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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)
Enrollment 986
Recruitment Details 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 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.
Arm/Group Title Placebo to Alirocumab 75 or 150 mg Q2W Alirocumab to Alirocumab 75 or 150 mg Q2W
Hide Arm/Group Description 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 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.
Period Title: Overall Study
Started 331 [1] 655 [1]
Treated 330 [2] 655 [2]
Completed 301 598
Not Completed 30 57
Reason Not Completed
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
Arm/Group Title Placebo to Alirocumab 75 or 150 mg Q2W Alirocumab to Alirocumab 75 or 150 mg Q2W Total
Hide Arm/Group Description 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 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 of all reporting groups
Overall Number of Baseline Participants 330 655 985
Hide Baseline Analysis Population Description
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.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 330 participants 655 participants 985 participants
54.8  (11.4) 54.1  (12.1) 54.4  (11.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 330 participants 655 participants 985 participants
Female
148
  44.8%
287
  43.8%
435
  44.2%
Male
182
  55.2%
368
  56.2%
550
  55.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 330 participants 655 participants 985 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  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 330 participants 655 participants 985 participants
White
310
  93.9%
628
  95.9%
938
  95.2%
Black or African American
2
   0.6%
2
   0.3%
4
   0.4%
Asian
2
   0.6%
6
   0.9%
8
   0.8%
American Indian or Alaska Native
1
   0.3%
2
   0.3%
3
   0.3%
Native Hawaiian or Other Pacific Islander
1
   0.3%
0
   0.0%
1
   0.1%
Other
4
   1.2%
7
   1.1%
11
   1.1%
White/Black or African American
6
   1.8%
5
   0.8%
11
   1.1%
White/Asian
2
   0.6%
5
   0.8%
7
   0.7%
White/American Indian or Alaska Native
1
   0.3%
0
   0.0%
1
   0.1%
Black or African American/Asian
1
   0.3%
0
   0.0%
1
   0.1%
Calculated LDL-C in mg/dL   [1] 
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 330 participants 655 participants 985 participants
148.8  (48.8) 153.5  (55.3) 152.0  (53.2)
[1]
Measure Description: 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] 
Mean (Standard Deviation)
Unit of measure:  mmol/L
Number Analyzed 330 participants 655 participants 985 participants
3.854  (1.265) 3.977  (1.432) 3.936  (1.379)
[1]
Measure Description: This parameter was evaluated at the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717).
1.Primary Outcome
Title Percentage of Participants Who Experienced Adverse Events (AEs)
Hide Description Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the ‘treatment-emergent period’ (the time from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study +70 days). Clinically significant lab and vital sign abnormalities were to be reported as AEs.
Time Frame Up to 10 weeks after last study drug administration (maximum of 176 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received at least one dose or part of a dose of alirocumab in this study.
Arm/Group Title Placebo to Alirocumab 75 or 150 mg Q2W Alirocumab to Alirocumab 75 or 150 mg Q2W Alirocumab: All Participants
Hide Arm/Group Description:
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 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.
All participants who received alirocumab/placebo in the parent studies and received alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 additional weeks in this study.
Overall Number of Participants Analyzed 330 655 985
Measure Type: Number
Unit of Measure: percentage of participants
Any AE 83.9 87.3 86.2
Any Serious AE 20.6 22.0 21.5
Any AE leading to treatment discontinuation 3.0 3.5 3.4
2.Secondary Outcome
Title Percent Change From Baseline in Calculated LDL-C at Weeks 8, 24, 48, 72, 96, 120, 144 and 168
Hide Description Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.
Time Frame Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168
Hide Outcome Measure Data
Hide Analysis Population Description
Modified ITT (mITT) population: all enrolled and treated participants with 1 baseline (from parent study) and at least 1 post-baseline calculated LDL-C value on-treatment. “Number analyzed” = participants evaluable at specified time-points. This number decreased significantly with visit because of the possibility to switch to commercial alirocumab.
Arm/Group Title Placebo to Alirocumab 75 or 150 mg Q2W Alirocumab to Alirocumab 75 or 150 mg Q2W Alirocumab: All Participants
Hide Arm/Group Description:
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 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.
All participants who received alirocumab/placebo in the parent studies and received alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 additional weeks in this study.
Overall Number of Participants Analyzed 323 651 974
Mean (Standard Deviation)
Unit of Measure: percent change
Week 8 Number Analyzed 306 participants 611 participants 917 participants
-44.9  (25.9) -43.8  (28.7) -44.2  (27.8)
Week 24 Number Analyzed 305 participants 621 participants 926 participants
-46.9  (27.5) -46.9  (29.3) -46.9  (28.7)
Week 48 Number Analyzed 309 participants 609 participants 918 participants
-45.6  (28.0) -47.5  (28.8) -46.9  (28.6)
Week 72 Number Analyzed 293 participants 594 participants 887 participants
-47.7  (23.5) -47.3  (28.4) -47.4  (26.8)
Week 96 Number Analyzed 236 participants 475 participants 711 participants
-47.4  (23.8) -48.2  (28.2) -47.9  (26.8)
Week 120 Number Analyzed 188 participants 352 participants 540 participants
-47.4  (24.0) -46.6  (31.1) -46.8  (28.8)
Week 144 Number Analyzed 69 participants 129 participants 198 participants
-46.5  (25.8) -49.6  (24.6) -48.5  (25.0)
Week 168 Number Analyzed 4 participants 6 participants 10 participants
-43.6  (13.4) -52.2  (20.7) -48.8  (17.8)
3.Secondary Outcome
Title Absolute Change From Baseline in Calculated LDL-C (mg/dL) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168
Hide Description Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.
Time Frame Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population. Here, “Number analyzed” signifies participants evaluable at specified time-points. This number decreased significantly with visit because of the possibility to switch to commercial alirocumab.
Arm/Group Title Placebo to Alirocumab 75 or 150 mg Q2W Alirocumab to Alirocumab 75 or 150 mg Q2W Alirocumab: All Participants
Hide Arm/Group Description:
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 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.
All participants who received alirocumab/placebo in the parent studies and received alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 additional weeks in this study.
Overall Number of Participants Analyzed 323 651 974
Mean (Standard Deviation)
Unit of Measure: mg/dL
Week 8 Number Analyzed 306 participants 611 participants 917 participants
-66.8  (45.6) -67.1  (49.2) -67.0  (48.0)
Week 24 Number Analyzed 305 participants 621 participants 926 participants
-70.3  (49.5) -72.7  (52.4) -71.9  (51.4)
Week 48 Number Analyzed 309 participants 609 participants 918 participants
-67.8  (49.7) -73.9  (54.3) -71.9  (52.8)
Week 72 Number Analyzed 293 participants 594 participants 887 participants
-71.2  (44.5) -74.9  (54.5) -73.7  (51.4)
Week 96 Number Analyzed 236 participants 475 participants 711 participants
-70.2  (45.9) -75.9  (55.0) -74.0  (52.2)
Week 120 Number Analyzed 188 participants 352 participants 540 participants
-72.3  (45.6) -75.2  (59.7) -74.2  (55.2)
Week 144 Number Analyzed 69 participants 129 participants 198 participants
-73.1  (50.0) -86.2  (57.8) -81.6  (55.4)
Week 168 Number Analyzed 4 participants 6 participants 10 participants
-66.1  (24.7) -99.4  (48.3) -86.1  (42.4)
4.Secondary Outcome
Title Absolute Change From Baseline in Calculated LDL-C (mmol/L) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168
Hide Description Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.
Time Frame Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population. Here, “Number analyzed” signifies participants evaluable at specified time-points. This number decreased significantly with visit because of the possibility to switch to commercial alirocumab.
Arm/Group Title Placebo to Alirocumab 75 or 150 mg Q2W Alirocumab to Alirocumab 75 or 150 mg Q2W Alirocumab: All Participants
Hide Arm/Group Description:
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 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.
All participants who received alirocumab/placebo in the parent studies and received alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 additional weeks in this study.
Overall Number of Participants Analyzed 323 651 974
Mean (Standard Deviation)
Unit of Measure: mmol/L
Week 8 Number Analyzed 306 participants 611 participants 917 participants
-1.729  (1.180) -1.738  (1.273) -1.735  (1.242)
Week 24 Number Analyzed 305 participants 621 participants 926 participants
-1.821  (1.282) -1.883  (1.356) -1.863  (1.332)
Week 48 Number Analyzed 309 participants 609 participants 918 participants
-1.757  (1.286) -1.914  (1.405) -1.861  (1.368)
Week 72 Number Analyzed 293 participants 594 participants 887 participants
-1.843  (1.154) -1.940  (1.411) -1.908  (1.332)
Week 96 Number Analyzed 236 participants 475 participants 711 participants
-1.818  (1.190) -1.965  (1.426) -1.916  (1.353)
Week 120 Number Analyzed 188 participants 352 participants 540 participants
-1.874  (1.180) -1.949  (1.546) -1.923  (1.428)
Week 144 Number Analyzed 69 participants 129 participants 198 participants
-1.894  (1.294) -2.232  (1.498) -2.114  (1.436)
Week 168 Number Analyzed 4 participants 6 participants 10 participants
-1.712  (0.641) -2.574  (1.252) -2.229  (1.098)
5.Secondary Outcome
Title Percentage of Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) Over Time
Hide Description Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.
Time Frame Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population. Here, “Number analyzed” signifies participants evaluable at specified time-points. This number decreased significantly with visit because of the possibility to switch to commercial alirocumab.
Arm/Group Title Placebo to Alirocumab 75 or 150 mg Q2W Alirocumab to Alirocumab 75 or 150 mg Q2W Alirocumab: All Participants
Hide Arm/Group Description:
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 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.
All participants who received alirocumab/placebo in the parent studies and received alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 additional weeks in this study.
Overall Number of Participants Analyzed 323 651 974
Measure Type: Number
Unit of Measure: percentage of participants
Baseline Number Analyzed 323 participants 651 participants 974 participants
12.1 11.5 11.7
Week 8 Number Analyzed 321 participants 648 participants 969 participants
71.0 86.1 81.1
Week 24 Number Analyzed 305 participants 621 participants 926 participants
77.0 75.7 76.1
Week 48 Number Analyzed 309 participants 609 participants 918 participants
77.7 76.4 76.8
Week 72 Number Analyzed 293 participants 594 participants 887 participants
82.9 77.6 79.4
Week 96 Number Analyzed 236 participants 475 participants 711 participants
79.2 76.8 77.6
Week 120 Number Analyzed 188 participants 352 participants 540 participants
78.2 76.7 77.2
Week 144 Number Analyzed 69 participants 129 participants 198 participants
72.5 74.4 73.7
Week 168 Number Analyzed 4 participants 6 participants 10 participants
75.0 83.3 80.0
6.Secondary Outcome
Title Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) Over Time
Hide Description Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.
Time Frame Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population. Here, “Number analyzed” signifies participants evaluable at specified time-points. This number decreased significantly with visit because of the possibility to switch to commercial alirocumab.
Arm/Group Title Placebo to Alirocumab 75 or 150 mg Q2W Alirocumab to Alirocumab 75 or 150 mg Q2W Alirocumab: All Participants
Hide Arm/Group Description:
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 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.
All participants who received alirocumab/placebo in the parent studies and received alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 additional weeks in this study.
Overall Number of Participants Analyzed 323 651 974
Measure Type: Number
Unit of Measure: percentage of participants
Baseline Number Analyzed 323 participants 651 participants 974 participants
0.9 1.2 1.1
Week 8 Number Analyzed 321 participants 648 participants 969 participants
47.4 66.4 60.1
Week 24 Number Analyzed 305 participants 621 participants 926 participants
53.4 53.1 53.2
Week 48 Number Analyzed 309 participants 609 participants 918 participants
51.1 53.5 52.7
Week 72 Number Analyzed 293 participants 594 participants 887 participants
57.0 53.2 54.5
Week 96 Number Analyzed 236 participants 475 participants 711 participants
53.0 56.4 55.3
Week 120 Number Analyzed 188 participants 352 participants 540 participants
52.7 50.9 51.5
Week 144 Number Analyzed 69 participants 129 participants 198 participants
46.4 48.1 47.5
Week 168 Number Analyzed 4 participants 6 participants 10 participants
50.0 33.3 40.0
7.Secondary Outcome
Title 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
Hide Description Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.
Time Frame Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population. Here, “Number analyzed” signifies participants evaluable at specified time-points. This number decreased significantly with visit because of the possibility to switch to commercial alirocumab.
Arm/Group Title Placebo to Alirocumab 75 or 150 mg Q2W Alirocumab to Alirocumab 75 or 150 mg Q2W Alirocumab: All Participants
Hide Arm/Group Description:
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 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.
All participants who received alirocumab/placebo in the parent studies and received alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 additional weeks in this study.
Overall Number of Participants Analyzed 323 651 974
Measure Type: Number
Unit of Measure: percentage of participants
Baseline Number Analyzed 323 participants 651 participants 974 participants
0.9 1.2 1.1
Week 8 Number Analyzed 321 participants 648 participants 969 participants
49.5 67.1 61.3
Week 24 Number Analyzed 305 participants 621 participants 926 participants
54.1 54.3 54.2
Week 48 Number Analyzed 309 participants 609 participants 918 participants
52.1 54.5 53.7
Week 72 Number Analyzed 293 participants 594 participants 887 participants
57.3 54.4 55.4
Week 96 Number Analyzed 236 participants 475 participants 711 participants
53.0 57.7 56.1
Week 120 Number Analyzed 188 participants 352 participants 540 participants
53.2 53.1 53.1
Week 144 Number Analyzed 69 participants 129 participants 198 participants
46.4 48.8 48.0
Week 168 Number Analyzed 4 participants 6 participants 10 participants
50.0 33.3 40.0
8.Secondary Outcome
Title Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168
Hide Description Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.
Time Frame Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population. Here, “Number analyzed” signifies participants evaluable at specified time-points. This number decreased significantly with visit because of the possibility to switch to commercial alirocumab.
Arm/Group Title Placebo to Alirocumab 75 or 150 mg Q2W Alirocumab to Alirocumab 75 or 150 mg Q2W Alirocumab: All Participants
Hide Arm/Group Description:
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 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.
All participants who received alirocumab/placebo in the parent studies and received alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 additional weeks in this study.
Overall Number of Participants Analyzed 323 651 974
Mean (Standard Deviation)
Unit of Measure: percent change
Week 8 Number Analyzed 310 participants 618 participants 928 participants
-38.1  (24.8) -37.6  (26.6) -37.8  (26.0)
Week 24 Number Analyzed 310 participants 625 participants 935 participants
-40.6  (25.5) -40.4  (27.9) -40.5  (27.1)
Week 48 Number Analyzed 310 participants 616 participants 926 participants
-39.7  (25.5) -40.6  (27.6) -40.3  (26.9)
Week 72 Number Analyzed 294 participants 597 participants 891 participants
-40.8  (22.6) -40.3  (26.5) -40.5  (25.3)
Week 96 Number Analyzed 240 participants 481 participants 721 participants
-39.9  (23.5) -40.5  (26.6) -40.3  (25.6)
Week 120 Number Analyzed 188 participants 358 participants 546 participants
-41.4  (22.1) -38.4  (29.7) -39.5  (27.3)
Week 144 Number Analyzed 70 participants 132 participants 202 participants
-39.8  (22.9) -41.8  (24.0) -41.1  (23.6)
Week 168 Number Analyzed 4 participants 6 participants 10 participants
-40.7  (12.3) -47.7  (18.8) -44.9  (16.1)
9.Secondary Outcome
Title Percent Change From Baseline in Total-cholesterol at Weeks 8, 24, 48, 72, 96, 120, 144 and 168
Hide Description Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.
Time Frame Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population. Here, “Number analyzed” signifies participants evaluable at specified time-points. This number decreased significantly with visit because of the possibility to switch to commercial alirocumab.
Arm/Group Title Placebo to Alirocumab 75 or 150 mg Q2W Alirocumab to Alirocumab 75 or 150 mg Q2W Alirocumab: All Participants
Hide Arm/Group Description:
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 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.
All participants who received alirocumab/placebo in the parent studies and received alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 additional weeks in this study.
Overall Number of Participants Analyzed 323 651 974
Mean (Standard Deviation)
Unit of Measure: percent change
Week 8 Number Analyzed 310 participants 618 participants 928 participants
-27.9  (19.3) -27.7  (20.7) -27.7  (20.2)
Week 24 Number Analyzed 310 participants 625 participants 935 participants
-30.1  (20.3) -30.2  (21.6) -30.1  (21.2)
Week 48 Number Analyzed 310 participants 616 participants 926 participants
-29.0  (20.5) -30.0  (21.6) -29.7  (21.2)
Week 72 Number Analyzed 294 participants 597 participants 891 participants
-29.9  (18.0) -30.1  (20.8) -30.0  (19.9)
Week 96 Number Analyzed 240 participants 481 participants 721 participants
-28.9  (18.3) -29.9  (21.1) -29.6  (20.2)
Week 120 Number Analyzed 188 participants 358 participants 546 participants
-30.2  (17.2) -28.4  (22.8) -29.0  (21.0)
Week 144 Number Analyzed 70 participants 132 participants 202 participants
-29.1  (18.2) -31.3  (19.1) -30.5  (18.8)
Week 168 Number Analyzed 4 participants 6 participants 10 participants
-32.3  (12.4) -39.1  (14.3) -36.4  (13.3)
10.Secondary Outcome
Title Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168
Hide Description Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.
Time Frame Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population. Here, “Number analyzed” signifies participants evaluable at specified time-points. This number decreased significantly with visit because of the possibility to switch to commercial alirocumab.
Arm/Group Title Placebo to Alirocumab 75 or 150 mg Q2W Alirocumab to Alirocumab 75 or 150 mg Q2W Alirocumab: All Participants
Hide Arm/Group Description:
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 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.
All participants who received alirocumab/placebo in the parent studies and received alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 additional weeks in this study.
Overall Number of Participants Analyzed 323 651 974
Mean (Standard Deviation)
Unit of Measure: percent change
Week 8 Number Analyzed 310 participants 618 participants 928 participants
5.6  (17.1) 6.6  (17.3) 6.3  (17.3)
Week 24 Number Analyzed 310 participants 625 participants 935 participants
5.7  (17.4) 5.8  (16.9) 5.8  (17.1)
Week 48 Number Analyzed 310 participants 616 participants 926 participants
7.1  (17.8) 7.2  (19.2) 7.2  (18.7)
Week 72 Number Analyzed 294 participants 597 participants 891 participants
6.7  (17.6) 7.2  (19.9) 7.0  (19.1)
Week 96 Number Analyzed 240 participants 481 participants 721 participants
7.2  (18.8) 7.2  (18.7) 7.2  (18.7)
Week 120 Number Analyzed 188 participants 358 participants 546 participants
8.0  (18.4) 8.1  (18.7) 8.1  (18.6)
Week 144 Number Analyzed 70 participants 132 participants 202 participants
8.8  (19.2) 8.8  (24.8) 8.8  (23.0)
Week 168 Number Analyzed 4 participants 6 participants 10 participants
-6.6  (26.2) -0.3  (9.9) -2.8  (17.1)
11.Secondary Outcome
Title Percent Change From Baseline in Fasting Triglycerides (TGs) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168
Hide Description Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.
Time Frame Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population. Here, “Number analyzed” signifies participants evaluable at specified time-points. This number decreased significantly with visit because of the possibility to switch to commercial alirocumab.
Arm/Group Title Placebo to Alirocumab 75 or 150 mg Q2W Alirocumab to Alirocumab 75 or 150 mg Q2W Alirocumab: All Participants
Hide Arm/Group Description:
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 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.
All participants who received alirocumab/placebo in the parent studies and received alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 additional weeks in this study.
Overall Number of Participants Analyzed 323 651 974
Mean (Standard Deviation)
Unit of Measure: percent change
Week 8 Number Analyzed 309 participants 618 participants 927 participants
3.4  (40.5) 3.5  (47.0) 3.5  (44.9)
Week 24 Number Analyzed 308 participants 624 participants 932 participants
0.6  (39.9) 1.0  (45.9) 0.9  (44.0)
Week 48 Number Analyzed 309 participants 616 participants 925 participants
0.8  (37.5) 5.1  (78.0) 3.7  (67.2)
Week 72 Number Analyzed 293 participants 596 participants 889 participants
4.3  (43.3) 3.6  (42.9) 3.8  (43.0)
Week 96 Number Analyzed 239 participants 479 participants 718 participants
9.1  (53.2) 9.3  (55.2) 9.2  (54.5)
Week 120 Number Analyzed 187 participants 358 participants 545 participants
-1.2  (35.3) 10.8  (48.5) 6.7  (44.8)
Week 144 Number Analyzed 70 participants 131 participants 201 participants
5.0  (38.0) 7.7  (49.8) 6.8  (45.9)
Week 168 Number Analyzed 4 participants 6 participants 10 participants
-22.1  (21.9) -10.3  (27.1) -15.0  (24.6)
12.Secondary Outcome
Title Percent Change From Baseline in Lipoprotein (a) at Weeks 48, 96, 144 and 168
Hide Description Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.
Time Frame Parent Baseline, Weeks 48, 96, 144, and 168
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population. Here, “Number analyzed” signifies participants evaluable at specified time-points. This number decreased significantly with visit because of the possibility to switch to commercial alirocumab.
Arm/Group Title Placebo to Alirocumab 75 or 150 mg Q2W Alirocumab to Alirocumab 75 or 150 mg Q2W Alirocumab: All Participants
Hide Arm/Group Description:
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 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.
All participants who received alirocumab/placebo in the parent studies and received alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 additional weeks in this study.
Overall Number of Participants Analyzed 323 651 974
Mean (Standard Deviation)
Unit of Measure: percent change
Week 48 Number Analyzed 307 participants 606 participants 913 participants
-15.0  (158.4) -26.4  (40.2) -22.6  (97.6)
Week 96 Number Analyzed 239 participants 474 participants 713 participants
-13.9  (171.7) -21.4  (132.7) -18.9  (146.9)
Week 144 Number Analyzed 69 participants 129 participants 198 participants
-20.1  (46.1) -33.0  (25.0) -28.5  (34.3)
Week 168 Number Analyzed 4 participants 6 participants 10 participants
-30.3  (18.2) -29.2  (15.4) -29.6  (15.6)
13.Secondary Outcome
Title Percent Change From Baseline in Apolipoprotein-B (Apo-B) at Weeks 48, 96, 144, and 168
Hide Description Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.
Time Frame Parent Baseline, Weeks 48, 96, 144, and 168
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population. Here, “Number analyzed” signifies participants evaluable at specified time-points. This number decreased significantly with visit because of the possibility to switch to commercial alirocumab.
Arm/Group Title Placebo to Alirocumab 75 or 150 mg Q2W Alirocumab to Alirocumab 75 or 150 mg Q2W Alirocumab: All Participants
Hide Arm/Group Description:
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 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.
All participants who received alirocumab/placebo in the parent studies and received alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 additional weeks in this study.
Overall Number of Participants Analyzed 323 651 974
Mean (Standard Deviation)
Unit of Measure: percent change
Week 48 Number Analyzed 308 participants 607 participants 915 participants
-36.9  (21.7) -37.8  (23.4) -37.5  (22.9)
Week 96 Number Analyzed 238 participants 475 participants 713 participants
-36.9  (20.9) -38.0  (22.9) -37.6  (22.3)
Week 144 Number Analyzed 69 participants 129 participants 198 participants
-33.9  (20.9) -36.9  (21.3) -35.9  (21.2)
Week 168 Number Analyzed 4 participants 6 participants 10 participants
-38.0  (9.0) -43.1  (20.7) -41.1  (16.5)
14.Secondary Outcome
Title Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1) at Weeks 48, 96, 144, and 168
Hide Description Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.
Time Frame Parent Baseline, Weeks 48, 96, 144, and 168
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population. Here, “Number analyzed” signifies participants evaluable at specified time-points. This number decreased significantly with visit because of the possibility to switch to commercial alirocumab.
Arm/Group Title Placebo to Alirocumab 75 or 150 mg Q2W Alirocumab to Alirocumab 75 or 150 mg Q2W Alirocumab: All Participants
Hide Arm/Group Description:
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 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.
All participants who received alirocumab/placebo in the parent studies and received alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 additional weeks in this study.
Overall Number of Participants Analyzed 323 651 974
Mean (Standard Deviation)
Unit of Measure: percent change
Week 48 Number Analyzed 308 participants 607 participants 915 participants
5.6  (14.5) 5.8  (17.2) 5.7  (16.3)
Week 96 Number Analyzed 238 participants 475 participants 713 participants
7.8  (15.4) 8.5  (14.1) 8.3  (14.5)
Week 144 Number Analyzed 69 participants 129 participants 198 participants
11.2  (16.3) 10.2  (18.7) 10.6  (17.8)
Week 168 Number Analyzed 4 participants 6 participants 10 participants
0.9  (19.3) 3.9  (9.3) 2.7  (13.2)
15.Secondary Outcome
Title Absolute Change From Baseline in Apo B/Apo A-1 Ratio at Weeks 48, 96, 144, and 168
Hide Description Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.
Time Frame Parent Baseline, Weeks 48, 96, 144, and 168
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population. Here, “Number analyzed” signifies participants evaluable at specified time-points. This number decreased significantly with visit because of the possibility to switch to commercial alirocumab.
Arm/Group Title Placebo to Alirocumab 75 or 150 mg Q2W Alirocumab to Alirocumab 75 or 150 mg Q2W Alirocumab: All Participants
Hide Arm/Group Description:
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 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.
All participants who received alirocumab/placebo in the parent studies and received alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 additional weeks in this study.
Overall Number of Participants Analyzed 323 651 974
Mean (Standard Deviation)
Unit of Measure: ratio
Week 48 Number Analyzed 308 participants 607 participants 915 participants
-0.340  (0.245) -0.361  (0.304) -0.354  (0.286)
Week 96 Number Analyzed 238 participants 475 participants 713 participants
-0.340  (0.228) -0.375  (0.268) -0.363  (0.256)
Week 144 Number Analyzed 69 participants 129 participants 198 participants
-0.342  (0.242) -0.414  (0.433) -0.389  (0.379)
Week 168 Number Analyzed 4 participants 6 participants 10 participants
-0.370  (0.161) -0.498  (0.280) -0.447  (0.238)
Time Frame All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product.
Adverse Event Reporting Description Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the ‘on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
 
Arm/Group Title Placebo to Alirocumab 75 or 150 mg Q2W Alirocumab to Alirocumab 75 or 150 mg Q2W Alirocumab: All Participants
Hide Arm/Group Description 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 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 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. All participants who received alirocumab/placebo in the parent studies and received alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 weeks in this study.
All-Cause Mortality
Placebo to Alirocumab 75 or 150 mg Q2W Alirocumab to Alirocumab 75 or 150 mg Q2W Alirocumab: All Participants
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/330 (1.21%)   7/655 (1.07%)   11/985 (1.12%) 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo to Alirocumab 75 or 150 mg Q2W Alirocumab to Alirocumab 75 or 150 mg Q2W Alirocumab: All Participants
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   68/330 (20.61%)   144/655 (21.98%)   212/985 (21.52%) 
Blood and lymphatic system disorders       
Haemorrhagic anaemia  1  1/330 (0.30%)  1/655 (0.15%)  2/985 (0.20%) 
Anaemia  1  1/330 (0.30%)  0/655 (0.00%)  1/985 (0.10%) 
Leukocytosis  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Cardiac disorders       
Angina pectoris  1  6/330 (1.82%)  8/655 (1.22%)  14/985 (1.42%) 
Angina unstable  1  4/330 (1.21%)  5/655 (0.76%)  9/985 (0.91%) 
Acute myocardial infarction  1  2/330 (0.61%)  4/655 (0.61%)  6/985 (0.61%) 
Coronary artery disease  1  2/330 (0.61%)  4/655 (0.61%)  6/985 (0.61%) 
Coronary artery stenosis  1  3/330 (0.91%)  3/655 (0.46%)  6/985 (0.61%) 
Myocardial infarction  1  2/330 (0.61%)  3/655 (0.46%)  5/985 (0.51%) 
Atrial fibrillation  1  1/330 (0.30%)  3/655 (0.46%)  4/985 (0.41%) 
Cardiac failure  1  2/330 (0.61%)  2/655 (0.31%)  4/985 (0.41%) 
Cardiac failure congestive  1  3/330 (0.91%)  1/655 (0.15%)  4/985 (0.41%) 
Ventricular tachycardia  1  1/330 (0.30%)  3/655 (0.46%)  4/985 (0.41%) 
Aortic valve stenosis  1  2/330 (0.61%)  1/655 (0.15%)  3/985 (0.30%) 
Supraventricular tachycardia  1  1/330 (0.30%)  1/655 (0.15%)  2/985 (0.20%) 
Aortic valve disease  1  1/330 (0.30%)  0/655 (0.00%)  1/985 (0.10%) 
Aortic valve disease mixed  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Arrhythmia  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Arteriosclerosis coronary artery  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Atrial flutter  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Bradycardia  1  1/330 (0.30%)  0/655 (0.00%)  1/985 (0.10%) 
Coronary artery occlusion  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Coronary artery thrombosis  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Ischaemic cardiomyopathy  1  1/330 (0.30%)  0/655 (0.00%)  1/985 (0.10%) 
Mitral valve incompetence  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Mitral valve stenosis  1  1/330 (0.30%)  0/655 (0.00%)  1/985 (0.10%) 
Pericarditis  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Prinzmetal angina  1  1/330 (0.30%)  0/655 (0.00%)  1/985 (0.10%) 
Ventricular dysfunction  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Congenital, familial and genetic disorders       
Hereditary non-polyposis colorectal cancer syndrome  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Ear and labyrinth disorders       
Acute vestibular syndrome  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Vertigo positional  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Eye disorders       
Glaucoma  1  0/330 (0.00%)  2/655 (0.31%)  2/985 (0.20%) 
Optic ischaemic neuropathy  1  1/330 (0.30%)  1/655 (0.15%)  2/985 (0.20%) 
Corneal decompensation  1  1/330 (0.30%)  0/655 (0.00%)  1/985 (0.10%) 
Open angle glaucoma  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Retinal detachment  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Retinal tear  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Retinal vein occlusion  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Gastrointestinal disorders       
Hiatus hernia  1  1/330 (0.30%)  1/655 (0.15%)  2/985 (0.20%) 
Inguinal hernia  1  0/330 (0.00%)  2/655 (0.31%)  2/985 (0.20%) 
Rectal haemorrhage  1  0/330 (0.00%)  2/655 (0.31%)  2/985 (0.20%) 
Small intestinal obstruction  1  0/330 (0.00%)  2/655 (0.31%)  2/985 (0.20%) 
Abdominal hernia  1  1/330 (0.30%)  0/655 (0.00%)  1/985 (0.10%) 
Abdominal pain  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Barrett's oesophagus  1  1/330 (0.30%)  0/655 (0.00%)  1/985 (0.10%) 
Colitis  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Colitis ischaemic  1  1/330 (0.30%)  0/655 (0.00%)  1/985 (0.10%) 
Diverticulum intestinal  1  1/330 (0.30%)  0/655 (0.00%)  1/985 (0.10%) 
Dysphagia  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Gastric polyps  1  1/330 (0.30%)  0/655 (0.00%)  1/985 (0.10%) 
Gastric ulcer haemorrhage  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Gastritis  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Gastritis haemorrhagic  1  1/330 (0.30%)  0/655 (0.00%)  1/985 (0.10%) 
Gastrointestinal haemorrhage  1  1/330 (0.30%)  0/655 (0.00%)  1/985 (0.10%) 
Haematemesis  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Haematochezia  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Ileus  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Internal hernia  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Lower gastrointestinal haemorrhage  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Pancreatitis acute  1  1/330 (0.30%)  0/655 (0.00%)  1/985 (0.10%) 
Pancreatitis chronic  1  1/330 (0.30%)  0/655 (0.00%)  1/985 (0.10%) 
Rectal ulcer haemorrhage  1  1/330 (0.30%)  0/655 (0.00%)  1/985 (0.10%) 
Umbilical hernia  1  1/330 (0.30%)  0/655 (0.00%)  1/985 (0.10%) 
Volvulus  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Vomiting  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
General disorders       
Non-cardiac chest pain  1  2/330 (0.61%)  4/655 (0.61%)  6/985 (0.61%) 
Chest pain  1  1/330 (0.30%)  2/655 (0.31%)  3/985 (0.30%) 
Death  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Malaise  1  1/330 (0.30%)  0/655 (0.00%)  1/985 (0.10%) 
Sudden cardiac death  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Vascular stent occlusion  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Hepatobiliary disorders       
Cholecystitis  1  1/330 (0.30%)  1/655 (0.15%)  2/985 (0.20%) 
Cholelithiasis  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Hepatic steatosis  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Hepatocellular injury  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Infections and infestations       
Pneumonia  1  2/330 (0.61%)  3/655 (0.46%)  5/985 (0.51%) 
Cellulitis  1  0/330 (0.00%)  3/655 (0.46%)  3/985 (0.30%) 
Bronchitis  1  0/330 (0.00%)  2/655 (0.31%)  2/985 (0.20%) 
Gastroenteritis  1  1/330 (0.30%)  1/655 (0.15%)  2/985 (0.20%) 
Hepatitis E  1  0/330 (0.00%)  2/655 (0.31%)  2/985 (0.20%) 
Catheter site infection  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Clostridium difficile colitis  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Corneal abscess  1  1/330 (0.30%)  0/655 (0.00%)  1/985 (0.10%) 
Cystitis bacterial  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Device related sepsis  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Diverticulitis  1  1/330 (0.30%)  0/655 (0.00%)  1/985 (0.10%) 
Haematoma infection  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Lung infection  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Peritoneal abscess  1  1/330 (0.30%)  0/655 (0.00%)  1/985 (0.10%) 
Pneumonia pseudomonal  1  1/330 (0.30%)  0/655 (0.00%)  1/985 (0.10%) 
Postoperative abscess  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Postoperative wound infection  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Pyelonephritis  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Stitch abscess  1  1/330 (0.30%)  0/655 (0.00%)  1/985 (0.10%) 
Viral myocarditis  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Injury, poisoning and procedural complications       
Muscle rupture  1  1/330 (0.30%)  1/655 (0.15%)  2/985 (0.20%) 
Subarachnoid haemorrhage  1  0/330 (0.00%)  2/655 (0.31%)  2/985 (0.20%) 
Acetabulum fracture  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Alcohol poisoning  1  1/330 (0.30%)  0/655 (0.00%)  1/985 (0.10%) 
Animal bite  1  1/330 (0.30%)  0/655 (0.00%)  1/985 (0.10%) 
Arthropod bite  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Cardiac valve replacement complication  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Fall  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Femoral neck fracture  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Humerus fracture  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Intentional overdose  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Ligament sprain  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Lumbar vertebral fracture  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Multiple injuries  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Post procedural haemorrhage  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Procedural haemorrhage  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Pubis fracture  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Rib fracture  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Road traffic accident  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Sternal fracture  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Subdural haematoma  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Tendon rupture  1  1/330 (0.30%)  0/655 (0.00%)  1/985 (0.10%) 
Thermal burn  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Thoracic vertebral fracture  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Tibia fracture  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Upper limb fracture  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Vascular bypass dysfunction  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Vascular graft thrombosis  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Wound dehiscence  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Investigations       
Alanine aminotransferase increased  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Anticoagulation drug level above therapeutic  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Aspartate aminotransferase increased  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Heart rate irregular  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Transaminases increased  1  1/330 (0.30%)  0/655 (0.00%)  1/985 (0.10%) 
Weight decreased  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Metabolism and nutrition disorders       
Hyperglycaemia  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Malnutrition  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Type 2 diabetes mellitus  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Musculoskeletal and connective tissue disorders       
Osteoarthritis  1  2/330 (0.61%)  5/655 (0.76%)  7/985 (0.71%) 
Intervertebral disc protrusion  1  1/330 (0.30%)  5/655 (0.76%)  6/985 (0.61%) 
Arthritis  1  1/330 (0.30%)  1/655 (0.15%)  2/985 (0.20%) 
Rheumatoid arthritis  1  1/330 (0.30%)  1/655 (0.15%)  2/985 (0.20%) 
Acquired claw toe  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Arthralgia  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Bone pain  1  1/330 (0.30%)  0/655 (0.00%)  1/985 (0.10%) 
Bursitis  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Exostosis  1  1/330 (0.30%)  0/655 (0.00%)  1/985 (0.10%) 
Fracture pain  1  1/330 (0.30%)  0/655 (0.00%)  1/985 (0.10%) 
Musculoskeletal pain  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Neck pain  1  1/330 (0.30%)  0/655 (0.00%)  1/985 (0.10%) 
Osteonecrosis  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Pain in extremity  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Periarthritis  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Rotator cuff syndrome  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Spinal column stenosis  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Breast cancer  1  1/330 (0.30%)  1/655 (0.15%)  2/985 (0.20%) 
Colon cancer  1  1/330 (0.30%)  1/655 (0.15%)  2/985 (0.20%) 
Adenocarcinoma gastric  1  1/330 (0.30%)  0/655 (0.00%)  1/985 (0.10%) 
Adenocarcinoma of colon  1  1/330 (0.30%)  0/655 (0.00%)  1/985 (0.10%) 
Basal cell carcinoma  1  1/330 (0.30%)  0/655 (0.00%)  1/985 (0.10%) 
Benign pancreatic neoplasm  1  1/330 (0.30%)  0/655 (0.00%)  1/985 (0.10%) 
Bladder transitional cell carcinoma recurrent  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Breast cancer recurrent  1  1/330 (0.30%)  0/655 (0.00%)  1/985 (0.10%) 
Chronic lymphocytic leukaemia stage 0  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Colon adenoma  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Colon cancer metastatic  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Hodgkin's disease  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Invasive ductal breast carcinoma  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Invasive lobular breast carcinoma  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Laryngeal papilloma  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Lobular breast carcinoma in situ  1  1/330 (0.30%)  0/655 (0.00%)  1/985 (0.10%) 
Lung adenocarcinoma  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Lymphocytic leukaemia  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Malignant melanoma  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Meningioma  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Metastatic glioma  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Ovarian adenoma  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Ovarian cancer stage III  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Papillary cystadenoma lymphomatosum  1  1/330 (0.30%)  0/655 (0.00%)  1/985 (0.10%) 
Phyllodes tumour  1  1/330 (0.30%)  0/655 (0.00%)  1/985 (0.10%) 
Prostate cancer metastatic  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Prostate cancer stage II  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Rectal cancer metastatic  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Salivary gland adenoma  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Squamous cell carcinoma of skin  1  1/330 (0.30%)  0/655 (0.00%)  1/985 (0.10%) 
Nervous system disorders       
Syncope  1  1/330 (0.30%)  6/655 (0.92%)  7/985 (0.71%) 
Transient ischaemic attack  1  0/330 (0.00%)  6/655 (0.92%)  6/985 (0.61%) 
Amnesia  1  2/330 (0.61%)  0/655 (0.00%)  2/985 (0.20%) 
Ischaemic stroke  1  0/330 (0.00%)  2/655 (0.31%)  2/985 (0.20%) 
Presyncope  1  1/330 (0.30%)  1/655 (0.15%)  2/985 (0.20%) 
Carotid arteriosclerosis  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Cervical radiculopathy  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Dementia  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Embolic cerebral infarction  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Focal dyscognitive seizures  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Headache  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Hemiparesis  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Hemiplegia  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Normal pressure hydrocephalus  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Sensory loss  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Toxic encephalopathy  1  1/330 (0.30%)  0/655 (0.00%)  1/985 (0.10%) 
Vascular dementia  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Pregnancy, puerperium and perinatal conditions       
Abortion spontaneous  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Product Issues       
Device defective  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Device loosening  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Psychiatric disorders       
Alcohol withdrawal syndrome  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Alcoholism  1  1/330 (0.30%)  0/655 (0.00%)  1/985 (0.10%) 
Anxiety  1  1/330 (0.30%)  0/655 (0.00%)  1/985 (0.10%) 
Delirium tremens  1  1/330 (0.30%)  0/655 (0.00%)  1/985 (0.10%) 
Depressed mood  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Major depression  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Suicidal ideation  1  1/330 (0.30%)  0/655 (0.00%)  1/985 (0.10%) 
Renal and urinary disorders       
Acute kidney injury  1  2/330 (0.61%)  2/655 (0.31%)  4/985 (0.41%) 
Nephrolithiasis  1  1/330 (0.30%)  3/655 (0.46%)  4/985 (0.41%) 
Renal colic  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Renal failure  1  1/330 (0.30%)  0/655 (0.00%)  1/985 (0.10%) 
Renal impairment  1  1/330 (0.30%)  0/655 (0.00%)  1/985 (0.10%) 
Renal pain  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Ureterolithiasis  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Urinary incontinence  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Reproductive system and breast disorders       
Benign prostatic hyperplasia  1  0/330 (0.00%)  2/655 (0.31%)  2/985 (0.20%) 
Bartholin's cyst  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Ovarian cyst  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Uterine polyp  1  1/330 (0.30%)  0/655 (0.00%)  1/985 (0.10%) 
Vaginal dysplasia  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Respiratory, thoracic and mediastinal disorders       
Chronic obstructive pulmonary disease  1  0/330 (0.00%)  2/655 (0.31%)  2/985 (0.20%) 
Dyspnoea  1  0/330 (0.00%)  2/655 (0.31%)  2/985 (0.20%) 
Acute pulmonary oedema  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Acute respiratory failure  1  1/330 (0.30%)  0/655 (0.00%)  1/985 (0.10%) 
Asthma  1  1/330 (0.30%)  0/655 (0.00%)  1/985 (0.10%) 
Pleural effusion  1  1/330 (0.30%)  0/655 (0.00%)  1/985 (0.10%) 
Pulmonary embolism  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Pulmonary hypertension  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Pulmonary oedema  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Skin and subcutaneous tissue disorders       
Hypersensitivity vasculitis  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Rash generalised  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Vascular disorders       
Hypertension  1  1/330 (0.30%)  1/655 (0.15%)  2/985 (0.20%) 
Neurogenic shock  1  1/330 (0.30%)  1/655 (0.15%)  2/985 (0.20%) 
Air embolism  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Aortic aneurysm  1  1/330 (0.30%)  0/655 (0.00%)  1/985 (0.10%) 
Aortic dissection  1  1/330 (0.30%)  0/655 (0.00%)  1/985 (0.10%) 
Iliac artery occlusion  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Intermittent claudication  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Malignant hypertension  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Peripheral arterial occlusive disease  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
Peripheral artery stenosis  1  0/330 (0.00%)  1/655 (0.15%)  1/985 (0.10%) 
1
Term from vocabulary, MedDRA 20.0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo to Alirocumab 75 or 150 mg Q2W Alirocumab to Alirocumab 75 or 150 mg Q2W Alirocumab: All Participants
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   183/330 (55.45%)   366/655 (55.88%)   549/985 (55.74%) 
Gastrointestinal disorders       
Diarrhoea  1  19/330 (5.76%)  43/655 (6.56%)  62/985 (6.29%) 
General disorders       
Influenza like illness  1  12/330 (3.64%)  40/655 (6.11%)  52/985 (5.28%) 
Injection site reaction  1  26/330 (7.88%)  28/655 (4.27%)  54/985 (5.48%) 
Infections and infestations       
Bronchitis  1  19/330 (5.76%)  41/655 (6.26%)  60/985 (6.09%) 
Influenza  1  34/330 (10.30%)  61/655 (9.31%)  95/985 (9.64%) 
Upper respiratory tract infection  1  31/330 (9.39%)  71/655 (10.84%)  102/985 (10.36%) 
Urinary tract infection  1  21/330 (6.36%)  28/655 (4.27%)  49/985 (4.97%) 
Viral upper respiratory tract infection  1  51/330 (15.45%)  93/655 (14.20%)  144/985 (14.62%) 
Musculoskeletal and connective tissue disorders       
Arthralgia  1  34/330 (10.30%)  53/655 (8.09%)  87/985 (8.83%) 
Back pain  1  26/330 (7.88%)  56/655 (8.55%)  82/985 (8.32%) 
Myalgia  1  15/330 (4.55%)  44/655 (6.72%)  59/985 (5.99%) 
Pain in extremity  1  18/330 (5.45%)  31/655 (4.73%)  49/985 (4.97%) 
Vascular disorders       
Hypertension  1  13/330 (3.94%)  37/655 (5.65%)  50/985 (5.08%) 
1
Term from vocabulary, MedDRA 20.0
Indicates events were collected by systematic assessment
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.
If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.
Results Point of Contact
Name/Title: Trial Transparency Team
Organization: Sanofi
Phone: 800-633-1610 ext 1#
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