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

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 |
- 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.
- 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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | 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:
- 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

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

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