A Study of LY3015014 in Participants With High Cholesterol
NCT ID: NCT01890967
Last Updated: 2019-09-18
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
527 participants
INTERVENTIONAL
2013-06-30
2014-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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20 mg LY3015014 Q4W
20 milligrams (mg) LY3015014 given subcutaneously (SC) once every 4 weeks (Q4W) for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
LY3015014
Administered SC
Statin
Administered orally
Ezetimibe
Administered orally
120 mg LY3015014 Q4W
120 mg LY3015014 given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
LY3015014
Administered SC
Statin
Administered orally
Ezetimibe
Administered orally
300 mg LY3015014 Q4W
300 mg LY3015014 given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
LY3015014
Administered SC
Statin
Administered orally
Ezetimibe
Administered orally
100 mg LY3015014 Q8W
100 mg LY3015014 given SC once every 8 weeks (Q8W) for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
LY3015014
Administered SC
Statin
Administered orally
Ezetimibe
Administered orally
300 mg LY3015014 Q8W
300 mg LY3015014 given SC Q8W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
LY3015014
Administered SC
Statin
Administered orally
Ezetimibe
Administered orally
Placebo Q4W
Placebo given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.
Placebo
Administered SC
Statin
Administered orally
Ezetimibe
Administered orally
Interventions
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LY3015014
Administered SC
Placebo
Administered SC
Statin
Administered orally
Ezetimibe
Administered orally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Are on stable daily dose of a statin or have a history of statin intolerance
* Men with a partner who can become pregnant must agree to use barrier protection during sexual intercourse to prevent pregnancies
* Women who cannot become pregnant, or women who are not pregnant or breast feeding and agree to use a reliable method of birth control to prevent pregnancies
Exclusion Criteria
* Have had recent heart attack, stroke, blood clot or heart surgery, have planned heart or blood vessel surgery, or has a heart that does not pump sufficiently well
* Have poorly controlled high blood pressure
* Have diabetes that requires an injectable medication (including insulin), or have diabetes that is poorly controlled
* Have thyroid blood test that is outside normal range
* Have a history of adrenal gland disorder
* Have a history of vitamin E deficiency or fat malabsorption syndrome
* Have poor kidney function
* Have active liver or gall bladder disease, history of hepatitis or liver blood tests that are high
* Have a history of muscle disease including muscle damage from a medicine or muscle blood test that is high
* Are anemic (low red blood cell counts)
* Have a history of allergy or intolerance to other antibody medications
* Have a history of human immunodeficiency virus infection (HIV) infection
* Are likely to have a major operation or be hospitalized during the study
* Have chronic alcohol or drug abuse or dependency
* Have or suspected to have any cancer or malignant tumor
* Have an active serious infection
* Have started or stopped taking a statin or ezetimibe medication, or changed statin dose regimen recently
* Are on a statin regimen other than daily dosing (for example, an every-other-day statin regimen)
* Have recently used simvastatin (highest dose level), fibrates, bile acid binders, niacin, probucol, or over-the-counter/health food preparations to lower cholesterol (such as red yeast rice, fish oil, omega 3 fatty acid)
* Have undergone LDL apheresis in the past 1 year
* Have recently used steroids, cyclosporine or isotretinoin
* Have recently used an immunosuppressive therapy
* Have recently received treatment with another antibody medication
* Are currently using medications injected into the skin , except for single injections (for example flu vaccines) or injections into muscles
* Are currently on a prescription or over-the-counter medicine for weight loss or are on a very low carbohydrate diet
18 Years
80 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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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.
Encino, California, United States
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Lancaster, California, United States
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Spring Valley, California, United States
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Aurora, Colorado, United States
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Safety Harbor, Florida, United States
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Tampa, Florida, United States
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Indianapolis, Indiana, United States
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Iowa City, Iowa, United States
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Louisville, Kentucky, United States
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Bossier City, Louisiana, United States
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Charlotte, North Carolina, United States
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Raleigh, North Carolina, United States
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Cincinnati, Ohio, United States
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Toledo, Ohio, United States
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Knoxville, Tennessee, United States
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Kamloops, British Columbia, Canada
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Kelowna, British Columbia, Canada
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Brampton, Ontario, Canada
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London, Ontario, Canada
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Toronto, Ontario, Canada
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Gatineau, Quebec, Canada
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Montreal, Quebec, Canada
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Saint-Marc-des-Carrieres, Quebec, Canada
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Český Krumlov, , Czechia
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Hodonín, , Czechia
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Prague, , Czechia
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Svitavy, , Czechia
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Aalborg, , Denmark
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Copenhagen, , Denmark
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Esbjerg, , Denmark
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Hellerup, , Denmark
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Hvidovre, , Denmark
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Fukuoka, , Japan
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Osaka, , Japan
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Tokyo, , Japan
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Amsterdam, , Netherlands
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Breda, , Netherlands
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Goes, , Netherlands
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Groningen, , Netherlands
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Maastricht, , Netherlands
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Nijmegen, , Netherlands
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Rotterdam, , Netherlands
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Utrecht, , Netherlands
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Bialystok, , Poland
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Gdansk, , Poland
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Krakow, , Poland
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Lodz, , Poland
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Lublin, , Poland
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Ponce, , Puerto Rico
Countries
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Other Identifiers
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I5S-MC-EFJE
Identifier Type: OTHER
Identifier Source: secondary_id
14853
Identifier Type: -
Identifier Source: org_study_id
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