Heterozygous Familial Hypercholesterolemia, Non-familial Hypercholesterolemia
Conditions
Brief summary
The primary objective of the study was to evaluate the long term safety of PRALUENT in participants with heterozygous familial hypercholesterolemia (heFH) or non-familial hypercholesterolemia (FH) participants at high or very high cardiovascular risk who completed the neurocognitive function study R727-CL-1532 (NCT02957682). The secondary objectives of the study were: * To evaluate the effect of PRALUENT on low-density lipoprotein cholesterol (LDL-C) * To evaluate the effect of PRALUENT on other lipid parameters * To evaluate the effect of PRALUENT on gonadal steroid hormones
Interventions
DRUGPraluent
Subcutaneous (SC) administration
Sponsors
Sanofi
Regeneron Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: Participants randomized into the neurocognitive function study (R727-CL-1532) who completed treatment and the end of study (EOS) visit with no premature or permanent discontinuation of study drug. Key
Exclusion criteria
1. Significant protocol deviation in the parent study (neurocognitive function study R727-CL-1532: NCT02957682) based on the investigator's or sponsor's judgment, such as noncompliance 2. Any participant who experienced an AE leading to permanent discontinuation from the neurocognitive function study R727-CL-1532 (NCT02957682). 3. Any new condition or worsening of an existing condition which, in the opinion of the investigator or per the PRALUENT local label, would make the participant unsuitable for enrollment or could interfere with the participant participating in or completing the open-label extension (OLE) study 4. Known hypersensitivity to monoclonal antibody or any component of the drug product 5. Pregnant or breastfeeding women Note: Other inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events (AE) After First Administration of Study Drug Through the Last Dose of Study Drug Plus 2 Weeks | After first administration of study drug through the last dose of study drug plus 2 weeks, up to 80 weeks | An AE is any untoward medical occurrence in a participant administered a study drug which may or may not have a causal relationship with the study drug. AEs include serious adverse events (SAEs), AEs leading to treatment discontinuation, and adverse events of special interest (AESI). AESI include local injection site reactions, general allergic events, elevated alanine aminotransferase (ALT) levels greater than or equal to (≥) 3 upper limit normal (ULN) (if baseline is less than (\<) ULN)/ALT ≥2 x ULN (if baseline ≥ ULN), neurologic events, neurocognitive events (according to Customized Medical Dictionary for Regulatory Activities \[MedDRA\] Query \[CMQ\] by Sponsor grouping and CMQ by FDA grouping), cataract, new onset diabetes (NOD), hepatic disorders, and diabetes mellitus (DM)/diabetic complications. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Aspartate Aminotransferase Values From Baseline Over Time | Up to week 72 | The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682) |
| Calculated Low-density Lipoprotein Cholesterol (LDL-C) Values From Baseline Over Time | Up to week 72 | The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682) |
| Percent Change in LDL-C From Baseline Over Time | Up to week 72 | — |
| Total Cholesterol (Total-C) Values From Baseline Over Time | Up to week 72 | The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682) |
| Percent Change From Baseline in Total-C Over Time | Up to week 72 | — |
| Lipoprotein a (Lp(a)) Values From Baseline Over Time | Up to week 72 | The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682) |
| Percent Change From Baseline in Lp(a) Over Time | Up to week 72 | — |
| Non-high-density Lipoprotein Cholesterol (Non-HDL-C) Values From Baseline Over Time | Up to week 72 | The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682) |
| Percent Change From Baseline in Non-HDL-C Over Time | Up to week 72 | — |
| High-density Lipoprotein Cholesterol (HDL-C) Values From Baseline Over Time | Up to week 72 | The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682) |
| Percent Change From Baseline in HDL-C Over Time | Up to week 72 | — |
| Fasting Triglycerides (TGs) Values From Baseline Over Time | Up to week 72 | The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682) |
| Percent Change From Baseline in Fasting TGs Over Time | Up to week 72 | — |
| Change From Baseline in Aspartate Aminotransferase Over Time | Up to week 72 | — |
| Apolipoprotein B (Apo B) Values From Baseline Over Time | Up to week 72 | The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682) |
| Change From Baseline in Alanine Aminotransferase Over Time | Up to week 72 | — |
| Apolipoprotein-A1 (Apo A1) Values From Baseline Over Time | Up to week 72 | The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682) |
| Percent Change From Baseline in Apo A1 Over Time | Up to week 72 | — |
| Gonadal Hormone (Follicle Stimulating Hormone [FSH] and Luteinizing Hormone [LH]) Values for Female Participants From Baseline Over Time | Up to week 72 | The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682) |
| Change From Baseline in Gonadal Hormones (FSH and LH) for Female Participants Over Time | Up to week 72 | — |
| Gonadal (FSH and LH) Hormone Values for Male Participants From Baseline Over Time | Up to week 72 | The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682) |
| Change From Baseline in Gonadal Hormones (FSH and LH) for Male Participants Over Time | Up to week 72 | — |
| Gonadotropin (Estradiol) Values for Female Participants From Baseline Over Time | Up to week 72 | The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682) |
| Change From Baseline in Gonadotropins (Estradiol) for Female Participants Over Time | Up to week 72 | — |
| Gonadotropin (Testosterone) Values for Male Participants From Baseline Over Time | Up to week 72 | The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682) |
| Change From Baseline in Gonadotropins (Testosterone) for Male Participants Over Time | Up to week 72 | — |
| Alanine Aminotransferase Values From Baseline Over Time | Up to week 72 | The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682) |
| Alkaline Phosphatase Values From Baseline Over Time | Up to week 72 | The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682) |
| Change From Baseline in Alkaline Phosphatase Over Time | Up to week 72 | — |
| Total Bilirubin Values From Baseline Over Time | Up to week 72 | The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682) |
| Change From Baseline in Total Bilirubin Over Time | Up to week 72 | — |
| Percent Change From Baseline in Apo B Over Time | Up to week 72 | — |
Countries
Bulgaria, Estonia, Russia, South Africa, Ukraine, United States
Participant flow
Recruitment details
The 1389 participants who completed double-blind treatment and the end-of-study (EOS) visit in R727-CL-1532 (NCT02957682) signed consent and were screened for this open-label study (EOS visit corresponded to day 1/visit 1 of this study).
Pre-assignment details
First subcutaneous (SC) injection was administered in the clinic (day 1/visit 1). Four of the1389 participants discontinued on day 1 before treatment: 2 discontinued due to failure to meet inclusion/exclusion criteria,1 withdrew consent, and 1 discontinued due to adverse event (AE). A total of 1385 participants received any study drug on day 1.
Participants by arm
| Arm | Count |
|---|---|
| Alirocumab 75 Q2W/Up150 Q2W All participants initiated treatment with PRALUENT (alirocumab) at the starting dose of 75 milligrams (mg) once every 2 weeks (Q2W). After week 8, the dose could be adjusted (up to 150 mg Q2W, maintained or from 150 mg Q2W to 75 mg Q2W) if needed based on low-density lipoprotein cholesterol (LDL-C) levels. | 1,385 |
| Total | 1,385 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 9 |
| Overall Study | Not disclosed | 5 |
| Overall Study | Participant moved | 5 |
| Overall Study | Participant withdrew consent | 10 |
| Overall Study | Physician Decision | 4 |
| Overall Study | Protocol became inconvenient to participate | 1 |
| Overall Study | Related to IMP administration | 1 |
| Overall Study | Study terminated by sponsor | 1,350 |
Baseline characteristics
| Characteristic | Alirocumab 75 Q2W/Up150 Q2W |
|---|---|
| Age, Continuous | 64.6 Years STANDARD_DEVIATION 8.63 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1372 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 Participants |
| Race/Ethnicity, Customized Asian | 7 Participants |
| Race/Ethnicity, Customized Black or African American | 81 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race/Ethnicity, Customized Other | 118 Participants |
| Race/Ethnicity, Customized White | 1178 Participants |
| Sex: Female, Male Female | 527 Participants |
| Sex: Female, Male Male | 858 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 5 / 1,385 |
| other Total, other adverse events | 0 / 1,385 |
| serious Total, serious adverse events | 89 / 1,385 |
Outcome results
Primary
Number of Participants With Adverse Events (AE) After First Administration of Study Drug Through the Last Dose of Study Drug Plus 2 Weeks
An AE is any untoward medical occurrence in a participant administered a study drug which may or may not have a causal relationship with the study drug. AEs include serious adverse events (SAEs), AEs leading to treatment discontinuation, and adverse events of special interest (AESI). AESI include local injection site reactions, general allergic events, elevated alanine aminotransferase (ALT) levels greater than or equal to (≥) 3 upper limit normal (ULN) (if baseline is less than (\<) ULN)/ALT ≥2 x ULN (if baseline ≥ ULN), neurologic events, neurocognitive events (according to Customized Medical Dictionary for Regulatory Activities \[MedDRA\] Query \[CMQ\] by Sponsor grouping and CMQ by FDA grouping), cataract, new onset diabetes (NOD), hepatic disorders, and diabetes mellitus (DM)/diabetic complications.
Time frame: After first administration of study drug through the last dose of study drug plus 2 weeks, up to 80 weeks
Population: Safety analysis set (SAF): All participants who received any study drug
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Alirocumab 75 Q2W/Up150 Q2W | Number of Participants With Adverse Events (AE) After First Administration of Study Drug Through the Last Dose of Study Drug Plus 2 Weeks | Any treatment emergent adverse event (TEAE) | 568 Participants |
| Alirocumab 75 Q2W/Up150 Q2W | Number of Participants With Adverse Events (AE) After First Administration of Study Drug Through the Last Dose of Study Drug Plus 2 Weeks | Any treatment emergent serious adverse event (SAE) | 89 Participants |
| Alirocumab 75 Q2W/Up150 Q2W | Number of Participants With Adverse Events (AE) After First Administration of Study Drug Through the Last Dose of Study Drug Plus 2 Weeks | Any TEAE leading to death | 5 Participants |
| Alirocumab 75 Q2W/Up150 Q2W | Number of Participants With Adverse Events (AE) After First Administration of Study Drug Through the Last Dose of Study Drug Plus 2 Weeks | Any TEAE leading to permanent treatment discontinuation | 9 Participants |
| Alirocumab 75 Q2W/Up150 Q2W | Number of Participants With Adverse Events (AE) After First Administration of Study Drug Through the Last Dose of Study Drug Plus 2 Weeks | Any neurocognitive disorders TEAE (by Sponsor CMQ) | 4 Participants |
| Alirocumab 75 Q2W/Up150 Q2W | Number of Participants With Adverse Events (AE) After First Administration of Study Drug Through the Last Dose of Study Drug Plus 2 Weeks | Any neurocognitive disorders TEAE (by FDA CMQ) | 0 Participants |
| Alirocumab 75 Q2W/Up150 Q2W | Number of Participants With Adverse Events (AE) After First Administration of Study Drug Through the Last Dose of Study Drug Plus 2 Weeks | Any NOD; # analyzed = # of participants w/out diabetes at baseline | 15 Participants |
| Alirocumab 75 Q2W/Up150 Q2W | Number of Participants With Adverse Events (AE) After First Administration of Study Drug Through the Last Dose of Study Drug Plus 2 Weeks | Any hepatic disorders TEAE | 14 Participants |
| Alirocumab 75 Q2W/Up150 Q2W | Number of Participants With Adverse Events (AE) After First Administration of Study Drug Through the Last Dose of Study Drug Plus 2 Weeks | Any neurological TEAE | 15 Participants |
| Alirocumab 75 Q2W/Up150 Q2W | Number of Participants With Adverse Events (AE) After First Administration of Study Drug Through the Last Dose of Study Drug Plus 2 Weeks | Any general allergic TEAE | 25 Participants |
| Alirocumab 75 Q2W/Up150 Q2W | Number of Participants With Adverse Events (AE) After First Administration of Study Drug Through the Last Dose of Study Drug Plus 2 Weeks | At least one treatment-emergent injection site reaction | 22 Participants |
| Alirocumab 75 Q2W/Up150 Q2W | Number of Participants With Adverse Events (AE) After First Administration of Study Drug Through the Last Dose of Study Drug Plus 2 Weeks | Any cataract TEAE | 5 Participants |
| Alirocumab 75 Q2W/Up150 Q2W | Number of Participants With Adverse Events (AE) After First Administration of Study Drug Through the Last Dose of Study Drug Plus 2 Weeks | Any elevated ALT ≥3 ULN | 1 Participants |
| Alirocumab 75 Q2W/Up150 Q2W | Number of Participants With Adverse Events (AE) After First Administration of Study Drug Through the Last Dose of Study Drug Plus 2 Weeks | Any DM/diabetic complications TEAE; # analyzed = # of participants w/diabetes at baseline | 41 Participants |
| Alirocumab 75 Q2W/Up150 Q2W | Number of Participants With Adverse Events (AE) After First Administration of Study Drug Through the Last Dose of Study Drug Plus 2 Weeks | Any DM/diabetic complications TEAE; # analyzed = # of participants w/out diabetes at baseline | 3 Participants |
Secondary
Alanine Aminotransferase Values From Baseline Over Time
The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
Time frame: Up to week 72
Population: SAF (All participants who received any study drug); Here, Number Analyzed = Number of participants evaluable at that timepoint
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Alirocumab 75 Q2W/Up150 Q2W | Alanine Aminotransferase Values From Baseline Over Time | Baseline | 0.516 U/L (Units per Liter) | Standard Deviation 0.3218 |
| Alirocumab 75 Q2W/Up150 Q2W | Alanine Aminotransferase Values From Baseline Over Time | Week 8 | 0.468 U/L (Units per Liter) | Standard Deviation 0.2745 |
| Alirocumab 75 Q2W/Up150 Q2W | Alanine Aminotransferase Values From Baseline Over Time | Week 12 | 0.505 U/L (Units per Liter) | Standard Deviation 0.494 |
| Alirocumab 75 Q2W/Up150 Q2W | Alanine Aminotransferase Values From Baseline Over Time | Week 24 | 0.493 U/L (Units per Liter) | Standard Deviation 0.2851 |
| Alirocumab 75 Q2W/Up150 Q2W | Alanine Aminotransferase Values From Baseline Over Time | Week 48 | 0.533 U/L (Units per Liter) | Standard Deviation 0.3267 |
| Alirocumab 75 Q2W/Up150 Q2W | Alanine Aminotransferase Values From Baseline Over Time | Week 72 | 0.468 U/L (Units per Liter) | Standard Deviation 0.234 |
Secondary
Alkaline Phosphatase Values From Baseline Over Time
The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
Time frame: Up to week 72
Population: SAF (All participants who received any study drug); Here, Number Analyzed = Number of participants evaluable at that timepoint
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Alirocumab 75 Q2W/Up150 Q2W | Alkaline Phosphatase Values From Baseline Over Time | Week 48 | 0.602 U/L | Standard Deviation 0.2657 |
| Alirocumab 75 Q2W/Up150 Q2W | Alkaline Phosphatase Values From Baseline Over Time | Week 72 | 0.553 U/L | Standard Deviation 0.1678 |
| Alirocumab 75 Q2W/Up150 Q2W | Alkaline Phosphatase Values From Baseline Over Time | Baseline | 0.601 U/L | Standard Deviation 0.1865 |
| Alirocumab 75 Q2W/Up150 Q2W | Alkaline Phosphatase Values From Baseline Over Time | Week 8 | 0.635 U/L | Standard Deviation 0.2151 |
| Alirocumab 75 Q2W/Up150 Q2W | Alkaline Phosphatase Values From Baseline Over Time | Week 12 | 0.605 U/L | Standard Deviation 0.1865 |
| Alirocumab 75 Q2W/Up150 Q2W | Alkaline Phosphatase Values From Baseline Over Time | Week 24 | 0.602 U/L | Standard Deviation 0.2012 |
Secondary
Apolipoprotein-A1 (Apo A1) Values From Baseline Over Time
The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
Time frame: Up to week 72
Population: SAF (All participants who received any study drug); Here, Number Analyzed = Number of participants evaluable at that timepoint
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Alirocumab 75 Q2W/Up150 Q2W | Apolipoprotein-A1 (Apo A1) Values From Baseline Over Time | Baseline | 145.3 mg/dL | Standard Deviation 24.95 |
| Alirocumab 75 Q2W/Up150 Q2W | Apolipoprotein-A1 (Apo A1) Values From Baseline Over Time | Week 8 | 148.5 mg/dL | Standard Deviation 24.73 |
| Alirocumab 75 Q2W/Up150 Q2W | Apolipoprotein-A1 (Apo A1) Values From Baseline Over Time | Week 12 | 149.4 mg/dL | Standard Deviation 25.38 |
| Alirocumab 75 Q2W/Up150 Q2W | Apolipoprotein-A1 (Apo A1) Values From Baseline Over Time | Week 24 | 150.7 mg/dL | Standard Deviation 26.36 |
| Alirocumab 75 Q2W/Up150 Q2W | Apolipoprotein-A1 (Apo A1) Values From Baseline Over Time | Week 48 | 152.6 mg/dL | Standard Deviation 25.96 |
| Alirocumab 75 Q2W/Up150 Q2W | Apolipoprotein-A1 (Apo A1) Values From Baseline Over Time | Week 72 | 151.4 mg/dL | Standard Deviation 26.03 |
Secondary
Apolipoprotein B (Apo B) Values From Baseline Over Time
The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
Time frame: Up to week 72
Population: SAF (All participants who received any study drug); Here, Number Analyzed = Number of participants evaluable at that timepoint
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Alirocumab 75 Q2W/Up150 Q2W | Apolipoprotein B (Apo B) Values From Baseline Over Time | Baseline | 103.8 mg/dL | Standard Deviation 27.25 |
| Alirocumab 75 Q2W/Up150 Q2W | Apolipoprotein B (Apo B) Values From Baseline Over Time | Week 8 | 62.5 mg/dL | Standard Deviation 27.63 |
| Alirocumab 75 Q2W/Up150 Q2W | Apolipoprotein B (Apo B) Values From Baseline Over Time | Week 12 | 68.0 mg/dL | Standard Deviation 31.32 |
| Alirocumab 75 Q2W/Up150 Q2W | Apolipoprotein B (Apo B) Values From Baseline Over Time | Week 24 | 61.5 mg/dL | Standard Deviation 26.2 |
| Alirocumab 75 Q2W/Up150 Q2W | Apolipoprotein B (Apo B) Values From Baseline Over Time | Week 48 | 63.7 mg/dL | Standard Deviation 26.4 |
| Alirocumab 75 Q2W/Up150 Q2W | Apolipoprotein B (Apo B) Values From Baseline Over Time | Week 72 | 58.5 mg/dL | Standard Deviation 25.82 |
Secondary
Aspartate Aminotransferase Values From Baseline Over Time
The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
Time frame: Up to week 72
Population: SAF (All participants who received any study drug); Here, Number Analyzed = Number of participants evaluable at that timepoint
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Alirocumab 75 Q2W/Up150 Q2W | Aspartate Aminotransferase Values From Baseline Over Time | Baseline | 0.553 U/L | Standard Deviation 0.2516 |
| Alirocumab 75 Q2W/Up150 Q2W | Aspartate Aminotransferase Values From Baseline Over Time | Week 8 | 0.520 U/L | Standard Deviation 0.2536 |
| Alirocumab 75 Q2W/Up150 Q2W | Aspartate Aminotransferase Values From Baseline Over Time | Week 12 | 0.527 U/L | Standard Deviation 0.2698 |
| Alirocumab 75 Q2W/Up150 Q2W | Aspartate Aminotransferase Values From Baseline Over Time | Week 24 | 0.544 U/L | Standard Deviation 0.3071 |
| Alirocumab 75 Q2W/Up150 Q2W | Aspartate Aminotransferase Values From Baseline Over Time | Week 48 | 0.565 U/L | Standard Deviation 0.2773 |
| Alirocumab 75 Q2W/Up150 Q2W | Aspartate Aminotransferase Values From Baseline Over Time | Week 72 | 0.556 U/L | Standard Deviation 0.2256 |
Secondary
Calculated Low-density Lipoprotein Cholesterol (LDL-C) Values From Baseline Over Time
The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
Time frame: Up to week 72
Population: SAF (All participants who received any study drug); Here, Number Analyzed = Number of participants evaluable at that timepoint
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Alirocumab 75 Q2W/Up150 Q2W | Calculated Low-density Lipoprotein Cholesterol (LDL-C) Values From Baseline Over Time | Baseline | 117.8 Milligrams per decilitre (mg/dL) | Standard Deviation 40.67 |
| Alirocumab 75 Q2W/Up150 Q2W | Calculated Low-density Lipoprotein Cholesterol (LDL-C) Values From Baseline Over Time | Week 8 | 58.9 Milligrams per decilitre (mg/dL) | Standard Deviation 37.31 |
| Alirocumab 75 Q2W/Up150 Q2W | Calculated Low-density Lipoprotein Cholesterol (LDL-C) Values From Baseline Over Time | Week 12 | 63.6 Milligrams per decilitre (mg/dL) | Standard Deviation 40.79 |
| Alirocumab 75 Q2W/Up150 Q2W | Calculated Low-density Lipoprotein Cholesterol (LDL-C) Values From Baseline Over Time | Week 24 | 56.2 Milligrams per decilitre (mg/dL) | Standard Deviation 36.59 |
| Alirocumab 75 Q2W/Up150 Q2W | Calculated Low-density Lipoprotein Cholesterol (LDL-C) Values From Baseline Over Time | Week 48 | 56.8 Milligrams per decilitre (mg/dL) | Standard Deviation 36.13 |
| Alirocumab 75 Q2W/Up150 Q2W | Calculated Low-density Lipoprotein Cholesterol (LDL-C) Values From Baseline Over Time | Week 72 | 52.2 Milligrams per decilitre (mg/dL) | Standard Deviation 38.8 |
Secondary
Change From Baseline in Alanine Aminotransferase Over Time
Time frame: Up to week 72
Population: SAF (All participants who received any study drug); Here, Number Analyzed = Number of participants evaluable at that timepoint
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Alirocumab 75 Q2W/Up150 Q2W | Change From Baseline in Alanine Aminotransferase Over Time | Week 8 | -0.025 U/L | Standard Deviation 0.3006 |
| Alirocumab 75 Q2W/Up150 Q2W | Change From Baseline in Alanine Aminotransferase Over Time | Week 12 | 0.009 U/L | Standard Deviation 0.5189 |
| Alirocumab 75 Q2W/Up150 Q2W | Change From Baseline in Alanine Aminotransferase Over Time | Week 24 | -0.036 U/L | Standard Deviation 0.3294 |
| Alirocumab 75 Q2W/Up150 Q2W | Change From Baseline in Alanine Aminotransferase Over Time | Week 48 | -0.027 U/L | Standard Deviation 0.3052 |
| Alirocumab 75 Q2W/Up150 Q2W | Change From Baseline in Alanine Aminotransferase Over Time | Week 72 | -0.062 U/L | Standard Deviation 0.1872 |
Secondary
Change From Baseline in Alkaline Phosphatase Over Time
Time frame: Up to week 72
Population: SAF (All participants who received any study drug); Here, Number Analyzed = Number of participants evaluable at that timepoint
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Alirocumab 75 Q2W/Up150 Q2W | Change From Baseline in Alkaline Phosphatase Over Time | Week 8 | 0.009 U/L | Standard Deviation 0.1371 |
| Alirocumab 75 Q2W/Up150 Q2W | Change From Baseline in Alkaline Phosphatase Over Time | Week 12 | 0.013 U/L | Standard Deviation 0.1203 |
| Alirocumab 75 Q2W/Up150 Q2W | Change From Baseline in Alkaline Phosphatase Over Time | Week 24 | 0.006 U/L | Standard Deviation 0.1152 |
| Alirocumab 75 Q2W/Up150 Q2W | Change From Baseline in Alkaline Phosphatase Over Time | Week 48 | 0.024 U/L | Standard Deviation 0.2333 |
| Alirocumab 75 Q2W/Up150 Q2W | Change From Baseline in Alkaline Phosphatase Over Time | Week 72 | -0.011 U/L | Standard Deviation 0.1029 |
Secondary
Change From Baseline in Aspartate Aminotransferase Over Time
Time frame: Up to week 72
Population: SAF (All participants who received any study drug); Here, Number Analyzed = Number of participants evaluable at that timepoint
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Alirocumab 75 Q2W/Up150 Q2W | Change From Baseline in Aspartate Aminotransferase Over Time | Week 8 | -0.022 U/L | Standard Deviation 0.2856 |
| Alirocumab 75 Q2W/Up150 Q2W | Change From Baseline in Aspartate Aminotransferase Over Time | Week 12 | -0.017 U/L | Standard Deviation 0.3004 |
| Alirocumab 75 Q2W/Up150 Q2W | Change From Baseline in Aspartate Aminotransferase Over Time | Week 24 | -0.013 U/L | Standard Deviation 0.2901 |
| Alirocumab 75 Q2W/Up150 Q2W | Change From Baseline in Aspartate Aminotransferase Over Time | Week 48 | -0.019 U/L | Standard Deviation 0.239 |
| Alirocumab 75 Q2W/Up150 Q2W | Change From Baseline in Aspartate Aminotransferase Over Time | Week 72 | -0.037 U/L | Standard Deviation 0.173 |
Secondary
Change From Baseline in Gonadal Hormones (FSH and LH) for Female Participants Over Time
Time frame: Up to week 72
Population: SAF (Female participants who received any study drug); Here, Number Analyzed = Number of female participants evaluable at that timepoint
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Alirocumab 75 Q2W/Up150 Q2W | Change From Baseline in Gonadal Hormones (FSH and LH) for Female Participants Over Time | FSH Week 8 | -0.765 IU/L | Standard Deviation 12.0083 |
| Alirocumab 75 Q2W/Up150 Q2W | Change From Baseline in Gonadal Hormones (FSH and LH) for Female Participants Over Time | FSH Week 12 | -0.984 IU/L | Standard Deviation 12.1584 |
| Alirocumab 75 Q2W/Up150 Q2W | Change From Baseline in Gonadal Hormones (FSH and LH) for Female Participants Over Time | FSH Week 24 | -0.575 IU/L | Standard Deviation 8.778 |
| Alirocumab 75 Q2W/Up150 Q2W | Change From Baseline in Gonadal Hormones (FSH and LH) for Female Participants Over Time | FSH Week 48 | -0.877 IU/L | Standard Deviation 15.9972 |
| Alirocumab 75 Q2W/Up150 Q2W | Change From Baseline in Gonadal Hormones (FSH and LH) for Female Participants Over Time | FSH Week 72 | -1.861 IU/L | Standard Deviation 8.6119 |
| Alirocumab 75 Q2W/Up150 Q2W | Change From Baseline in Gonadal Hormones (FSH and LH) for Female Participants Over Time | LH Week 8 | 2.730 IU/L | Standard Deviation 8.2258 |
| Alirocumab 75 Q2W/Up150 Q2W | Change From Baseline in Gonadal Hormones (FSH and LH) for Female Participants Over Time | LH Week 12 | 1.882 IU/L | Standard Deviation 8.2884 |
| Alirocumab 75 Q2W/Up150 Q2W | Change From Baseline in Gonadal Hormones (FSH and LH) for Female Participants Over Time | LH Week 24 | 0.939 IU/L | Standard Deviation 6.3694 |
| Alirocumab 75 Q2W/Up150 Q2W | Change From Baseline in Gonadal Hormones (FSH and LH) for Female Participants Over Time | LH Week 48 | 0.367 IU/L | Standard Deviation 8.5631 |
| Alirocumab 75 Q2W/Up150 Q2W | Change From Baseline in Gonadal Hormones (FSH and LH) for Female Participants Over Time | LH Week 72 | 0.222 IU/L | Standard Deviation 6.891 |
Secondary
Change From Baseline in Gonadal Hormones (FSH and LH) for Male Participants Over Time
Time frame: Up to week 72
Population: SAF (Male participants who received any study drug); Here, Number Analyzed = Number of male participants evaluable at that timepoint
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Alirocumab 75 Q2W/Up150 Q2W | Change From Baseline in Gonadal Hormones (FSH and LH) for Male Participants Over Time | LH Week 24 | 0.582 IU/L | Standard Deviation 4.4964 |
| Alirocumab 75 Q2W/Up150 Q2W | Change From Baseline in Gonadal Hormones (FSH and LH) for Male Participants Over Time | FSH Week 8 | 0.285 IU/L | Standard Deviation 3.7264 |
| Alirocumab 75 Q2W/Up150 Q2W | Change From Baseline in Gonadal Hormones (FSH and LH) for Male Participants Over Time | FSH Week 12 | -0.598 IU/L | Standard Deviation 4.1076 |
| Alirocumab 75 Q2W/Up150 Q2W | Change From Baseline in Gonadal Hormones (FSH and LH) for Male Participants Over Time | FSH Week 24 | 0.331 IU/L | Standard Deviation 6.0522 |
| Alirocumab 75 Q2W/Up150 Q2W | Change From Baseline in Gonadal Hormones (FSH and LH) for Male Participants Over Time | FSH Week 48 | 0.960 IU/L | Standard Deviation 10.3803 |
| Alirocumab 75 Q2W/Up150 Q2W | Change From Baseline in Gonadal Hormones (FSH and LH) for Male Participants Over Time | FSH Week 72 | 2.458 IU/L | Standard Deviation 13.473 |
| Alirocumab 75 Q2W/Up150 Q2W | Change From Baseline in Gonadal Hormones (FSH and LH) for Male Participants Over Time | LH Week 8 | 0.535 IU/L | Standard Deviation 2.4847 |
| Alirocumab 75 Q2W/Up150 Q2W | Change From Baseline in Gonadal Hormones (FSH and LH) for Male Participants Over Time | LH Week 12 | -0.136 IU/L | Standard Deviation 3.2638 |
| Alirocumab 75 Q2W/Up150 Q2W | Change From Baseline in Gonadal Hormones (FSH and LH) for Male Participants Over Time | LH Week 48 | 1.015 IU/L | Standard Deviation 6.6344 |
| Alirocumab 75 Q2W/Up150 Q2W | Change From Baseline in Gonadal Hormones (FSH and LH) for Male Participants Over Time | LH Week 72 | 1.964 IU/L | Standard Deviation 9.3028 |
Secondary
Change From Baseline in Gonadotropins (Estradiol) for Female Participants Over Time
Time frame: Up to week 72
Population: SAF (Female participants who received any study drug); Here, Number Analyzed = Number of female participants evaluable at that timepoint
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Alirocumab 75 Q2W/Up150 Q2W | Change From Baseline in Gonadotropins (Estradiol) for Female Participants Over Time | Week 8 | 4.272 pmol/L | Standard Deviation 77.1561 |
| Alirocumab 75 Q2W/Up150 Q2W | Change From Baseline in Gonadotropins (Estradiol) for Female Participants Over Time | Week 12 | 9.262 pmol/L | Standard Deviation 73.105 |
| Alirocumab 75 Q2W/Up150 Q2W | Change From Baseline in Gonadotropins (Estradiol) for Female Participants Over Time | Week 24 | 7.869 pmol/L | Standard Deviation 78.4151 |
| Alirocumab 75 Q2W/Up150 Q2W | Change From Baseline in Gonadotropins (Estradiol) for Female Participants Over Time | Week 48 | 11.763 pmol/L | Standard Deviation 97.535 |
| Alirocumab 75 Q2W/Up150 Q2W | Change From Baseline in Gonadotropins (Estradiol) for Female Participants Over Time | Week 72 | 9.569 pmol/L | Standard Deviation 38.0952 |
Secondary
Change From Baseline in Gonadotropins (Testosterone) for Male Participants Over Time
Time frame: Up to week 72
Population: SAF (Male participants who received any study drug); Here, Number Analyzed = Number of male participants evaluable at that timepoint
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Alirocumab 75 Q2W/Up150 Q2W | Change From Baseline in Gonadotropins (Testosterone) for Male Participants Over Time | Week 8 | 0.6030 nmol/L | Standard Deviation 4.46401 |
| Alirocumab 75 Q2W/Up150 Q2W | Change From Baseline in Gonadotropins (Testosterone) for Male Participants Over Time | Week 12 | 0.7965 nmol/L | Standard Deviation 4.74765 |
| Alirocumab 75 Q2W/Up150 Q2W | Change From Baseline in Gonadotropins (Testosterone) for Male Participants Over Time | Week 24 | 0.1946 nmol/L | Standard Deviation 5.8922 |
| Alirocumab 75 Q2W/Up150 Q2W | Change From Baseline in Gonadotropins (Testosterone) for Male Participants Over Time | Week 48 | 0.0498 nmol/L | Standard Deviation 6.34201 |
| Alirocumab 75 Q2W/Up150 Q2W | Change From Baseline in Gonadotropins (Testosterone) for Male Participants Over Time | Week 72 | 1.2569 nmol/L | Standard Deviation 5.29335 |
Secondary
Change From Baseline in Total Bilirubin Over Time
Time frame: Up to week 72
Population: SAF (All participants who received any study drug); Here, Number Analyzed = Number of participants evaluable at that timepoint
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Alirocumab 75 Q2W/Up150 Q2W | Change From Baseline in Total Bilirubin Over Time | Week 8 | -0.37 umol/L | Standard Deviation 3.12 |
| Alirocumab 75 Q2W/Up150 Q2W | Change From Baseline in Total Bilirubin Over Time | Week 12 | -0.44 umol/L | Standard Deviation 3.854 |
| Alirocumab 75 Q2W/Up150 Q2W | Change From Baseline in Total Bilirubin Over Time | Week 24 | -0.48 umol/L | Standard Deviation 3.962 |
| Alirocumab 75 Q2W/Up150 Q2W | Change From Baseline in Total Bilirubin Over Time | Week 48 | -0.05 umol/L | Standard Deviation 3.991 |
| Alirocumab 75 Q2W/Up150 Q2W | Change From Baseline in Total Bilirubin Over Time | Week 72 | 0.71 umol/L | Standard Deviation 2.152 |
Secondary
Fasting Triglycerides (TGs) Values From Baseline Over Time
The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
Time frame: Up to week 72
Population: SAF (All participants who received any study drug); Here, Number Analyzed = Number of participants evaluable at that timepoint
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Alirocumab 75 Q2W/Up150 Q2W | Fasting Triglycerides (TGs) Values From Baseline Over Time | Baseline | 179.2 mg/dL | Standard Deviation 146.51 |
| Alirocumab 75 Q2W/Up150 Q2W | Fasting Triglycerides (TGs) Values From Baseline Over Time | Week 24 | 169.3 mg/dL | Standard Deviation 161.45 |
| Alirocumab 75 Q2W/Up150 Q2W | Fasting Triglycerides (TGs) Values From Baseline Over Time | Week 48 | 171.1 mg/dL | Standard Deviation 131.35 |
| Alirocumab 75 Q2W/Up150 Q2W | Fasting Triglycerides (TGs) Values From Baseline Over Time | Week 12 | 162.2 mg/dL | Standard Deviation 182 |
| Alirocumab 75 Q2W/Up150 Q2W | Fasting Triglycerides (TGs) Values From Baseline Over Time | Week 8 | 154.8 mg/dL | Standard Deviation 113.05 |
| Alirocumab 75 Q2W/Up150 Q2W | Fasting Triglycerides (TGs) Values From Baseline Over Time | Week 72 | 156.9 mg/dL | Standard Deviation 65.21 |
Secondary
Gonadal (FSH and LH) Hormone Values for Male Participants From Baseline Over Time
The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
Time frame: Up to week 72
Population: SAF (Male participants who received any study drug); Here, Number Analyzed = Number of male participants evaluable at that timepoint
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Alirocumab 75 Q2W/Up150 Q2W | Gonadal (FSH and LH) Hormone Values for Male Participants From Baseline Over Time | FSH Baseline | 8.006 International units per litre (IU/L) | Standard Deviation 7.4451 |
| Alirocumab 75 Q2W/Up150 Q2W | Gonadal (FSH and LH) Hormone Values for Male Participants From Baseline Over Time | FSH Week 8 | 7.959 International units per litre (IU/L) | Standard Deviation 7.55 |
| Alirocumab 75 Q2W/Up150 Q2W | Gonadal (FSH and LH) Hormone Values for Male Participants From Baseline Over Time | FSH Week 12 | 7.766 International units per litre (IU/L) | Standard Deviation 6.8204 |
| Alirocumab 75 Q2W/Up150 Q2W | Gonadal (FSH and LH) Hormone Values for Male Participants From Baseline Over Time | FSH Week 24 | 8.268 International units per litre (IU/L) | Standard Deviation 8.1355 |
| Alirocumab 75 Q2W/Up150 Q2W | Gonadal (FSH and LH) Hormone Values for Male Participants From Baseline Over Time | FSH Week 48 | 9.597 International units per litre (IU/L) | Standard Deviation 11.2138 |
| Alirocumab 75 Q2W/Up150 Q2W | Gonadal (FSH and LH) Hormone Values for Male Participants From Baseline Over Time | FSH Week 72 | 10.005 International units per litre (IU/L) | Standard Deviation 13.2973 |
| Alirocumab 75 Q2W/Up150 Q2W | Gonadal (FSH and LH) Hormone Values for Male Participants From Baseline Over Time | LH Baseline | 6.500 International units per litre (IU/L) | Standard Deviation 4.2832 |
| Alirocumab 75 Q2W/Up150 Q2W | Gonadal (FSH and LH) Hormone Values for Male Participants From Baseline Over Time | LH Week 8 | 7.094 International units per litre (IU/L) | Standard Deviation 4.7226 |
| Alirocumab 75 Q2W/Up150 Q2W | Gonadal (FSH and LH) Hormone Values for Male Participants From Baseline Over Time | LH Week 12 | 6.688 International units per litre (IU/L) | Standard Deviation 4.4079 |
| Alirocumab 75 Q2W/Up150 Q2W | Gonadal (FSH and LH) Hormone Values for Male Participants From Baseline Over Time | LH Week 24 | 6.931 International units per litre (IU/L) | Standard Deviation 4.8597 |
| Alirocumab 75 Q2W/Up150 Q2W | Gonadal (FSH and LH) Hormone Values for Male Participants From Baseline Over Time | LH Week 48 | 7.677 International units per litre (IU/L) | Standard Deviation 6.5478 |
| Alirocumab 75 Q2W/Up150 Q2W | Gonadal (FSH and LH) Hormone Values for Male Participants From Baseline Over Time | LH Week 72 | 8.173 International units per litre (IU/L) | Standard Deviation 8.9083 |
Secondary
Gonadal Hormone (Follicle Stimulating Hormone [FSH] and Luteinizing Hormone [LH]) Values for Female Participants From Baseline Over Time
The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
Time frame: Up to week 72
Population: SAF (Female participants who received any study drug); Here, Number Analyzed = Number of female participants evaluable at that timepoint
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Alirocumab 75 Q2W/Up150 Q2W | Gonadal Hormone (Follicle Stimulating Hormone [FSH] and Luteinizing Hormone [LH]) Values for Female Participants From Baseline Over Time | FSH Baseline | 57.948 International units per litre (IU/L) | Standard Deviation 26.7383 |
| Alirocumab 75 Q2W/Up150 Q2W | Gonadal Hormone (Follicle Stimulating Hormone [FSH] and Luteinizing Hormone [LH]) Values for Female Participants From Baseline Over Time | FSH Week 8 | 59.264 International units per litre (IU/L) | Standard Deviation 24.7912 |
| Alirocumab 75 Q2W/Up150 Q2W | Gonadal Hormone (Follicle Stimulating Hormone [FSH] and Luteinizing Hormone [LH]) Values for Female Participants From Baseline Over Time | FSH Week 12 | 54.279 International units per litre (IU/L) | Standard Deviation 23.9923 |
| Alirocumab 75 Q2W/Up150 Q2W | Gonadal Hormone (Follicle Stimulating Hormone [FSH] and Luteinizing Hormone [LH]) Values for Female Participants From Baseline Over Time | FSH Week 24 | 57.664 International units per litre (IU/L) | Standard Deviation 25.983 |
| Alirocumab 75 Q2W/Up150 Q2W | Gonadal Hormone (Follicle Stimulating Hormone [FSH] and Luteinizing Hormone [LH]) Values for Female Participants From Baseline Over Time | FSH Week 48 | 56.529 International units per litre (IU/L) | Standard Deviation 25.1408 |
| Alirocumab 75 Q2W/Up150 Q2W | Gonadal Hormone (Follicle Stimulating Hormone [FSH] and Luteinizing Hormone [LH]) Values for Female Participants From Baseline Over Time | FSH Week 72 | 58.600 International units per litre (IU/L) | Standard Deviation 24.5205 |
| Alirocumab 75 Q2W/Up150 Q2W | Gonadal Hormone (Follicle Stimulating Hormone [FSH] and Luteinizing Hormone [LH]) Values for Female Participants From Baseline Over Time | LH Baseline | 30.155 International units per litre (IU/L) | Standard Deviation 13.109 |
| Alirocumab 75 Q2W/Up150 Q2W | Gonadal Hormone (Follicle Stimulating Hormone [FSH] and Luteinizing Hormone [LH]) Values for Female Participants From Baseline Over Time | LH Week 8 | 33.794 International units per litre (IU/L) | Standard Deviation 14.4459 |
| Alirocumab 75 Q2W/Up150 Q2W | Gonadal Hormone (Follicle Stimulating Hormone [FSH] and Luteinizing Hormone [LH]) Values for Female Participants From Baseline Over Time | LH Week 12 | 30.779 International units per litre (IU/L) | Standard Deviation 13.0946 |
| Alirocumab 75 Q2W/Up150 Q2W | Gonadal Hormone (Follicle Stimulating Hormone [FSH] and Luteinizing Hormone [LH]) Values for Female Participants From Baseline Over Time | LH Week 24 | 31.260 International units per litre (IU/L) | Standard Deviation 13.7344 |
| Alirocumab 75 Q2W/Up150 Q2W | Gonadal Hormone (Follicle Stimulating Hormone [FSH] and Luteinizing Hormone [LH]) Values for Female Participants From Baseline Over Time | LH Week 48 | 29.585 International units per litre (IU/L) | Standard Deviation 13.9792 |
| Alirocumab 75 Q2W/Up150 Q2W | Gonadal Hormone (Follicle Stimulating Hormone [FSH] and Luteinizing Hormone [LH]) Values for Female Participants From Baseline Over Time | LH Week 72 | 29.248 International units per litre (IU/L) | Standard Deviation 11.0829 |
Secondary
Gonadotropin (Estradiol) Values for Female Participants From Baseline Over Time
The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
Time frame: Up to week 72
Population: SAF (Female participants who received any study drug); Here, Number Analyzed = Number of female participants evaluable at that timepoint
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Alirocumab 75 Q2W/Up150 Q2W | Gonadotropin (Estradiol) Values for Female Participants From Baseline Over Time | Baseline | 55.589 picomoles per litre (pmol/L) | Standard Deviation 80.8238 |
| Alirocumab 75 Q2W/Up150 Q2W | Gonadotropin (Estradiol) Values for Female Participants From Baseline Over Time | Week 8 | 58.676 picomoles per litre (pmol/L) | Standard Deviation 69.0119 |
| Alirocumab 75 Q2W/Up150 Q2W | Gonadotropin (Estradiol) Values for Female Participants From Baseline Over Time | Week 12 | 59.673 picomoles per litre (pmol/L) | Standard Deviation 74.7587 |
| Alirocumab 75 Q2W/Up150 Q2W | Gonadotropin (Estradiol) Values for Female Participants From Baseline Over Time | Week 24 | 64.304 picomoles per litre (pmol/L) | Standard Deviation 103.8955 |
| Alirocumab 75 Q2W/Up150 Q2W | Gonadotropin (Estradiol) Values for Female Participants From Baseline Over Time | Week 48 | 64.503 picomoles per litre (pmol/L) | Standard Deviation 102.1595 |
| Alirocumab 75 Q2W/Up150 Q2W | Gonadotropin (Estradiol) Values for Female Participants From Baseline Over Time | Week 72 | 57.926 picomoles per litre (pmol/L) | Standard Deviation 67.1795 |
Secondary
Gonadotropin (Testosterone) Values for Male Participants From Baseline Over Time
The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
Time frame: Up to week 72
Population: SAF (Male participants who received any study drug); Here, Number Analyzed = Number of male participants evaluable at that timepoint
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Alirocumab 75 Q2W/Up150 Q2W | Gonadotropin (Testosterone) Values for Male Participants From Baseline Over Time | Baseline | 13.4370 nanomoles per litre (nmol/L) | Standard Deviation 6.36321 |
| Alirocumab 75 Q2W/Up150 Q2W | Gonadotropin (Testosterone) Values for Male Participants From Baseline Over Time | Week 8 | 14.5802 nanomoles per litre (nmol/L) | Standard Deviation 5.99821 |
| Alirocumab 75 Q2W/Up150 Q2W | Gonadotropin (Testosterone) Values for Male Participants From Baseline Over Time | Week 12 | 14.2443 nanomoles per litre (nmol/L) | Standard Deviation 6.7707 |
| Alirocumab 75 Q2W/Up150 Q2W | Gonadotropin (Testosterone) Values for Male Participants From Baseline Over Time | Week 24 | 13.5818 nanomoles per litre (nmol/L) | Standard Deviation 6.11269 |
| Alirocumab 75 Q2W/Up150 Q2W | Gonadotropin (Testosterone) Values for Male Participants From Baseline Over Time | Week 48 | 13.4798 nanomoles per litre (nmol/L) | Standard Deviation 7.04977 |
| Alirocumab 75 Q2W/Up150 Q2W | Gonadotropin (Testosterone) Values for Male Participants From Baseline Over Time | Week 72 | 12.7538 nanomoles per litre (nmol/L) | Standard Deviation 6.37408 |
Secondary
High-density Lipoprotein Cholesterol (HDL-C) Values From Baseline Over Time
The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
Time frame: Up to week 72
Population: SAF (All participants who received any study drug); Here, Number Analyzed = Number of participants evaluable at that timepoint
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Alirocumab 75 Q2W/Up150 Q2W | High-density Lipoprotein Cholesterol (HDL-C) Values From Baseline Over Time | Baseline | 47.1 mg/dL | Standard Deviation 13.92 |
| Alirocumab 75 Q2W/Up150 Q2W | High-density Lipoprotein Cholesterol (HDL-C) Values From Baseline Over Time | Week 8 | 51.0 mg/dL | Standard Deviation 14.82 |
| Alirocumab 75 Q2W/Up150 Q2W | High-density Lipoprotein Cholesterol (HDL-C) Values From Baseline Over Time | Week 12 | 50.6 mg/dL | Standard Deviation 13.95 |
| Alirocumab 75 Q2W/Up150 Q2W | High-density Lipoprotein Cholesterol (HDL-C) Values From Baseline Over Time | Week 24 | 49.9 mg/dL | Standard Deviation 14.8 |
| Alirocumab 75 Q2W/Up150 Q2W | High-density Lipoprotein Cholesterol (HDL-C) Values From Baseline Over Time | Week 48 | 50.5 mg/dL | Standard Deviation 14.66 |
| Alirocumab 75 Q2W/Up150 Q2W | High-density Lipoprotein Cholesterol (HDL-C) Values From Baseline Over Time | Week 72 | 50.8 mg/dL | Standard Deviation 14.61 |
Secondary
Lipoprotein a (Lp(a)) Values From Baseline Over Time
The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
Time frame: Up to week 72
Population: SAF (All participants who received any study drug); Here, Number Analyzed = Number of participants evaluable at that timepoint
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Alirocumab 75 Q2W/Up150 Q2W | Lipoprotein a (Lp(a)) Values From Baseline Over Time | Week 24 | 33.9 mg/dL | Standard Deviation 42.54 |
| Alirocumab 75 Q2W/Up150 Q2W | Lipoprotein a (Lp(a)) Values From Baseline Over Time | Week 48 | 38.6 mg/dL | Standard Deviation 50.66 |
| Alirocumab 75 Q2W/Up150 Q2W | Lipoprotein a (Lp(a)) Values From Baseline Over Time | Baseline | 39.7 mg/dL | Standard Deviation 47.86 |
| Alirocumab 75 Q2W/Up150 Q2W | Lipoprotein a (Lp(a)) Values From Baseline Over Time | Week 8 | 35.0 mg/dL | Standard Deviation 41.99 |
| Alirocumab 75 Q2W/Up150 Q2W | Lipoprotein a (Lp(a)) Values From Baseline Over Time | Week 12 | 32.7 mg/dL | Standard Deviation 39.42 |
| Alirocumab 75 Q2W/Up150 Q2W | Lipoprotein a (Lp(a)) Values From Baseline Over Time | Week 72 | 40.4 mg/dL | Standard Deviation 56.47 |
Secondary
Non-high-density Lipoprotein Cholesterol (Non-HDL-C) Values From Baseline Over Time
The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
Time frame: Up to week 72
Population: SAF (All participants who received any study drug); Here, Number Analyzed = Number of participants evaluable at that timepoint
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Alirocumab 75 Q2W/Up150 Q2W | Non-high-density Lipoprotein Cholesterol (Non-HDL-C) Values From Baseline Over Time | Baseline | 152.4 mg/dL | Standard Deviation 48.81 |
| Alirocumab 75 Q2W/Up150 Q2W | Non-high-density Lipoprotein Cholesterol (Non-HDL-C) Values From Baseline Over Time | Week 8 | 88.5 mg/dL | Standard Deviation 43.54 |
| Alirocumab 75 Q2W/Up150 Q2W | Non-high-density Lipoprotein Cholesterol (Non-HDL-C) Values From Baseline Over Time | Week 12 | 94.3 mg/dL | Standard Deviation 48.77 |
| Alirocumab 75 Q2W/Up150 Q2W | Non-high-density Lipoprotein Cholesterol (Non-HDL-C) Values From Baseline Over Time | Week 24 | 87.3 mg/dL | Standard Deviation 43.56 |
| Alirocumab 75 Q2W/Up150 Q2W | Non-high-density Lipoprotein Cholesterol (Non-HDL-C) Values From Baseline Over Time | Week 48 | 88.9 mg/dL | Standard Deviation 44.25 |
| Alirocumab 75 Q2W/Up150 Q2W | Non-high-density Lipoprotein Cholesterol (Non-HDL-C) Values From Baseline Over Time | Week 72 | 80.9 mg/dL | Standard Deviation 42.67 |
Secondary
Percent Change From Baseline in Apo A1 Over Time
Time frame: Up to week 72
Population: SAF (All participants who received any study drug); Here, Number Analyzed = Number of participants evaluable at that timepoint
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Alirocumab 75 Q2W/Up150 Q2W | Percent Change From Baseline in Apo A1 Over Time | Week 8 | 5.07 Percent Change | Standard Deviation 13.385 |
| Alirocumab 75 Q2W/Up150 Q2W | Percent Change From Baseline in Apo A1 Over Time | Week 12 | 2.99 Percent Change | Standard Deviation 13.638 |
| Alirocumab 75 Q2W/Up150 Q2W | Percent Change From Baseline in Apo A1 Over Time | Week 24 | 5.35 Percent Change | Standard Deviation 14.108 |
| Alirocumab 75 Q2W/Up150 Q2W | Percent Change From Baseline in Apo A1 Over Time | Week 48 | 4.77 Percent Change | Standard Deviation 13.836 |
| Alirocumab 75 Q2W/Up150 Q2W | Percent Change From Baseline in Apo A1 Over Time | Week 72 | 1.21 Percent Change | Standard Deviation 13.17 |
Secondary
Percent Change From Baseline in Apo B Over Time
Time frame: Up to week 72
Population: SAF (All participants who received any study drug); Here, Number Analyzed = Number of participants evaluable at that timepoint
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Alirocumab 75 Q2W/Up150 Q2W | Percent Change From Baseline in Apo B Over Time | Week 8 | -36.51 Percent Change | Standard Deviation 34.46 |
| Alirocumab 75 Q2W/Up150 Q2W | Percent Change From Baseline in Apo B Over Time | Week 12 | -34.48 Percent Change | Standard Deviation 27.905 |
| Alirocumab 75 Q2W/Up150 Q2W | Percent Change From Baseline in Apo B Over Time | Week 24 | -38.16 Percent Change | Standard Deviation 24.867 |
| Alirocumab 75 Q2W/Up150 Q2W | Percent Change From Baseline in Apo B Over Time | Week 48 | -37.93 Percent Change | Standard Deviation 23.767 |
| Alirocumab 75 Q2W/Up150 Q2W | Percent Change From Baseline in Apo B Over Time | Week 72 | -39.04 Percent Change | Standard Deviation 26.383 |
Secondary
Percent Change From Baseline in Fasting TGs Over Time
Time frame: Up to week 72
Population: SAF (All participants who received any study drug); Here, Number Analyzed = Number of participants evaluable at that timepoint
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Alirocumab 75 Q2W/Up150 Q2W | Percent Change From Baseline in Fasting TGs Over Time | Week 8 | -4.68 Percent Change | Standard Deviation 49.23 |
| Alirocumab 75 Q2W/Up150 Q2W | Percent Change From Baseline in Fasting TGs Over Time | Week 12 | -4.29 Percent Change | Standard Deviation 40.748 |
| Alirocumab 75 Q2W/Up150 Q2W | Percent Change From Baseline in Fasting TGs Over Time | Week 24 | 0.42 Percent Change | Standard Deviation 54.118 |
| Alirocumab 75 Q2W/Up150 Q2W | Percent Change From Baseline in Fasting TGs Over Time | Week 48 | 1.54 Percent Change | Standard Deviation 69.156 |
| Alirocumab 75 Q2W/Up150 Q2W | Percent Change From Baseline in Fasting TGs Over Time | Week 72 | -5.97 Percent Change | Standard Deviation 41.44 |
Secondary
Percent Change From Baseline in HDL-C Over Time
Time frame: Up to week 72
Population: SAF (All participants who received any study drug); Here, Number Analyzed = Number of participants evaluable at that timepoint
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Alirocumab 75 Q2W/Up150 Q2W | Percent Change From Baseline in HDL-C Over Time | Week 8 | 10.54 Percent Change | Standard Deviation 22.735 |
| Alirocumab 75 Q2W/Up150 Q2W | Percent Change From Baseline in HDL-C Over Time | Week 12 | 10.33 Percent Change | Standard Deviation 21.933 |
| Alirocumab 75 Q2W/Up150 Q2W | Percent Change From Baseline in HDL-C Over Time | Week 24 | 8.53 Percent Change | Standard Deviation 21.824 |
| Alirocumab 75 Q2W/Up150 Q2W | Percent Change From Baseline in HDL-C Over Time | Week 48 | 9.81 Percent Change | Standard Deviation 23.69 |
| Alirocumab 75 Q2W/Up150 Q2W | Percent Change From Baseline in HDL-C Over Time | Week 72 | 9.24 Percent Change | Standard Deviation 21.505 |
Secondary
Percent Change From Baseline in Lp(a) Over Time
Time frame: Up to week 72
Population: SAF (All participants who received any study drug); Here, Number Analyzed = Number of participants evaluable at that timepoint
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Alirocumab 75 Q2W/Up150 Q2W | Percent Change From Baseline in Lp(a) Over Time | Week 8 | -12.69 Percent Change | Standard Deviation 35.452 |
| Alirocumab 75 Q2W/Up150 Q2W | Percent Change From Baseline in Lp(a) Over Time | Week 12 | 10.63 Percent Change | Standard Deviation 228.659 |
| Alirocumab 75 Q2W/Up150 Q2W | Percent Change From Baseline in Lp(a) Over Time | Week 24 | -6.80 Percent Change | Standard Deviation 110.827 |
| Alirocumab 75 Q2W/Up150 Q2W | Percent Change From Baseline in Lp(a) Over Time | Week 48 | -7.89 Percent Change | Standard Deviation 116.831 |
| Alirocumab 75 Q2W/Up150 Q2W | Percent Change From Baseline in Lp(a) Over Time | Week 72 | -22.23 Percent Change | Standard Deviation 28.233 |
Secondary
Percent Change From Baseline in Non-HDL-C Over Time
Time frame: Up to week 72
Population: SAF (All participants who received any study drug); Here, Number Analyzed = Number of participants evaluable at that timepoint
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Alirocumab 75 Q2W/Up150 Q2W | Percent Change From Baseline in Non-HDL-C Over Time | Week 8 | -40.35 Percent Change | Standard Deviation 27.47 |
| Alirocumab 75 Q2W/Up150 Q2W | Percent Change From Baseline in Non-HDL-C Over Time | Week 12 | -36.89 Percent Change | Standard Deviation 29.567 |
| Alirocumab 75 Q2W/Up150 Q2W | Percent Change From Baseline in Non-HDL-C Over Time | Week 24 | -41.47 Percent Change | Standard Deviation 26.763 |
| Alirocumab 75 Q2W/Up150 Q2W | Percent Change From Baseline in Non-HDL-C Over Time | Week 48 | -42.33 Percent Change | Standard Deviation 28.728 |
| Alirocumab 75 Q2W/Up150 Q2W | Percent Change From Baseline in Non-HDL-C Over Time | Week 72 | -43.28 Percent Change | Standard Deviation 29.534 |
Secondary
Percent Change From Baseline in Total-C Over Time
Time frame: Up to week 72
Population: SAF (All participants who received any study drug); Here, Number Analyzed = Number of participants evaluable at that timepoint
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Alirocumab 75 Q2W/Up150 Q2W | Percent Change From Baseline in Total-C Over Time | Week 8 | -28.68 Percent Change | Standard Deviation 20.158 |
| Alirocumab 75 Q2W/Up150 Q2W | Percent Change From Baseline in Total-C Over Time | Week 12 | -25.99 Percent Change | Standard Deviation 23.058 |
| Alirocumab 75 Q2W/Up150 Q2W | Percent Change From Baseline in Total-C Over Time | Week 24 | -29.98 Percent Change | Standard Deviation 20.93 |
| Alirocumab 75 Q2W/Up150 Q2W | Percent Change From Baseline in Total-C Over Time | Week 48 | -30.89 Percent Change | Standard Deviation 21.004 |
| Alirocumab 75 Q2W/Up150 Q2W | Percent Change From Baseline in Total-C Over Time | Week 72 | -31.55 Percent Change | Standard Deviation 22.238 |
Secondary
Percent Change in LDL-C From Baseline Over Time
Time frame: Up to week 72
Population: SAF (All participants who received any study drug); Here, Number Analyzed = Number of participants evaluable at that timepoint
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Alirocumab 75 Q2W/Up150 Q2W | Percent Change in LDL-C From Baseline Over Time | Week 8 | -48.74 Percent Change | Standard Deviation 31.121 |
| Alirocumab 75 Q2W/Up150 Q2W | Percent Change in LDL-C From Baseline Over Time | Week 12 | -44.64 Percent Change | Standard Deviation 35.338 |
| Alirocumab 75 Q2W/Up150 Q2W | Percent Change in LDL-C From Baseline Over Time | Week 24 | -50.75 Percent Change | Standard Deviation 30.249 |
| Alirocumab 75 Q2W/Up150 Q2W | Percent Change in LDL-C From Baseline Over Time | Week 48 | -52.35 Percent Change | Standard Deviation 27.929 |
| Alirocumab 75 Q2W/Up150 Q2W | Percent Change in LDL-C From Baseline Over Time | Week 72 | -51.21 Percent Change | Standard Deviation 32.742 |
Secondary
Total Bilirubin Values From Baseline Over Time
The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
Time frame: Up to week 72
Population: SAF (All participants who received any study drug); Here, Number Analyzed = Number of participants evaluable at that timepoint
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Alirocumab 75 Q2W/Up150 Q2W | Total Bilirubin Values From Baseline Over Time | Baseline | 10.76 micromoles per litre (umol/L) | Standard Deviation 4.736 |
| Alirocumab 75 Q2W/Up150 Q2W | Total Bilirubin Values From Baseline Over Time | Week 8 | 10.01 micromoles per litre (umol/L) | Standard Deviation 4.123 |
| Alirocumab 75 Q2W/Up150 Q2W | Total Bilirubin Values From Baseline Over Time | Week 12 | 10.26 micromoles per litre (umol/L) | Standard Deviation 4.758 |
| Alirocumab 75 Q2W/Up150 Q2W | Total Bilirubin Values From Baseline Over Time | Week 24 | 10.41 micromoles per litre (umol/L) | Standard Deviation 4.922 |
| Alirocumab 75 Q2W/Up150 Q2W | Total Bilirubin Values From Baseline Over Time | Week 48 | 10.06 micromoles per litre (umol/L) | Standard Deviation 4.503 |
| Alirocumab 75 Q2W/Up150 Q2W | Total Bilirubin Values From Baseline Over Time | Week 72 | 8.82 micromoles per litre (umol/L) | Standard Deviation 3.77 |
Secondary
Total Cholesterol (Total-C) Values From Baseline Over Time
The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
Time frame: Up to week 72
Population: SAF (All participants who received any study drug); Here, Number Analyzed = Number of participants evaluable at that timepoint
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Alirocumab 75 Q2W/Up150 Q2W | Total Cholesterol (Total-C) Values From Baseline Over Time | Baseline | 199.5 mg/dL | Standard Deviation 48.88 |
| Alirocumab 75 Q2W/Up150 Q2W | Total Cholesterol (Total-C) Values From Baseline Over Time | Week 8 | 139.5 mg/dL | Standard Deviation 44.76 |
| Alirocumab 75 Q2W/Up150 Q2W | Total Cholesterol (Total-C) Values From Baseline Over Time | Week 12 | 145.0 mg/dL | Standard Deviation 48.68 |
| Alirocumab 75 Q2W/Up150 Q2W | Total Cholesterol (Total-C) Values From Baseline Over Time | Week 24 | 137.3 mg/dL | Standard Deviation 44.18 |
| Alirocumab 75 Q2W/Up150 Q2W | Total Cholesterol (Total-C) Values From Baseline Over Time | Week 48 | 139.5 mg/dL | Standard Deviation 44.53 |
| Alirocumab 75 Q2W/Up150 Q2W | Total Cholesterol (Total-C) Values From Baseline Over Time | Week 72 | 131.7 mg/dL | Standard Deviation 43.25 |