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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: July 14, 2017
Last verified: July 2017
  Purpose
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.

Condition Intervention Phase
Hypercholesterolemia Drug: LY3015014 Drug: Placebo Drug: Statin Drug: Ezetimibe Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2 Efficacy and Safety Dose-Ranging Study of LY3015014 in Patients With Primary Hypercholesterolemia

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.

  • 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.

  • 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.

  • 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.

  • Number of Participants Who Develop Treatment Emergent Anti-LY3015014 Antibodies [ Time Frame: Baseline through Week 24 ]
  • 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.

  • 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.

  • 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 ]
  • Number of Participants With an Injection Site Reaction [ Time Frame: Baseline through Week 24 ]

Enrollment: 527
Study Start Date: June 2013
Study Completion Date: June 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Drug: LY3015014
Administered SC
Drug: Statin
Administered orally
Other Names:
  • atorvastatin
  • simvastatin
  • rosuvastatin
  • pravastatin
  • lovastatin
  • fluvastatin
  • pitavastatin
Drug: Ezetimibe
Administered orally
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.

Drug: LY3015014
Administered SC
Drug: Statin
Administered orally
Other Names:
  • atorvastatin
  • simvastatin
  • rosuvastatin
  • pravastatin
  • lovastatin
  • fluvastatin
  • pitavastatin
Drug: Ezetimibe
Administered orally
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.

Drug: LY3015014
Administered SC
Drug: Statin
Administered orally
Other Names:
  • atorvastatin
  • simvastatin
  • rosuvastatin
  • pravastatin
  • lovastatin
  • fluvastatin
  • pitavastatin
Drug: Ezetimibe
Administered orally
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.

Drug: LY3015014
Administered SC
Drug: Statin
Administered orally
Other Names:
  • atorvastatin
  • simvastatin
  • rosuvastatin
  • pravastatin
  • lovastatin
  • fluvastatin
  • pitavastatin
Drug: Ezetimibe
Administered orally
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.

Drug: LY3015014
Administered SC
Drug: Statin
Administered orally
Other Names:
  • atorvastatin
  • simvastatin
  • rosuvastatin
  • pravastatin
  • lovastatin
  • fluvastatin
  • pitavastatin
Drug: Ezetimibe
Administered orally
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.

Drug: Placebo
Administered SC
Drug: Statin
Administered orally
Other Names:
  • atorvastatin
  • simvastatin
  • rosuvastatin
  • pravastatin
  • lovastatin
  • fluvastatin
  • pitavastatin
Drug: Ezetimibe
Administered orally

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01890967

  Hide Study Locations
Locations
United States, California
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Encino, California, United States, 91436
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Lancaster, California, United States, 93534
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Spring Valley, California, United States, 91978
United States, Colorado
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Aurora, Colorado, United States, 80012
United States, Florida
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Safety Harbor, Florida, United States, 34695
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Tampa, Florida, United States, 33613
United States, Indiana
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Indianapolis, Indiana, United States, 46290
United States, Iowa
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Iowa City, Iowa, United States, 52242
United States, Kentucky
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Louisville, Kentucky, United States, 40213
United States, Louisiana
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Bossier City, Louisiana, United States, 71111
United States, North Carolina
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Charlotte, North Carolina, United States, 28205
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Raleigh, North Carolina, United States, 27609
United States, Ohio
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Cincinnati, Ohio, United States, 45227
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Toledo, Ohio, United States, 43615
United States, Tennessee
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Knoxville, Tennessee, United States, 37920
Canada, British Columbia
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Kamloops, British Columbia, Canada, V2C 1K7
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Kelowna, British Columbia, Canada, V1Y3G5
Canada, Ontario
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Brampton, Ontario, Canada, L6T 0G1
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London, Ontario, Canada, N6A 5K8c
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Toronto, Ontario, Canada, M4G 3E8
Canada, Quebec
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Gatineau, Quebec, Canada, J8Y 6S8
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Montreal, Quebec, Canada, H1T 1C8
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St Marc Des Carrieres, Quebec, Canada, G0A 4B0
Czechia
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Cesky Krumlov, Czechia, 381 01
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Hodonin, Czechia, 695 01
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Prague, Czechia, 150 06
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Svitavy, Czechia, 568 25
Denmark
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Aalborg, Denmark, DK-9000
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Copenhagen, Denmark, 2100 CPH
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Esbjerg, Denmark, 6700
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Hellerup, Denmark, 2900
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Hvidovre, Denmark, 2650
Japan
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Fukuoka, Japan, 819-0375
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Osaka, Japan, 530-0001
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Tokyo, Japan, 171-0033
Netherlands
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Amsterdam, Netherlands, 1105 AZ
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Breda, Netherlands, 4811 SW
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Goes, Netherlands, 4462 RA
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Groningen, Netherlands, 9711 SG
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Maastricht, Netherlands, 6229 HX
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Nijmegen, Netherlands, 6525 HB
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Rotterdam, Netherlands, 3021 HC
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Utrecht, Netherlands, 3584 CX
Poland
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Bialystok, Poland, 15-351
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Gdansk, Poland, 80-546
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Krakow, Poland, 30-015
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Lodz, Poland, 90-242
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Lublin, Poland, 20-582
Puerto Rico
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Ponce, Puerto Rico, 00717-1322
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

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01890967     History of Changes
Other Study ID Numbers: 14853
I5S-MC-EFJE ( Other Identifier: Eli Lilly and Company )
Study First Received: June 27, 2013
Results First Received: May 25, 2017
Last Updated: July 14, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com.

This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.


Keywords provided by Eli Lilly and Company:
low density lipoprotein, heterozygous familial hypercholesterolemia, polygenic hypercholesterolemia

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Ezetimibe
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents

ClinicalTrials.gov processed this record on August 18, 2017