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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: May 25, 2017
Last verified: May 2017
Results First Received: May 25, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Participant, Investigator;   Primary Purpose: Treatment
Condition: Hypercholesterolemia
Interventions: Drug: LY3015014
Drug: Placebo
Drug: Statin
Drug: Ezetimibe

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo Q4W

Placebo 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.

20 mg LY3015014 Q4W

20 milligrams (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.

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.

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.

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.

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.


Participant Flow:   Overall Study
    Placebo Q4W   20 mg LY3015014 Q4W   120 mg LY3015014 Q4W   300 mg LY3015014 Q4W   100 mg LY3015014 Q8W   300 mg LY3015014 Q8W
STARTED   88   88   88   88   87   88 
COMPLETED   78   77   78   77   77   75 
NOT COMPLETED   10   11   10   11   10   13 
Adverse Event                3                3                3                2                1                7 
Death                1                0                0                0                0                0 
Lost to Follow-up                1                1                1                1                0                1 
Protocol Violation                0                3                3                2                4                1 
Sponsor Decision                2                0                1                3                2                3 
Withdrawal by Subject                3                4                2                3                3                1 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

20 mg LY3015014 Q4W

20 mg LY3015014 given subcutaneously SC Q4W for 16 weeks.

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

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.

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.

100 mg LY3015014 Q8W

100 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.

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.

Total Total of all reporting groups

Baseline Measures
   Placebo Q4W   20 mg LY3015014 Q4W   120 mg LY3015014 Q4W   300 mg LY3015014 Q4W   100 mg LY3015014 Q8W   300 mg LY3015014 Q8W   Total 
Overall Participants Analyzed 
[Units: Participants]
 87   87   86   86   86   87   519 
Age 
[Units: Years]
Mean (Standard Deviation)
 57.9  (11.2)   57.2  (9.4)   57.1  (12.4)   59.7  (9.4)   59.6  (8.1)   58.7  (10.1)   58.4  (10.2) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
             
Female      40  46.0%      42  48.3%      41  47.7%      39  45.3%      36  41.9%      43  49.4%      241  46.4% 
Male      47  54.0%      45  51.7%      45  52.3%      47  54.7%      50  58.1%      44  50.6%      278  53.6% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
             
Hispanic or Latino      3   3.4%      2   2.3%      2   2.3%      3   3.5%      1   1.2%      2   2.3%      13   2.5% 
Not Hispanic or Latino      56  64.4%      53  60.9%      52  60.5%      51  59.3%      51  59.3%      52  59.8%      315  60.7% 
Unknown or Not Reported      28  32.2%      32  36.8%      32  37.2%      32  37.2%      34  39.5%      33  37.9%      191  36.8% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
             
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Asian      25  28.7%      22  25.3%      21  24.4%      25  29.1%      21  24.4%      23  26.4%      137  26.4% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Black or African American      1   1.1%      4   4.6%      6   7.0%      1   1.2%      6   7.0%      5   5.7%      23   4.4% 
White      60  69.0%      61  70.1%      59  68.6%      60  69.8%      58  67.4%      58  66.7%      356  68.6% 
More than one race      1   1.1%      0   0.0%      0   0.0%      0   0.0%      1   1.2%      1   1.1%      3   0.6% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
             
Canada   13   17   13   15   17   19   94 
Netherlands   16   16   17   11   13   15   88 
Czech Republic   5   2   3   4   5   4   23 
Puerto Rico   2   0   1   1   0   1   5 
United States   25   23   26   26   22   21   143 
Japan   17   18   18   17   18   18   106 
Denmark   3   4   5   6   6   5   29 
Poland   6   7   3   6   5   4   31 
Serum LDL Cholesterol Beta Quantification 
[Units: Milligrams per deciliter (mg/dL)]
Mean (Standard Deviation)
 136.5  (39.6)   134.1  (42.4)   134.0  (40.7)   132.1  (42.3)   135.2  (41.2)   146.0  (60.5)   136.3  (45.0) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C)   [ Time Frame: Baseline, Week 16 ]

2.  Secondary:   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 ]

3.  Secondary:   Percentage Change From Baseline in Apolipoprotein A1 (Apo A1), Apolipoprotein B (Apo B)   [ Time Frame: Baseline, Week 16 ]

4.  Secondary:   Percentage Change From Baseline in Lipoprotein(a) [Lp(a)]   [ Time Frame: Baseline, Week 16 ]

5.  Secondary:   Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP)   [ Time Frame: Baseline, Week 16 ]

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

7.  Secondary:   Percentage Change From Baseline in Total Proprotein Convertase Subtilisin/Kexin Type 9 Antibody (PCSK9) Levels   [ Time Frame: Baseline, Week 16 ]

8.  Secondary:   Percentage Change From Baseline in Free Proprotein Convertase Subtilisin/Kexin Type 9 Antibody (PCSK9) Levels   [ Time Frame: Baseline, Week 16 ]

9.  Secondary:   Pharmacokinetics (PK): Area Under the Concentration-Time Curve at Steady-State (AUC,ss) for LY3015014   [ Time Frame: Week 12-16 (Q4W), Week 8-16 (Q8W) ]

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
phone: 800-545-5979



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: May 25, 2017