A Study of LY3015014 in Participants With High Cholesterol

NCT ID: NCT01890967

Last Updated: 2019-09-18

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

527 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2014-06-30

Brief Summary

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This study is designed to define the amount and duration of cholesterol lowering and to assess the safety and tolerability of different dose regimens of LY3015014 in participants with high cholesterol. The study will also investigate how the body processes the drug and how the drug affects the body. Participants will remain on a stable diet and will continue taking cholesterol-lowering medications (statins with or without ezetimibe). After signing the informed consent document, the participant will complete a screening/run-in period that will last at most 8 weeks. Then, the treatment period will last approximately 16 weeks. After the treatment period, the participants will complete a follow-up period lasting approximately 8 weeks for a total study duration ranging from approximately 25 to 32 weeks.

Detailed Description

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Conditions

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Hypercholesterolemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

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.

Group Type EXPERIMENTAL

LY3015014

Intervention Type DRUG

Administered SC

Statin

Intervention Type DRUG

Administered orally

Ezetimibe

Intervention Type DRUG

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.

Group Type EXPERIMENTAL

LY3015014

Intervention Type DRUG

Administered SC

Statin

Intervention Type DRUG

Administered orally

Ezetimibe

Intervention Type DRUG

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.

Group Type EXPERIMENTAL

LY3015014

Intervention Type DRUG

Administered SC

Statin

Intervention Type DRUG

Administered orally

Ezetimibe

Intervention Type DRUG

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.

Group Type EXPERIMENTAL

LY3015014

Intervention Type DRUG

Administered SC

Statin

Intervention Type DRUG

Administered orally

Ezetimibe

Intervention Type DRUG

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.

Group Type EXPERIMENTAL

LY3015014

Intervention Type DRUG

Administered SC

Statin

Intervention Type DRUG

Administered orally

Ezetimibe

Intervention Type DRUG

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered SC

Statin

Intervention Type DRUG

Administered orally

Ezetimibe

Intervention Type DRUG

Administered orally

Interventions

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LY3015014

Administered SC

Intervention Type DRUG

Placebo

Administered SC

Intervention Type DRUG

Statin

Administered orally

Intervention Type DRUG

Ezetimibe

Administered orally

Intervention Type DRUG

Other Intervention Names

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atorvastatin simvastatin rosuvastatin pravastatin lovastatin fluvastatin pitavastatin

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with high low density lipoprotein (LDL) cholesterol
* 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 high cholesterol due to another disease or have a rare and serious form of hereditary high cholesterol
* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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Encino, California, United States

Site Status

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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

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Countries

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United States Canada Czechia Denmark Japan Netherlands Poland Puerto Rico

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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