A Study of LY2484595 in Patients With High LDL-C or Low HDL-C
This study has been completed.
Sponsor:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01105975
First Posted: April 19, 2010
Last Update Posted: September 26, 2011
Information provided by (Responsible Party):
Eli Lilly and Company
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Purpose
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 | Intervention | Phase |
|---|---|---|
| Dyslipidemia | Drug: LY2484595 Drug: Atorvastatin Drug: Simvastatin Drug: Rosuvastatin Drug: Placebo for LY2484595 Drug: Placebo for Statins | Phase 2 |
| Study Type: | Interventional |
| Study Design: | 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 |
Resource links provided by NLM:
Further study details as provided by Eli Lilly and Company:
Primary Outcome Measures:
- Percent change from baseline to 12 week endpoint in high density lipoprotein cholesterol (HDL-C) with LY2484595 in combination with atorvastatin and atorvastatin monotherapy [ Time Frame: Baseline, 12 weeks ]
- Percent change from baseline to 12 week endpoint in low density lipoprotein cholesterol (LDL-C) with LY2484595 in combination with atorvastatin and atorvastatin monotherapy [ Time Frame: Baseline, 12 weeks ]
Secondary Outcome Measures:
- Percent change from baseline to 12 weeks in HDL-C with LY2484595 and Placebo [ Time Frame: Baseline, 12 weeks ]
- Percent change from baseline to 12 weeks in LDL-C with LY2484595 and Placebo [ Time Frame: Baseline, 12 weeks ]
- Percent change from baseline to 12 week endpoint in HDL-C with LY2484595 in combination with simvastatin or rosuvastatin and simvastatin/rosuvastatin monotherapy [ Time Frame: Baseline, 12 weeks ]
- Percent change from baseline to 12 week endpoint in LDL-C with LY2484595 in combination with simvastatin or rosuvastatin and simvastatin/rosuvastatin monotherapy [ Time Frame: Baseline, 12 weeks ]
- Pharmacokinetics - Area Under the Curve (AUC) [ Time Frame: 2, 4, 8, and 12 weeks and 4-6 weeks follow-up ]
- Percent change in plasma Cholesteryl Ester Transfer Protein (CETP) activity [ Time Frame: Baseline, 4, 8, and 12 weeks and 4-6 weeks follow-up ]
- Percent change in plasma Cholesteryl Ester Transfer Protein (CETP) mass [ Time Frame: Baseline, 4, 8 and 12 weeks and 4-6 weeks follow-up ]
- Incidence and severity of rashes [ Time Frame: 12 weeks ]
- Change from baseline to 12 week endpoint in blood pressure [ Time Frame: Baseline, 12 weeks ]
- Change from baseline to 12 week endpoint in serum aldosterone [ Time Frame: Baseline, 12 weeks ]
- Change from baseline to 12 week endpoint in plasma renin activity [ Time Frame: Baseline, 12 weeks ]
- Change from baseline to 12 week endpoint in plasma potassium [ Time Frame: Baseline, 12 weeks ]
- Change from baseline to 12 week endpoint in serum sodium [ Time Frame: Baseline, 12 weeks ]
- Change from baseline to 12 week endpoint in serum bicarbonate [ Time Frame: Baseline, 12 weeks ]
- Change from baseline to 6 week follow-up in EuroQol-5 dimensions (EQ-5D) score [ Time Frame: Baseline, 6 week follow-up ]
| Enrollment: | 430 |
| Study Start Date: | April 2010 |
| Study Completion Date: | June 2011 |
| Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 30 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
|
Detailed Description:
Patients will be stratified according to baseline levels of serum triglycerides (<150 or greater than or equal to 150 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.
Eligibility
Information from the National Library of Medicine
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, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
• Diagnosed with Low 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 (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 are a woman who can still become pregnant, but are not willing to use a valid birth control measure to prevent pregnancies
Contacts and Locations
Information from the National Library of Medicine
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
| 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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| Mt. 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
| 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):
| 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 Submitted: | April 15, 2010 |
| First Posted: | April 19, 2010 |
| Last Update Posted: | September 26, 2011 |
| Last Verified: | July 2011 |
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:
|
Hypercholesterolemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Atorvastatin Calcium Rosuvastatin Calcium Simvastatin |
Evacetrapib Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors |