A Study of LY3015014 in Healthy Participants With High Cholesterol
This study has been completed.
Sponsor:
Eli Lilly and Company
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01671085
First received: August 20, 2012
Last updated: April 30, 2013
Last verified: April 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy Volunteers Hypercholesterolemia |
Drug: LY3015014 Drug: Placebo |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Basic Science |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by Eli Lilly and Company:
Primary Outcome Measures:
- Number of participants with one or more Adverse Events (AEs) or any serious AEs [ Time Frame: Baseline through study completion (Day 127) ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Pharmacokinetics: Maximum concentration (Cmax) of LY3015014 [ Time Frame: Predose through Day 127 ] [ Designated as safety issue: No ]
- Pharmacokinetics: Area under the concentration curve (AUC) of LY3015014 [ Time Frame: Predose through Day 127 ] [ Designated as safety issue: No ]
- Pharmacokinetics: Time of maximum concentration (Tmax) of LY3015014 [ Time Frame: Predose through Day 127 ] [ Designated as safety issue: No ]
- Change from baseline to Day 127 in low density lipoprotein cholesterol (LDL-C) [ Time Frame: Predose, Day 127 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 12 |
| Study Start Date: | August 2012 |
| Study Completion Date: | March 2013 |
| Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1.0 mg/kg of LY3015014
1.0 milligrams per kilogram (mg/kg) of LY3015014 given subcutaneously (SQ) on 2 dosing occasions occurring 4 weeks apart (Q4W) (Days 1 and 29).
|
Drug: LY3015014
Administered SQ
|
|
Placebo Comparator: Placebo
0.9% sodium chloride injection given subcutaneously (SQ) (to match LY3015014) on 2 dosing occasions occurring 4 weeks apart (Q4W) (Days 1 and 29).
|
Drug: Placebo
Administered SQ
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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 LDL-Cs 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 posttreatment 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01671085
Locations
| United States, Florida | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
| Miramar, Florida, United States | |
Sponsors and Collaborators
Eli Lilly and Company
Investigators
| Study Director: | Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company |
More Information
No publications provided
| Responsible Party: | Eli Lilly and Company |
| ClinicalTrials.gov Identifier: | NCT01671085 History of Changes |
| Other Study ID Numbers: | 14938, I5S-EW-EFJD |
| Study First Received: | August 20, 2012 |
| Last Updated: | April 30, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Hypercholesterolemia Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases |
ClinicalTrials.gov processed this record on June 18, 2013