    Picayune, Mississippi 39466, United States
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    Edison, New Jersey 08817, United States
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    Endwell, New York 13760, United States
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    Cary, North Carolina 27518, United States
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    Charlotte, North Carolina 28209, United States
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    Greensboro, North Carolina 27408, United States
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    Hickory, North Carolina 28601, United States
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    Raleigh, North Carolina 27609, United States
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    Salisbury, North Carolina 28144, United States
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    Wilmington, North Carolina 28401, United States
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    Winston-Salem, North Carolina 27103, United States
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    Philadelphia, Pennsylvania 19152, United States
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    Red Lion, Pennsylvania 17356, United States
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    Yardley, Pennsylvania 19067, United States
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    Greer, South Carolina 29651, United States
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    Mount Pleasant, South Carolina 29464, United States
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    Simpsonville, South Carolina 29681, United States
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    Bristol, Tennessee 37620, United States
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    Kingsport, Tennessee 37660, United States
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    Dallas, Texas 75231, United States
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    Houston, Texas 77030, United States
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    Tacoma, Washington 98405, United States
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    Oregon, Wisconsin 53575, United States
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    Ballerup, 2750, Denmark
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    Vejle, 7100, Denmark
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    Berlin, 12627, Germany
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    Bochum, 44787, Germany
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    Leipzig, 04103, Germany
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    Amsterdam, 1105 AZ, Netherlands
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    Breda, 4811 VL, Netherlands
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    Eindhoven, 5611 NJ, Netherlands
  • 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.
    Geleen, 6160 BB, Netherlands
  • 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.
    Groningen, 9711 SG, Netherlands
  • 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.
    Leiderdorp, 2352 RA, Netherlands
  • 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.
    Rotterdam, 3021 HC, Netherlands
  • 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.
    Zoetermeer, 2724 EK, Netherlands
  • 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.
    Gdynia, 81-572, Poland
  • 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.
    Warsaw, 02-777, Poland
  • 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.
    Wroclaw, 50-088, Poland
  • 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.
    Reading, Berkshire RG2 7AG, United Kingdom
  • 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.
    Chorley, Lancashire PR 7 7NA, United Kingdom
  • 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.
    Liverpool, Merseyside L22 0LG, United Kingdom
  • 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.
    Glasgow, Scotland G81 2DR, United Kingdom
  • 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.
    Birmingham, B15 2SQ, United Kingdom
09

References and documents

Publications

  • Nicholls SJ, Ruotolo G, Brewer HB, Wang MD, Liu L, Willey MB, Deeg MA, Krueger KA, Nissen SE. Evacetrapib alone or in combination with statins lowers lipoprotein(a) and total and small LDL particle concentrations in mildly hypercholesterolemic patients. J Clin Lipidol. 2016 May-Jun;10(3):519-527.e4. doi: 10.1016/j.jacl.2015.11.014. Epub 2015 Dec 18. PubMed 27206939 ↗
  • Nicholls SJ, Ruotolo G, Brewer HB, Kane JP, Wang MD, Krueger KA, Adelman SJ, Nissen SE, Rader DJ. Cholesterol Efflux Capacity and Pre-Beta-1 HDL Concentrations Are Increased in Dyslipidemic Patients Treated With Evacetrapib. J Am Coll Cardiol. 2015 Nov 17;66(20):2201-2210. doi: 10.1016/j.jacc.2015.09.013. PubMed 26564598 ↗
  • Nicholls SJ, Brewer HB, Kastelein JJ, Krueger KA, Wang MD, Shao M, Hu B, McErlean E, Nissen SE. Effects of the CETP inhibitor evacetrapib administered as monotherapy or in combination with statins on HDL and LDL cholesterol: a randomized controlled trial. JAMA. 2011 Nov 16;306(19):2099-109. doi: 10.1001/jama.2011.1649. PubMed 22089718 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 22, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01105975
Lead sponsor
Eli Lilly and Company
Responsible party
Sponsor
First posted
Apr 19, 2010
Start date
Apr 2010
Primary completion
Jun 2011
Completion
Jun 2011
Results posted
Mar 22, 2018
Last update
Mar 22, 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
Yes
View the source record on ClinicalTrials.gov ↗

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