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A Study of LY2484595 in Patients With High LDL-C or Low HDL-C

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ClinicalTrials.gov Identifier: NCT01105975
Recruitment Status : Completed
First Posted : April 19, 2010
Results First Posted : March 22, 2018
Last Update Posted : March 22, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Dyslipidemia
Interventions: Drug: LY2484595
Drug: Atorvastatin
Drug: Simvastatin
Drug: Rosuvastatin
Drug: Placebo for LY2484595
Drug: Placebo for Statins

  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
30 mg LY2484595 Monotherapy Administered daily by mouth for 12 weeks
100 mg LY2484595 Monotherapy Administered daily by mouth for 12 weeks
500 mg LY2484595 Monotherapy Administered daily by mouth for 12 weeks
Placebo Administered daily by mouth for 12 weeks
20 mg Atorvastatin Monotherapy Administered daily by mouth for 12 weeks
100 mg LY2484595 + 20 mg Atorvastatin Administered daily by mouth for 12 weeks
40 mg Simvastatin Monotherapy Administered daily by mouth for 12 weeks
100 mg LY2484595 + 40 mg Simvastatin Administered daily by mouth for 12 weeks
10 mg Rosuvastatin Monotherapy Administered daily by mouth for 12 weeks
100 mg LY2484595 + 10 mg Rosuvastatin Administered daily by mouth for 12 weeks

Participant Flow:   Overall Study
    30 mg LY2484595 Monotherapy   100 mg LY2484595 Monotherapy   500 mg LY2484595 Monotherapy   Placebo   20 mg Atorvastatin Monotherapy   100 mg LY2484595 + 20 mg Atorvastatin   40 mg Simvastatin Monotherapy   100 mg LY2484595 + 40 mg Simvastatin   10 mg Rosuvastatin Monotherapy   100 mg LY2484595 + 10 mg Rosuvastatin
STARTED   40   39   42   38   41   35   42   40   40   41 
Took at Least One Dose of Study Drug   40   38   40   38   41   35   41   40   39   41 
COMPLETED   35   34   32   36   35   30   34   33   34   32 
NOT COMPLETED   5   5   10   2   6   5   8   7   6   9 
Adverse Event                2                1                5                1                0                1                2                4                1                4 
Withdrawal by Subject                2                2                2                0                4                1                2                1                0                3 
Lost to Follow-up                1                0                0                1                1                0                0                0                1                0 
Physician Decision                0                0                0                0                0                0                2                0                0                0 
Protocol Violation                0                2                2                0                1                1                1                1                2                2 
Abnormal Lab/Electrocardiogram Result                0                0                1                0                0                2                1                1                2                0 



  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
30 mg LY2484595 Monotherapy Administered daily by mouth for 12 weeks
100 mg LY2484595 Monotherapy Administered daily by mouth for 12 weeks
500 mg LY2484595 Monotherapy Administered daily by mouth for 12 weeks
Placebo Administered daily by mouth for 12 weeks
20 mg Atorvastatin Monotherapy Administered daily by mouth for 12 weeks
100 mg LY2484595 + 20 mg Atorvastatin Administered daily by mouth for 12 weeks
40 mg Simvastatin Monotherapy Administered daily by mouth for 12 weeks
100 mg LY2484595 + 40 mg Simvastatin Administered daily by mouth for 12 weeks
10 mg Rosuvastatin Monotherapy Administered daily by mouth for 12 weeks
100 mg LY2484595 + 10 mg Rosuvastatin Administered daily by mouth for 12 weeks
Total Total of all reporting groups

Baseline Measures
   30 mg LY2484595 Monotherapy   100 mg LY2484595 Monotherapy   500 mg LY2484595 Monotherapy   Placebo   20 mg Atorvastatin Monotherapy   100 mg LY2484595 + 20 mg Atorvastatin   40 mg Simvastatin Monotherapy   100 mg LY2484595 + 40 mg Simvastatin   10 mg Rosuvastatin Monotherapy   100 mg LY2484595 + 10 mg Rosuvastatin   Total 
Overall Participants Analyzed 
[Units: Participants]
 40   38   40   38   41   35   41   40   39   41   393 
Age 
[Units: Years]
Mean (Standard Deviation)
 58.5  (11.1)   58.5  (9.2)   58.8  (12.2)   55.2  (10.5)   57.8  (11.3)   57.4  (11.8)   61.3  (10.0)   58.4  (9.0)   57.4  (12.6)   59.7  (10.1)   58.3  (10.8) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
                     
Female      23  57.5%      22  57.9%      21  52.5%      20  52.6%      26  63.4%      18  51.4%      29  70.7%      25  62.5%      13  33.3%      23  56.1%      220  56.0% 
Male      17  42.5%      16  42.1%      19  47.5%      18  47.4%      15  36.6%      17  48.6%      12  29.3%      15  37.5%      26  66.7%      18  43.9%      173  44.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
                     
Hispanic or Latino      2   5.0%      3   7.9%      2   5.0%      3   7.9%      2   4.9%      2   5.7%      2   4.9%      1   2.5%      1   2.6%      1   2.4%      19   4.8% 
Not Hispanic or Latino      27  67.5%      28  73.7%      29  72.5%      26  68.4%      29  70.7%      25  71.4%      29  70.7%      30  75.0%      25  64.1%      34  82.9%      282  71.8% 
Unknown or Not Reported      11  27.5%      7  18.4%      9  22.5%      9  23.7%      10  24.4%      8  22.9%      10  24.4%      9  22.5%      13  33.3%      6  14.6%      92  23.4% 
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%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Asian      1   2.5%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      1   0.3% 
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%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Black or African American      5  12.5%      1   2.6%      4  10.0%      1   2.6%      1   2.4%      2   5.7%      2   4.9%      0   0.0%      3   7.7%      1   2.4%      20   5.1% 
White      33  82.5%      36  94.7%      35  87.5%      36  94.7%      39  95.1%      33  94.3%      39  95.1%      39  97.5%      35  89.7%      40  97.6%      365  92.9% 
More than one race      1   2.5%      1   2.6%      1   2.5%      1   2.6%      1   2.4%      0   0.0%      0   0.0%      1   2.5%      1   2.6%      0   0.0%      7   1.8% 
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%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
                     
United States   22   23   22   22   23   18   21   23   22   22   218 
Poland   2   2   2   0   2   1   1   2   0   4   16 
Denmark   12   9   8   10   10   9   12   11   11   10   102 
Germany   2   1   1   1   2   1   0   1   2   0   11 
Netherlands   2   2   5   5   4   5   6   2   4   4   39 
United Kingdom   0   1   2   0   0   1   1   1   0   1   7 
Weight 
[Units: Kilogram]
Mean (Standard Deviation)
 84.6  (23.2)   79.9  (18.3)   82.6  (20.6)   89.3  (18.5)   81.4  (16.4)   87.4  (22.4)   79.6  (15.4)   84.5  (16.7)   85.7  (19.4)   82.2  (18.0)   83.6  (19.0) 
Body Mass Index (BMI) 
[Units: Kilogram/square meter (kg/m²)]
Mean (Standard Deviation)
 29.8  (7.8)   27.6  (5.7)   29.0  (5.6)   29.8  (6.1)   28.8  (5.1)   30.0  (7.5)   28.3  (5.0)   29.9  (5.3)   28.3  (4.2)   28.4  (5.3)   29.0  (5.8) 
High-Density Lipoprotein Cholesterol (HDL-C) 
[Units: Milligram/deciliter (mg/dL)]
Mean (Standard Deviation)
 54.7  (12.0)   57.0  (14.1)   54.7  (16.3)   53.0  (11.8)   53.9  (17.0)   55.7  (18.2)   57.3  (16.2)   53.7  (13.6)   53.5  (15.2)   57.8  (18.1)   55.1  (15.3) 
Low-Density Lipoprotein Cholesterol (LDL-C) 
[Units: mg/dL]
Mean (Standard Deviation)
 143.5  (26.0)   148.0  (25.0)   135.7  (26.0)   147.3  (21.6)   139.0  (26.7)   143.6  (26.0)   154.8  (35.1)   143.7  (29.1)   141.6  (23.8)   145.7  (21.8)   144.3  (26.6) 
Fasting Triglycerides 
[Units: mg/dL]
Mean (Standard Deviation)
 133.9  (56.6)   129.8  (51.7)   133.1  (69.8)   154.4  (93.0)   144.1  (83.4)   133.0  (67.8)   145.3  (84.6)   142.4  (62.4)   142.8  (65.6)   138.1  (69.0)   139.8  (71.1) 


  Outcome Measures

1.  Primary:   Percent Change From Baseline to 12 Weeks Endpoint in High Density Lipoprotein Cholesterol (HDL-C) With LY2484595 in Combination With Atorvastatin and Atorvastatin Monotherapy   [ Time Frame: Baseline, Week 12 ]

2.  Primary:   Percent Change From Baseline to 12 Weeks Endpoint in Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 in Combination With Atorvastatin and Atorvastatin Monotherapy   [ Time Frame: Baseline, Week 12 ]

3.  Secondary:   Percent Change From Baseline to 12 Weeks Endpoint in High Density Lipoprotein Cholesterol (HDL-C) With LY2484595 and Placebo   [ Time Frame: Baseline, Week 12 ]

4.  Secondary:   Percent Change From Baseline to 12 Weeks Endpoint in Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 and Placebo   [ Time Frame: Baseline, Week 12 ]

5.  Secondary:   Percent Change From Baseline to 12 Weeks Endpoint in High Density Lipoprotein Cholesterol (HDL-C) With LY2484595 in Combination With Simvastatin or Rosuvastatin and Simvastatin/Rosuvastatin Monotherapy   [ Time Frame: Baseline, Week 12 ]

6.  Secondary:   Percent Change From Baseline to 12 Weeks Endpoint in Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 in Combination With Simvastatin or Rosuvastatin and Simvastatin/Rosuvastatin Monotherapy   [ Time Frame: Baseline, Week 12 ]

7.  Secondary:   Pharmacokinetics - LY2484595 Area Under the Concentration-Time Curve (AUC) at Steady-State   [ Time Frame: Baseline up to 12 weeks ]

8.  Secondary:   Percent Change From Baseline to 12 Weeks Endpoint in Plasma Cholesteryl Ester Transfer Protein (CETP) Activity   [ Time Frame: Baseline, Week 12 ]

9.  Secondary:   Percent Change From Baseline to 12 Weeks Endpoint in Plasma Cholesteryl Ester Transfer Protein (CETP) Mass   [ Time Frame: Baseline, Week 12 ]

10.  Secondary:   The Number of Episodes of Rashes at Any Time From Baseline Through Week 12   [ Time Frame: Baseline through Week 12 ]

11.  Secondary:   Change From Baseline to 12 Weeks Endpoint in Blood Pressure (BP)   [ Time Frame: Baseline, Week 12 ]

12.  Secondary:   Change From Baseline to 12 Weeks Endpoint in Serum Aldosterone   [ Time Frame: Baseline, Week 12 ]

13.  Secondary:   Change From Baseline to 12 Weeks Endpoint in Plasma Renin Activity   [ Time Frame: Baseline, Week 12 ]

14.  Secondary:   Change From Baseline to 12 Weeks Endpoint in Serum Potassium   [ Time Frame: Baseline, Week 12 ]

15.  Secondary:   Change From Baseline to 12 Weeks Endpoint in Serum Sodium   [ Time Frame: Baseline, Week 12 ]

16.  Secondary:   Change From Baseline to 12 Weeks Endpoint in Serum Bicarbonate   [ Time Frame: Baseline, Week 12 ]

17.  Secondary:   Change From Baseline to 18 Weeks Endpoint in EuroQoL Questionnaire - 5 Dimensions (EQ-5D) Score   [ Time Frame: Baseline up to Week 18 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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

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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01105975     History of Changes
Other Study ID Numbers: 12468
I1V-MC-EIAF ( Other Identifier: Eli Lilly and Company )
First Submitted: April 15, 2010
First Posted: April 19, 2010
Results First Submitted: February 18, 2018
Results First Posted: March 22, 2018
Last Update Posted: March 22, 2018