ClinicalTrials.gov
ClinicalTrials.gov Menu

Open Label Study of Long Term Safety Evaluation of Alirocumab (ODYSSEY OLE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01954394
Recruitment Status : Completed
First Posted : October 1, 2013
Results First Posted : July 24, 2018
Last Update Posted : July 24, 2018
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Hypercholesterolemia
Interventions: Drug: Alirocumab
Drug: Lipid-Modifying Therapy (LMT)

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study was conducted at 177 centers in 24 countries. Overall, 986 participants who completed study EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500), EFC12732 (NCT01617655) and LTS11717 (NCT01507831) were enrolled between December 2013 and December 2014.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The Day 1 visit of this study was: the end of treatment visit of the 78-week treatment period for participants who completed EFC12492, R727-CL-1112 and EFC12732; and the end of study visit i.e. 8 weeks after completion of the 78-week treatment period for participants who completed LTS11717.

Reporting Groups
  Description
Placebo to Alirocumab 75 or 150 mg Q2W Alirocumab 75 mg or 150 mg subcutaneous (SC) injection every 2 weeks (Q2W) added to stable lipid-modifying therapy (LMT) for up to 168 weeks in participants who received placebo in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and low-density lipoprotein cholesterol (LDL-C) values.
Alirocumab to Alirocumab 75 or 150 mg Q2W Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 additional weeks in participants who received Alirocumab in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values.

Participant Flow:   Overall Study
    Placebo to Alirocumab 75 or 150 mg Q2W   Alirocumab to Alirocumab 75 or 150 mg Q2W
STARTED   331 [1]   655 [1] 
Treated   330 [2]   655 [2] 
COMPLETED   301   598 
NOT COMPLETED   30   57 
Enrolled but not treated                1                0 
Adverse Event                10                23 
Poor compliance to protocol                7                7 
Participant Moved                0                4 
Related to Study Drug administration                2                2 
Other than specified above                10                21 
[1] Enrolled
[2] Safety population



  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.
All enrolled participants who received at least one dose or part of a dose of alirocumab in this study. Participant who was not treated, was not included in any analysis.

Reporting Groups
  Description
Placebo to Alirocumab 75 or 150 mg Q2W Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 weeks in participants who received placebo in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values.
Alirocumab to Alirocumab 75 or 150 mg Q2W Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 additional weeks in participants who received Alirocumab in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values.
Total Total of all reporting groups

Baseline Measures
   Placebo to Alirocumab 75 or 150 mg Q2W   Alirocumab to Alirocumab 75 or 150 mg Q2W   Total 
Overall Participants Analyzed 
[Units: Participants]
 330   655   985 
Age 
[Units: Years]
Mean (Standard Deviation)
 54.8  (11.4)   54.1  (12.1)   54.4  (11.9) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      148  44.8%      287  43.8%      435  44.2% 
Male      182  55.2%      368  56.2%      550  55.8% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      12   3.6%      27   4.1%      39   4.0% 
Not Hispanic or Latino      317  96.1%      623  95.1%      940  95.4% 
Unknown or Not Reported      1   0.3%      5   0.8%      6   0.6% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
White   310   628   938 
Black or African American   2   2   4 
Asian   2   6   8 
American Indian or Alaska Native   1   2   3 
Native Hawaiian or Other Pacific Islander   1   0   1 
Other   4   7   11 
White/Black or African American   6   5   11 
White/Asian   2   5   7 
White/American Indian or Alaska Native   1   0   1 
Black or African American/Asian   1   0   1 
Calculated LDL-C in mg/dL [1] 
[Units: mg/dL]
Mean (Standard Deviation)
 148.8  (48.8)   153.5  (55.3)   152.0  (53.2) 
[1] Calculated LDL-C in mg/dL from Friedewald formula (LDL-C = Total cholesterol - High-density lipoprotein cholesterol - [Triglyceride/5]). This parameter was evaluated at the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717).
Calculated LDL-C in mmol/L [1] 
[Units: mmol/L]
Mean (Standard Deviation)
 3.854  (1.265)   3.977  (1.432)   3.936  (1.379) 
[1] This parameter was evaluated at the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717).


  Outcome Measures

1.  Primary:   Percentage of Participants Who Experienced Adverse Events (AEs)   [ Time Frame: Up to 10 weeks after last study drug administration (maximum of 176 weeks) ]

2.  Secondary:   Percent Change From Baseline in Calculated LDL-C at Weeks 8, 24, 48, 72, 96, 120, 144 and 168   [ Time Frame: Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168 ]

3.  Secondary:   Absolute Change From Baseline in Calculated LDL-C (mg/dL) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168   [ Time Frame: Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168 ]

4.  Secondary:   Absolute Change From Baseline in Calculated LDL-C (mmol/L) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168   [ Time Frame: Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168 ]

5.  Secondary:   Percentage of Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) Over Time   [ Time Frame: Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168 ]

6.  Secondary:   Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) Over Time   [ Time Frame: Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168 ]

7.  Secondary:   Percentage of Participants With Calculated LDL-C <70 mg/dL (1.81mmol/L) and/or >=50% Reduction in Calculated LDL-C From Baseline (if Calculated LDL-C >=70 mg/dL [1.81mmol/L]) Over Time   [ Time Frame: Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168 ]

8.  Secondary:   Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168   [ Time Frame: Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168 ]

9.  Secondary:   Percent Change From Baseline in Total-cholesterol at Weeks 8, 24, 48, 72, 96, 120, 144 and 168   [ Time Frame: Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168 ]

10.  Secondary:   Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168   [ Time Frame: Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168 ]

11.  Secondary:   Percent Change From Baseline in Fasting Triglycerides (TGs) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168   [ Time Frame: Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168 ]

12.  Secondary:   Percent Change From Baseline in Lipoprotein (a) at Weeks 48, 96, 144 and 168   [ Time Frame: Parent Baseline, Weeks 48, 96, 144, and 168 ]

13.  Secondary:   Percent Change From Baseline in Apolipoprotein-B (Apo-B) at Weeks 48, 96, 144, and 168   [ Time Frame: Parent Baseline, Weeks 48, 96, 144, and 168 ]

14.  Secondary:   Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1) at Weeks 48, 96, 144, and 168   [ Time Frame: Parent Baseline, Weeks 48, 96, 144, and 168 ]

15.  Secondary:   Absolute Change From Baseline in Apo B/Apo A-1 Ratio at Weeks 48, 96, 144, and 168   [ Time Frame: Parent Baseline, Weeks 48, 96, 144, and 168 ]


  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 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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Trial Transparency Team
Organization: Sanofi
phone: 800-633-1610 ext 1#
e-mail: Contact-US@sanofi.com



Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01954394     History of Changes
Other Study ID Numbers: LTS13463
2013-002572-40 ( EudraCT Number )
U1111-1143-3810 ( Other Identifier: UTN )
First Submitted: September 16, 2013
First Posted: October 1, 2013
Results First Submitted: June 29, 2018
Results First Posted: July 24, 2018
Last Update Posted: July 24, 2018