A Study of LY3015014 in Healthy Participants With Elevated Low Density Lipoprotein Cholesterol
Condition: Hyperlipidemia
MeSH terms: Hyperlipidemias
Intervention: LY3015014 IV; Placebo IV; LY3015014 SC; Placebo SC
Intervention description: Administered IV over 30-90 minutes; Administered IV only over 30-90 minutes; Administered SC; Administered SC
Intervention MeSH terms: Antibodies, Monoclonal
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 69.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a study in otherwise healthy Japanese and non-Japanese participants with elevated low
      density lipoprotein cholesterol (LDL-C). Following single doses of LY3015014, the safety and
      tolerability of the drug, how the body handles the drug, and the drug's effect on the body
      will be evaluated. Participants will remain in the study for approximately up to 6 months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Are overtly healthy males or females, as determined by medical history and physical
             examination

          -  To qualify as Japanese for the purpose of this study, the participant must be
             first-generation Japanese, defined as the participant's biological parents and all of
             the participant's biological grandparents must be of exclusive Japanese descent, and
             must have been born in Japan. Japanese participants have to be between the ages of
             20-65, inclusive, at screening

          -  Statin naive participants, have a screening LDL-C of between 100 and 180 milligrams
             per deciliter (mg/dL), inclusive; for participants currently taking a statin, have a
             screening LDL-C of between 100 and 160 mg/dL

          -  Have serum triglycerides <400 mg/dL

        Additional inclusion criteria for participants in the statin-interaction cohort:

          -  At screening, must have been on a stable dose of either atorvastatin [10 to 40 mg once
             daily (QD)], rosuvastatin (5 to 20 mg QD), simvastatin (20 to 40 mg QD), lovastatin
             (40 to 80 mg QD), or pravastatin (40 to 80 mg QD) which has been well tolerated for at
             least 3 months

        Exclusion Criteria:

          -  Have known allergies to compounds related to LY3015014 or any components of the
             formulation, or known clinically significant hypersensitivity to biologic agents, or
             known allergies to acetaminophen and/or antihistamines

          -  Intend to use over-the-counter or prescription medication within 14 days prior to
             dosing (excluding the statins listed in Inclusion Criterion), other than
             estrogen/progesterone as hormone replacement therapy (HRT) and thyroid medications.
             Participants taking these medications should be on chronic, stable doses. Certain
             medications, for example vitamin supplements, may be permitted at the discretion of
             the investigator and the sponsor. Participants on statins may be allowed to be on a
             stable dose of single hypertensive agent if agreed upon by sponsor and investigator

          -  Have received any vaccine(s) within 1 month of LY3015014 dosing, or intend to during
             the study

          -  Have received treatment with biologic agents (such as monoclonal antibodies) within 3
             months or 5 half-lives (whichever is longer) prior to dosing

          -  Have a history of atopy, or significant allergies to humanized monoclonal antibodies,
             or clinically significant multiple or severe drug allergies, or intolerance to topical
             corticosteroids, or severe post-treatment hypersensitivity reactions [including, but
             not limited to, erythema multiforme major, linear immunoglobulin (Ig)A dermatosis,
             toxic epidermal necrolysis, or exfoliative dermatitis]

        Additional exclusion criteria for participants in the statin-interaction cohort:

          -  Incidence of unexplained muscle pain, or incidence of frequent muscle cramp within the
             last 6 months