A Study of LY2484595 in Patients With High LDL-C or Low HDL-C
Condition: Dyslipidemia
MeSH terms: Dyslipidemias
Intervention: LY2484595; Atorvastatin; Simvastatin; Rosuvastatin; Placebo for LY2484595; Placebo for Statins
Intervention description: Administered daily by mouth for 12 weeks; Administered daily by mouth for 12 weeks; Administered daily by mouth for 12 weeks; Administered daily by mouth for 12 weeks; Administered daily by mouth for 12 weeks; Administered daily by mouth for 12 weeks
Intervention MeSH terms: Atorvastatin; Rosuvastatin Calcium; Simvastatin; Evacetrapib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 398.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Dyslipidemias; Mixed dyslipidemia; Hypercholesterolemia; Atherosclerosis; Atorvastatin; Simvastatin; Rosuvastatin; Metabolic Diseases; Antilipemic Agents; Enzyme Inhibitors; Anticholesteremic Agents; Cholesteryl Ester Transfer Protein Inhibitors; Cholesteryl Ester; Lipid Metabolism Disorders

Summary:

      The primary purpose of your participation in this study is to help answer the following
      research question(s)

        -  Whether LY2484595 in combination with a statin drug (atorvastatin, simvastatin or
           rosuvastatin; currently used to treat abnormal fat or cholesterol in blood) improves the
           blood fat profile more than statins alone.

        -  Whether LY2484595 alone improves blood fats profile compared to sugar pills.

        -  Whether LY2484595 interferes with break down or functioning of statins.

        -  Whether LY2484595 has any side effects that would not support testing it in future
           studies.
    

Eligibility criteria:

        Inclusion Criteria:

        • Diagnosed with Low High Density Lipoprotein Cholesterol (HDL-C) or hypercholesterolemia,
        after diet lead-in/washout of lipid therapies

        Exclusion Criteria:

          -  History of coronary heart disease, or hardening of the arteries, or heart does not
             pump sufficiently well

          -  Hypertension or high blood pressure that is not under control or your study physician
             does not consider the electrical activity of heart (Electrocardiogram [ECG]) to be
             compatible with participation in the study

          -  History of a bad skin rash, a prior rash due to a drug or a history of chronic skin
             disorder (such as psoriasis or eczema)

          -  Intolerance to certain lipid modifying drugs (including statins and Cholesteryl Ester
             Transfer Protein (CETP) inhibitors)

          -  Not willing to stop taking prescription or over the counter drugs you use to control
             fats in your blood (like fish oil, niacin or statin) or pills to decrease your weight,
             including herbs

          -  Not willing to follow the diet (low-fat) that the study physician will recommend

          -  Have disease of liver, kidneys, muscles or other organs of body, a serious infection
             or cancer, or abnormal laboratory tests that study physician does not consider
             compatible with participation in the study

          -  Breastfeeding woman or a woman who can still become pregnant, but are not willing to
             use a valid birth control measure to prevent pregnancies