A Study of LY3015014 in Participants With High Cholesterol

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01890967
First received: June 27, 2013
Last updated: September 29, 2014
Last verified: June 2014

June 27, 2013
September 29, 2014
June 2013
April 2014   (final data collection date for primary outcome measure)
Percentage Change from Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) [ Time Frame: Baseline, Week 16 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01890967 on ClinicalTrials.gov Archive Site
  • Percentage Change from Baseline in Total Cholesterol (TC), High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), Non-HDL-C, Apolipoprotein B (Apo B), Apolipoprotein A-1 (Apo A-1), Lipoprotein(a) (Lp[a]) [ Time Frame: Baseline, Week 16 ] [ Designated as safety issue: No ]
  • Change from Baseline in high sensitivity C-Reactive Protein (hsCRP) [ Time Frame: Baseline, Week 16 ] [ Designated as safety issue: No ]
  • Percentage of Participants Who Develop Treatment Emergent Anti-LY3015014 Antibodies [ Time Frame: Baseline through Week 24 ] [ Designated as safety issue: No ]
  • Percentage Change from Baseline in Total and Free Proprotein Convertase Subtilisin/Kexin Type 9 Antibody (PCSK9) Levels [ Time Frame: Baseline, Week 16 ] [ Designated as safety issue: No ]
  • Pharmacokinetics (PK): Area Under the Concentration-Time Curve (AUC) at Steady-State for LY3015014 [ Time Frame: Pre-dose through Week 16 ] [ Designated as safety issue: No ]
  • Percentage of Participants with an Injection Site Reaction [ Time Frame: Baseline through Week 24 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
A Study of LY3015014 in Participants With High Cholesterol
A Phase 2 Efficacy and Safety Dose-Ranging Study of LY3015014 in Patients With Primary Hypercholesterolemia

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Hypercholesterolemia
  • Drug: LY3015014
    Administered SC
  • Drug: Placebo
    Administered SC
  • Experimental: 20 mg LY3015014 Q4W

    20 milligrams (mg) LY3015014 given subcutaneously (SC) once every 4 weeks (Q4W) for 16 weeks.

    Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.

    Intervention: Drug: LY3015014
  • Experimental: 120 mg LY3015014 Q4W

    120 mg LY3015014 given SC Q4W for 16 weeks.

    Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.

    Intervention: Drug: LY3015014
  • Experimental: 300 mg LY3015014 Q4W

    300 mg LY3015014 given SC Q4W for 16 weeks.

    Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.

    Intervention: Drug: LY3015014
  • Experimental: 100 mg LY3015014 Q8W

    100 mg LY3015014 given SC once every 8 weeks (Q8W) for 16 weeks.

    Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.

    Intervention: Drug: LY3015014
  • Experimental: 300 mg LY3015014 Q8W

    300 mg LY3015014 given SC Q8W for 16 weeks.

    Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.

    Intervention: Drug: LY3015014
  • Placebo Comparator: Placebo Q4W

    Placebo given SC Q4W for 16 weeks.

    Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.

    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
528
June 2014
April 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan,   United States,   Canada,   Czech Republic,   Denmark,   Puerto Rico,   Netherlands,   Poland
 
NCT01890967
14853, I5S-MC-EFJE
Yes
Eli Lilly and Company
Eli Lilly and Company
Not Provided
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
Eli Lilly and Company
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP