Trial Outcomes & Findings for Efficacy and Safety of Alirocumab in Patients With Hypercholesterolemia Not Adequately Controlled With Non-statin Lipid Modifying Therapy or the Lowest Strength of Statin (NCT NCT02584504)

Results Overview

Adjusted Least-squares (LS) means and standard errors at Week 12 were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data. All available post-baseline data from Week 4 to Week 12 regardless of status on- or off-treatment were used in the model (ITT analysis).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

163 participants

Primary outcome timeframe

From Baseline to Week 12

Results posted on

2019-01-23

Participant Flow

The study was conducted at 30 active centers in Japan. Overall 241 participants were screened between 30 November 2015 and 19 October 2016, of whom 78 were screen failures and 163 were randomized. Screen failures were mainly due to exclusion criteria met.

Randomization stratified per background statin therapy (Yes/No). "No statin" also stratified per background fibrate/ezetimibe therapy (Yes/No), 'Yes' =fibrate/ezetimibe, 'No' =diet therapy alone. Randomization followed 1:1:1 ratio (Alirocumab 150 mg Q4W: Alirocumab 150 mg Q2W: Placebo Q2W).

Participant milestones

Participant milestones
Measure	Alirocumab 150 mg Q4W In double-blind treatment period (DBTP), participants received Alirocumab 150 mg subcutaneous (SC) injection every 4 weeks (Q4W) alternating with placebo (for alirocumab) Q4W added to lowest-strength statin therapy (atorvastatin 5 mg daily), stable non-statin Lipid-Modifying Therapy (LMT) or diet therapy alone for 12 weeks. Participants who completed DBTP, entered in open-label treatment period (OLTP) and received alirocumab 150 mg Q4W up to additional 52 weeks (up to Week 64). Alirocumab dose up-titrated to 150 mg every 2 weeks (Q2W) at Week 24 (Week 12 of OLTP), when LDL-C levels ≥100 mg/dL (2.59 mmol/L) or ≥120 mg/dL (3.10 mmol/L) at Week 20 according to Japan Atherosclerosis Society (JAS) Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.	Alirocumab 150 mg Q2W In DBTP, participants received Alirocumab 150 mg SC injection Q2W added to lowest-strength statin therapy (atorvastatin 5 mg), stable non-statin LMT or diet therapy alone for 12 weeks. Participants who completed DBTP were entered in OLTP and received alirocumab 150 mg Q4W up to additional 52 weeks (up to Week 64). Alirocumab dose up-titrated to 150 mg Q2W at Week 24 (Week 12 of OLTP), when LDL-C levels ≥100 mg/dL (2.59 mmol/L) or ≥120 mg/dL (3.10 mmol/L) at Week 20 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.	Placebo Q2W In DBTP, participants received Placebo (for alirocumab) SC injection Q2W added to lowest-strength statin therapy (atorvastatin 5 mg), stable non-statin LMT or diet therapy alone for 12 weeks. Participants who completed DBTP were entered in OLTP and received alirocumab 150 mg Q4W up to additional 52 weeks (up to Week 64). Alirocumab dose up-titrated to 150 mg Q2W at Week 24 (Week 12 of OLTP), when LDL-C levels ≥100 mg/dL (2.59 mmol/L) or ≥120 mg/dL (3.10 mmol/L) at Week 20 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
Double-blind Treatment STARTED	54	53	56
Double-blind Treatment ITT Population	54	53	56
Double-blind Treatment mITT Population	54	53	56
Double-blind Treatment Safety Population	54	53	56
Double-blind Treatment COMPLETED	54	51	55
Double-blind Treatment NOT COMPLETED	0	2	1
Open-label Treatment STARTED	54	51	55
Open-label Treatment Treated	54	50	54
Open-label Treatment COMPLETED	52	47	47
Open-label Treatment NOT COMPLETED	2	4	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Alirocumab 150 mg Q4W In double-blind treatment period (DBTP), participants received Alirocumab 150 mg subcutaneous (SC) injection every 4 weeks (Q4W) alternating with placebo (for alirocumab) Q4W added to lowest-strength statin therapy (atorvastatin 5 mg daily), stable non-statin Lipid-Modifying Therapy (LMT) or diet therapy alone for 12 weeks. Participants who completed DBTP, entered in open-label treatment period (OLTP) and received alirocumab 150 mg Q4W up to additional 52 weeks (up to Week 64). Alirocumab dose up-titrated to 150 mg every 2 weeks (Q2W) at Week 24 (Week 12 of OLTP), when LDL-C levels ≥100 mg/dL (2.59 mmol/L) or ≥120 mg/dL (3.10 mmol/L) at Week 20 according to Japan Atherosclerosis Society (JAS) Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.	Alirocumab 150 mg Q2W In DBTP, participants received Alirocumab 150 mg SC injection Q2W added to lowest-strength statin therapy (atorvastatin 5 mg), stable non-statin LMT or diet therapy alone for 12 weeks. Participants who completed DBTP were entered in OLTP and received alirocumab 150 mg Q4W up to additional 52 weeks (up to Week 64). Alirocumab dose up-titrated to 150 mg Q2W at Week 24 (Week 12 of OLTP), when LDL-C levels ≥100 mg/dL (2.59 mmol/L) or ≥120 mg/dL (3.10 mmol/L) at Week 20 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.	Placebo Q2W In DBTP, participants received Placebo (for alirocumab) SC injection Q2W added to lowest-strength statin therapy (atorvastatin 5 mg), stable non-statin LMT or diet therapy alone for 12 weeks. Participants who completed DBTP were entered in OLTP and received alirocumab 150 mg Q4W up to additional 52 weeks (up to Week 64). Alirocumab dose up-titrated to 150 mg Q2W at Week 24 (Week 12 of OLTP), when LDL-C levels ≥100 mg/dL (2.59 mmol/L) or ≥120 mg/dL (3.10 mmol/L) at Week 20 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
Double-blind Treatment Participant withdrew consent	0	0	1
Double-blind Treatment Adverse Event	0	1	0
Double-blind Treatment Family Matter	0	1	0
Open-label Treatment Participant withdrew consent	0	0	4
Open-label Treatment Adverse Event	2	2	3
Open-label Treatment Physician Decision	0	1	0
Open-label Treatment Entered but not treated	0	1	1

Baseline Characteristics

Efficacy and Safety of Alirocumab in Patients With Hypercholesterolemia Not Adequately Controlled With Non-statin Lipid Modifying Therapy or the Lowest Strength of Statin

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Alirocumab 150 mg Q4W n=54 Participants In DBTP, participants received Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to lowest-strength of statin therapy (atorvastatin 5 mg daily), stable non-statin LMT or diet therapy alone for 12 weeks. Participants who completed DBTP were entered in OLTP and received alirocumab 150 mg Q4W up to additional 52 weeks (up to Week 64). Alirocumab dose up-titrated to 150 mg Q2W at Week 24 (Week 12 of OLTP), when LDL-C levels ≥100 mg/dL (2.59 mmol/L) or ≥120 mg/dL (3.10 mmol/L) at Week 20 according to Japan Atherosclerosis Society (JAS) Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.	Alirocumab 150 mg Q2W n=53 Participants In DBTP, participants received Alirocumab 150 mg SC injection Q2W added to lowest-strength statin therapy (atorvastatin 5 mg), stable non-statin LMT or diet therapy alone for 12 weeks. Participants who completed DBTP were entered in OLTP and received alirocumab 150 mg Q4W up to additional 52 weeks (up to Week 64). Alirocumab dose up-titrated to 150 mg Q2W at Week 24 (Week 12 of OLTP), when LDL-C levels ≥100 mg/dL (2.59 mmol/L) or ≥120 mg/dL (3.10 mmol/L) at Week 20 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.	Placebo Q2W n=56 Participants In DBTP, participants received Placebo (for alirocumab) SC injection Q2W added to lowest-strength statin therapy (atorvastatin 5 mg), stable non-statin LMT or diet therapy alone for 12 weeks. Participants who completed DBTP were entered in OLTP and received alirocumab 150 mg Q4W up to additional 52 weeks (up to Week 64). Alirocumab dose up-titrated to 150 mg Q2W at Week 24 (Week 12 of OLTP), when LDL-C levels ≥100 mg/dL (2.59 mmol/L) or ≥120 mg/dL (3.10 mmol/L) at Week 20 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.	Total n=163 Participants Total of all reporting groups
Age, Continuous	62.6 years STANDARD_DEVIATION 9.8 • n=5 Participants	63.6 years STANDARD_DEVIATION 10.4 • n=7 Participants	64.6 years STANDARD_DEVIATION 10.0 • n=5 Participants	63.6 years STANDARD_DEVIATION 10.1 • n=4 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	20 Participants n=7 Participants	19 Participants n=5 Participants	60 Participants n=4 Participants
Sex: Female, Male Male	33 Participants n=5 Participants	33 Participants n=7 Participants	37 Participants n=5 Participants	103 Participants n=4 Participants
Race/Ethnicity, Customized Asian	54 Participants n=5 Participants	53 Participants n=7 Participants	56 Participants n=5 Participants	163 Participants n=4 Participants
Calculated LDL-C in mg/dL	154.2 mg/dL STANDARD_DEVIATION 59.5 • n=5 Participants	149.2 mg/dL STANDARD_DEVIATION 31.1 • n=7 Participants	149.4 mg/dL STANDARD_DEVIATION 32.6 • n=5 Participants	150.9 mg/dL STANDARD_DEVIATION 42.8 • n=4 Participants
Calculated LDL-C in mmol/L	3.993 mmol/L STANDARD_DEVIATION 1.541 • n=5 Participants	3.865 mmol/L STANDARD_DEVIATION 0.806 • n=7 Participants	3.870 mmol/L STANDARD_DEVIATION 0.844 • n=5 Participants	3.909 mmol/L STANDARD_DEVIATION 1.109 • n=4 Participants

PRIMARY outcome

Timeframe: From Baseline to Week 12

Population: ITT population: all randomized participants with one baseline and at least one post-baseline calculated LDL-C value on- or off-treatment.

Adjusted Least-squares (LS) means and standard errors at Week 12 were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data. All available post-baseline data from Week 4 to Week 12 regardless of status on- or off-treatment were used in the model (ITT analysis).

Outcome measures

Outcome measures
Measure	Alirocumab 150 mg Q4W n=54 Participants Participants received Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to lowest-strength of statin therapy (atorvastatin 5 mg daily), stable non-statin LMT or diet therapy alone for 12 weeks in DBTP.	Alirocumab 150 mg Q2W n=53 Participants Participants received Alirocumab 150 mg SC injection Q2W added to lowest-strength statin therapy (atorvastatin 5 mg), stable non-statin LMT or diet therapy alone for 12 weeks in DBTP.	Placebo Q2W n=56 Participants Participants received Placebo (for alirocumab) SC injection Q2W added to lowest-strength statin therapy (atorvastatin 5 mg), stable non-statin LMT or diet therapy alone for 12 weeks in DBTP.
Percent Change From Baseline in Calculated LDL-C at Week 12- Intent to Treat (ITT) Analysis	-43.8 percent change Standard Error 2.2	-70.1 percent change Standard Error 2.3	-4.3 percent change Standard Error 2.2

SECONDARY outcome

Timeframe: From Baseline to Week 12

Population: Modified ITT (mITT) population: all randomized and treated participants with one baseline and at least one post-baseline calculated LDL-C value on-treatment.

Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 12 (i.e. up to 21 days after last double-blind injection).

Outcome measures

Outcome measures
Measure	Alirocumab 150 mg Q4W n=54 Participants Participants received Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to lowest-strength of statin therapy (atorvastatin 5 mg daily), stable non-statin LMT or diet therapy alone for 12 weeks in DBTP.	Alirocumab 150 mg Q2W n=53 Participants Participants received Alirocumab 150 mg SC injection Q2W added to lowest-strength statin therapy (atorvastatin 5 mg), stable non-statin LMT or diet therapy alone for 12 weeks in DBTP.	Placebo Q2W n=56 Participants Participants received Placebo (for alirocumab) SC injection Q2W added to lowest-strength statin therapy (atorvastatin 5 mg), stable non-statin LMT or diet therapy alone for 12 weeks in DBTP.
Percent Change From Baseline in Calculated LDL-C at Week 12- On-Treatment Analysis	-43.4 percent change Standard Error 2.1	-70.1 percent change Standard Error 2.2	-2.8 percent change Standard Error 2.1

SECONDARY outcome

Timeframe: From Baseline to Week 12

Population: ITT population.

Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 12 regardless of status on- or off-treatment and assigning a weight of 0.5 for Week 10 and 12 time points.

Outcome measures

Outcome measures
Measure	Alirocumab 150 mg Q4W n=54 Participants Participants received Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to lowest-strength of statin therapy (atorvastatin 5 mg daily), stable non-statin LMT or diet therapy alone for 12 weeks in DBTP.	Alirocumab 150 mg Q2W n=53 Participants Participants received Alirocumab 150 mg SC injection Q2W added to lowest-strength statin therapy (atorvastatin 5 mg), stable non-statin LMT or diet therapy alone for 12 weeks in DBTP.	Placebo Q2W n=56 Participants Participants received Placebo (for alirocumab) SC injection Q2W added to lowest-strength statin therapy (atorvastatin 5 mg), stable non-statin LMT or diet therapy alone for 12 weeks in DBTP.
Percent Change From Baseline in Calculated LDL-C to Averaged Week 10 to 12: ITT Analysis	-54.2 percent change Standard Error 1.9	-69.9 percent change Standard Error 1.9	-3.7 percent change Standard Error 1.9

SECONDARY outcome

Timeframe: From Baseline to Week 12

Population: mITT population.

Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 12 (i.e. up to 21 days after last double-blind injection) and assigning a weight of 0.5 for Week 10 and 12 time points.

Outcome measures

Outcome measures
Measure	Alirocumab 150 mg Q4W n=54 Participants Participants received Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to lowest-strength of statin therapy (atorvastatin 5 mg daily), stable non-statin LMT or diet therapy alone for 12 weeks in DBTP.	Alirocumab 150 mg Q2W n=53 Participants Participants received Alirocumab 150 mg SC injection Q2W added to lowest-strength statin therapy (atorvastatin 5 mg), stable non-statin LMT or diet therapy alone for 12 weeks in DBTP.	Placebo Q2W n=56 Participants Participants received Placebo (for alirocumab) SC injection Q2W added to lowest-strength statin therapy (atorvastatin 5 mg), stable non-statin LMT or diet therapy alone for 12 weeks in DBTP.
Percent Change From Baseline in Calculated LDL-C to Averaged Week 10 to 12- On-Treatment Analysis	-54.0 percent change Standard Error 1.9	-69.9 percent change Standard Error 1.9	-2.6 percent change Standard Error 1.9

SECONDARY outcome

Timeframe: From Baseline to Week 12

Population: Participants of the ITT population with one baseline and at least one post-baseline Apo B value on- or off-treatment (Apo B ITT population).

Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 12 regardless of status on- or off-treatment.

Outcome measures

Outcome measures
Measure	Alirocumab 150 mg Q4W n=54 Participants Participants received Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to lowest-strength of statin therapy (atorvastatin 5 mg daily), stable non-statin LMT or diet therapy alone for 12 weeks in DBTP.	Alirocumab 150 mg Q2W n=53 Participants Participants received Alirocumab 150 mg SC injection Q2W added to lowest-strength statin therapy (atorvastatin 5 mg), stable non-statin LMT or diet therapy alone for 12 weeks in DBTP.	Placebo Q2W n=56 Participants Participants received Placebo (for alirocumab) SC injection Q2W added to lowest-strength statin therapy (atorvastatin 5 mg), stable non-statin LMT or diet therapy alone for 12 weeks in DBTP.
Percent Change From Baseline in Apolipoprotein B (Apo-B) at Week 12: ITT Analysis	-32.2 percent change Standard Error 2.0	-57.9 percent change Standard Error 2.0	-6.0 percent change Standard Error 2.0

SECONDARY outcome

Timeframe: From Baseline to Week 12

Population: Participants of the mITT population with one baseline and at least one post-baseline Apo B value on-treatment (Apo-B mITT population).

Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including available post-baseline on-treatment data at from Week 4 to Week 12 (i.e. up to 21 days after last double-blind injection).

Outcome measures

Outcome measures
Measure	Alirocumab 150 mg Q4W n=54 Participants Participants received Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to lowest-strength of statin therapy (atorvastatin 5 mg daily), stable non-statin LMT or diet therapy alone for 12 weeks in DBTP.	Alirocumab 150 mg Q2W n=53 Participants Participants received Alirocumab 150 mg SC injection Q2W added to lowest-strength statin therapy (atorvastatin 5 mg), stable non-statin LMT or diet therapy alone for 12 weeks in DBTP.	Placebo Q2W n=55 Participants Participants received Placebo (for alirocumab) SC injection Q2W added to lowest-strength statin therapy (atorvastatin 5 mg), stable non-statin LMT or diet therapy alone for 12 weeks in DBTP.
Percent Change From Baseline in Apo-B at Week 12- On-Treatment Analysis	-31.8 percent change Standard Error 2.0	-58.0 percent change Standard Error 2.0	-4.6 percent change Standard Error 1.9

SECONDARY outcome

Timeframe: From Baseline to Week 12

Population: Participants of the ITT population with one baseline and at least one post-baseline non-HDL-C value on- or off-treatment (non-HDL-C ITT population).

Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 12 regardless of status on- or off-treatment.

Outcome measures

Outcome measures
Measure	Alirocumab 150 mg Q4W n=54 Participants Participants received Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to lowest-strength of statin therapy (atorvastatin 5 mg daily), stable non-statin LMT or diet therapy alone for 12 weeks in DBTP.	Alirocumab 150 mg Q2W n=53 Participants Participants received Alirocumab 150 mg SC injection Q2W added to lowest-strength statin therapy (atorvastatin 5 mg), stable non-statin LMT or diet therapy alone for 12 weeks in DBTP.	Placebo Q2W n=56 Participants Participants received Placebo (for alirocumab) SC injection Q2W added to lowest-strength statin therapy (atorvastatin 5 mg), stable non-statin LMT or diet therapy alone for 12 weeks in DBTP.
Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12: ITT Analysis	-36.2 percent change Standard Error 2.0	-61.1 percent change Standard Error 2.0	-4.9 percent change Standard Error 2.0

SECONDARY outcome

Timeframe: From Baseline to Week 12

Population: Participants of the mITT population with one baseline and at least one post-baseline non-HDL-C value on- treatment (non-HDL-C mITT population).

Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 12 (i.e. up to 21 days after last double-blind injection).

Outcome measures

Outcome measures
Measure	Alirocumab 150 mg Q4W n=54 Participants Participants received Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to lowest-strength of statin therapy (atorvastatin 5 mg daily), stable non-statin LMT or diet therapy alone for 12 weeks in DBTP.	Alirocumab 150 mg Q2W n=53 Participants Participants received Alirocumab 150 mg SC injection Q2W added to lowest-strength statin therapy (atorvastatin 5 mg), stable non-statin LMT or diet therapy alone for 12 weeks in DBTP.	Placebo Q2W n=56 Participants Participants received Placebo (for alirocumab) SC injection Q2W added to lowest-strength statin therapy (atorvastatin 5 mg), stable non-statin LMT or diet therapy alone for 12 weeks in DBTP.
Percent Change From Baseline in Non-HDL-C at Week 12- On-treatment Analysis	-35.9 percent change Standard Error 1.9	-61.1 percent change Standard Error 2.0	-3.5 percent change Standard Error 1.9

SECONDARY outcome

Timeframe: From Baseline to Week 12

Population: Participants of the ITT population with one baseline and at least one post-baseline total-C value on- or off-treatment (Total-C ITT population).

Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 12 regardless of status on- or off-treatment.

Outcome measures

Outcome measures
Measure	Alirocumab 150 mg Q4W n=54 Participants Participants received Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to lowest-strength of statin therapy (atorvastatin 5 mg daily), stable non-statin LMT or diet therapy alone for 12 weeks in DBTP.	Alirocumab 150 mg Q2W n=53 Participants Participants received Alirocumab 150 mg SC injection Q2W added to lowest-strength statin therapy (atorvastatin 5 mg), stable non-statin LMT or diet therapy alone for 12 weeks in DBTP.	Placebo Q2W n=56 Participants Participants received Placebo (for alirocumab) SC injection Q2W added to lowest-strength statin therapy (atorvastatin 5 mg), stable non-statin LMT or diet therapy alone for 12 weeks in DBTP.
Percent Change From Baseline in Total Cholesterol (Total-C) at Week 12- ITT Analysis	-25.8 percent change Standard Error 1.5	-44.7 percent change Standard Error 1.6	-3.3 percent change Standard Error 1.5

SECONDARY outcome

Timeframe: Up to Week 12

Population: ITT population.

Calculated LDL-C goal was defined as calculated LDL-C \<100 mg/dL (2.59 mmol/L) for heterozygous familiar hypercholesterolemia (heFH) participants or non-familial hypercholesterolemia (non-FH) participants who had a history of documented CHD, or \<120 mg/dL (3.10 mmol/L) for non-FH participants who had a history of documented diseases or other risk factors as defined in JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012. Adjusted percentages at Week 12 were obtained from multiple imputation approach for handling of missing data. All available post-baseline data from Week 4 to Week 12 regardless of status on- or off-treatment were included in the imputation model.

Outcome measures

Outcome measures
Measure	Alirocumab 150 mg Q4W n=54 Participants Participants received Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to lowest-strength of statin therapy (atorvastatin 5 mg daily), stable non-statin LMT or diet therapy alone for 12 weeks in DBTP.	Alirocumab 150 mg Q2W n=53 Participants Participants received Alirocumab 150 mg SC injection Q2W added to lowest-strength statin therapy (atorvastatin 5 mg), stable non-statin LMT or diet therapy alone for 12 weeks in DBTP.	Placebo Q2W n=56 Participants Participants received Placebo (for alirocumab) SC injection Q2W added to lowest-strength statin therapy (atorvastatin 5 mg), stable non-statin LMT or diet therapy alone for 12 weeks in DBTP.
Percentage of Participants Reaching Calculated LDL-C Goal at Week 12- ITT Analysis	85.2 percentage of participants	96.2 percentage of participants	14.3 percentage of participants

SECONDARY outcome

Timeframe: Up to Week 12

Population: mITT population.

Calculated LDL-C goal was defined as calculated LDL-C \<100 mg/dL (2.59 mmol/L) for heFH participants or non-FH participants who had a history of documented CHD, or \<120 mg/dL (3.10 mmol/L) for non-FH participants who had a history of documented diseases or other risk factors as defined in JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012. Adjusted percentages at Week 12 from multiple imputation approach including available post-baseline on-treatment data from Week 4 to Week 12 (i.e. up to 21 days after last double-blind injection).

Outcome measures

Outcome measures
Measure	Alirocumab 150 mg Q4W n=54 Participants Participants received Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to lowest-strength of statin therapy (atorvastatin 5 mg daily), stable non-statin LMT or diet therapy alone for 12 weeks in DBTP.	Alirocumab 150 mg Q2W n=53 Participants Participants received Alirocumab 150 mg SC injection Q2W added to lowest-strength statin therapy (atorvastatin 5 mg), stable non-statin LMT or diet therapy alone for 12 weeks in DBTP.	Placebo Q2W n=56 Participants Participants received Placebo (for alirocumab) SC injection Q2W added to lowest-strength statin therapy (atorvastatin 5 mg), stable non-statin LMT or diet therapy alone for 12 weeks in DBTP.
Percentage of Participants Reaching Calculated LDL-C Goal at Week 12- On-Treatment Analysis	85.2 percentage of participants	96.2 percentage of participants	10.8 percentage of participants

SECONDARY outcome

Timeframe: From Baseline to Week 12

Population: ITT population.

Adjusted means and standard errors at Week 12 were obtained from multiple imputation approach followed by robust regression model for handling of missing data. All available post-baseline data from Week 4 to Week 12 regardless of status on- or off-treatment were included in the imputation model.

Outcome measures

Outcome measures
Measure	Alirocumab 150 mg Q4W n=54 Participants Participants received Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to lowest-strength of statin therapy (atorvastatin 5 mg daily), stable non-statin LMT or diet therapy alone for 12 weeks in DBTP.	Alirocumab 150 mg Q2W n=53 Participants Participants received Alirocumab 150 mg SC injection Q2W added to lowest-strength statin therapy (atorvastatin 5 mg), stable non-statin LMT or diet therapy alone for 12 weeks in DBTP.	Placebo Q2W n=56 Participants Participants received Placebo (for alirocumab) SC injection Q2W added to lowest-strength statin therapy (atorvastatin 5 mg), stable non-statin LMT or diet therapy alone for 12 weeks in DBTP.
Percent Change From Baseline in Lipoprotein (a) at Week 12: ITT Analysis	-31.7 percent change Standard Error 3.3	-49.6 percent change Standard Error 3.3	1.3 percent change Standard Error 3.3

SECONDARY outcome

Timeframe: From Baseline to Week 12

Population: Participants of the ITT population with one baseline and at least one post-baseline HDL-C value on- or off-treatment (HDL-C ITT population).

Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 12 regardless of status on- or off-treatment.

Outcome measures

Outcome measures
Measure	Alirocumab 150 mg Q4W n=54 Participants Participants received Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to lowest-strength of statin therapy (atorvastatin 5 mg daily), stable non-statin LMT or diet therapy alone for 12 weeks in DBTP.	Alirocumab 150 mg Q2W n=53 Participants Participants received Alirocumab 150 mg SC injection Q2W added to lowest-strength statin therapy (atorvastatin 5 mg), stable non-statin LMT or diet therapy alone for 12 weeks in DBTP.	Placebo Q2W n=56 Participants Participants received Placebo (for alirocumab) SC injection Q2W added to lowest-strength statin therapy (atorvastatin 5 mg), stable non-statin LMT or diet therapy alone for 12 weeks in DBTP.
Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12- ITT Analysis	7.7 percent change Standard Error 1.8	9.9 percent change Standard Error 1.8	2.0 percent change Standard Error 1.8

SECONDARY outcome

Timeframe: From Baseline to Week 12

Population: ITT population.

Adjusted means and standard errors at Week 12 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 12 regardless of status on- or off-treatment.

Outcome measures

Outcome measures
Measure	Alirocumab 150 mg Q4W n=54 Participants Participants received Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to lowest-strength of statin therapy (atorvastatin 5 mg daily), stable non-statin LMT or diet therapy alone for 12 weeks in DBTP.	Alirocumab 150 mg Q2W n=53 Participants Participants received Alirocumab 150 mg SC injection Q2W added to lowest-strength statin therapy (atorvastatin 5 mg), stable non-statin LMT or diet therapy alone for 12 weeks in DBTP.	Placebo Q2W n=56 Participants Participants received Placebo (for alirocumab) SC injection Q2W added to lowest-strength statin therapy (atorvastatin 5 mg), stable non-statin LMT or diet therapy alone for 12 weeks in DBTP.
Percent Change From Baseline in Fasting Triglycerides (TGs) at Week 12: ITT Analysis	-0.6 percent change Standard Error 3.7	-18.0 percent change Standard Error 3.8	-6.4 percent change Standard Error 3.7

SECONDARY outcome

Timeframe: From Baseline to Week 12

Population: Participants of the ITT population with one baseline and at least one post-baseline Apo A-1 value on- or off-treatment (Apo A-1 ITT population).

Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 12 regardless of status on- or off-treatment.

Outcome measures

Outcome measures
Measure	Alirocumab 150 mg Q4W n=54 Participants Participants received Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to lowest-strength of statin therapy (atorvastatin 5 mg daily), stable non-statin LMT or diet therapy alone for 12 weeks in DBTP.	Alirocumab 150 mg Q2W n=53 Participants Participants received Alirocumab 150 mg SC injection Q2W added to lowest-strength statin therapy (atorvastatin 5 mg), stable non-statin LMT or diet therapy alone for 12 weeks in DBTP.	Placebo Q2W n=56 Participants Participants received Placebo (for alirocumab) SC injection Q2W added to lowest-strength statin therapy (atorvastatin 5 mg), stable non-statin LMT or diet therapy alone for 12 weeks in DBTP.
Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1) at Week 12: ITT Analysis	6.8 percent change Standard Error 1.6	9.1 percent change Standard Error 1.7	2.9 percent change Standard Error 1.6

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Weeks 20, 24, 36, 48 and 64

Population: Open-label treatment (OLT) population included all randomized participants who received at least one dose or part of dose of open-label investigational medicinal product. Here, "number analyzed" signifies participants with available data at each specified time-point.

Outcome measures

Outcome measures
Measure	Alirocumab 150 mg Q4W n=54 Participants Participants received Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to lowest-strength of statin therapy (atorvastatin 5 mg daily), stable non-statin LMT or diet therapy alone for 12 weeks in DBTP.	Alirocumab 150 mg Q2W n=50 Participants Participants received Alirocumab 150 mg SC injection Q2W added to lowest-strength statin therapy (atorvastatin 5 mg), stable non-statin LMT or diet therapy alone for 12 weeks in DBTP.	Placebo Q2W n=54 Participants Participants received Placebo (for alirocumab) SC injection Q2W added to lowest-strength statin therapy (atorvastatin 5 mg), stable non-statin LMT or diet therapy alone for 12 weeks in DBTP.
Percent Change From Baseline in Calculated LDL-C at Week 20, 24, 36, 48 and 64 -OLTP Analysis Week 20	-42.1 Percent change Standard Deviation 20.1	-47.8 Percent change Standard Deviation 24.2	-45.5 Percent change Standard Deviation 20.5
Percent Change From Baseline in Calculated LDL-C at Week 20, 24, 36, 48 and 64 -OLTP Analysis Week 24	-39.7 Percent change Standard Deviation 20.4	-46.0 Percent change Standard Deviation 20.0	-47.8 Percent change Standard Deviation 21.7
Percent Change From Baseline in Calculated LDL-C at Week 20, 24, 36, 48 and 64 -OLTP Analysis Week 36	-49.2 Percent change Standard Deviation 19.4	-51.5 Percent change Standard Deviation 19.6	-56.2 Percent change Standard Deviation 18.8
Percent Change From Baseline in Calculated LDL-C at Week 20, 24, 36, 48 and 64 -OLTP Analysis Week 48	-48.6 Percent change Standard Deviation 21.6	-53.9 Percent change Standard Deviation 17.6	-57.8 Percent change Standard Deviation 17.4
Percent Change From Baseline in Calculated LDL-C at Week 20, 24, 36, 48 and 64 -OLTP Analysis Week 64	-44.3 Percent change Standard Deviation 22.8	-55.2 Percent change Standard Deviation 17.5	-58.1 Percent change Standard Deviation 19.6

Adverse Events

Double-blind Treatment Period: Placebo Q2W

Serious events: 1 serious events

Other events: 14 other events

Deaths: 0 deaths

Double-blind Treatment Period: Alirocumab 150 mg Q4W

Serious events: 1 serious events

Other events: 11 other events

Deaths: 0 deaths

Double-blind Treatment Period: Alirocumab 150 mg Q2W

Serious events: 2 serious events

Other events: 13 other events

Deaths: 1 deaths

Open-label Treatment Period: Alirocumab 150 mg Q4W/Up Q2W

Serious events: 12 serious events

Other events: 72 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Double-blind Treatment Period: Placebo Q2W n=56 participants at risk Participants received Placebo (for alirocumab) SC injection Q2W added to lowest-strength statin therapy (atorvastatin 5 mg), stable non-statin LMT or diet therapy alone for 12 weeks.	Double-blind Treatment Period: Alirocumab 150 mg Q4W n=54 participants at risk Participants received Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to lowest-strength of statin therapy (atorvastatin 5 mg daily) stable non-statin LMT or diet therapy alone for 12 weeks.	Double-blind Treatment Period: Alirocumab 150 mg Q2W n=53 participants at risk Participants received Alirocumab 150 mg SC injection Q2W added to lowest-strength statin therapy (atorvastatin 5 mg), stable non-statin LMT or diet therapy alone for 12 weeks.	Open-label Treatment Period: Alirocumab 150 mg Q4W/Up Q2W n=158 participants at risk All participants received alirocumab 150 mg Q4W from the start of the open-label treatment period. Alirocumab dose up-titrated from 150 mg Q4W to 150 mg Q2W at Week 24 (Week 12 of OLTP), when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 20 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
Infections and infestations Pharyngitis	0.00% 0/56 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (up to Week 64) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are TEAEs that is AEs that developed/ worsened and death that occurred during 'treatment-emergent period' (time from first dose of study drug up to last dose of study drug +70 days). Analysis performed on safety population which included randomized participants who actually received at least 1 dose or partial dose of double-blind IMP injection for double-blind treatment period and at least 1 dose or partial dose of open-label IMP injection for open-label treatment period.	5.6% 3/54 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (up to Week 64) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are TEAEs that is AEs that developed/ worsened and death that occurred during 'treatment-emergent period' (time from first dose of study drug up to last dose of study drug +70 days). Analysis performed on safety population which included randomized participants who actually received at least 1 dose or partial dose of double-blind IMP injection for double-blind treatment period and at least 1 dose or partial dose of open-label IMP injection for open-label treatment period.	0.00% 0/53 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (up to Week 64) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are TEAEs that is AEs that developed/ worsened and death that occurred during 'treatment-emergent period' (time from first dose of study drug up to last dose of study drug +70 days). Analysis performed on safety population which included randomized participants who actually received at least 1 dose or partial dose of double-blind IMP injection for double-blind treatment period and at least 1 dose or partial dose of open-label IMP injection for open-label treatment period.	3.2% 5/158 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (up to Week 64) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are TEAEs that is AEs that developed/ worsened and death that occurred during 'treatment-emergent period' (time from first dose of study drug up to last dose of study drug +70 days). Analysis performed on safety population which included randomized participants who actually received at least 1 dose or partial dose of double-blind IMP injection for double-blind treatment period and at least 1 dose or partial dose of open-label IMP injection for open-label treatment period.
Infections and infestations Viral upper respiratory tract infection	16.1% 9/56 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (up to Week 64) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are TEAEs that is AEs that developed/ worsened and death that occurred during 'treatment-emergent period' (time from first dose of study drug up to last dose of study drug +70 days). Analysis performed on safety population which included randomized participants who actually received at least 1 dose or partial dose of double-blind IMP injection for double-blind treatment period and at least 1 dose or partial dose of open-label IMP injection for open-label treatment period.	14.8% 8/54 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (up to Week 64) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are TEAEs that is AEs that developed/ worsened and death that occurred during 'treatment-emergent period' (time from first dose of study drug up to last dose of study drug +70 days). Analysis performed on safety population which included randomized participants who actually received at least 1 dose or partial dose of double-blind IMP injection for double-blind treatment period and at least 1 dose or partial dose of open-label IMP injection for open-label treatment period.	15.1% 8/53 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (up to Week 64) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are TEAEs that is AEs that developed/ worsened and death that occurred during 'treatment-emergent period' (time from first dose of study drug up to last dose of study drug +70 days). Analysis performed on safety population which included randomized participants who actually received at least 1 dose or partial dose of double-blind IMP injection for double-blind treatment period and at least 1 dose or partial dose of open-label IMP injection for open-label treatment period.	34.2% 54/158 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (up to Week 64) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are TEAEs that is AEs that developed/ worsened and death that occurred during 'treatment-emergent period' (time from first dose of study drug up to last dose of study drug +70 days). Analysis performed on safety population which included randomized participants who actually received at least 1 dose or partial dose of double-blind IMP injection for double-blind treatment period and at least 1 dose or partial dose of open-label IMP injection for open-label treatment period.
Nervous system disorders Dizziness	5.4% 3/56 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (up to Week 64) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are TEAEs that is AEs that developed/ worsened and death that occurred during 'treatment-emergent period' (time from first dose of study drug up to last dose of study drug +70 days). Analysis performed on safety population which included randomized participants who actually received at least 1 dose or partial dose of double-blind IMP injection for double-blind treatment period and at least 1 dose or partial dose of open-label IMP injection for open-label treatment period.	0.00% 0/54 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (up to Week 64) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are TEAEs that is AEs that developed/ worsened and death that occurred during 'treatment-emergent period' (time from first dose of study drug up to last dose of study drug +70 days). Analysis performed on safety population which included randomized participants who actually received at least 1 dose or partial dose of double-blind IMP injection for double-blind treatment period and at least 1 dose or partial dose of open-label IMP injection for open-label treatment period.	0.00% 0/53 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (up to Week 64) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are TEAEs that is AEs that developed/ worsened and death that occurred during 'treatment-emergent period' (time from first dose of study drug up to last dose of study drug +70 days). Analysis performed on safety population which included randomized participants who actually received at least 1 dose or partial dose of double-blind IMP injection for double-blind treatment period and at least 1 dose or partial dose of open-label IMP injection for open-label treatment period.	1.3% 2/158 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (up to Week 64) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are TEAEs that is AEs that developed/ worsened and death that occurred during 'treatment-emergent period' (time from first dose of study drug up to last dose of study drug +70 days). Analysis performed on safety population which included randomized participants who actually received at least 1 dose or partial dose of double-blind IMP injection for double-blind treatment period and at least 1 dose or partial dose of open-label IMP injection for open-label treatment period.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/56 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (up to Week 64) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are TEAEs that is AEs that developed/ worsened and death that occurred during 'treatment-emergent period' (time from first dose of study drug up to last dose of study drug +70 days). Analysis performed on safety population which included randomized participants who actually received at least 1 dose or partial dose of double-blind IMP injection for double-blind treatment period and at least 1 dose or partial dose of open-label IMP injection for open-label treatment period.	0.00% 0/54 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (up to Week 64) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are TEAEs that is AEs that developed/ worsened and death that occurred during 'treatment-emergent period' (time from first dose of study drug up to last dose of study drug +70 days). Analysis performed on safety population which included randomized participants who actually received at least 1 dose or partial dose of double-blind IMP injection for double-blind treatment period and at least 1 dose or partial dose of open-label IMP injection for open-label treatment period.	1.9% 1/53 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (up to Week 64) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are TEAEs that is AEs that developed/ worsened and death that occurred during 'treatment-emergent period' (time from first dose of study drug up to last dose of study drug +70 days). Analysis performed on safety population which included randomized participants who actually received at least 1 dose or partial dose of double-blind IMP injection for double-blind treatment period and at least 1 dose or partial dose of open-label IMP injection for open-label treatment period.	5.1% 8/158 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (up to Week 64) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are TEAEs that is AEs that developed/ worsened and death that occurred during 'treatment-emergent period' (time from first dose of study drug up to last dose of study drug +70 days). Analysis performed on safety population which included randomized participants who actually received at least 1 dose or partial dose of double-blind IMP injection for double-blind treatment period and at least 1 dose or partial dose of open-label IMP injection for open-label treatment period.
General disorders Non-cardiac chest pain	1.8% 1/56 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (up to Week 64) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are TEAEs that is AEs that developed/ worsened and death that occurred during 'treatment-emergent period' (time from first dose of study drug up to last dose of study drug +70 days). Analysis performed on safety population which included randomized participants who actually received at least 1 dose or partial dose of double-blind IMP injection for double-blind treatment period and at least 1 dose or partial dose of open-label IMP injection for open-label treatment period.	0.00% 0/54 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (up to Week 64) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are TEAEs that is AEs that developed/ worsened and death that occurred during 'treatment-emergent period' (time from first dose of study drug up to last dose of study drug +70 days). Analysis performed on safety population which included randomized participants who actually received at least 1 dose or partial dose of double-blind IMP injection for double-blind treatment period and at least 1 dose or partial dose of open-label IMP injection for open-label treatment period.	7.5% 4/53 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (up to Week 64) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are TEAEs that is AEs that developed/ worsened and death that occurred during 'treatment-emergent period' (time from first dose of study drug up to last dose of study drug +70 days). Analysis performed on safety population which included randomized participants who actually received at least 1 dose or partial dose of double-blind IMP injection for double-blind treatment period and at least 1 dose or partial dose of open-label IMP injection for open-label treatment period.	1.9% 3/158 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (up to Week 64) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are TEAEs that is AEs that developed/ worsened and death that occurred during 'treatment-emergent period' (time from first dose of study drug up to last dose of study drug +70 days). Analysis performed on safety population which included randomized participants who actually received at least 1 dose or partial dose of double-blind IMP injection for double-blind treatment period and at least 1 dose or partial dose of open-label IMP injection for open-label treatment period.
Injury, poisoning and procedural complications Fall	5.4% 3/56 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (up to Week 64) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are TEAEs that is AEs that developed/ worsened and death that occurred during 'treatment-emergent period' (time from first dose of study drug up to last dose of study drug +70 days). Analysis performed on safety population which included randomized participants who actually received at least 1 dose or partial dose of double-blind IMP injection for double-blind treatment period and at least 1 dose or partial dose of open-label IMP injection for open-label treatment period.	0.00% 0/54 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (up to Week 64) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are TEAEs that is AEs that developed/ worsened and death that occurred during 'treatment-emergent period' (time from first dose of study drug up to last dose of study drug +70 days). Analysis performed on safety population which included randomized participants who actually received at least 1 dose or partial dose of double-blind IMP injection for double-blind treatment period and at least 1 dose or partial dose of open-label IMP injection for open-label treatment period.	1.9% 1/53 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (up to Week 64) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are TEAEs that is AEs that developed/ worsened and death that occurred during 'treatment-emergent period' (time from first dose of study drug up to last dose of study drug +70 days). Analysis performed on safety population which included randomized participants who actually received at least 1 dose or partial dose of double-blind IMP injection for double-blind treatment period and at least 1 dose or partial dose of open-label IMP injection for open-label treatment period.	7.0% 11/158 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of study (up to Week 64) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are TEAEs that is AEs that developed/ worsened and death that occurred during 'treatment-emergent period' (time from first dose of study drug up to last dose of study drug +70 days). Analysis performed on safety population which included randomized participants who actually received at least 1 dose or partial dose of double-blind IMP injection for double-blind treatment period and at least 1 dose or partial dose of open-label IMP injection for open-label treatment period.

Additional Information

Trial Transparency Team

Sanofi

Phone: 800-633-1610

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER