A Study of LY3015014 in Participants With High Cholesterol
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Intervention: LY3015014; Placebo; Statin; Ezetimibe
Intervention description: Administered SC; Administered SC; Administered orally; Administered orally
Intervention MeSH terms: Atorvastatin; Rosuvastatin Calcium; Simvastatin; Ezetimibe; Pravastatin; Pitavastatin; Lovastatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 527.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: low density lipoprotein, heterozygous familial hypercholesterolemia, polygenic hypercholesterolemia

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. 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.
    

Eligibility criteria:

        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