Clinical trial NCT01671085: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Hypercholesterolemia
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2012-08-23
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: Number of Participants With One or More Other Non-Serious Adverse Events (AEs) or Any Serious AEs (SAEs)
timeFrame: Baseline through study completion (Day 127)
Secondary outcomes:
measure: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3015014
timeFrame: Day 1 and 29: 4 hours (h) and 24 h postdose
measure: PK: Area Under the Concentration Curve During One Dosing Interval (AUCt) of LY3015014
timeFrame: Day 1 and 29: 4 h and 24 h postdose
measure: PK: Time of Maximum Concentration (Tmax) of LY3015014
timeFrame: Day 1 and 29: 4 h and 24 h postdose
measure: Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C)
timeFrame: Baseline, Day 43 and Day 57
Other outcomes:
Locations:
city: Miramar
country: United States
facility: 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.
state: Florida
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: