Hypercholesterolemia
Conditions
Brief summary
Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds proprotein convertase subtilisin/kexin type 9 (PCSK9). Primary Objective of the study: To evaluate the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels after 12 weeks of treatment in comparison with placebo in participants with LDL-C ≥100 mg/dL (≥2.59 mmol/L) on ongoing stable atorvastatin therapy. Secondary Objectives: * To evaluate the effects of alirocumab on other lipid levels after 12 weeks of treatment in comparison with placebo * To evaluate the safety and tolerability of alirocumab * To evaluate the development of anti-alirocumab antibodies * To evaluate the pharmacokinetics of alirocumab
Detailed description
The duration of study participation depended on the status of the participant at screening: 21 to 27 weeks including a screening/run-in period of 1 to 7 weeks, a double-blind treatment period of 12 weeks, followed by an 8-week follow-up period.
Interventions
DRUGAlirocumab
Two SC injections in the abdomen only
Two subcutaneous (SC) injections in the abdomen only Route of administration: subcutaneous injection (1 mL) in the abdomen
DRUGAtorvastatin
Orally once daily at a stable dose of 5 to 20 mg as background therapy Route of administration: oral administration in the evening
Sponsors
Regeneron Pharmaceuticals
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
: \- Participants with primary hypercholesterolemia treated with atorvastatin at stable dose of 5-20 mg for at least 6 weeks prior to screening and likely to have LDL-C ≥100 mg/dL (≥2.59 mmol/L) at the screening visit. OR \- Participants with primary hypercholesterolemia who were receiving a lipid-lowering treatment other than atorvastatin, or who were not at stable dose of atorvastatin 5-20 mg for at least 6 weeks prior to screening if they were likely to have LDL-C ≥100 mg/dL (≥2.59 mmol/L) after a 6-week run-in treatment period on atorvastatin therapy.
Exclusion criteria
1. LDL-C \<100 mg/dL (\<2.59 mmol/L) * at screening visit for participants who were being treated with stable dose of atorvastatin 5-20 mg for at least 6 weeks prior to screening OR * at the end of the 6-week run-in period on atorvastatin for participants receiving a lipid lowering treatment other than atorvastatin, or not at stable dose of atorvastatin 5-20 mg for at least 6 weeks prior to screening 2. Participants with type 1 diabetes 3. Participants with type 2 diabetes treated with insulin, or without, and considered poorly controlled at screening. The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in Calculated LDL-C at Week 12 - On-Treatment Analysis | Baseline to Week 12 (LOCF) | Calculated LDL-C values were obtained using the Friedewald formula. Baseline adjusted least squares (LS) means and standard errors were estimated using an analysis of covariance (ANCOVA) model including available post-baseline data on treatment from first investigational product (IP) injection up to 21 days after last IP injection (on-treatment analysis). Missing Week 12 data were imputed by last observation carried forward \[LOCF\] method. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Absolute Change From Baseline in Calculated LDL-C (mg/dL) at Week 12 - On-Treatment Analysis | Baseline to Week 12 (LOCF) | Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint. |
| Percentage of Participants Achieving Calculated LDL-C <100 mg/dL (2.59 mmol/L) and < 70 mg/dL (1.81 mmol/L) at Week 12 - On-Treatment Analysis | Week 12 (LOCF) | — |
| Absolute Change From Baseline in Calculated LDL-C (mmol/L) at Week 12 - On-Treatment Analysis | Baseline to Week 12 (LOCF) | Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint. |
| Percent Change From Baseline in Fasting Triglycerides and Lipoprotein (a) at Week 12 - On-Treatment Analysis | Baseline to Week 12 (LOCF) | Since the assumptions of normal distribution and equality of variances were not verified for the lipid parameters, percent changes were expressed as median (inter-quartile range). |
| Absolute Change From Baseline in Apolipoprotein B/Apolipoprotein A-1 (ApoB/ApoA-1) Ratio at Week 12 - On-Treatment Analysis | From Baseline to Week 12 (LOCF) | Adjusted LS mean and standard errors were estimated using the same ANCOVA as for primary endpoint. |
| Percent Change From Baseline in Total Cholesterol, High-Density Lipoprotein Cholesterol (HDL-C), Non-HDL-C, and Apolipoprotein B (Apo-B) at Week 12 - On-Treatment Analysis | Baseline to Week 12 (LOCF) | Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint. |
Countries
Japan
Participant flow
Recruitment details
The study was conducted at 4 centers in Japan. Overall, 162 participants were screened between March 2013 and August 2013, 62 of whom were run-in/screen failures, mainly due to exclusion criteria met.
Pre-assignment details
Randomization was stratified according to atorvastatin dose. Assignment to treatment arms was done centrally using an Interactive Voice/Web Response System in a 1:1:1:1 ratio after confirmation of selection criteria. 100 participants were randomized.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose. | 25 |
| Alirocumab 50 mg Q2W Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose. | 25 |
| Alirocumab 75 mg Q2W Alirocumab 75 mg Q2W for 12-weeks in combination with atorvastatin stable dose. | 25 |
| Alirocumab 150 mg Q2W Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose. | 25 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 0 | 2 |
| Overall Study | Consent withdrawn by participant | 1 | 0 | 0 | 0 |
| Overall Study | Poor compliance to protocol | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Placebo | Alirocumab 50 mg Q2W | Alirocumab 75 mg Q2W | Alirocumab 150 mg Q2W | Total |
|---|---|---|---|---|---|
| Age, Continuous | 58.6 years STANDARD_DEVIATION 9.2 | 57.8 years STANDARD_DEVIATION 12.3 | 56.3 years STANDARD_DEVIATION 12 | 58.2 years STANDARD_DEVIATION 8.8 | 57.7 years STANDARD_DEVIATION 10.6 |
| LDL-C in mg/dL | 121.0 mg/dL STANDARD_DEVIATION 21.1 | 122.2 mg/dL STANDARD_DEVIATION 16.6 | 120.9 mg/dL STANDARD_DEVIATION 16.7 | 120.5 mg/dL STANDARD_DEVIATION 16.2 | 121.2 mg/dL STANDARD_DEVIATION 17.5 |
| Low-Density Lipoprotein Cholesterol (LDL-C) in mmol/L | 3.13 mmol/L STANDARD_DEVIATION 0.55 | 3.16 mmol/L STANDARD_DEVIATION 0.43 | 3.13 mmol/L STANDARD_DEVIATION 0.43 | 3.12 mmol/L STANDARD_DEVIATION 0.42 | 3.14 mmol/L STANDARD_DEVIATION 0.45 |
| Sex: Female, Male Female | 11 Participants | 16 Participants | 12 Participants | 16 Participants | 55 Participants |
| Sex: Female, Male Male | 14 Participants | 9 Participants | 13 Participants | 9 Participants | 45 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 5 / 25 | 11 / 25 | 8 / 25 | 9 / 25 |
| serious Total, serious adverse events | 1 / 25 | 0 / 25 | 0 / 25 | 1 / 25 |
Outcome results
Primary
Percent Change From Baseline in Calculated LDL-C at Week 12 - On-Treatment Analysis
Calculated LDL-C values were obtained using the Friedewald formula. Baseline adjusted least squares (LS) means and standard errors were estimated using an analysis of covariance (ANCOVA) model including available post-baseline data on treatment from first investigational product (IP) injection up to 21 days after last IP injection (on-treatment analysis). Missing Week 12 data were imputed by last observation carried forward \[LOCF\] method.
Time frame: Baseline to Week 12 (LOCF)
Population: Modified Intent-To-Treat (mITT) population included all randomized participants with one baseline and at least one post-baseline calculated LDL-C value on-treatment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Percent Change From Baseline in Calculated LDL-C at Week 12 - On-Treatment Analysis | -2.7 percent change | Standard Error 3.1 |
| Alirocumab 50 mg Q2W | Percent Change From Baseline in Calculated LDL-C at Week 12 - On-Treatment Analysis | -54.8 percent change | Standard Error 3.1 |
| Alirocumab 75 mg Q2W | Percent Change From Baseline in Calculated LDL-C at Week 12 - On-Treatment Analysis | -62.3 percent change | Standard Error 3.1 |
| Alirocumab 150 mg Q2W | Percent Change From Baseline in Calculated LDL-C at Week 12 - On-Treatment Analysis | -71.7 percent change | Standard Error 3.1 |
Comparison: Each treatment group was compared to placebo using ANCOVA-derived contrasts.~A hierarchical testing procedure was applied to ensure strong control of overall Type-I error rate at 0.05 level. Order was following:~1. Alirocumab 150 mg Q2W versus placebo~2. Alirocumab 75 mg Q2W versus placebo~3. Alirocumab 50 mg Q2W versus placebo~Testing continued only when high-order test was statistically significant at 5% level.p-value: <0.0001ANCOVA
p-value: <0.0001ANCOVA
p-value: <0.0001ANCOVA
Secondary
Absolute Change From Baseline in Apolipoprotein B/Apolipoprotein A-1 (ApoB/ApoA-1) Ratio at Week 12 - On-Treatment Analysis
Adjusted LS mean and standard errors were estimated using the same ANCOVA as for primary endpoint.
Time frame: From Baseline to Week 12 (LOCF)
Population: Participants of the mITT population with one baseline and at least one post baseline on-treatment value of ApoB/ApoA-1 ratio analyzed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Absolute Change From Baseline in Apolipoprotein B/Apolipoprotein A-1 (ApoB/ApoA-1) Ratio at Week 12 - On-Treatment Analysis | 0.02 ratio | Standard Error 0.02 |
| Alirocumab 50 mg Q2W | Absolute Change From Baseline in Apolipoprotein B/Apolipoprotein A-1 (ApoB/ApoA-1) Ratio at Week 12 - On-Treatment Analysis | -0.30 ratio | Standard Error 0.02 |
| Alirocumab 75 mg Q2W | Absolute Change From Baseline in Apolipoprotein B/Apolipoprotein A-1 (ApoB/ApoA-1) Ratio at Week 12 - On-Treatment Analysis | -0.32 ratio | Standard Error 0.02 |
| Alirocumab 150 mg Q2W | Absolute Change From Baseline in Apolipoprotein B/Apolipoprotein A-1 (ApoB/ApoA-1) Ratio at Week 12 - On-Treatment Analysis | -0.38 ratio | Standard Error 0.02 |
Secondary
Absolute Change From Baseline in Calculated LDL-C (mg/dL) at Week 12 - On-Treatment Analysis
Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.
Time frame: Baseline to Week 12 (LOCF)
Population: mITT population.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Absolute Change From Baseline in Calculated LDL-C (mg/dL) at Week 12 - On-Treatment Analysis | -5.0 mg/dL | Standard Error 3.6 |
| Alirocumab 50 mg Q2W | Absolute Change From Baseline in Calculated LDL-C (mg/dL) at Week 12 - On-Treatment Analysis | -67.1 mg/dL | Standard Error 3.6 |
| Alirocumab 75 mg Q2W | Absolute Change From Baseline in Calculated LDL-C (mg/dL) at Week 12 - On-Treatment Analysis | -74.6 mg/dL | Standard Error 3.6 |
| Alirocumab 150 mg Q2W | Absolute Change From Baseline in Calculated LDL-C (mg/dL) at Week 12 - On-Treatment Analysis | -85.8 mg/dL | Standard Error 3.6 |
Secondary
Absolute Change From Baseline in Calculated LDL-C (mmol/L) at Week 12 - On-Treatment Analysis
Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.
Time frame: Baseline to Week 12 (LOCF)
Population: mITT population.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Absolute Change From Baseline in Calculated LDL-C (mmol/L) at Week 12 - On-Treatment Analysis | -0.1 mmol/L | Standard Error 0.1 |
| Alirocumab 50 mg Q2W | Absolute Change From Baseline in Calculated LDL-C (mmol/L) at Week 12 - On-Treatment Analysis | -1.7 mmol/L | Standard Error 0.1 |
| Alirocumab 75 mg Q2W | Absolute Change From Baseline in Calculated LDL-C (mmol/L) at Week 12 - On-Treatment Analysis | -1.9 mmol/L | Standard Error 0.1 |
| Alirocumab 150 mg Q2W | Absolute Change From Baseline in Calculated LDL-C (mmol/L) at Week 12 - On-Treatment Analysis | -2.2 mmol/L | Standard Error 0.1 |
Secondary
Percentage of Participants Achieving Calculated LDL-C <100 mg/dL (2.59 mmol/L) and < 70 mg/dL (1.81 mmol/L) at Week 12 - On-Treatment Analysis
Time frame: Week 12 (LOCF)
Population: mITT population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Achieving Calculated LDL-C <100 mg/dL (2.59 mmol/L) and < 70 mg/dL (1.81 mmol/L) at Week 12 - On-Treatment Analysis | LDL-C < 70 mg/dL (1.81 mmol/L) | 0.0 percentage of participants |
| Placebo | Percentage of Participants Achieving Calculated LDL-C <100 mg/dL (2.59 mmol/L) and < 70 mg/dL (1.81 mmol/L) at Week 12 - On-Treatment Analysis | LDL-C <100 mg/dL (2.59 mmol/L) | 8.0 percentage of participants |
| Alirocumab 50 mg Q2W | Percentage of Participants Achieving Calculated LDL-C <100 mg/dL (2.59 mmol/L) and < 70 mg/dL (1.81 mmol/L) at Week 12 - On-Treatment Analysis | LDL-C <100 mg/dL (2.59 mmol/L) | 100.0 percentage of participants |
| Alirocumab 50 mg Q2W | Percentage of Participants Achieving Calculated LDL-C <100 mg/dL (2.59 mmol/L) and < 70 mg/dL (1.81 mmol/L) at Week 12 - On-Treatment Analysis | LDL-C < 70 mg/dL (1.81 mmol/L) | 84.0 percentage of participants |
| Alirocumab 75 mg Q2W | Percentage of Participants Achieving Calculated LDL-C <100 mg/dL (2.59 mmol/L) and < 70 mg/dL (1.81 mmol/L) at Week 12 - On-Treatment Analysis | LDL-C <100 mg/dL (2.59 mmol/L) | 100.0 percentage of participants |
| Alirocumab 75 mg Q2W | Percentage of Participants Achieving Calculated LDL-C <100 mg/dL (2.59 mmol/L) and < 70 mg/dL (1.81 mmol/L) at Week 12 - On-Treatment Analysis | LDL-C < 70 mg/dL (1.81 mmol/L) | 84.0 percentage of participants |
| Alirocumab 150 mg Q2W | Percentage of Participants Achieving Calculated LDL-C <100 mg/dL (2.59 mmol/L) and < 70 mg/dL (1.81 mmol/L) at Week 12 - On-Treatment Analysis | LDL-C < 70 mg/dL (1.81 mmol/L) | 88.0 percentage of participants |
| Alirocumab 150 mg Q2W | Percentage of Participants Achieving Calculated LDL-C <100 mg/dL (2.59 mmol/L) and < 70 mg/dL (1.81 mmol/L) at Week 12 - On-Treatment Analysis | LDL-C <100 mg/dL (2.59 mmol/L) | 100.0 percentage of participants |
Secondary
Percent Change From Baseline in Fasting Triglycerides and Lipoprotein (a) at Week 12 - On-Treatment Analysis
Since the assumptions of normal distribution and equality of variances were not verified for the lipid parameters, percent changes were expressed as median (inter-quartile range).
Time frame: Baseline to Week 12 (LOCF)
Population: Participants of the mITT population with one baseline and at least one post baseline on-treatment value of Fasting Triglycerides and Lipoprotein (a) analyzed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Percent Change From Baseline in Fasting Triglycerides and Lipoprotein (a) at Week 12 - On-Treatment Analysis | Fasting Triglycerides | 1.3 percent change |
| Placebo | Percent Change From Baseline in Fasting Triglycerides and Lipoprotein (a) at Week 12 - On-Treatment Analysis | Lipoprotein (a) | -3.7 percent change |
| Alirocumab 50 mg Q2W | Percent Change From Baseline in Fasting Triglycerides and Lipoprotein (a) at Week 12 - On-Treatment Analysis | Lipoprotein (a) | -35.6 percent change |
| Alirocumab 50 mg Q2W | Percent Change From Baseline in Fasting Triglycerides and Lipoprotein (a) at Week 12 - On-Treatment Analysis | Fasting Triglycerides | -21.1 percent change |
| Alirocumab 75 mg Q2W | Percent Change From Baseline in Fasting Triglycerides and Lipoprotein (a) at Week 12 - On-Treatment Analysis | Fasting Triglycerides | -10.7 percent change |
| Alirocumab 75 mg Q2W | Percent Change From Baseline in Fasting Triglycerides and Lipoprotein (a) at Week 12 - On-Treatment Analysis | Lipoprotein (a) | -40.2 percent change |
| Alirocumab 150 mg Q2W | Percent Change From Baseline in Fasting Triglycerides and Lipoprotein (a) at Week 12 - On-Treatment Analysis | Fasting Triglycerides | -15.0 percent change |
| Alirocumab 150 mg Q2W | Percent Change From Baseline in Fasting Triglycerides and Lipoprotein (a) at Week 12 - On-Treatment Analysis | Lipoprotein (a) | -43.3 percent change |
Secondary
Percent Change From Baseline in Total Cholesterol, High-Density Lipoprotein Cholesterol (HDL-C), Non-HDL-C, and Apolipoprotein B (Apo-B) at Week 12 - On-Treatment Analysis
Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.
Time frame: Baseline to Week 12 (LOCF)
Population: Participants of the mITT population with one baseline and at least one post baseline on-treatment value of lipid parameters analyzed.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percent Change From Baseline in Total Cholesterol, High-Density Lipoprotein Cholesterol (HDL-C), Non-HDL-C, and Apolipoprotein B (Apo-B) at Week 12 - On-Treatment Analysis | Total Cholesterol | -1.2 percent change | Standard Error 2.1 |
| Placebo | Percent Change From Baseline in Total Cholesterol, High-Density Lipoprotein Cholesterol (HDL-C), Non-HDL-C, and Apolipoprotein B (Apo-B) at Week 12 - On-Treatment Analysis | HDL-C | -0.2 percent change | Standard Error 2 |
| Placebo | Percent Change From Baseline in Total Cholesterol, High-Density Lipoprotein Cholesterol (HDL-C), Non-HDL-C, and Apolipoprotein B (Apo-B) at Week 12 - On-Treatment Analysis | Non-HDL-C | -0.9 percent change | Standard Error 2.9 |
| Placebo | Percent Change From Baseline in Total Cholesterol, High-Density Lipoprotein Cholesterol (HDL-C), Non-HDL-C, and Apolipoprotein B (Apo-B) at Week 12 - On-Treatment Analysis | Apo-B | -2.3 percent change | Standard Error 3.3 |
| Alirocumab 50 mg Q2W | Percent Change From Baseline in Total Cholesterol, High-Density Lipoprotein Cholesterol (HDL-C), Non-HDL-C, and Apolipoprotein B (Apo-B) at Week 12 - On-Treatment Analysis | Apo-B | -43.5 percent change | Standard Error 3.3 |
| Alirocumab 50 mg Q2W | Percent Change From Baseline in Total Cholesterol, High-Density Lipoprotein Cholesterol (HDL-C), Non-HDL-C, and Apolipoprotein B (Apo-B) at Week 12 - On-Treatment Analysis | Non-HDL-C | -46.3 percent change | Standard Error 2.9 |
| Alirocumab 50 mg Q2W | Percent Change From Baseline in Total Cholesterol, High-Density Lipoprotein Cholesterol (HDL-C), Non-HDL-C, and Apolipoprotein B (Apo-B) at Week 12 - On-Treatment Analysis | HDL-C | 5.1 percent change | Standard Error 2 |
| Alirocumab 50 mg Q2W | Percent Change From Baseline in Total Cholesterol, High-Density Lipoprotein Cholesterol (HDL-C), Non-HDL-C, and Apolipoprotein B (Apo-B) at Week 12 - On-Treatment Analysis | Total Cholesterol | -31.9 percent change | Standard Error 2.1 |
| Alirocumab 75 mg Q2W | Percent Change From Baseline in Total Cholesterol, High-Density Lipoprotein Cholesterol (HDL-C), Non-HDL-C, and Apolipoprotein B (Apo-B) at Week 12 - On-Treatment Analysis | Non-HDL-C | -53.1 percent change | Standard Error 2.9 |
| Alirocumab 75 mg Q2W | Percent Change From Baseline in Total Cholesterol, High-Density Lipoprotein Cholesterol (HDL-C), Non-HDL-C, and Apolipoprotein B (Apo-B) at Week 12 - On-Treatment Analysis | Apo-B | -48.6 percent change | Standard Error 3.3 |
| Alirocumab 75 mg Q2W | Percent Change From Baseline in Total Cholesterol, High-Density Lipoprotein Cholesterol (HDL-C), Non-HDL-C, and Apolipoprotein B (Apo-B) at Week 12 - On-Treatment Analysis | HDL-C | 5.0 percent change | Standard Error 2 |
| Alirocumab 75 mg Q2W | Percent Change From Baseline in Total Cholesterol, High-Density Lipoprotein Cholesterol (HDL-C), Non-HDL-C, and Apolipoprotein B (Apo-B) at Week 12 - On-Treatment Analysis | Total Cholesterol | -36.3 percent change | Standard Error 2.1 |
| Alirocumab 150 mg Q2W | Percent Change From Baseline in Total Cholesterol, High-Density Lipoprotein Cholesterol (HDL-C), Non-HDL-C, and Apolipoprotein B (Apo-B) at Week 12 - On-Treatment Analysis | HDL-C | 3.2 percent change | Standard Error 2.1 |
| Alirocumab 150 mg Q2W | Percent Change From Baseline in Total Cholesterol, High-Density Lipoprotein Cholesterol (HDL-C), Non-HDL-C, and Apolipoprotein B (Apo-B) at Week 12 - On-Treatment Analysis | Total Cholesterol | -41.4 percent change | Standard Error 2.1 |
| Alirocumab 150 mg Q2W | Percent Change From Baseline in Total Cholesterol, High-Density Lipoprotein Cholesterol (HDL-C), Non-HDL-C, and Apolipoprotein B (Apo-B) at Week 12 - On-Treatment Analysis | Apo-B | -60.0 percent change | Standard Error 3.3 |
| Alirocumab 150 mg Q2W | Percent Change From Baseline in Total Cholesterol, High-Density Lipoprotein Cholesterol (HDL-C), Non-HDL-C, and Apolipoprotein B (Apo-B) at Week 12 - On-Treatment Analysis | Non-HDL-C | -62.2 percent change | Standard Error 2.9 |