A Study of LY3015014 in Participants With High Cholesterol

Lilly

Status and phase: Completed; Phase 2

Conditions: Hypercholesterolemia

Treatments: Drug: Ezetimibe; Drug: LY3015014; Drug: Statin; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01890967

I5S-MC-EFJE (Other Identifier)

14853

Details and patient eligibility

About

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.

Enrollment: 527 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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527 participants in 6 patient groups, including a placebo group

20 mg LY3015014 Q4W

Experimental group

Description:

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.

Treatment:

Drug: Statin

Drug: LY3015014

Drug: Ezetimibe

120 mg LY3015014 Q4W

Experimental group

Description:

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.

Treatment:

Drug: Statin

Drug: LY3015014

Drug: Ezetimibe

300 mg LY3015014 Q4W

Experimental group

Description:

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.

Treatment:

Drug: Statin

Drug: LY3015014

Drug: Ezetimibe

100 mg LY3015014 Q8W

Experimental group

Description:

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.

Treatment:

Drug: Statin

Drug: LY3015014

Drug: Ezetimibe

300 mg LY3015014 Q8W

Experimental group

Description:

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.

Treatment:

Drug: Statin

Drug: LY3015014

Drug: Ezetimibe

Placebo Q4W

Placebo Comparator group

Description:

Placebo given SC Q4W for 16 weeks. Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.

Treatment:

Drug: Placebo

Drug: Statin

Drug: Ezetimibe