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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT01105975

Recruitment Status : Completed

First Posted : April 19, 2010

Results First Posted : March 22, 2018

Last Update Posted : March 22, 2018

Sponsor:

Information provided by (Responsible Party):

Eli Lilly and Company

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Dyslipidemia	Drug: LY2484595 Drug: Atorvastatin Drug: Simvastatin Drug: Rosuvastatin Drug: Placebo for LY2484595 Drug: Placebo for Statins	Phase 2

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	398 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	A Phase 2 Efficacy and Safety Study of LY2484595 Alone and in Combination With Atorvastatin, Simvastatin, and Rosuvastatin in Patients With Hypercholesterolemia or Low HDL-C
Study Start Date :	April 2010
Actual Primary Completion Date :	June 2011
Actual Study Completion Date :	June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cholesterol Cholesterol Levels: What You Need to Know

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: 30 milligram (mg) LY2484595 monotherapy	Drug: LY2484595 Administered daily by mouth for 12 weeks Drug: Placebo for Statins Administered daily by mouth for 12 weeks
Experimental: 100 mg LY2484595 monotherapy	Drug: LY2484595 Administered daily by mouth for 12 weeks Drug: Placebo for Statins Administered daily by mouth for 12 weeks
Experimental: 500 mg LY2484595 monotherapy	Drug: LY2484595 Administered daily by mouth for 12 weeks Drug: Placebo for Statins Administered daily by mouth for 12 weeks
Placebo Comparator: Placebo	Drug: Placebo for LY2484595 Administered daily by mouth for 12 weeks Drug: Placebo for Statins Administered daily by mouth for 12 weeks
Active Comparator: 20 mg Atorvastatin monotherapy	Drug: Atorvastatin Administered daily by mouth for 12 weeks Drug: Placebo for LY2484595 Administered daily by mouth for 12 weeks
Experimental: 100 mg LY2484595 + 20 mg Atorvastatin	Drug: LY2484595 Administered daily by mouth for 12 weeks Drug: Atorvastatin Administered daily by mouth for 12 weeks
Active Comparator: 40 mg Simvastatin monotherapy	Drug: Simvastatin Administered daily by mouth for 12 weeks Drug: Placebo for LY2484595 Administered daily by mouth for 12 weeks
Experimental: 100 mg LY2484595 + 40 mg Simvastatin	Drug: LY2484595 Administered daily by mouth for 12 weeks Drug: Simvastatin Administered daily by mouth for 12 weeks
Active Comparator: 10 mg Rosuvastatin monotherapy	Drug: Rosuvastatin Administered daily by mouth for 12 weeks Drug: Placebo for LY2484595 Administered daily by mouth for 12 weeks
Experimental: 100 mg LY2484595 + 10 mg Rosuvastatin	Drug: LY2484595 Administered daily by mouth for 12 weeks Drug: Rosuvastatin Administered daily by mouth for 12 weeks

Outcome Measures

Primary Outcome Measures :

Percent Change From Baseline to 12 Weeks Endpoint in High Density Lipoprotein Cholesterol (HDL-C) With LY2484595 in Combination With Atorvastatin and Atorvastatin Monotherapy [ Time Frame: Baseline, Week 12 ]
Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.
Percent Change From Baseline to 12 Weeks Endpoint in Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 in Combination With Atorvastatin and Atorvastatin Monotherapy [ Time Frame: Baseline, Week 12 ]
Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.

Secondary Outcome Measures :

Percent Change From Baseline to 12 Weeks Endpoint in High Density Lipoprotein Cholesterol (HDL-C) With LY2484595 and Placebo [ Time Frame: Baseline, Week 12 ]
Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.
Percent Change From Baseline to 12 Weeks Endpoint in Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 and Placebo [ Time Frame: Baseline, Week 12 ]
Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.
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 [ Time Frame: Baseline, Week 12 ]
Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.
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 [ Time Frame: Baseline, Week 12 ]
Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.
Pharmacokinetics - LY2484595 Area Under the Concentration-Time Curve (AUC) at Steady-State [ Time Frame: Baseline up to 12 weeks ]
Percent Change From Baseline to 12 Weeks Endpoint in Plasma Cholesteryl Ester Transfer Protein (CETP) Activity [ Time Frame: Baseline, Week 12 ]
Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.
Percent Change From Baseline to 12 Weeks Endpoint in Plasma Cholesteryl Ester Transfer Protein (CETP) Mass [ Time Frame: Baseline, Week 12 ]
Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.
The Number of Episodes of Rashes at Any Time From Baseline Through Week 12 [ Time Frame: 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.
Change From Baseline to 12 Weeks Endpoint in Blood Pressure (BP) [ Time Frame: Baseline, Week 12 ]
Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.
Change From Baseline to 12 Weeks Endpoint in Serum Aldosterone [ Time Frame: Baseline, Week 12 ]
Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.
Change From Baseline to 12 Weeks Endpoint in Plasma Renin Activity [ Time Frame: Baseline, Week 12 ]
Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.
Change From Baseline to 12 Weeks Endpoint in Serum Potassium [ Time Frame: Baseline, Week 12 ]
Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.
Change From Baseline to 12 Weeks Endpoint in Serum Sodium [ Time Frame: Baseline, Week 12 ]
Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.
Change From Baseline to 12 Weeks Endpoint in Serum Bicarbonate [ Time Frame: Baseline, Week 12 ]
Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.
Change From Baseline to 18 Weeks Endpoint in EuroQoL Questionnaire - 5 Dimensions (EQ-5D) Score [ Time Frame: Baseline up to Week 18 ]
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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

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

Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01105975

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Locations

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

Sponsors and Collaborators

Eli Lilly and Company

Investigators

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Study Director:	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)	Eli Lilly and Company

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

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.

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Responsible Party:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT01105975 History of Changes
Other Study ID Numbers:	12468 I1V-MC-EIAF ( Other Identifier: Eli Lilly and Company )
First Posted:	April 19, 2010 Key Record Dates
Results First Posted:	March 22, 2018
Last Update Posted:	March 22, 2018
Last Verified:	February 2018

Keywords provided by Eli Lilly and Company:


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

Additional relevant MeSH terms:

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Hypercholesterolemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Atorvastatin Rosuvastatin Calcium Simvastatin	Evacetrapib Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors

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