A Study of LY3015014 in Healthy Participants With Elevated Low Density Lipoprotein Cholesterol

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01426412
First received: August 29, 2011
Last updated: August 15, 2013
Last verified: August 2013
  Purpose

This is a study in otherwise healthy Japanese and non-Japanese participants with elevated low density lipoprotein cholesterol (LDL-C). Following single 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 remain in the study for approximately up to 6 months.


Condition Intervention Phase
Hyperlipidemia
Drug: LY3015014 (intravenously)
Drug: Placebo (intravenously)
Drug: LY3015014 (subcutaneously)
Drug: Placebo (subcutaneously)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Single-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3015014 in 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 clinically significant effects (vital signs, Electrocardiogram (ECG), infusion reaction, immunogenicity, and labs) [ Time Frame: Baseline to study completion (up to 22 weeks) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetics: area under the concentration-time curve (AUC) of LY3015014 [ Time Frame: Pre-dose up to Day 155 post-dose ] [ Designated as safety issue: No ]
  • Pharmacokinetics: maximum concentration (Cmax) of LY3015014 [ Time Frame: Pre-dose up to Day 155 post-dose ] [ Designated as safety issue: No ]
  • Change in low density lipoprotein cholesterol (LDL-C) [ Time Frame: Pre-dose up to Day 155 post-dose ] [ Designated as safety issue: No ]

Estimated Enrollment: 68
Study Start Date: September 2011
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LY3015014 IV
A single dose of LY3015014 up to 10.0 mg/kg administered intravenously
Drug: LY3015014 (intravenously)
Administered intravenously over 30-90 minutes
Experimental: LY3015014 IV Japanese
Single dose of LY3015014 10.0 mg/kg administered intravenously to Japanese participants. Added per protocol amendment effective October, 2012.
Drug: LY3015014 (intravenously)
Administered intravenously over 30-90 minutes
Placebo Comparator: Placebo IV
Administered intravenously once only
Drug: Placebo (intravenously)
Administered intravenously only over 30-90 minutes
Experimental: LY3015014 SC
A single dose of LY3015014 up to 3.0 mg/kg administered subcutaneously
Drug: LY3015014 (subcutaneously)
Administered subcutaneously
Experimental: LY3015014 SC + Statin
A single dose of LY3015014 up to 3 mg/kg administered subcutaneously in addition to participant's dose of statin
Drug: LY3015014 (subcutaneously)
Administered subcutaneously
Placebo Comparator: Placebo SC
Administered subcutaneously once only
Drug: Placebo (subcutaneously)
Administered subcutaneously

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Are overtly healthy males or females, as determined by medical history and physical examination
  • To qualify as Japanese for the purpose of this study, the participant must be first-generation Japanese, defined as the participant's biological parents and all of the participant's biological grandparents must be of exclusive Japanese descent, and must have been born in Japan. Japanese participants have to be between the ages of 20-65, inclusive, at screening
  • Statin naive participants, have a screening LDL-C of between 100 and 180 milligrams per deciliter (mg/dL), inclusive; for participants currently taking a statin, have a screening LDL-C of between 100 and 160 mg/dL
  • Have serum triglycerides <400 mg/dL

Additional inclusion criteria for participants in the statin-interaction cohort:

  • At screening, must have been on a stable dose of either atorvastatin (10 to 40 mg once daily [QD]), rosuvastatin (5 to 20 mg QD), simvastatin (20 to 40 mg QD), lovastatin (40 to 80 mg QD), or pravastatin (40 to 80 mg QD) which has been well tolerated for at least 3 months

Exclusion Criteria:

  • Have known allergies to compounds related to LY3015014 or any components of the formulation, or known clinically significant hypersensitivity to biologic agents, or known allergies to acetaminophen and/or antihistamines
  • Intend to use over-the-counter or prescription medication within 14 days prior to dosing (excluding the statins listed in Inclusion Criterion other than estrogen/progesterone as hormone replacement therapy (HRT) and thyroid medications. Participants taking these medications should be on chronic, stable doses. Certain medications, for example vitamin supplements, may be permitted at the discretion of the investigator and the sponsor. Participants on statins may be allowed to be on a stable dose of single hypertensive agent if agreed upon by sponsor and investigator
  • Have received any vaccine(s) within 1 month of LY3015014 dosing, or intend to 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
  • Have a history of atopy, or significant allergies to humanized monoclonal antibodies, or clinically significant multiple or severe drug allergies, or intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear immunoglobulin (Ig)A dermatosis, toxic epidermal necrolysis, or exfoliative dermatitis)

Additional exclusion criteria for participants in the statin-interaction cohort:

  • Incidence of unexplained muscle pain, or incidence of frequent muscle cramp within the last 6 months
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01426412

Locations
United States, California
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.
Glendale, California, United States, 91206
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
United States, Wisconsin
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.
Madison, Wisconsin, United States, 53704
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: NCT01426412     History of Changes
Other Study ID Numbers: 13980, I5S-EW-EFJA
Study First Received: August 29, 2011
Last Updated: August 15, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on April 15, 2014