A Study of LY3015014 in Otherwise Healthy Participants With High Low-density Lipoprotein (LDL) Cholesterol
This study has been completed.
Sponsor:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01618916
First Posted: June 13, 2012
Last Update Posted: February 27, 2013
Information provided by (Responsible Party):
Eli Lilly and Company
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Purpose
This is a phase 1 study in otherwise healthy participants with high LDL cholesterol. Following multiple 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 participate in the study for approximately 3 months not including screening. Screening is required within 42 days prior to the start of the study.
| Condition | Intervention | Phase |
|---|---|---|
| Healthy Volunteers | Drug: LY3015014 Other: Placebo | Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Basic Science |
| Official Title: | A Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3015014 in Japanese and Non-Japanese Subjects With Elevated LDL-C |
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 drug related adverse events (AEs) or any serious AEs [ Time Frame: Baseline to study completion (Day 127) ]
Secondary Outcome Measures:
- Pharmacokinetics: Maximum concentration (Cmax) of LY3015014 [ Time Frame: Baseline up to Day 127 ]
- Pharmacokinetics: Area under the concentration curve (AUC) of LY3015014 [ Time Frame: Baseline up to Day 127 ]
- Pharmacokinetics: Time of maximum concentration (Tmax) of LY3015014 [ Time Frame: Baseline up to Day 127 ]
- Change from baseline to Day 127 in low density lipoprotein cholesterol (LDL-C) [ Time Frame: Baseline, Day 127 ]
| Estimated Enrollment: | 48 |
| Study Start Date: | June 2012 |
| Study Completion Date: | February 2013 |
| Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1.0 mg/kg LY3015014 Every 2 Weeks
1.0 milligrams per kilogram (mg/kg) LY3015014 given subcutaneously (SQ) once every 2 weeks for 29 days.
|
Drug: LY3015014
Administered SQ
|
|
Experimental: 1.0 mg/kg LY3015014 Every 4 Weeks
1.0 mg/kg LY3015014 given SQ once every 4 weeks for 29 days.
|
Drug: LY3015014
Administered SQ
|
|
Experimental: 3.0 mg/kg LY3015014 Every 2 Weeks
3.0 mg/kg LY3015014 given SQ once every 2 weeks for 29 days.
|
Drug: LY3015014
Administered SQ
|
|
Experimental: 3.0 mg/kg LY3015014 Every 4 Weeks
3.0 mg/kg LY3015014 given SQ once every 4 weeks for 29 days.
|
Drug: LY3015014
Administered SQ
|
|
Placebo Comparator: Placebo Every 2 Weeks
Saline injection (to match LY3015014) given SQ once every 2 weeks for 29 days.
|
Other: Placebo
Administered SQ
|
|
Placebo Comparator: Placebo Every 4 Weeks
Saline injection (to match LY3015014) given SQ once every 4 weeks for 29 days.
|
Other: Placebo
Administered SQ
|
Eligibility
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
| Sexes Eligible for Study: | All |
| 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, including first-generation Japanese participants
- Have body mass indexes of 18 to 35 kg/m^2, inclusive, at screening
- Have screening low-density lipoprotein cholesterol (LDL-Cs) of between 100 and 180 milligrams per deciliter (mg/dL), inclusive
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 [Ig]A dermatosis, toxic epidermal necrolysis, or exfoliative dermatitis)
- Have significant history of or current cardiovascular, 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01618916
Locations
| United States, Hawaii | |
| 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. | |
| Honolulu, Hawaii, United States, 96814 | |
| United States, Texas | |
| 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. | |
| Dallas, Texas, United States, 75247 | |
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
| Responsible Party: | Eli Lilly and Company |
| ClinicalTrials.gov Identifier: | NCT01618916 History of Changes |
| Other Study ID Numbers: |
14354 I5S-EW-EFJB ( Other Identifier: Eli Lilly and Company ) |
| First Submitted: | June 11, 2012 |
| First Posted: | June 13, 2012 |
| Last Update Posted: | February 27, 2013 |
| Last Verified: | February 2013 |