A Study of LY3015014 in Healthy Participants With Elevated Low Density Lipoprotein Cholesterol



Status:Completed
Conditions:High Cholesterol
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 65
Updated:4/6/2019
Start Date:September 2011
End Date:June 2013

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A Single-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3015014 in Subjects With Elevated LDL-C

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.


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
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