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Completed

NCT Number: NCT01618916

A Study of LY3015014 in Otherwise Healthy Participants With High Low-density Lipoprotein (LDL) Cholesterol

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.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

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

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 kilograms per meter square (kg/m^2), inclusive, at screening
  • Have screening low-density lipoprotein cholesterol (LDL-C) 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

Treatment and study plan

LY3015014

Drug

Administered SC

Placebo

Other

Administered SC

Primary outcomes

  1. Number of Participants With 1 or More Drug Related Treatment-Emergent Adverse Events (TEAEs) or Any Serious AEs (SAEs)

    Time frame: Baseline through study completion (up to Day 127)

    TEAEs were defined as SAEs and other non-serious AEs that occurred or worsened after study treatment. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events section of this report.

Secondary outcomes

  1. Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3015014

    Time frame: First Dose (Day 1) and Last Dose (Day 29): Predose, 4 Hours and 24 Hours Postdose

    The Cmax following the first dose and last dose of LY3015014 is reported.

  2. PK: Area Under the Concentration Curve of LY3015014 During 1 Dosing Interval (AUC[0-tau])

    Time frame: First Dose (Day 1) and Last Dose (Day 29): Predose, 4 Hours and 24 Hours Postdose

    The AUC(0-tau) following the first dose and last dose of LY3015014 is reported.

  3. PK: Time of Maximum Concentration (Tmax) of LY3015014

    Time frame: First Dose: Predose (Day 1) up to Week 4 postdose and Last Dose: predose (Day 29) up to Week 14 postdose

    The tmax following the first dose and last dose of LY3015014 is reported.

  4. Percent Change From Baseline to Days 43, 57, and 127 in LDL-C

    Time frame: Baseline, Day 43, Day 57, and Day 127

    Percent change from baseline in LDL-C was calculated as Least Squares (LS) mean using mixed effect model repeated measures (MMRM) analysis adjusted for baseline measurement, treatment, day after dosing, and treatment by day interaction.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jun 13, 2012
Registry last updated
Mar 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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