A Study of LY3015014 in Participants With High Cholesterol

Status:

COMPLETED

A Study of LY3015014 in Participants With High Cholesterol

Lead Sponsor:

Eli Lilly and Company

Conditions:

Hypercholesterolemia

Eligibility:

All Genders

18-80 years

Phase:

PHASE2

Brief Summary

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...

Eligibility Criteria

Inclusion

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

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

Key Trial Info

Start Date :

June 1 2013

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 1 2014

Estimated Enrollment :

527 Patients enrolled

Trial Details

Trial ID

NCT01890967

Start Date

June 1 2013

End Date

June 1 2014

Last Update

September 18 2019

Active Locations (49)

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Page 1 of 13 (49 locations)

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, 91436

Lancaster, California, United States, 93534

Spring Valley, California, United States, 91978

Aurora, Colorado, United States, 80012

Trial Details

Trial ID

NCT01890967

Start Date

June 1 2013

End Date

June 1 2014

Last Update

September 18 2019

Status: