A Study of LY3015014 in Participants With High Cholesterol

Lilly logo

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

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

Trial contacts and locations

49

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems