A Study of LY3015014 in Healthy Participants With High Cholesterol
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies, High Cholesterol |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Other |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 3/17/2019 |
| Start Date: | August 2012 |
| End Date: | March 2013 |
A Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3015014 in Subjects With Elevated LDL-C on a Stable Statin Therapy
This is a study in healthy participants with high levels of "bad" cholesterol who are already
taking a popular type of cholesterol-lowering medication called statins. Following multiple
doses of LY3015014, investigators will study the safety and tolerability of the drug, how the
body handles the drug, and the drug's effect on the body. Participants will remain in the
study for about 3 months, not including screening. Screening is required within 28 days
before the study starts.
taking a popular type of cholesterol-lowering medication called statins. Following multiple
doses of LY3015014, investigators will study the safety and tolerability of the drug, how the
body handles the drug, and the drug's effect on the body. Participants will remain in the
study for about 3 months, not including screening. Screening is required within 28 days
before the study starts.
Inclusion Criteria:
- Participants must be healthy males or females without childbearing potential as
determined by medical history and physical examination
- Have body mass indexes of 18 to 35 kilograms per square meter (kg/m^2), inclusive, at
screening
- Have screening low density lipoprotein-C (LDL-C) of between 100 and 180 milligrams per
deciliter (mg/dL), inclusive, while having taken a stable dose of statin
Exclusion Criteria:
- Have known allergies to compounds related to LY3015014 or any components of the
formulation or known clinically significant hypersensitivity to biologic agents
- Have a history of atopy, significant allergies to humanized monoclonal antibodies,
clinically significant multiple or severe drug allergies, intolerance to topical
corticosteroids, or severe post treatment hypersensitivity reactions [including but
not limited to erythema multiforme major, linear immunoglobulin A (IgA) dermatosis,
toxic epidermal necrolysis, or exfoliative dermatitis]
- Have significant history of or current cardiovascular (excluding controlled
hypertension), respiratory, hepatic, renal, gastrointestinal, endocrine,
hematological, or neurological disorders capable of significantly altering the
absorption, metabolism, or elimination of drugs, of constituting a risk when taking
the study medication, or of interfering with the interpretation of data
- Have received any vaccine(s) within 1 month of LY3015014 dosing or intend to do so
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
We found this trial at
1
site
Click here to add this to my saved trials
