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OpenTrials
Completed

NCT Number: NCT01671085

A Study of LY3015014 in Healthy Participants With High Cholesterol

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.

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Key information

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.

Miramar, Florida, United States

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
  • 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

Treatment and study plan

LY3015014

Drug

Administered SQ

Placebo

Drug

Administered SQ

Primary outcomes

  1. Number of Participants With One or More Other Non-Serious Adverse Events (AEs) or Any Serious AEs (SAEs)

    Time frame: Baseline through study completion (Day 127)

    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 outcomes

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

    Time frame: Day 1 and 29: 4 hours (h) and 24 h postdose

    The Cmax was calculated after each dose of LY3015014.

  2. PK: Area Under the Concentration Curve During One Dosing Interval (AUCt) of LY3015014

    Time frame: Day 1 and 29: 4 h and 24 h postdose

    The AUCt was calculated after each dose of LY3015014.

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

    Time frame: Day 1 and 29: 4 h and 24 h postdose

    tmax was calculated after each dosing of LY3015014 and is reported as the number of days for observed maximum concentration of LY3015014.

  4. Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C)

    Time frame: Baseline, Day 43 and Day 57

    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.

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 Subjects With Elevated LDL-C on a Stable Statin Therapy

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Aug 23, 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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