A Study of LY3015014 in Healthy Participants With High Cholesterol

This study has been completed.
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Dyslipidemias
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 23, 2014