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A Study of LY3015014 in Participants With High Cholesterol

Primary Purpose

Hypercholesterolemia

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

LY3015014

Placebo

Statin

Ezetimibe

About this trial

This is an interventional treatment trial for Hypercholesterolemia focused on measuring low density lipoprotein, heterozygous familial hypercholesterolemia, polygenic hypercholesterolemia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Placebo Comparator

Arm Label

20 mg LY3015014 Q4W

120 mg LY3015014 Q4W

300 mg LY3015014 Q4W

100 mg LY3015014 Q8W

300 mg LY3015014 Q8W

Placebo Q4W

Arm Description

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.

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.

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.

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.

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.

Placebo given SC Q4W for 16 weeks. Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe.

Outcomes

Primary Outcome Measures

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

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

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)

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)]

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)

Number of Participants Who Develop Treatment Emergent Anti-LY3015014 Antibodies

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

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

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

Number of Participants With an Injection Site Reaction

Full Information

NCT ID

NCT01890967

First Posted

June 27, 2013

Last Updated

September 9, 2019

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT01890967

Brief Title

A Study of LY3015014 in Participants With High Cholesterol

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Completed

Study Start Date

June 2013 (undefined)

Primary Completion Date

April 2014 (Actual)

Study Completion Date

June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypercholesterolemia

Keywords

low density lipoprotein, heterozygous familial hypercholesterolemia, polygenic hypercholesterolemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

527 (Actual)

8. Arms, Groups, and Interventions

Arm Title

20 mg LY3015014 Q4W

Arm Type

Experimental

Arm Description

Arm Title

120 mg LY3015014 Q4W

Arm Type

Experimental

Arm Description

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.

Arm Title

300 mg LY3015014 Q4W

Arm Type

Experimental

Arm Description

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.

Arm Title

100 mg LY3015014 Q8W

Arm Type

Experimental

Arm Description

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.

Arm Title

300 mg LY3015014 Q8W

Arm Type

Experimental

Arm Description

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.

Arm Title

Placebo Q4W

Arm Type

Placebo Comparator

Arm Description

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 Type

Drug

Intervention Name(s)

LY3015014

Intervention Description

Administered SC

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Administered SC

Intervention Type

Drug

Intervention Name(s)

Statin

Other Intervention Name(s)

atorvastatin, simvastatin, rosuvastatin, pravastatin, lovastatin, fluvastatin, pitavastatin

Intervention Description

Administered orally

Intervention Type

Drug

Intervention Name(s)

Ezetimibe

Intervention Description

Administered orally

Primary Outcome Measure Information:

Title

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

Description

Time Frame

Baseline, Week 16

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

Baseline, Week 16

Title

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

Description

Time Frame

Baseline, Week 16

Title

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

Description

Time Frame

Baseline, Week 16

Title

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

Description

Time Frame

Baseline, Week 16

Title

Number of Participants Who Develop Treatment Emergent Anti-LY3015014 Antibodies

Time Frame

Baseline through Week 24

Title

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

Description

Time Frame

Baseline, Week 16

Title

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

Description

Time Frame

Baseline, Week 16

Title

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

Title

Number of Participants With an Injection Site Reaction

Time Frame

Baseline through Week 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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)

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

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.

City

Encino

State/Province

California

ZIP/Postal Code

91436

Country

United States

Facility Name

City

Lancaster

State/Province

California

ZIP/Postal Code

93534

Country

United States

Facility Name

City

Spring Valley

State/Province

California

ZIP/Postal Code

91978

Country

United States

Facility Name

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80012

Country

United States

Facility Name

City

Safety Harbor

State/Province

Florida

ZIP/Postal Code

34695

Country

United States

Facility Name

City

Tampa

State/Province

Florida

ZIP/Postal Code

33613

Country

United States

Facility Name

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46290

Country

United States

Facility Name

City

Iowa City

State/Province

Iowa

ZIP/Postal Code

52242

Country

United States

Facility Name

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40213

Country

United States

Facility Name

City

Bossier City

State/Province

Louisiana

ZIP/Postal Code

71111

Country

United States

Facility Name

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28205

Country

United States

Facility Name

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27609

Country

United States

Facility Name

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45227

Country

United States

Facility Name

City

Toledo

State/Province

Ohio

ZIP/Postal Code

43615

Country

United States

Facility Name

City

Knoxville

State/Province

Tennessee

ZIP/Postal Code

37920

Country

United States

Facility Name

City

Kamloops

State/Province

British Columbia

ZIP/Postal Code

V2C 1K7

Country

Canada

Facility Name

City

Kelowna

State/Province

British Columbia

ZIP/Postal Code

V1Y3G5

Country

Canada

Facility Name

City

Brampton

State/Province

Ontario

ZIP/Postal Code

L6T 0G1

Country

Canada

Facility Name

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 5K8c

Country

Canada

Facility Name

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M4G 3E8

Country

Canada

Facility Name

City

Gatineau

State/Province

Quebec

ZIP/Postal Code

J8Y 6S8

Country

Canada

Facility Name

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H1T 1C8

Country

Canada

Facility Name

City

St Marc Des Carrieres

State/Province

Quebec

ZIP/Postal Code

G0A 4B0

Country

Canada

Facility Name

City

Cesky Krumlov

ZIP/Postal Code

381 01

Country

Czechia

Facility Name

City

Hodonin

ZIP/Postal Code

695 01

Country

Czechia

Facility Name

City

Prague

ZIP/Postal Code

150 06

Country

Czechia

Facility Name

City

Svitavy

ZIP/Postal Code

568 25

Country

Czechia

Facility Name

City

Aalborg

ZIP/Postal Code

DK-9000

Country

Denmark

Facility Name

City

Copenhagen

ZIP/Postal Code

2100 CPH

Country

Denmark

Facility Name

City

Esbjerg

ZIP/Postal Code

6700

Country

Denmark

Facility Name

City

Hellerup

ZIP/Postal Code

2900

Country

Denmark

Facility Name

City

Hvidovre

ZIP/Postal Code

2650

Country

Denmark

Facility Name

City

Fukuoka

ZIP/Postal Code

819-0375

Country

Japan

Facility Name

City

Osaka

ZIP/Postal Code

530-0001

Country

Japan

Facility Name

City

Tokyo

ZIP/Postal Code

171-0033

Country

Japan

Facility Name

City

Amsterdam

ZIP/Postal Code

1105 AZ

Country

Netherlands

Facility Name

City

Breda

ZIP/Postal Code

4811 SW

Country

Netherlands

Facility Name

City

Goes

ZIP/Postal Code

4462 RA

Country

Netherlands

Facility Name

City

Groningen

ZIP/Postal Code

9711 SG

Country

Netherlands

Facility Name

City

Maastricht

ZIP/Postal Code

6229 HX

Country

Netherlands

Facility Name

City

Nijmegen

ZIP/Postal Code

6525 HB

Country

Netherlands

Facility Name

City

Rotterdam

ZIP/Postal Code

3021 HC

Country

Netherlands

Facility Name

City

Utrecht

ZIP/Postal Code

3584 CX

Country

Netherlands

Facility Name

City

Bialystok

ZIP/Postal Code

15-351

Country

Poland

Facility Name

City

Gdansk

ZIP/Postal Code

80-546

Country

Poland

Facility Name

City

Krakow

ZIP/Postal Code

30-015

Country

Poland

Facility Name

City

Lodz

ZIP/Postal Code

90-242

Country

Poland

Facility Name

City

Lublin

ZIP/Postal Code

20-582

Country

Poland

Facility Name

City

Ponce

ZIP/Postal Code

00717-1322

Country

Puerto Rico

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

IPD Sharing Time Frame

Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing URL

https://vivli.org/

Learn more about this trial

A Study of LY3015014 in Participants With High Cholesterol

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