Back to resultsA Study of LY3015014 in Healthy Participants With High Cholesterol
Primary Purpose
Healthy Volunteers, Hypercholesterolemia
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
LY3015014
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Healthy Volunteers
Eligibility 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 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
Sites / Locations
- 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.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1.0 milligrams per kilogram (mg/kg) of LY3015014
Placebo
Arm Description
1.0 mg/kg of LY3015014 given subcutaneously (SQ) on 2 dosing occasions occurring 4 weeks apart (Q4W) (Days 1 and 29).
0.9% sodium chloride injection given SQ (to match LY3015014) on 2 dosing occasions Q4W (Days 1 and 29).
Outcomes
Primary Outcome Measures
Number of Participants With One or More Other Non-Serious Adverse Events (AEs) or Any Serious AEs (SAEs)
Events deemed to be SAEs by the Investigator as related to study drug administration were collected during the study and 30 days following study drug administration. A summary of SAEs and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.
Secondary Outcome Measures
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3015014
The Cmax was calculated after each dose of LY3015014.
PK: Area Under the Concentration Curve During One Dosing Interval (AUCt) of LY3015014
The AUCt was calculated after each dose of LY3015014.
PK: Time of Maximum Concentration (Tmax) of LY3015014
tmax was calculated after each dosing of LY3015014 and is reported as the number of days for observed maximum concentration of LY3015014.
Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C)
Percentage change from baseline in LDL-C was calculated as Least Squares (LS) mean using mixed model repeated measures (MMRM) analysis adjusted for baseline measurement. Treatment, day after dosing, and treatment-by-day interaction were included in the model.
Full Information
NCT ID
NCT01671085
First Posted
August 20, 2012
Last Updated
February 22, 2019
Sponsor
Eli Lilly and Company
1. Study Identification
Unique Protocol Identification Number
NCT01671085
Brief Title
A Study of LY3015014 in Healthy Participants With High Cholesterol
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Volunteers, Hypercholesterolemia
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1.0 milligrams per kilogram (mg/kg) of LY3015014
Arm Type
Experimental
Arm Description
1.0 mg/kg of LY3015014 given subcutaneously (SQ) on 2 dosing occasions occurring 4 weeks apart (Q4W) (Days 1 and 29).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
0.9% sodium chloride injection given SQ (to match LY3015014) on 2 dosing occasions Q4W (Days 1 and 29).
Intervention Type
Drug
Intervention Name(s)
LY3015014
Intervention Description
Administered SQ
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered SQ
Primary Outcome Measure Information:
Title
Number of Participants With One or More Other Non-Serious Adverse Events (AEs) or Any Serious AEs (SAEs)
Description
Events deemed to be SAEs by the Investigator as related to study drug administration were collected during the study and 30 days following study drug administration. A summary of SAEs and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.
Time Frame
Baseline through study completion (Day 127)
Secondary Outcome Measure Information:
Title
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3015014
Description
The Cmax was calculated after each dose of LY3015014.
Time Frame
Day 1 and 29: 4 hours (h) and 24 h postdose
Title
PK: Area Under the Concentration Curve During One Dosing Interval (AUCt) of LY3015014
Description
The AUCt was calculated after each dose of LY3015014.
Time Frame
Day 1 and 29: 4 h and 24 h postdose
Title
PK: Time of Maximum Concentration (Tmax) of LY3015014
Description
tmax was calculated after each dosing of LY3015014 and is reported as the number of days for observed maximum concentration of LY3015014.
Time Frame
Day 1 and 29: 4 h and 24 h postdose
Title
Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C)
Description
Percentage change from baseline in LDL-C was calculated as Least Squares (LS) mean using mixed model repeated measures (MMRM) analysis adjusted for baseline measurement. Treatment, day after dosing, and treatment-by-day interaction were included in the model.
Time Frame
Baseline, Day 43 and Day 57
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
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.
City
Miramar
State/Province
Florida
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study of LY3015014 in Healthy Participants With High Cholesterol
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