Skip to main content
OpenTrials
Completed

NCT Number: NCT01890967

A Study of LY3015014 in Participants With High Cholesterol

This study is designed to define the amount and duration of cholesterol lowering and to assess the safety and tolerability of different dose regimens of LY3015014 in participants with high cholesterol. The study will also investigate how the body processes the drug and how the drug affects the body. Participants will remain on a stable diet and will continue taking cholesterol-lowering medications (statins with or without ezetimibe). After signing the informed consent document, the participant will complete a screening/run-in period that will last at most 8 weeks. Then, the treatment period will last approximately 16 weeks. After the treatment period, the participants will complete a follow-up period lasting approximately 8 weeks for a total study duration ranging from approximately 25 to 32 weeks.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

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., Kamloops, British Columbia, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosed with high low density lipoprotein (LDL) cholesterol
  • Are on stable daily dose of a statin or have a history of statin intolerance
  • Men with a partner who can become pregnant must agree to use barrier protection during sexual intercourse to prevent pregnancies
  • Women who cannot become pregnant, or women who are not pregnant or breast feeding and agree to use a reliable method of birth control to prevent pregnancies

Exclusion criteria

  • Have high cholesterol due to another disease or have a rare and serious form of hereditary high cholesterol
  • Have had recent heart attack, stroke, blood clot or heart surgery, have planned heart or blood vessel surgery, or has a heart that does not pump sufficiently well
  • Have poorly controlled high blood pressure
  • Have diabetes that requires an injectable medication (including insulin), or have diabetes that is poorly controlled
  • Have thyroid blood test that is outside normal range
  • Have a history of adrenal gland disorder
  • Have a history of vitamin E deficiency or fat malabsorption syndrome
  • Have poor kidney function
  • Have active liver or gall bladder disease, history of hepatitis or liver blood tests that are high
  • Have a history of muscle disease including muscle damage from a medicine or muscle blood test that is high
  • Are anemic (low red blood cell counts)
  • Have a history of allergy or intolerance to other antibody medications
  • Have a history of human immunodeficiency virus infection (HIV) infection
  • Are likely to have a major operation or be hospitalized during the study
  • Have chronic alcohol or drug abuse or dependency
  • Have or suspected to have any cancer or malignant tumor
  • Have an active serious infection
  • Have started or stopped taking a statin or ezetimibe medication, or changed statin dose regimen recently
  • Are on a statin regimen other than daily dosing (for example, an every-other-day statin regimen)
  • Have recently used simvastatin (highest dose level), fibrates, bile acid binders, niacin, probucol, or over-the-counter/health food preparations to lower cholesterol (such as red yeast rice, fish oil, omega 3 fatty acid)
  • Have undergone LDL apheresis in the past 1 year
  • Have recently used steroids, cyclosporine or isotretinoin
  • Have recently used an immunosuppressive therapy
  • Have recently received treatment with another antibody medication
  • Are currently using medications injected into the skin , except for single injections (for example flu vaccines) or injections into muscles
  • Are currently on a prescription or over-the-counter medicine for weight loss or are on a very low carbohydrate diet

Treatment and study plan

LY3015014

Drug

Administered SC

Placebo

Drug

Administered SC

Statin

Drug

Administered orally

Other names: atorvastatin, simvastatin, rosuvastatin, pravastatin, lovastatin, fluvastatin, pitavastatin

ezetimibe

Drug

Administered orally

Primary outcomes

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

    Time frame: Baseline, Week 16

    Least square (LS) Means was calculated using analysis of covariance (ANCOVA) adjusted for disease classification, statin dose, baseline LDL-C measurement. Percent change from baseline response is the dependent variable.

Secondary outcomes

  1. Percentage Change From Baseline in LDL-C, Total Cholesterol (TC), High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), Non-HDL-C

    Time frame: Baseline, Week 16

    LS Mean was calculated using mixed model repeated measures (MMRM) analysis with baseline measurement, disease classification, statin dose, treatment, visit, and treatment by visit interaction included in the model. Percent change from baseline response is the dependent variable.

  2. Percentage Change From Baseline in Apolipoprotein A1 (Apo A1), Apolipoprotein B (Apo B)

    Time frame: Baseline, Week 16

    LS Mean was calculated using MMRM analysis with baseline measurement, disease classification, statin dose, treatment, visit, and treatment by visit interaction included in the model. Percent change from baseline response is the dependent variable.

  3. Percentage Change From Baseline in Lipoprotein(a) [Lp(a)]

    Time frame: Baseline, Week 16

    Data was log-transformed for MMRM analysis, with change from baseline as the dependent variable, and baseline measurement, disease classification, statin dose, treatment, visit, and treatment by visit interaction included as independent variables. Percentage change from baseline in the original scale was then back-calculated from the log-transformed MMRM analysis.

  4. Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP)

    Time frame: Baseline, Week 16

    LS Mean was calculated using MMRM analysis with baseline measurement, disease classification, statin dose, treatment, visit, and treatment by visit interaction included in the model. Percent change from baseline response is the dependent variable.

  5. Number of Participants Who Develop Treatment Emergent Anti-LY3015014 Antibodies

    Time frame: Baseline through Week 24

  6. Percentage Change From Baseline in Total Proprotein Convertase Subtilisin/Kexin Type 9 Antibody (PCSK9) Levels

    Time frame: Baseline, Week 16

    LS Mean was calculated using MMRM analysis with baseline measurement, disease classification, statin dose, treatment, visit, and treatment by visit interaction included in the model. Percent change from baseline response is the dependent variable.

  7. Percentage Change From Baseline in Free Proprotein Convertase Subtilisin/Kexin Type 9 Antibody (PCSK9) Levels

    Time frame: Baseline, Week 16

    LS Mean was calculated using MMRM analysis with baseline measurement, disease classification, statin dose, treatment, visit, and treatment by visit interaction included in the model. Percent change from baseline response is the dependent variable.

  8. Pharmacokinetics (PK): Area Under the Concentration-Time Curve at Steady-State (AUC,ss) for LY3015014

    Time frame: Week 12-16 (Q4W) - Predose, Week 8-16 (Q8W) - Predose

  9. Number of Participants With an Injection Site Reaction

    Time frame: Baseline through Week 24

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Phase 2 Efficacy and Safety Dose-Ranging Study of LY3015014 in Patients With Primary Hypercholesterolemia

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jul 2, 2013
Registry last updated
Sep 18, 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.

Published trials that share one or more normalized conditions with this study.