Homozygous Familial Hypercholesterolemia
Conditions
Brief summary
This is an open-label, single-arm study to assess the reduction of low-density lipoprotein cholesterol (LDL-C) by REGN1500 in patients with homozygous familial hypercholesterolemia (HoFH).
Interventions
DRUGREGN1500 250 mg SC/15 mg/kg IV/450 mg SC
Participants received single dose of REGN1500 subcutaneous (SC) injection of 250 milligrams (mg) at Week 0 (Day 1), followed by single dose of REGN1500 intravenous (IV) injection of 15 milligrams per kilogram (mg/kg) at Week 2 (Day 15) and then followed by 4 doses of REGN1500 SC injection of 450 mg once weekly starting from Week 12 (Day 85). Only the first 2 enrolled participants received 4 weekly REGN1500 450 mg SC doses at weeks 12, 13, 14, and 15 per the protocol. This dose regimen was removed under protocol amendment 4. Participants were followed for a period of 24 weeks (through Week 26 \[Day 183\]) after the last dose of study drug in the main study period.
Sponsors
Regeneron Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Men and women ≥18 years of age at the time of the screening visit 2. Diagnosis of homozygous familial hypercholesterolemia (HoFH) 3. Willing to consistently maintain usual diet for the duration of the study
Exclusion criteria
1. Background medical lipid modifying therapy that has not been stable for at least 4 weeks (6 weeks for fibrates) prior to the screening visit 2. Having undergone lipid apheresis within 4 weeks prior to the screening visit 3. Use of another investigational drug or therapy within 30 days or at least 5 half-lives (whichever is longer) prior to the screening visit 4. Previous participation in any clinical trial of REGN1500 Note: The information listed above is not intended to contain all considerations relevant to a patient's potential participation in this clinical trial therefore not all inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) to Week 4 in the Main Study Period | Baseline (Week 0) up to Week 4 | Percent change was reported for low-density lipoprotein cholesterol (LDL-C) from baseline (week 0) up to week 4. LDL-C was measured using conventional units mg/dL. The efficacy analysis set included all participants in the safety analysis set (SAF) who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Week 2 to Week 4 in the Main Study Period | Week 2 to Week 4 | Absolute change in low-density lipoprotein cholesterol (LDL-C) from week 2 to week 4 was reported. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period. |
| Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Week 2 to Week 4 in the Main Study Period | Week 2 to Week 4 | Percent change was reported in low-density lipoprotein cholesterol (LDL-C) from week 2 to week 4. LDL-C was measured using conventional units mg/dL. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period. |
| Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) Over Time in the Main Study Period | Baseline (Week 0) up to Week 26 | Absolute change was reported in low-density lipoprotein cholesterol (LDL-C) from baseline (week 0) up to week 26. The efficacy analysis set included all participants in the safety analysis set (SAF) who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period. |
| Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) Over Time in the Main Study Period | Baseline (Week 0) up to Week 26 | Percent change was reported in low-density lipoprotein cholesterol (LDL-C) from baseline (week 0) up to week 26. LDL-C was measured using conventional units mg/dL. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period. |
| Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Baseline (Week 26) up to Week 214 | Absolute change in low-density lipoprotein cholesterol (LDL-C) from baseline (week 26) up to week 214 was reported. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period. (ET= Early Termination; EOS = End of Study) |
| Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Baseline (Week 26) up to Week 214 | Percent change was reported in low-density lipoprotein cholesterol (LDL-C) from baseline (week 26) to week 214 in the OLE period. LDL-C was measured using conventional units mg/dL. The efficacy analysis set included all participants in the SAF who had at least 1 post-baseline measure of the lipid panel in the main study period. (ET= Early Termination; EOS = End of Study) |
| Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Baseline (Week 0) up to Week 26 | Absolute change was reported for Apo B, Non-HDL-C, Total-C, and Lp(a) from baseline (week 0) up to Week 26. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period. |
| Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Baseline (Week 0) up to Week 26 | Percent change was reported for Apo B, Non-HDL-C, Total-C, and Lp(a) from baseline (week 0) up to week 26. Apo B, Non-HDL-C, Total-C, and Lp(a) were measured using conventional units mg/dL. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period. |
| Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Baseline (Week 26) up to Week 214 | Absolute changein Apo B, Non-HDL-C, Total-C, and Lp(a) from baseline to week 214 in open label extension (OLE) period. The efficacy analysis set included all participants in the SAF who had baseline and at least one post-baseline measure of the lipid panel in the main study period. (ET = Early Termination; EOS = End of Study) |
| Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Baseline (Week 26) up to Week 214 | Percent change was reported in Apo B, Non-HDL-C, Total-C, and Lp(a) from baseline (week 26) up to week 214 in OLE Period. Apo B, Non-HDL-C, Total-C, and Lp(a) were measured using conventional units mg/dL. The efficacy analysis set included all participants in the SAF who had baseline and at least one post-baseline measure of the lipid panel in the main study period. (ET= Early Termination; EOS = End of Study) |
| Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) to Week 4 in the Main Study Period | Baseline (Week 0) up to Week 4 | Absolute change in low-density lipoprotein cholesterol (LDL-C) from baseline (week 0) up to week 4 was reported. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period. |
| Percentage of Participants Who Achieved Reduction in Low-Density Lipoprotein Cholesterol (LDL-C) of ≥ 25% From Baseline (Week 26) in the Open Label Extension (OLE) Period | Baseline (Week 26) to Week 214 | Percentage of participants who achieved a reduction in low-density lipoprotein cholesterol (LDL-C) of ≥ 25% from baseline (week 26) to week 214 was reported. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period. |
| Percentage of Participants Who Achieved Reduction in Low-Density Lipoprotein Cholesterol (LDL-C) of ≥ 50% From Baseline (Week 0) in the Main Study Period | Baseline (Week 0) to Week 26 | Percentage of participants who achieved a reduction in low-density lipoprotein cholesterol (LDL-C) of ≥ 50% from baseline (week 0) to week 26 was reported. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period. |
| Percentage of Participants Who Achieved Reduction in Low-Density Lipoprotein Cholesterol (LDL-C) of ≥ 50% From Baseline (Week 26) in the Open Label Extension (OLE) Period | Baseline (Week 26) up to Week 214 | Percentage of participants who achieved reduction in low-density lipoprotein cholesterol (LDL-C) of ≥ 50% from baseline (week 26) in the OLE period was reported. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period. |
| Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | Baseline (Week 0) up to Week 26 | Absolute change was reported in HDL-C, TG, and Apo A-1 from baseline (week 0) up to week 26. The efficacy analysis set included all participants in the SAF who had baseline and at least one post-baseline measure of the lipid panel in the main study period. |
| Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | Baseline (Week 0) up to Week 26 | Percent change was reported in HDL-C, TG, and Apo A-1 from baseline (week 0) up to week 26. HDL-C, TG, and Apo A-1 were measured using conventional units mg/dL. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period. |
| Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Baseline (Week 26) up to Week 214 | Percent change was reported in HDL-C, TG and Apo A-1 from baseline (week 26) up to week 214. HDL-C, TG and Apo A-1 were measured using conventional units mg/dL. The efficacy analysis set included all participants in the SAF who had baseline and at least one post-baseline measure of the lipid panel in the main study period. (ET= Early Termination; EOS = End of Study) |
| Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Baseline (Week 26) up to Week 214 | Absolute change was reported in HDL-C, TG and Apo A-1 from baseline (week 26) up to week 214. The efficacy analysis set included all participants in the SAF who had baseline and at least one post-baseline measure of the lipid panel in the main study period. (ET= Early Termination; EOS = End of Study) |
| Absolute Change in Apolipoprotein CIII (Apo CIII) From Baseline (Week 0) Over Time in the Main Study Period | Baseline (Week 0) up to Week 16 | Absolute change was reported in Apo CIII from baseline (week 0) up to week 16. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period. |
| Percent Change in Apolipoprotein CIII (Apo CIII) From Baseline (Week 0) Over Time in the Main Study Period | Baseline (Week 0) to Week 16 | Percent change was reported in Apo CIII from baseline (week 0) up to week 16. Apo CIII was measured using conventional units mg/dL. The efficacy analysis set included all participants in the SAF who had baseline and at least one post-baseline measure of the lipid panel in the main study period. |
| Percentage of Participants Who Achieved Reduction in Low-Density Lipoprotein Cholesterol (LDL-C) of ≥ 25% From Baseline (Week 0) in the Main Study Period | Baseline (Week 0) up to Week 26 | Percentage of participants who achieved reduction in low-density lipoprotein cholesterol (LDL-C) of greater than or equal to (≥) 25 percent (%) from baseline in the main study period was reported. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period. |
Countries
Canada, Netherlands, United States
Participant flow
Recruitment details
The study was conducted at five sites in United States, Canada, and the Netherlands between 04 Feb 2015 and 23 Jul 2018. A total of 12 participants were screened in the study. Out of 12 participants, 9 participants received the study treatment.
Pre-assignment details
This study consisted of 2 screening periods: 1st for main study and 2nd for open label extension (OLE) period. Participants on stable background medical lipid-modifying therapy for at least 4 weeks prior to screening, or who didn't undergo lipid apheresis within 4 weeks prior to screening visit, were directly entered into a 2-week screening period.
Participants by arm
| Arm | Count |
|---|---|
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC Participants received single dose of REGN1500 subcutaneous (SC) injection of 250 milligrams (mg) at Week 0 (Day 1), followed by single dose of REGN1500 intravenous (IV) injection of 15 milligrams per kilogram (mg/kg) at Week 2 (Day 15) and then followed by 4 doses of REGN1500 SC injection of 450 mg once weekly starting from Week 12 (Day 85). Only the first 2 enrolled participants received 4 weekly REGN1500 450 mg SC doses at weeks 12, 13, 14, and 15 per the protocol. This dose regimen was removed under protocol amendment 4. Participants were followed for a period of 24 weeks (through Week 26 \[Day 183\]) after the last dose of study drug in the main study period. | 9 |
| Total | 9 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Open Label Extension (OLE) Period | Physician Decision | 0 | 7 |
| Open Label Extension (OLE) Period | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | REGN1500 250 mg SC/15 mg/kg IV/450 mg SC |
|---|---|
| Age, Continuous | 35.9 years STANDARD_DEVIATION 9.06 |
| Age, Customized ≥ 45 to < 65 years | 2 Participants |
| Age, Customized < 45 years | 7 Participants |
| Age, Customized ≥ 65 to < 75 years | 0 Participants |
| Age, Customized < 75 years | 0 Participants |
| Baseline Apolipoprotein A-1 (Apo A-1) | 110.4 mg/dL STANDARD_DEVIATION 23.74 |
| Baseline Apolipoprotein B (Apo B) | 226.1 mg/dL STANDARD_DEVIATION 131.7 |
| Baseline Apolipoprotein CIII (Apo CIII) | 7.976 mg/dL STANDARD_DEVIATION 3.3747 |
| Baseline High-Density Lipoprotein Cholesterol (HDL-C) | 38.8 mg/dL STANDARD_DEVIATION 14.24 |
| Baseline Lipoprotein(a) (Lp[a]) | 154.9 mg/dL STANDARD_DEVIATION 109.25 |
| Baseline Low-Density Lipoprotein Cholesterol (LDL-C) | 376.0 Milligram per Deciliter (mg/dL) STANDARD_DEVIATION 240.85 |
| Baseline Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) | 392.1 mg/dL STANDARD_DEVIATION 246.41 |
| Baseline Total Cholesterol (Total -C) | 430.9 mg/dL STANDARD_DEVIATION 235.6 |
| Baseline Triglyceride (TG) | 80.0 mg/dL STANDARD_DEVIATION 41.2 |
| Ethnicity Hispanic or Latino | 3 Participants |
| Ethnicity Not Hispanic or Latino | 6 Participants |
| Ethnicity Not Reported | 0 Participants |
| Race American Indian or Alaska Native | 0 Participants |
| Race Asian | 0 Participants |
| Race Black or African American | 0 Participants |
| Race Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race Not Reported | 2 Participants |
| Race Other | 0 Participants |
| Race White | 7 Participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 0 / 8 |
| other Total, other adverse events | 9 / 9 | 8 / 8 |
| serious Total, serious adverse events | 1 / 9 | 2 / 8 |
Outcome results
Primary
Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) to Week 4 in the Main Study Period
Percent change was reported for low-density lipoprotein cholesterol (LDL-C) from baseline (week 0) up to week 4. LDL-C was measured using conventional units mg/dL. The efficacy analysis set included all participants in the safety analysis set (SAF) who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period.
Time frame: Baseline (Week 0) up to Week 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) to Week 4 in the Main Study Period | -49.17 Percent Change | Standard Deviation 23.136 |
Secondary
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Absolute change was reported for Apo B, Non-HDL-C, Total-C, and Lp(a) from baseline (week 0) up to Week 26. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period.
Time frame: Baseline (Week 0) up to Week 26
Population: n = Number of participants who were evaluable for this endpoint at a given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Non-HDL-C: Change at Week 3 (n = 9) | -138.09 mg/dL | Standard Deviation 91.574 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Non-HDL-C: Change at Week 4 (n = 9) | -165.64 mg/dL | Standard Deviation 93.13 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Non-HDL-C: Change at Week 17 (n = 2) | -185.40 mg/dL | Standard Deviation 114.834 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Total-C: Change at Week 3 (n = 9) | -154.10 mg/dL | Standard Deviation 86.927 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Total-C: Change at Week 4 (n = 9) | -180.79 mg/dL | Standard Deviation 87.304 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Total-C: Change at Week 10 (n = 9) | -167.87 mg/dL | Standard Deviation 76.914 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Total-C: Change at Week 15 (n = 2) | -205.60 mg/dL | Standard Deviation 136.047 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Total-C: Change at Week 16 (n = 9) | -105.24 mg/dL | Standard Deviation 186.103 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Total-C: Change at Week 20 (n = 2) | -170.45 mg/dL | Standard Deviation 78.135 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Total-C: Change at Week 22 (n = 7) | -41.30 mg/dL | Standard Deviation 174.597 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Total-C: Change at Week 23 (n = 2) | -167.55 mg/dL | Standard Deviation 80.539 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Total-C: Change at Week 25 (n = 2) | -90.15 mg/dL | Standard Deviation 26.234 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Total-C: Change at Week 26 (n = 6) | -30.77 mg/dL | Standard Deviation 156.736 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Lp(a): Change at Week 2 (n = 9) | -22.4 mg/dL | Standard Deviation 30.18 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Lp(a): Change at Week 3 (n = 9) | -20.8 mg/dL | Standard Deviation 30.11 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Lp(a): Change at Week 4 (n = 9) | -21.1 mg/dL | Standard Deviation 28.29 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Lp(a): Change at Week 5 (n = 8) | -30.1 mg/dL | Standard Deviation 24.91 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Lp(a): Change at Week 6 (n = 9) | -25.0 mg/dL | Standard Deviation 31.4 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Lp(a): Change at Week 8 (n = 9) | -28.9 mg/dL | Standard Deviation 23.81 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Lp(a): Change at Week 12 (n = 9) | -20.9 mg/dL | Standard Deviation 16.3 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Lp(a): Change at Week 14 (n = 9) | -22.3 mg/dL | Standard Deviation 21.01 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Lp(a): Change at Week 16 (n = 9) | -26.9 mg/dL | Standard Deviation 38.97 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Lp(a): Change at Week 18 (n = 7) | -29.9 mg/dL | Standard Deviation 29.27 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Lp(a): Change at Week 20 (n = 2) | -19.0 mg/dL | Standard Deviation 46.67 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Lp(a): Change at Week 22 (n = 7) | -24.3 mg/dL | Standard Deviation 37.53 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Lp(a): Change at Week 23 (n = 2) | -12.5 mg/dL | Standard Deviation 19.09 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Lp(a): Change at Week 26 (n = 6) | -16.3 mg/dL | Standard Deviation 37.9 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Apo B: Change at Week 2 (n = 9) | -53.0 mg/dL | Standard Deviation 56.29 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Apo B: Change at Week 3 (n = 9) | -81.0 mg/dL | Standard Deviation 54.97 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Apo B: Change at Week 4 (n = 9) | -96.3 mg/dL | Standard Deviation 56.01 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Apo B: Change at Week 5 (n = 8) | -104.6 mg/dL | Standard Deviation 61.43 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Apo B: Change at Week 6 (n = 9) | -100.7 mg/dL | Standard Deviation 71.12 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Apo B: Change at Week 8 (n = 9) | -96.8 mg/dL | Standard Deviation 67.36 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Apo B: Change at Week 12 (n = 9) | -60.0 mg/dL | Standard Deviation 63.61 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Apo B: Change at Week 14 (n = 9) | -61.7 mg/dL | Standard Deviation 64.18 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Apo B: Change at Week 16 (n = 9) | -62.6 mg/dL | Standard Deviation 98.77 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Apo B: Change at Week 18 (n = 7) | -28.6 mg/dL | Standard Deviation 80.58 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Apo B: Change at Week 20 (n = 2) | -114.0 mg/dL | Standard Deviation 67.88 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Apo B: Change at Week 22 (n = 7) | -22.7 mg/dL | Standard Deviation 77.82 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Apo B: Change at Week 23 (n = 2) | -119.0 mg/dL | Standard Deviation 79.2 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Apo B: Change at Week 26 (n = 6) | -4.7 mg/dL | Standard Deviation 68.52 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Non-HDL-C: Change at Day 4 (n = 9) | -44.61 mg/dL | Standard Deviation 42.322 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Non-HDL-C: Change at Week 1 (n = 9) | -72.16 mg/dL | Standard Deviation 46.48 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Non-HDL-C: Change at Week 2 (n = 9) | -97.12 mg/dL | Standard Deviation 88.026 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Non-HDL-C: Change at Week 5 (n = 8) | -187.46 mg/dL | Standard Deviation 104.826 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Non-HDL-C: Change at Week 6 (n = 9) | -191.20 mg/dL | Standard Deviation 116.337 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Non-HDL-C: Change at Week 8 (n = 9) | -182.98 mg/dL | Standard Deviation 121.701 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Non-HDL-C: Change at Week 10 (n = 9) | -156.98 mg/dL | Standard Deviation 81.636 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Non-HDL-C: Change at Week 12 (n = 9) | -116.20 mg/dL | Standard Deviation 77.582 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Non-HDL-C: Change at Week 13 (n = 2) | -180.25 mg/dL | Standard Deviation 116.178 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Non-HDL-C: Change at Week 14 (n = 9) | -108.58 mg/dL | Standard Deviation 83.773 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Non-HDL-C: Change at Week 15 (n = 2) | -196.85 mg/dL | Standard Deviation 135.27 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Non-HDL-C: Change at Week 16 (n = 9) | -99.58 mg/dL | Standard Deviation 186.796 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Non-HDL-C: Change at Week 18 (n = 7) | -60.41 mg/dL | Standard Deviation 169.805 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Non-HDL-C: Change at Week 20 (n = 2) | -161.90 mg/dL | Standard Deviation 85.843 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Non-HDL-C: Change at Week 22 (n = 7) | -41.16 mg/dL | Standard Deviation 175.121 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Non-HDL-C: Change at Week 23 (n = 2) | -163.25 mg/dL | Standard Deviation 85.065 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Non-HDL-C: Change at Week 25 (n = 2) | -92.20 mg/dL | Standard Deviation 29.981 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Non-HDL-C: Change at Week 26 (n = 6) | -25.47 mg/dL | Standard Deviation 156.948 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Total-C: Change at Day 4 (n = 9) | -50.36 mg/dL | Standard Deviation 41.86 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Total-C: Change at Week 1 (n = 9) | -81.99 mg/dL | Standard Deviation 46.513 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Total-C: Change at Week 2 (n = 9) | -109.03 mg/dL | Standard Deviation 86.365 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Total-C: Change at Week 5 (n = 8) | -199.11 mg/dL | Standard Deviation 98.202 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Total-C: Change at Week 6 (n = 9) | -207.63 mg/dL | Standard Deviation 107.187 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Total-C: Change at Week 8 (n = 9) | -195.18 mg/dL | Standard Deviation 113.993 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Total-C: Change at Week 12 (n = 9) | -122.94 mg/dL | Standard Deviation 76.104 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Total-C: Change at Week 13 (n = 2) | -188.45 mg/dL | Standard Deviation 113.349 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Total-C: Change at Week 14 (n = 9) | -114.68 mg/dL | Standard Deviation 84.082 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Total-C: Change at Week 17 (n = 2) | -195.00 mg/dL | Standard Deviation 111.157 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Total-C: Change at Week 18 (n = 7) | -63.27 mg/dL | Standard Deviation 166.911 |
Secondary
Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Absolute changein Apo B, Non-HDL-C, Total-C, and Lp(a) from baseline to week 214 in open label extension (OLE) period. The efficacy analysis set included all participants in the SAF who had baseline and at least one post-baseline measure of the lipid panel in the main study period. (ET = Early Termination; EOS = End of Study)
Time frame: Baseline (Week 26) up to Week 214
Population: n = Number of participants who were evaluable for this endpoint at a given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Apo B: Change at Week 30 (n= 7) | -48.1 mg/dL | Standard Deviation 61.41 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Apo B: Change at Week 34 (n= 8) | -65.9 mg/dL | Standard Deviation 58.96 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Apo B: Change at Week 38 (n= 8) | -40.9 mg/dL | Standard Deviation 56.34 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Apo B: Change at Week 42 (n= 6) | -79.5 mg/dL | Standard Deviation 71.19 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Apo B: Change at Week 44 (n= 8) | -78.6 mg/dL | Standard Deviation 58.93 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Apo B: Change at Week 50 (n= 8) | -57.8 mg/dL | Standard Deviation 50.82 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Apo B: Change at Week 70 (n= 4) | -60.3 mg/dL | Standard Deviation 78.24 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Apo B: Change at Week 82 (n= 4) | -38.0 mg/dL | Standard Deviation 35.66 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Apo B: Change at Week 106 (n= 1) | -173.0 mg/dL | — |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Apo B: Change at ET (n= 8) | -3.5 mg/dL | Standard Deviation 42.88 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Apo B: Change at EOS (n= 3) | 65.0 mg/dL | Standard Deviation 100.53 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Non- HDL-C: Change at Week 27 (n= 8) | -65.06 mg/dL | Standard Deviation 61.756 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Non- HDL-C: Change at Week 30 (n= 7) | -94.33 mg/dL | Standard Deviation 113.286 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Non- HDL-C: Change at Week 31 (n= 8) | -152.98 mg/dL | Standard Deviation 135.977 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Non- HDL-C: Change at Week 32 (n= 8) | -166.94 mg/dL | Standard Deviation 133.99 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Non- HDL-C: Change at Week 34 (n= 8) | -133.69 mg/dL | Standard Deviation 112.247 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Non- HDL-C: Change at Week 36 (n= 8) | -111.06 mg/dL | Standard Deviation 93.635 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Non- HDL-C: Change at Week 38 (n= 8) | -84.16 mg/dL | Standard Deviation 101.21 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Non- HDL-C: Change at Week 39 (n= 6) | -146.35 mg/dL | Standard Deviation 128.368 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Non- HDL-C: Change at Week 40 (n= 6) | -134.50 mg/dL | Standard Deviation 128.198 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Non- HDL-C: Change at Week 41 (n= 6) | -171.25 mg/dL | Standard Deviation 143.692 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Non- HDL-C:Change at Week 42 (n= 6) | -150.28 mg/dL | Standard Deviation 132.214 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Non- HDL-C: Change at Week 44 (n= 8) | -149.00 mg/dL | Standard Deviation 114.152 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Non- HDL-C: Change at Week 46 (n= 8) | -129.99 mg/dL | Standard Deviation 116.77 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Non- HDL-C: Change at Week 50 (n= 8) | -110.83 mg/dL | Standard Deviation 104.353 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Non- HDL-C: Change at Week 54 (n= 8) | -14.79 mg/dL | Standard Deviation 178.797 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Non- HDL-C: Change at Week 82 (n= 4) | -69.00 mg/dL | Standard Deviation 66.715 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Non- HDL-C: Change at Week 94 (n= 1) | -388.10 mg/dL | — |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Non- HDL-C: Change at Week 106 (n= 1) | -303.10 mg/dL | — |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Non- HDL-C: Change at ET (n= 8) | -12.45 mg/dL | Standard Deviation 64.513 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Non- HDL-C: Change at EOS (n= 3) | 102.07 mg/dL | Standard Deviation 153.301 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Total-C: Change at Week 27 (n= 8) | -73.80 mg/dL | Standard Deviation 60.737 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Total-C: Change at Week 28 (n= 8) | -107.78 mg/dL | Standard Deviation 83.051 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Total-C: Change at Week 29 (n= 8) | -134.33 mg/dL | Standard Deviation 102.667 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Total-C: Change at Week 30 (n= 7) | -107.61 mg/dL | Standard Deviation 109.689 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Total-C: Change at Week 32 (n= 8) | -181.09 mg/dL | Standard Deviation 130.048 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Total-C: Change at Week 34 (n= 8) | -148.90 mg/dL | Standard Deviation 106.534 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Total-C: Change at Week 36 (n= 8) | -125.14 mg/dL | Standard Deviation 89.065 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Total-C: Change at Week 38 (n= 8) | -93.00 mg/dL | Standard Deviation 99.558 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Total-C: Change at Week 39 (n= 6) | -160.38 mg/dL | Standard Deviation 125.452 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Total-C: Change at Week 40 (n= 6) | -150.42 mg/dL | Standard Deviation 124.695 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Total-C: Change at Week 41 (n= 6) | -188.42 mg/dL | Standard Deviation 141.249 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Total-C: Change at Week 42 (n= 6) | -166.80 mg/dL | Standard Deviation 128.247 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Total-C: Change at Week 44 (n= 8) | -164.68 mg/dL | Standard Deviation 110.222 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Total-C: Change at Week 46 (n= 8) | -144.69 mg/dL | Standard Deviation 110.682 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Total-C: Change at Week 50 (n= 8) | -123.04 mg/dL | Standard Deviation 99.299 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Total-C: Change at Week 54 (n= 8) | -23.80 mg/dL | Standard Deviation 180.982 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Total-C: Change at Week 58 (n= 6) | -54.45 mg/dL | Standard Deviation 97.16 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Total-C: Change at Week 70 (n= 4) | -132.55 mg/dL | Standard Deviation 152.664 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Total-C: Change at Week 82 (n= 4) | -75.43 mg/dL | Standard Deviation 67.802 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Total-C: Change at Week 94 (n= 1) | -392.30 mg/dL | — |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Total-C: Change at Week 106 (n= 1) | -303.10 mg/dL | — |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Total-C: Change at ET (n= 8) | -20.38 mg/dL | Standard Deviation 68.809 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Total-C: Change at EOS (n= 3) | 100.40 mg/dL | Standard Deviation 144.828 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Lp(a): Change at Week 30 (n= 7) | -9.0 mg/dL | Standard Deviation 27.59 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Lp(a): Change at Week 34 (n= 8) | -10.8 mg/dL | Standard Deviation 24 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Lp(a): Change at Week 38 (n= 8) | -16.0 mg/dL | Standard Deviation 19.7 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Lp(a): Change at Week 42 (n= 6) | -0.8 mg/dL | Standard Deviation 41.36 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Lp(a): Change at Week 44 (n= 8) | 1.5 mg/dL | Standard Deviation 37.73 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Lp(a): Change at Week 50 (n= 8) | 11.6 mg/dL | Standard Deviation 48.23 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Lp(a): Change at Week 70 (n= 4) | 36.8 mg/dL | Standard Deviation 77.92 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Lp(a): Change at Week 82 (n= 4) | -5.3 mg/dL | Standard Deviation 27.04 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Lp(a): Change at Week 94 (n= 1) | -18.0 mg/dL | — |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Lp(a): Change at Week 106 (n= 1) | 39.0 mg/dL | — |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Lp(a): Change at Week ET (n= 8) | 11.6 mg/dL | Standard Deviation 26.72 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Lp(a): Change at EOS (n= 3) | 18.3 mg/dL | Standard Deviation 18.01 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Apo B: Change at Week 94 (n= 1) | -212.0 mg/dL | — |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Non- HDL-C: Change at Week 28 (n= 8) | -95.65 mg/dL | Standard Deviation 87.499 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Non- HDL-C: Change at Week 29 (n= 8) | -122.94 mg/dL | Standard Deviation 106.296 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Non- HDL-C: Change at Week 58 (n= 6) | -49.13 mg/dL | Standard Deviation 97.212 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Non- HDL-C: Change at Week 70 (n= 4) | -121.83 mg/dL | Standard Deviation 152.887 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Total-C: Change at Week 31 (n= 8) | -166.85 mg/dL | Standard Deviation 130.925 |
Secondary
Absolute Change in Apolipoprotein CIII (Apo CIII) From Baseline (Week 0) Over Time in the Main Study Period
Absolute change was reported in Apo CIII from baseline (week 0) up to week 16. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period.
Time frame: Baseline (Week 0) up to Week 16
Population: n = Number of participants who were evaluable for this endpoint at a given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein CIII (Apo CIII) From Baseline (Week 0) Over Time in the Main Study Period | Apo CIII: Change at Day 4 (n = 9) | -3.729 mg/dL | Standard Deviation 1.6905 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein CIII (Apo CIII) From Baseline (Week 0) Over Time in the Main Study Period | Apo CIII: Change at Week 1 (n = 9) | -4.296 mg/dL | Standard Deviation 1.9829 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein CIII (Apo CIII) From Baseline (Week 0) Over Time in the Main Study Period | Apo CIII: Change at Week 2 (n = 9) | -4.301 mg/dL | Standard Deviation 2.2542 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein CIII (Apo CIII) From Baseline (Week 0) Over Time in the Main Study Period | Apo CIII: Change at Week 5 (n = 8) | -6.000 mg/dL | Standard Deviation 2.8541 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein CIII (Apo CIII) From Baseline (Week 0) Over Time in the Main Study Period | Apo CIII: Change at Week 6 (n = 1) | -8.380 mg/dL | — |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein CIII (Apo CIII) From Baseline (Week 0) Over Time in the Main Study Period | Apo CIII: Change at Week 12 (n = 9) | -3.772 mg/dL | Standard Deviation 2.8443 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein CIII (Apo CIII) From Baseline (Week 0) Over Time in the Main Study Period | Apo CIII: Change at Week 14 (n = 9) | -3.866 mg/dL | Standard Deviation 3.7327 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Apolipoprotein CIII (Apo CIII) From Baseline (Week 0) Over Time in the Main Study Period | Apo CIII: Change at Week 16 (n = 9) | -2.757 mg/dL | Standard Deviation 4.4877 |
Secondary
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
Absolute change was reported in HDL-C, TG, and Apo A-1 from baseline (week 0) up to week 26. The efficacy analysis set included all participants in the SAF who had baseline and at least one post-baseline measure of the lipid panel in the main study period.
Time frame: Baseline (Week 0) up to Week 26
Population: n = Number of participants who were evaluable for this endpoint at a given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | HDL-C: Change at Day 4 (n = 9) | -5.81 mg/dL | Standard Deviation 4.789 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | HDL-C: Change at Week 1 (n = 9) | -9.92 mg/dL | Standard Deviation 6.578 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | HDL-C: Change at Week 2 (n = 9) | -11.99 mg/dL | Standard Deviation 7.351 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | HDL-C: Change at Week 3 (n = 9) | -16.02 mg/dL | Standard Deviation 10.737 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | HDL-C: Change at Week 4 (n = 9) | -15.07 mg/dL | Standard Deviation 10.792 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | HDL-C: Change at Week 5 (n = 8) | -11.66 mg/dL | Standard Deviation 8.442 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | HDL-C: Change at Week 6 (n = 9) | -16.46 mg/dL | Standard Deviation 11.868 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | HDL-C: Change at Week 8 (n = 9) | -12.06 mg/dL | Standard Deviation 11.334 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | HDL-C: Change at Week 10 (n = 9) | -10.94 mg/dL | Standard Deviation 8.215 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | HDL-C: Change at Week 12 (n = 9) | -6.82 mg/dL | Standard Deviation 6.811 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | HDL-C: Change at Week 13 (n = 2) | -8.10 mg/dL | Standard Deviation 2.97 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | HDL-C: Change at Week 14 (n = 9) | -6.18 mg/dL | Standard Deviation 4.205 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | HDL-C: Change at Week 15 (n = 2) | -8.70 mg/dL | Standard Deviation 0.566 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | HDL-C: Change at Week 16 (n = 9) | -5.54 mg/dL | Standard Deviation 5.785 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | HDL-C: Change at Week 17 (n = 2) | -9.40 mg/dL | Standard Deviation 3.818 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | HDL-C: Change at Week 18 (n = 7) | -2.93 mg/dL | Standard Deviation 7.435 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | HDL-C: Change at Week 20 (n = 2) | -8.70 mg/dL | Standard Deviation 8.202 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | HDL-C: Change at Week 22 (n = 7) | -0.30 mg/dL | Standard Deviation 6.943 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | HDL-C: Change at Week 23 (n = 2) | -4.00 mg/dL | Standard Deviation 4.384 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | HDL-C: Change at Week 25 (n = 2) | 2.50 mg/dL | Standard Deviation 3.818 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | TG: Change at Week 6 (n = 9) | -38.73 mg/dL | Standard Deviation 35.12 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | TG: Change at Week 8 (n = 9) | -30.37 mg/dL | Standard Deviation 26.383 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | TG: Change at Week 10 (n = 9) | -28.79 mg/dL | Standard Deviation 21.095 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | TG: Change at Week 12 (n = 9) | -33.23 mg/dL | Standard Deviation 32.901 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | TG: Change at Week 13 (n = 2) | -49.15 mg/dL | Standard Deviation 56.922 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | TG: Change at Week 14 (n = 9) | -22.11 mg/dL | Standard Deviation 35.348 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | TG: Change at Week 16 (n = 9) | -11.20 mg/dL | Standard Deviation 48.136 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | TG: Change at Week 17 (n = 2) | -55.35 mg/dL | Standard Deviation 58.195 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | TG: Change at Week 18 (n = 7) | 9.77 mg/dL | Standard Deviation 24.537 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | TG: Change at Week 20 (n = 2) | -33.65 mg/dL | Standard Deviation 33.729 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | TG: Change at Week 22 (n = 7) | 1.90 mg/dL | Standard Deviation 33.916 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | TG: Change at Week 23 (n = 2) | -36.30 mg/dL | Standard Deviation 31.254 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | Apo A-1: Change at Week 2 (n = 9) | -28.6 mg/dL | Standard Deviation 18.64 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | Apo A-1: Change at Week 3 (n = 9) | -43.3 mg/dL | Standard Deviation 22.54 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | Apo A-1: Change at Week 4 (n = 9) | -43.4 mg/dL | Standard Deviation 16.88 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | Apo A-1: Change at Week 5 (n = 8) | -35.8 mg/dL | Standard Deviation 17.53 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | Apo A-1: Change at Week 6 (n = 9) | -40.7 mg/dL | Standard Deviation 19.86 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | Apo A-1: Change at Week 8 (n = 9) | -33.6 mg/dL | Standard Deviation 20.64 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | Apo A-1: Change at Week 12 (n = 9) | -17.2 mg/dL | Standard Deviation 20.04 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | Apo A-1: Change at Week 14 (n = 9) | -17.7 mg/dL | Standard Deviation 11.97 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | HDL-C: Change at Week 26 (n = 6) | -5.30 mg/dL | Standard Deviation 5.266 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | TG: Change at Day 4 (n = 9) | -25.17 mg/dL | Standard Deviation 18.545 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | TG: Change at Week 1 (n = 9) | -21.41 mg/dL | Standard Deviation 17.603 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | TG: Change at Week 2 (n = 9) | -15.83 mg/dL | Standard Deviation 15.908 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | TG: Change at Week 3 (n = 9) | -39.73 mg/dL | Standard Deviation 31.977 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | TG: Change at Week 4 (n = 9) | -40.81 mg/dL | Standard Deviation 30.277 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | TG: Change at Week 5 (n = 8) | -42.04 mg/dL | Standard Deviation 28.887 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | TG: Change at Week 15 (n = 2) | -52.20 mg/dL | Standard Deviation 82.59 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | TG: Change at Week 25 (n = 2) | -23.45 mg/dL | Standard Deviation 34.436 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | TG: Change at Week 26 (n = 6) | -5.87 mg/dL | Standard Deviation 28.748 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | Apo A-1: Change at Week 16 (n = 9) | -11.3 mg/dL | Standard Deviation 16.5 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | Apo A-1: Change at Week 18 (n = 7) | -4.9 mg/dL | Standard Deviation 17.72 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | Apo A-1: Change at Week 20 (n = 2) | -24.0 mg/dL | Standard Deviation 8.49 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | Apo A-1: Change at Week 22 (n = 7) | 1.9 mg/dL | Standard Deviation 15.42 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | Apo A-1: Change at Week 23 (n = 2) | -23.0 mg/dL | Standard Deviation 8.49 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | Apo A-1: Change at Week 26 (n = 6) | -10.8 mg/dL | Standard Deviation 13.83 |
Secondary
Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Absolute change was reported in HDL-C, TG and Apo A-1 from baseline (week 26) up to week 214. The efficacy analysis set included all participants in the SAF who had baseline and at least one post-baseline measure of the lipid panel in the main study period. (ET= Early Termination; EOS = End of Study)
Time frame: Baseline (Week 26) up to Week 214
Population: n = Number of participants who were evaluable for this endpoint at a given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | HDL-C: Change at Week 106 (n= 1) | 0.00 mg/dL | — |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Triglycerides: Change at Week 27 (n= 8) | -31.19 mg/dL | Standard Deviation 28.59 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Triglycerides: Change at Week 28 (n= 8) | -36.28 mg/dL | Standard Deviation 30.63 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | HDL-C: Change at Week 94 (n= 1) | -4.20 mg/dL | — |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | HDL-C: Change at Week 27 (n= 8) | -8.78 mg/dL | Standard Deviation 5.736 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | HDL-C: Change at Week 28 (n= 8) | -12.08 mg/dL | Standard Deviation 7.244 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | HDL-C: Change at Week 29 (n= 8) | -11.44 mg/dL | Standard Deviation 7.858 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | HDL-C: Change at Week 30 (n= 7) | -13.29 mg/dL | Standard Deviation 9.27 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | HDL-C: Change at Week 31 (n= 8) | -13.94 mg/dL | Standard Deviation 8.655 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | HDL-C: Change at Week 32 (n= 8) | -14.11 mg/dL | Standard Deviation 8.163 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | HDL-C: Change at Week 34 (n= 8) | -15.10 mg/dL | Standard Deviation 9.167 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | HDL-C: Change at Week 36 (n= 8) | -14.14 mg/dL | Standard Deviation 10.426 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | HDL-C: Change at Week 38 (n= 8) | -8.89 mg/dL | Standard Deviation 7.513 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | HDL-C: Change at Week 39 (n= 6) | -14.02 mg/dL | Standard Deviation 8.023 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | HDL-C: Change at Week 40 (n= 6) | -15.90 mg/dL | Standard Deviation 7.171 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | HDL-C: Change at Week 41 (n= 6) | -17.17 mg/dL | Standard Deviation 8.262 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | HDL-C: Change at Week 42 (n= 6) | -16.65 mg/dL | Standard Deviation 7.148 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | HDL-C: Change at Week 44 (n= 8) | -15.83 mg/dL | Standard Deviation 8.167 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | HDL-C: Change at Week 46 (n= 8) | -14.85 mg/dL | Standard Deviation 10.173 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | HDL-C: Change at Week 50 (n= 8) | -12.25 mg/dL | Standard Deviation 10.985 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | HDL-C: Change at Week 54 (n= 8) | -9.06 mg/dL | Standard Deviation 9.107 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | HDL-C: Change at Week 58 (n= 6) | -5.42 mg/dL | Standard Deviation 6.058 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | HDL-C: Change at Week 70 (n= 4) | -10.83 mg/dL | Standard Deviation 10.448 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | HDL-C: Change at Week 82 (n= 4) | -6.28 mg/dL | Standard Deviation 2.655 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | HDL-C: Percent change at ET (n= 8) | -7.86 mg/dL | Standard Deviation 8.258 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | HDL-C: Change at EOS (n= 3) | -1.67 mg/dL | Standard Deviation 10.698 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Triglycerides: Change at Week 29 (n= 8) | -32.86 mg/dL | Standard Deviation 25.188 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Triglycerides: Change at Week 30 (n= 7) | -32.37 mg/dL | Standard Deviation 30.475 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Triglycerides: Change at Week 31 (n= 8) | -39.04 mg/dL | Standard Deviation 30.169 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Triglycerides: Change at Week 32 (n= 8) | -37.83 mg/dL | Standard Deviation 30.808 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Triglycerides: Change at Week 34 (n= 8) | -25.41 mg/dL | Standard Deviation 26.559 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Triglycerides: Change at Week 36 (n= 8) | -24.66 mg/dL | Standard Deviation 28.139 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Triglycerides: Change at Week 38 (n= 8) | -21.13 mg/dL | Standard Deviation 25.19 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Triglycerides: Change at Week 39 (n= 6) | -40.27 mg/dL | Standard Deviation 32.803 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Triglycerides: Change at Week 40 (n= 6) | -37.30 mg/dL | Standard Deviation 33.559 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Triglycerides: Change at Week 41 (n= 6) | -39.37 mg/dL | Standard Deviation 33.251 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Triglycerides: Change at Week 42 (n= 6) | -37.62 mg/dL | Standard Deviation 33.724 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Triglycerides: Change at Week 44 (n= 8) | -42.25 mg/dL | Standard Deviation 32.682 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Triglycerides: Change at Week 46 (n= 8) | -31.53 mg/dL | Standard Deviation 28.209 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Triglycerides: Change at Week 50 (n= 8) | -20.00 mg/dL | Standard Deviation 27.72 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Triglycerides: Change at Week 54 (n= 8) | -6.40 mg/dL | Standard Deviation 26.869 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Triglycerides: Change at Week 58 (n= 6) | -3.53 mg/dL | Standard Deviation 21.753 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Triglycerides: Change at Week 70 (n= 4) | -21.23 mg/dL | Standard Deviation 35.614 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Triglycerides: Change at Week 82 (n= 4) | -26.33 mg/dL | Standard Deviation 21.457 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Triglycerides: Change at Week 94 (n= 1) | -88.50 mg/dL | — |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Triglycerides: Change at Week 106 (n= 1) | -67.20 mg/dL | — |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Triglycerides: Change at ET (n= 8) | -11.71 mg/dL | Standard Deviation 21.343 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Triglycerides: Change at EOS (n= 3) | 30.67 mg/dL | Standard Deviation 35.39 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Apo A-1: Change at Week 30 (n= 7) | -34.4 mg/dL | Standard Deviation 20.18 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Apo A-1: Change at Week 34 (n= 8) | -35.1 mg/dL | Standard Deviation 24.7 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Apo A-1: Change at Week 38 (n= 8) | -18.0 mg/dL | Standard Deviation 26.54 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Apo A-1: Change at Week 42 (n= 6) | -43.7 mg/dL | Standard Deviation 15.71 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Apo A-1: Change at Week 44 (n= 8) | -39.4 mg/dL | Standard Deviation 18.12 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Apo A-1: Change at Week 50 (n= 8) | -26.9 mg/dL | Standard Deviation 23.56 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Apo A-1: Change at Week 70 (n= 4) | -30.3 mg/dL | Standard Deviation 20.12 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Apo A-1: Change at Week 82 (n= 4) | -21.0 mg/dL | Standard Deviation 5.83 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Apo A-1: Change at Week 94 (n= 1) | -22.0 mg/dL | — |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Apo A-1: Change at Week 106 (n= 1) | 3.0 mg/dL | — |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Apo A-1: Change at ET (n= 8) | -15.6 mg/dL | Standard Deviation 24.34 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Apo A-1: Change at EOS (n= 3) | 7.0 mg/dL | Standard Deviation 24.98 |
Secondary
Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) Over Time in the Main Study Period
Absolute change was reported in low-density lipoprotein cholesterol (LDL-C) from baseline (week 0) up to week 26. The efficacy analysis set included all participants in the safety analysis set (SAF) who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period.
Time frame: Baseline (Week 0) up to Week 26
Population: n = Number of participants who were evaluable for this endpoint at a given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) Over Time in the Main Study Period | Change at Week 26 (n= 6) | -23.98 mg/dL | Standard Deviation 152.794 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) Over Time in the Main Study Period | Change at Day 4 (n= 9) | -39.60 mg/dL | Standard Deviation 41.677 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) Over Time in the Main Study Period | Change at Week 1 (n= 9) | -67.59 mg/dL | Standard Deviation 46.041 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) Over Time in the Main Study Period | Change at Week 2 (n= 9) | -93.71 mg/dL | Standard Deviation 86.504 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) Over Time in the Main Study Period | Change at Week 3 (n= 9) | -129.97 mg/dL | Standard Deviation 90.533 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) Over Time in the Main Study Period | Change at Week 4 (n= 9) | -157.34 mg/dL | Standard Deviation 89.59 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) Over Time in the Main Study Period | Change at Week 5 (n= 8) | -179.18 mg/dL | Standard Deviation 101.26 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) Over Time in the Main Study Period | Change at Week 6 (n= 9) | -183.41 mg/dL | Standard Deviation 111.313 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) Over Time in the Main Study Period | Change at Week 8 (n= 9) | -176.72 mg/dL | Standard Deviation 118.441 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) Over Time in the Main Study Period | Change at Week 10 (n= 9) | -151.19 mg/dL | Standard Deviation 78.164 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) Over Time in the Main Study Period | Change at Week 12 (n= 9) | -109.40 mg/dL | Standard Deviation 74.108 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) Over Time in the Main Study Period | Change at Week 13 (n= 2) | -170.15 mg/dL | Standard Deviation 105.288 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) Over Time in the Main Study Period | Change at Week 14 (n= 9) | -104.16 mg/dL | Standard Deviation 78.954 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) Over Time in the Main Study Period | Change at Week 15 (n= 2) | -186.15 mg/dL | Standard Deviation 119.147 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) Over Time in the Main Study Period | Change at Week 16 (n= 9) | -97.29 mg/dL | Standard Deviation 179.016 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) Over Time in the Main Study Period | Change at Week 17 (n= 2) | -174.20 mg/dL | Standard Deviation 103.803 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) Over Time in the Main Study Period | Change at Week 18 (n= 7) | -62.11 mg/dL | Standard Deviation 167.004 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) Over Time in the Main Study Period | Change at Week 20 (n= 2) | -155.25 mg/dL | Standard Deviation 79.832 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) Over Time in the Main Study Period | Change at Week 22 (n= 7) | -41.37 mg/dL | Standard Deviation 169.432 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) Over Time in the Main Study Period | Change at Week 23 (n= 2) | -155.85 mg/dL | Standard Deviation 78.984 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) Over Time in the Main Study Period | Change at Week 25 (n= 2) | -87.90 mg/dL | Standard Deviation 23.9 |
Secondary
Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) to Week 4 in the Main Study Period
Absolute change in low-density lipoprotein cholesterol (LDL-C) from baseline (week 0) up to week 4 was reported. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period.
Time frame: Baseline (Week 0) up to Week 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) to Week 4 in the Main Study Period | -157.34 mg/dL | Standard Deviation 89.59 |
Secondary
Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Absolute change in low-density lipoprotein cholesterol (LDL-C) from baseline (week 26) up to week 214 was reported. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period. (ET= Early Termination; EOS = End of Study)
Time frame: Baseline (Week 26) up to Week 214
Population: n = Number of participants who were evaluable for this endpoint at a given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Change at Week 26 (n= 8) | 261.34 mg/dL | Standard Deviation 178.792 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Change at Week 27 (n= 8) | -58.73 mg/dL | Standard Deviation 56.992 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Change at Week 28 (n= 8) | -88.16 mg/dL | Standard Deviation 83.196 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Change at Week 29 (n= 8) | -116.20 mg/dL | Standard Deviation 102.219 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Change at Week 30 (n= 7) | -87.80 mg/dL | Standard Deviation 108.905 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Change at Week 31 (n= 8) | -144.99 mg/dL | Standard Deviation 130.764 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Change at Week 32 (n= 8) | -159.16 mg/dL | Standard Deviation 128.072 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Change at Week 34 (n= 8) | -128.38 mg/dL | Standard Deviation 108.331 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Change at Week 36 (n= 8) | -105.94 mg/dL | Standard Deviation 89.99 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Change at Week 38 (n= 8) | -79.98 mg/dL | Standard Deviation 97.851 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Change at Week 39 (n= 6) | -138.28 mg/dL | Standard Deviation 123.133 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Change at Week 40 (n= 6) | -127.13 mg/dL | Standard Deviation 122.808 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Change at Week 41 (n= 6) | -163.28 mg/dL | Standard Deviation 137.365 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Change at Week 42 (n= 6) | -142.65 mg/dL | Standard Deviation 126.647 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Change at Week 44 (n= 8) | -140.36 mg/dL | Standard Deviation 109.275 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Change at Week 46 (n= 8) | -123.25 mg/dL | Standard Deviation 112.503 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Change at Week 50 (n= 8) | -106.61 mg/dL | Standard Deviation 99.458 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Change at Week 54 (n= 8) | -13.38 mg/dL | Standard Deviation 177.649 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Change at Week 58 (n= 6) | -48.27 mg/dL | Standard Deviation 93.443 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Change at Week 70 (n= 4) | -117.93 mg/dL | Standard Deviation 145.917 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Change at Week 82 (n= 4) | -63.88 mg/dL | Standard Deviation 64.738 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Change at Week 94 (n= 1) | -369.90 mg/dL | — |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Change at Week 106 (n= 1) | -290.00 mg/dL | — |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Change at ET (n= 8) | -9.78 mg/dL | Standard Deviation 64.93 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Change at EOS (n= 3) | 95.63 mg/dL | Standard Deviation 147.1 |
Secondary
Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Week 2 to Week 4 in the Main Study Period
Absolute change in low-density lipoprotein cholesterol (LDL-C) from week 2 to week 4 was reported. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period.
Time frame: Week 2 to Week 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Week 2 to Week 4 in the Main Study Period | -63.63 Milligram per Deciliter (mg/dL) | Standard Deviation 50.97 |
Secondary
Percentage of Participants Who Achieved Reduction in Low-Density Lipoprotein Cholesterol (LDL-C) of ≥ 25% From Baseline (Week 0) in the Main Study Period
Percentage of participants who achieved reduction in low-density lipoprotein cholesterol (LDL-C) of greater than or equal to (≥) 25 percent (%) from baseline in the main study period was reported. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period.
Time frame: Baseline (Week 0) up to Week 26
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percentage of Participants Who Achieved Reduction in Low-Density Lipoprotein Cholesterol (LDL-C) of ≥ 25% From Baseline (Week 0) in the Main Study Period | 100 Percentage of participants |
Secondary
Percentage of Participants Who Achieved Reduction in Low-Density Lipoprotein Cholesterol (LDL-C) of ≥ 25% From Baseline (Week 26) in the Open Label Extension (OLE) Period
Percentage of participants who achieved a reduction in low-density lipoprotein cholesterol (LDL-C) of ≥ 25% from baseline (week 26) to week 214 was reported. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period.
Time frame: Baseline (Week 26) to Week 214
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percentage of Participants Who Achieved Reduction in Low-Density Lipoprotein Cholesterol (LDL-C) of ≥ 25% From Baseline (Week 26) in the Open Label Extension (OLE) Period | 100 Percentage of participants |
Secondary
Percentage of Participants Who Achieved Reduction in Low-Density Lipoprotein Cholesterol (LDL-C) of ≥ 50% From Baseline (Week 0) in the Main Study Period
Percentage of participants who achieved a reduction in low-density lipoprotein cholesterol (LDL-C) of ≥ 50% from baseline (week 0) to week 26 was reported. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period.
Time frame: Baseline (Week 0) to Week 26
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percentage of Participants Who Achieved Reduction in Low-Density Lipoprotein Cholesterol (LDL-C) of ≥ 50% From Baseline (Week 0) in the Main Study Period | 77.8 Percentage of participants |
Secondary
Percentage of Participants Who Achieved Reduction in Low-Density Lipoprotein Cholesterol (LDL-C) of ≥ 50% From Baseline (Week 26) in the Open Label Extension (OLE) Period
Percentage of participants who achieved reduction in low-density lipoprotein cholesterol (LDL-C) of ≥ 50% from baseline (week 26) in the OLE period was reported. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period.
Time frame: Baseline (Week 26) up to Week 214
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percentage of Participants Who Achieved Reduction in Low-Density Lipoprotein Cholesterol (LDL-C) of ≥ 50% From Baseline (Week 26) in the Open Label Extension (OLE) Period | 87.5 Percentage |
Secondary
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period
Percent change was reported for Apo B, Non-HDL-C, Total-C, and Lp(a) from baseline (week 0) up to week 26. Apo B, Non-HDL-C, Total-C, and Lp(a) were measured using conventional units mg/dL. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period.
Time frame: Baseline (Week 0) up to Week 26
Population: n = Number of participants who were evaluable for this endpoint at a given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Apo B: Percent change at Week 2 (n = 9) | -24.38 Percent Change | Standard Deviation 20.959 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Apo B: Percent change at Week 4 (n = 9) | -45.89 Percent Change | Standard Deviation 18.222 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Apo B: Percent change at Week 5 (n = 8) | -42.28 Percent Change | Standard Deviation 13.247 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Apo B: Percent change at Week 6 (n = 9) | -43.12 Percent Change | Standard Deviation 14.716 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Apo B: Percent change at Week 8 (n = 9) | -42.66 Percent Change | Standard Deviation 14.475 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Apo B: Percent change at Week 12 (n = 9) | -29.47 Percent Change | Standard Deviation 21.736 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Apo B: Percent change at Week 14 (n = 9) | -27.42 Percent Change | Standard Deviation 18.418 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Apo B: Percent change at Week 16 (n = 9) | -21.60 Percent Change | Standard Deviation 24.97 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Apo B: Percent change at Week 18 (n = 7) | -7.63 Percent Change | Standard Deviation 24.347 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Apo B: Percent change at Week 20 (n = 2) | -39.32 Percent Change | Standard Deviation 6.481 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Apo B: Percent change at Week 22 (n = 7) | -8.07 Percent Change | Standard Deviation 30.444 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Apo B: Percent change at Week 23 (n = 2) | -40.29 Percent Change | Standard Deviation 10.089 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Apo B: Percent change at Week 26 (n = 6) | -2.03 Percent Change | Standard Deviation 25.32 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Non-HDL-C: Percent change at Day 4 (n = 9) | -13.61 Percent Change | Standard Deviation 10.721 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Non-HDL-C: Percent change at Week 1 (n = 9) | -24.12 Percent Change | Standard Deviation 20.083 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Non-HDL-C: Percent change at Week 2 (n = 9) | -29.61 Percent Change | Standard Deviation 23.406 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Non-HDL-C: Percent change at Week 3 (n = 9) | -41.62 Percent Change | Standard Deviation 23.969 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Non-HDL-C: Percent change at Week 4 (n = 9) | -48.91 Percent Change | Standard Deviation 22.257 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Non-HDL-C: Percent change at Week 5 (n = 8) | -46.61 Percent Change | Standard Deviation 14.172 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Non-HDL-C: Percent change at Week 6 (n = 9) | -51.49 Percent Change | Standard Deviation 14.344 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Non-HDL-C: Percent change at Week 8 (n = 9) | -50.65 Percent Change | Standard Deviation 17.231 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Non-HDL-C: Percent change at Week 10 (n = 9) | -44.80 Percent Change | Standard Deviation 13.148 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Non-HDL-C: Percent change at Week 12 (n = 9) | -36.40 Percent Change | Standard Deviation 18.711 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Non-HDL-C: Percent change at Week 13 (n = 2) | -39.84 Percent Change | Standard Deviation 11.313 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Non-HDL-C: Percent change at Week 14 (n = 9) | -32.71 Percent Change | Standard Deviation 18.214 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Non-HDL-C: Percent change at Week 15 (n = 2) | -43.09 Percent Change | Standard Deviation 14.482 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Non-HDL-C: Percent change at Week 16 (n = 9) | -24.22 Percent Change | Standard Deviation 25.899 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Non-HDL-C: Percent change at Week 17 (n = 2) | -41.21 Percent Change | Standard Deviation 10.455 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Non-HDL-C: Percent change at Week 18 (n = 7) | -12.70 Percent Change | Standard Deviation 27.798 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Non-HDL-C: Percent change at Week 20 (n = 2) | -36.71 Percent Change | Standard Deviation 5.471 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Non-HDL-C: Percent change at Week 22 (n = 7) | -9.43 Percent Change | Standard Deviation 37.102 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Non-HDL-C: Percent change at Week 23 (n = 2) | -37.10 Percent Change | Standard Deviation 5.138 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Non-HDL-C: Percent change at Week 25 (n = 2) | -21.86 Percent Change | Standard Deviation 1.676 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Non-HDL-C: Percent change at Week 26 (n = 6) | -9.99 Percent Change | Standard Deviation 25.292 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Total-C: Percent change at Day 4 (n = 9) | -13.18 Percent Change | Standard Deviation 8.932 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Total-C: Percent change at Week 1 (n = 9) | -23.23 Percent Change | Standard Deviation 16.602 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Total-C: Percent change at Week 2 (n = 9) | -29.14 Percent Change | Standard Deviation 20.307 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Total-C: Percent change at Week 3 (n = 9) | -40.81 Percent Change | Standard Deviation 21.011 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Total-C: Percent change at Week 4 (n = 9) | -46.95 Percent Change | Standard Deviation 19.083 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Total-C: Percent change at Week 5 (n = 8) | -45.43 Percent Change | Standard Deviation 12.909 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Total-C: Percent change at Week 6 (n = 9) | -50.68 Percent Change | Standard Deviation 13.327 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Total-C: Percent change at Week 8 (n = 9) | -48.29 Percent Change | Standard Deviation 15.556 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Total-C: Percent change at Week 10 (n = 9) | -42.15 Percent Change | Standard Deviation 10.858 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Total-C: Percent change at Week 12 (n = 9) | -33.48 Percent Change | Standard Deviation 16.136 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Total-C: Percent change at Week 13 (n = 2) | -38.98 Percent Change | Standard Deviation 10.525 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Total-C: Percent change at Week 14 (n = 9) | -29.66 Percent Change | Standard Deviation 15.759 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Total-C: Percent change at Week 15 (n = 2) | -42.01 Percent Change | Standard Deviation 14.356 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Total-C: Percent change at Week 16 (n = 9) | -23.51 Percent Change | Standard Deviation 25.208 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Total-C: Percent change at Week 17 (n = 2) | -40.59 Percent Change | Standard Deviation 9.468 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Total-C: Percent change at Week 18 (n = 7) | -12.65 Percent Change | Standard Deviation 26.105 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Total-C: Percent change at Week 20 (n = 2) | -36.28 Percent Change | Standard Deviation 3.862 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Total-C: Percent change at Week 22 (n = 7) | -7.73 Percent Change | Standard Deviation 33.729 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Total-C: Percent change at Week 23 (n = 2) | -35.50 Percent Change | Standard Deviation 4.662 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Total-C: Percent change at Week 25 (n = 2) | -19.82 Percent Change | Standard Deviation 1.459 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Total-C: Percent change at Week 26 (n = 6) | -10.05 Percent Change | Standard Deviation 22.903 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Lp(a): Percent change at Week 3 (n = 9) | -12.25 Percent Change | Standard Deviation 19.35 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Lp(a): Percent change at Week 4 (n = 9) | -10.85 Percent Change | Standard Deviation 24.465 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Lp(a): Percent change at Week 5 (n = 8) | -23.79 Percent Change | Standard Deviation 17.908 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Lp(a): Percent change at Week 6 (n = 9) | -17.12 Percent Change | Standard Deviation 23.68 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Lp(a): Percent change at Week 8 (n = 9) | -17.24 Percent Change | Standard Deviation 17.764 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Lp(a): Percent change at Week 12 (n = 9) | -13.09 Percent Change | Standard Deviation 12.614 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Lp(a): Percent change at Week 14 (n = 9) | -13.54 Percent Change | Standard Deviation 10.151 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Lp(a): Percent change at Week 16 (n = 9) | -16.93 Percent Change | Standard Deviation 24.795 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Lp(a): Percent change at Week 18 (n = 7) | -19.61 Percent Change | Standard Deviation 21.686 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Lp(a): Percent change at Week 20 (n = 2) | -19.72 Percent Change | Standard Deviation 32.894 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Lp(a): Percent change at Week 22 (n = 7) | -10.37 Percent Change | Standard Deviation 29.23 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Lp(a): Percent change at Week 23 (n = 2) | -10.62 Percent Change | Standard Deviation 15.373 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Lp(a): Percent change at Week 26 (n = 6) | 3.46 Percent Change | Standard Deviation 39.4 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Apo B: Percent change at Week 3 (n = 9) | -38.63 Percent Change | Standard Deviation 22.114 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period | Lp(a): Percent change at Week 2 (n = 9) | -11.64 Percent Change | Standard Deviation 20.323 |
Secondary
Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Percent change was reported in Apo B, Non-HDL-C, Total-C, and Lp(a) from baseline (week 26) up to week 214 in OLE Period. Apo B, Non-HDL-C, Total-C, and Lp(a) were measured using conventional units mg/dL. The efficacy analysis set included all participants in the SAF who had baseline and at least one post-baseline measure of the lipid panel in the main study period. (ET= Early Termination; EOS = End of Study)
Time frame: Baseline (Week 26) up to Week 214
Population: n = Number of participants who were evaluable for this endpoint at a given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Apo B: Percent change at Week 30 (n= 7) | -30.59 Percent change | Standard Deviation 25.991 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Apo B: Percent change at Week 34 (n= 8) | -41.27 Percent change | Standard Deviation 19.573 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Apo B: Percent change at Week 38 (n= 8) | -29.02 Percent change | Standard Deviation 25.029 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Apo B: Percent change at Week 42 (n= 6) | -50.90 Percent change | Standard Deviation 17.497 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Apo B: Percent change at Week 44 (n= 8) | -48.59 Percent change | Standard Deviation 16.201 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Apo B: Percent change at Week 50 (n= 8) | -36.68 Percent change | Standard Deviation 19.62 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Apo B: Percent change at Week 82 (n= 4) | -24.87 Percent change | Standard Deviation 17.148 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Apo B: Percent change at Week 94 (n= 1) | -77.09 Percent change | — |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Apo B: Percent change at Week 106 (n= 1) | -62.91 Percent change | — |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Apo B: Percent change at ET (n= 8) | -11.94 Percent change | Standard Deviation 25.708 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Apo B: Percent change at EOS (n= 3) | 22.60 Percent change | Standard Deviation 38.988 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Non- HDL-C: Percent change at Week 27 (n= 8) | -23.62 Percent change | Standard Deviation 15.342 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Non- HDL-C: Percent change at Week 28 (n= 8) | -37.22 Percent change | Standard Deviation 19.207 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Non- HDL-C: Percent change at Week 29 (n= 8) | -44.30 Percent change | Standard Deviation 19.766 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Non- HDL-C: Percent change at Week 30 (n= 7) | -37.90 Percent change | Standard Deviation 29.133 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Non- HDL-C: Percent change at Week 31 (n= 8) | -50.59 Percent change | Standard Deviation 19.285 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Non- HDL-C: Percent change at Week 32 (n= 8) | -59.09 Percent change | Standard Deviation 18.2 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Non- HDL-C: Percent change at Week 34 (n= 8) | -51.55 Percent change | Standard Deviation 21.112 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Non- HDL-C: Percent change at Week 38 (n= 8) | -36.10 Percent change | Standard Deviation 24.473 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Non- HDL-C: Percent change at Week 39 (n= 6) | -59.25 Percent change | Standard Deviation 21.381 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Non- HDL-C: Percent change at Week 40 (n= 6) | -53.24 Percent change | Standard Deviation 20.135 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Non- HDL-C: Percent change at Week 41 (n= 6) | -65.07 Percent change | Standard Deviation 18.375 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Non- HDL-C: Percent change at Week 42 (n= 6) | -58.92 Percent change | Standard Deviation 18.287 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Non- HDL-C: Percent change at Week 44 (n= 8) | -57.03 Percent change | Standard Deviation 17.675 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Non- HDL-C: Percent change at Week 46 (n= 8) | -48.27 Percent change | Standard Deviation 18.674 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Non- HDL-C: Percent change at Week 50 (n= 8) | -41.16 Percent change | Standard Deviation 22.284 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Non- HDL-C: Percent change at Week 54 (n= 8) | -12.93 Percent change | Standard Deviation 42.412 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Non- HDL-C: Percent change at Week 58 (n= 6) | -12.28 Percent change | Standard Deviation 26.06 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Non- HDL-C: Percent change at Week 70 (n= 4) | -37.68 Percent change | Standard Deviation 35.771 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Non- HDL-C: Percent change at Week 82 (n= 4) | -26.16 Percent change | Standard Deviation 27.153 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Non- HDL-C: Percent change at Week 94 (n= 1) | -81.52 Percent change | — |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Non- HDL-C: Percent change at Week 106 (n= 1) | -63.66 Percent change | — |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Non- HDL-C: Percent change at ET (n= 8) | -17.65 Percent change | Standard Deviation 27.339 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Non- HDL-C: Percent change at EOS (n= 3) | 19.98 Percent change | Standard Deviation 40.313 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Total-C: Percent change at Week 27 (n= 8) | -22.24 Percent change | Standard Deviation 11.566 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Total-C: Percent change at Week 28 (n= 8) | -34.78 Percent change | Standard Deviation 14.984 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Total-C: Percent change at Week 29 (n= 8) | -40.57 Percent change | Standard Deviation 14.335 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Total-C: Percent change at Week 30 (n= 7) | -36.37 Percent change | Standard Deviation 23.55 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Total-C: Percent change at Week 31 (n= 8) | -48.83 Percent change | Standard Deviation 16.944 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Total-C: Percent change at Week 32 (n= 8) | -55.05 Percent change | Standard Deviation 16.624 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Total-C: Percent change at Week 34 (n= 8) | -48.67 Percent change | Standard Deviation 18.123 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Total-C: Percent change at Week 36 (n= 8) | -44.16 Percent change | Standard Deviation 19.175 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Total-C: Percent change at Week 38 (n= 8) | -33.29 Percent change | Standard Deviation 22.145 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Total-C: Percent change at Week 39 (n= 6) | -54.40 Percent change | Standard Deviation 19.803 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Total-C: Percent change at Week 40 (n= 6) | -50.13 Percent change | Standard Deviation 18.316 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Total-C: Percent change at Week 41 (n= 6) | -60.87 Percent change | Standard Deviation 17.966 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Total-C: Percent change at Week 42 (n= 6) | -54.88 Percent change | Standard Deviation 15.886 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Total-C: Percent change at Week 44 (n= 8) | -53.41 Percent change | Standard Deviation 16.231 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Total-C: Percent change at Week 46 (n= 8) | -46.06 Percent change | Standard Deviation 16.855 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Total-C: Percent change at Week 50 (n= 8) | -39.04 Percent change | Standard Deviation 19.318 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Total-C: Percent change at Week 54 (n= 8) | -12.82 Percent change | Standard Deviation 38.323 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Total-C: Percent change at Week 58 (n= 6) | -13.78 Percent change | Standard Deviation 21.976 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Total-C: Percent change at Week 70 (n= 4) | -36.63 Percent change | Standard Deviation 32.371 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Total-C: Percent change at Week 82 (n= 4) | -23.09 Percent change | Standard Deviation 19.171 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Total-C: Percent change at Week 94 (n= 1) | -77.50 Percent change | — |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Total-C: Percent change at Week 106 (n= 1) | -59.88 Percent change | — |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Total-C: Percent change at ET (n= 8) | -16.76 Percent change | Standard Deviation 25.085 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Total-C: Percent change at EOS (n= 3) | 18.20 Percent change | Standard Deviation 33.9 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Lp(a): Percent change at Week 34 (n= 8) | -6.43 Percent change | Standard Deviation 21.281 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Lp(a): Percent change at Week 38 (n= 8) | -9.50 Percent change | Standard Deviation 14.429 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Lp(a): Percent change at Week 42 (n= 6) | -4.76 Percent change | Standard Deviation 24.227 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Lp(a): Percent change at Week 44 (n= 8) | -5.13 Percent change | Standard Deviation 25.377 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Lp(a): Percent change at Week 50 (n= 8) | 1.02 Percent change | Standard Deviation 29.756 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Lp(a): Percent change at Week 70 (n= 4) | 15.80 Percent change | Standard Deviation 36.28 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Lp(a): Percent change at Week 82 (n= 4) | -3.77 Percent change | Standard Deviation 16.168 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Lp(a): Percent change at Week 94 (n= 1) | -11.92 Percent change | — |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Lp(a): Percent change at Week 106 (n= 1) | 25.83 Percent change | — |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Lp(a): Percent change at ET (n= 8) | 9.96 Percent change | Standard Deviation 21.597 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Lp(a): Percent change at EOS (n= 3) | 40.51 Percent change | Standard Deviation 39.616 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Apo B: Percent change at Week 70 (n= 4) | -33.44 Percent change | Standard Deviation 26.773 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Non- HDL-C: Percent change at Week 36 (n= 8) | -46.62 Percent change | Standard Deviation 20.797 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Lp(a): Percent change at Week 30 (n= 7) | -3.57 Percent change | Standard Deviation 24.61 |
Secondary
Percent Change in Apolipoprotein CIII (Apo CIII) From Baseline (Week 0) Over Time in the Main Study Period
Percent change was reported in Apo CIII from baseline (week 0) up to week 16. Apo CIII was measured using conventional units mg/dL. The efficacy analysis set included all participants in the SAF who had baseline and at least one post-baseline measure of the lipid panel in the main study period.
Time frame: Baseline (Week 0) to Week 16
Population: n = Number of participants who were evaluable for this endpoint at a given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein CIII (Apo CIII) From Baseline (Week 0) Over Time in the Main Study Period | Apo CIII: Percent Change at Day 4 (n = 9) | -46.59 Percent Change | Standard Deviation 22.129 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein CIII (Apo CIII) From Baseline (Week 0) Over Time in the Main Study Period | Apo CIII: Percent Change at Week 1 (n = 9) | -55.43 Percent Change | Standard Deviation 18.541 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein CIII (Apo CIII) From Baseline (Week 0) Over Time in the Main Study Period | Apo CIII: Percent Change at Week 2 (n = 9) | -56.57 Percent Change | Standard Deviation 24.815 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein CIII (Apo CIII) From Baseline (Week 0) Over Time in the Main Study Period | Apo CIII: Percent Change at Week 5 (n = 8) | -75.44 Percent Change | Standard Deviation 9.667 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein CIII (Apo CIII) From Baseline (Week 0) Over Time in the Main Study Period | Apo CIII: Percent Change at Week 6 (n = 1) | -91.48 Percent Change | — |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein CIII (Apo CIII) From Baseline (Week 0) Over Time in the Main Study Period | Apo CIII: Percent Change at Week 12 (n = 9) | -49.07 Percent Change | Standard Deviation 25.517 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein CIII (Apo CIII) From Baseline (Week 0) Over Time in the Main Study Period | Apo CIII: Percent Change at Week 14 (n = 9) | -40.67 Percent Change | Standard Deviation 44.674 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Apolipoprotein CIII (Apo CIII) From Baseline (Week 0) Over Time in the Main Study Period | Apo CIII: Percent Change at Week 16 (n = 9) | -28.30 Percent Change | Standard Deviation 54.676 |
Secondary
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period
Percent change was reported in HDL-C, TG, and Apo A-1 from baseline (week 0) up to week 26. HDL-C, TG, and Apo A-1 were measured using conventional units mg/dL. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period.
Time frame: Baseline (Week 0) up to Week 26
Population: n = Number of participants who were evaluable for this endpoint at a given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | HDL-C: Percent Change at Week 23 (n = 2) | -11.56 Percent Change | Standard Deviation 12.094 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | HDL-C: Percent Change at Week 25 (n = 2) | 8.41 Percent Change | Standard Deviation 12.698 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | HDL-C: Percent Change at Week 26 (n = 6) | -12.00 Percent Change | Standard Deviation 11.109 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | TG: Percent Change at Day 4 (n = 9) | -29.61 Percent Change | Standard Deviation 18.562 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | TG: Percent Change at Week 1 (n = 9) | -23.41 Percent Change | Standard Deviation 20.15 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | TG: Percent Change at Week 2 (n = 9) | -17.19 Percent Change | Standard Deviation 18.735 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | TG: Percent Change at Week 3 (n = 9) | -44.38 Percent Change | Standard Deviation 19.223 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | Apo A-1: Percent Change at Week 8 (n = 9) | -29.03 Percent Change | Standard Deviation 14.765 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | HDL-C: Percent Change at Day 4 (n = 9) | -14.37 Percent Change | Standard Deviation 10.83 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | HDL-C: Percent Change at Week 1 (n = 9) | -23.34 Percent Change | Standard Deviation 10.783 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | HDL-C: Percent Change at Week 2 (n = 9) | -28.75 Percent Change | Standard Deviation 8.458 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | HDL-C: Percent Change at Week 3 (n = 9) | -36.96 Percent Change | Standard Deviation 16.495 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | HDL-C: Percent Change at Week 4 (n = 9) | -35.24 Percent Change | Standard Deviation 16.212 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | HDL-C: Percent Change at Week 5 (n = 8) | -29.74 Percent Change | Standard Deviation 14.24 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | HDL-C: Percent Change at Week 6 (n = 9) | -37.88 Percent Change | Standard Deviation 15.864 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | HDL-C: Percent Change at Week 8 (n = 9) | -25.42 Percent Change | Standard Deviation 23.199 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | HDL-C: Percent Change at Week 10 (n = 9) | -24.57 Percent Change | Standard Deviation 22.409 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | HDL-C: Percent Change at Week 12 (n = 9) | -13.59 Percent Change | Standard Deviation 23.189 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | HDL-C: Percent Change at Week 13 (n = 2) | -24.48 Percent Change | Standard Deviation 6.243 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | HDL-C: Percent Change at Week 14 (n = 9) | -16.81 Percent Change | Standard Deviation 14.822 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | HDL-C: Percent Change at Week 15 (n = 2) | -26.97 Percent Change | Standard Deviation 4.895 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | HDL-C: Percent Change at Week 16 (n = 9) | -12.03 Percent Change | Standard Deviation 16.026 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | HDL-C: Percent Change at Week 17 (n = 2) | -28.34 Percent Change | Standard Deviation 8.393 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | HDL-C: Percent Change at Week 18 (n = 7) | -1.05 Percent Change | Standard Deviation 24.171 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | HDL-C: Percent Change at Week 20 (n = 2) | -25.39 Percent Change | Standard Deviation 22.187 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | HDL-C: Percent Change at Week 22 (n = 7) | 3.78 Percent Change | Standard Deviation 20.466 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | TG: Percent Change at Week 4 (n = 9) | -46.57 Percent Change | Standard Deviation 17.014 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | TG: Percent Change at Week 5 (n = 8) | -44.49 Percent Change | Standard Deviation 16.583 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | TG: Percent Change at Week 6 (n = 9) | -40.03 Percent Change | Standard Deviation 26.83 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | TG: Percent Change at Week 8 (n = 9) | -30.69 Percent Change | Standard Deviation 24.8 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | TG: Percent Change at Week 10 (n = 9) | -31.40 Percent Change | Standard Deviation 16.697 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | TG: Percent Change at Week 12 (n = 9) | -35.38 Percent Change | Standard Deviation 25.014 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | TG: Percent Change at Week 13 (n = 2) | -35.11 Percent Change | Standard Deviation 26.733 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | TG: Percent Change at Week 14 (n = 9) | -23.51 Percent Change | Standard Deviation 28.335 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | TG: Percent Change at Week 15 (n = 2) | -27.77 Percent Change | Standard Deviation 55.24 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | TG: Percent Change at Week 16 (n = 9) | -6.70 Percent Change | Standard Deviation 40.326 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | TG: Percent Change at Week 17 (n = 2) | -42.09 Percent Change | Standard Deviation 22.941 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | TG: Percent Change at Week 18 (n = 7) | 23.13 Percent Change | Standard Deviation 55.349 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | TG: Percent Change at Week 20 (n = 2) | -26.30 Percent Change | Standard Deviation 11.945 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | TG: Percent Change at Week 22 (n = 7) | 8.86 Percent Change | Standard Deviation 43.819 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | TG: Percent Change at Week 23 (n = 2) | -30.58 Percent Change | Standard Deviation 6.662 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | TG: Percent Change at Week 25 (n = 2) | -13.62 Percent Change | Standard Deviation 21.582 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | TG: Percent Change at Week 26 (n = 6) | -1.60 Percent Change | Standard Deviation 33.318 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | Apo A-1: Percent Change at Week 2 (n = 9) | -24.37 Percent Change | Standard Deviation 12.794 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | Apo A-1: Percent Change at Week 3 (n = 9) | -36.47 Percent Change | Standard Deviation 16.93 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | Apo A-1: Percent Change at Week 4 (n = 9) | -38.54 Percent Change | Standard Deviation 8.906 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | Apo A-1: Percent Change at Week 5 (n = 8) | -31.91 Percent Change | Standard Deviation 11.491 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | Apo A-1: Percent Change at Week 6 (n = 9) | -34.72 Percent Change | Standard Deviation 12.342 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | Apo A-1: Percent Change at Week 12 (n = 9) | -11.85 Percent Change | Standard Deviation 25.176 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | Apo A-1: Percent Change at Week 14 (n = 9) | -17.65 Percent Change | Standard Deviation 13.824 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | Apo A-1: Percent Change at Week 16 (n = 9) | -9.86 Percent Change | Standard Deviation 14.372 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | Apo A-1: Percent Change at Week 18 (n = 7) | -1.16 Percent Change | Standard Deviation 19.598 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | Apo A-1: Percent Change at Week 20 (n = 2) | -22.15 Percent Change | Standard Deviation 7.965 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | Apo A-1: Percent Change at Week 22 (n = 7) | 4.21 Percent Change | Standard Deviation 17.857 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | Apo A-1: Percent Change at Week 23 (n = 2) | -21.22 Percent Change | Standard Deviation 7.959 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period | Apo A-1: Percent Change at Week 26 (n = 6) | -9.68 Percent Change | Standard Deviation 11.25 |
Secondary
Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Percent change was reported in HDL-C, TG and Apo A-1 from baseline (week 26) up to week 214. HDL-C, TG and Apo A-1 were measured using conventional units mg/dL. The efficacy analysis set included all participants in the SAF who had baseline and at least one post-baseline measure of the lipid panel in the main study period. (ET= Early Termination; EOS = End of Study)
Time frame: Baseline (Week 26) up to Week 214
Population: n = Number of participants who were evaluable for this endpoint at a given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | HDL-C: Percent change at Week 27 (n= 8) | -21.47 Percent change | Standard Deviation 11.815 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | HDL-C: Percent change at Week 28 (n= 8) | -27.60 Percent change | Standard Deviation 11.485 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | HDL-C: Percent change at Week 29 (n= 8) | -26.51 Percent change | Standard Deviation 16.584 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | HDL-C: Percent change at Week 30 (n= 7) | -27.57 Percent change | Standard Deviation 14.566 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | HDL-C: Percent change at Week 31 (n= 8) | -32.81 Percent change | Standard Deviation 18.939 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | HDL-C: Percent change at Week 32 (n= 8) | -32.72 Percent change | Standard Deviation 14.684 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | HDL-C: Percent change at Week 34 (n= 8) | -34.60 Percent change | Standard Deviation 15.971 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | HDL-C: Percent change at Week 36 (n= 8) | -31.14 Percent change | Standard Deviation 18.695 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | HDL-C: Percent change at Week 38 (n= 8) | -18.57 Percent change | Standard Deviation 15.411 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | HDL-C: Percent change at Week 39 (n= 6) | -32.09 Percent change | Standard Deviation 16.062 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | HDL-C: Percent change at Week 40 (n= 6) | -36.25 Percent change | Standard Deviation 9.327 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | HDL-C: Percent change at Week 41 (n= 6) | -39.14 Percent change | Standard Deviation 13.804 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | HDL-C: Percent change at Week 42 (n= 6) | -38.31 Percent change | Standard Deviation 10.67 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | HDL-C: Percent change at Week 44 (n= 8) | -37.01 Percent change | Standard Deviation 12.049 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | HDL-C: Percent change at Week 46 (n= 8) | -32.77 Percent change | Standard Deviation 13.829 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | HDL-C: Percent change at Week 50 (n= 8) | -25.17 Percent change | Standard Deviation 17.957 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | HDL-C: Percent change at Week 54 (n= 8) | -20.16 Percent change | Standard Deviation 18.657 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | HDL-C: Percent change at Week 58 (n= 6) | -10.87 Percent change | Standard Deviation 14.194 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | HDL-C: Percent change at Week 70 (n= 4) | -24.67 Percent change | Standard Deviation 15.473 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | HDL-C: Percent change at Week 82 (n= 4) | -17.56 Percent change | Standard Deviation 10.574 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | HDL-C: Percent change at Week 94 (n= 1) | -13.95 Percent change | — |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | HDL-C: Percent change at Week 106 (n= 1) | 0.00 Percent change | — |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | HDL-C: Percent change at ET (n= 8) | -15.08 Percent change | Standard Deviation 21.569 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | HDL-C: Percent change at EOS (n= 3) | -0.78 Percent change | Standard Deviation 27.385 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Triglycerides: Percent change at Week 27 (n= 8) | -38.62 Percent change | Standard Deviation 26.036 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Triglycerides: Percent change at Week 28 (n= 8) | -41.76 Percent change | Standard Deviation 27.247 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Triglycerides: Percent change at Week 29 (n= 8) | -41.17 Percent change | Standard Deviation 18.721 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Triglycerides: Percent change at Week 30 (n= 7) | -38.82 Percent change | Standard Deviation 23.649 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Triglycerides: Percent change at Week 31 (n= 8) | -44.86 Percent change | Standard Deviation 28.212 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Triglycerides: Percent change at Week 32 (n= 8) | -45.33 Percent change | Standard Deviation 23.671 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Triglycerides: Percent change at Week 34 (n= 8) | -28.58 Percent change | Standard Deviation 23.643 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Triglycerides: Percent change at Week 36 (n= 8) | -25.89 Percent change | Standard Deviation 36.606 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Triglycerides: Percent change at Week 38 (n= 8) | -24.32 Percent change | Standard Deviation 25.386 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Triglycerides: Percent change at Week 39 (n= 6) | -48.37 Percent change | Standard Deviation 26.457 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Triglycerides: Percent change at Week 40 (n= 6) | -43.36 Percent change | Standard Deviation 26.527 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Triglycerides: Percent change at Week 41 (n= 6) | -46.65 Percent change | Standard Deviation 25.386 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Triglycerides: Percent change at Week 42 (n= 6) | -43.09 Percent change | Standard Deviation 29.631 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Triglycerides: Percent change at Week 44 (n= 8) | -47.98 Percent change | Standard Deviation 35.076 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Triglycerides: Percent change at Week 46 (n= 8) | -37.64 Percent change | Standard Deviation 26.234 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Triglycerides: Percent change at Week 50 (n= 8) | -22.10 Percent change | Standard Deviation 27.247 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Triglycerides: Percent change at Week 54 (n= 8) | -1.08 Percent change | Standard Deviation 30.518 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Triglycerides: Percent change at Week 58 (n= 6) | 3.72 Percent change | Standard Deviation 25.13 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Triglycerides: Percent change at Week 70 (n= 4) | -22.28 Percent change | Standard Deviation 31.761 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Triglycerides: Percent change at Week 82 (n= 4) | -36.47 Percent change | Standard Deviation 9.998 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Triglycerides: Percent change at Week 94 (n= 1) | -76.36 Percent change | — |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Triglycerides: Percent change at Week 106 (n= 1) | -57.98 Percent change | — |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Triglycerides: Percent change at ET (n= 8) | -14.52 Percent change | Standard Deviation 25.892 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Triglycerides: Percent change at EOS (n= 3) | 30.98 Percent change | Standard Deviation 40.511 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Apo A-1: Percent change at Week 30 (n= 7) | -27.20 Percent change | Standard Deviation 12.119 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Apo A-1: Percent change at Week 34 (n= 8) | -29.05 Percent change | Standard Deviation 17.483 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Apo A-1: Percent change at Week 38 (n= 8) | -11.79 Percent change | Standard Deviation 23.939 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Apo A-1: Percent change at Week 42 (n= 6) | -35.47 Percent change | Standard Deviation 9.512 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Apo A-1: Percent change at Week 44 (n= 8) | -34.28 Percent change | Standard Deviation 11.306 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Apo A-1: Percent change at Week 50 (n= 8) | -21.01 Percent change | Standard Deviation 15.471 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Apo A-1: Percent change at Week 70 (n= 4) | -25.28 Percent change | Standard Deviation 11.95 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Apo A-1: Percent change at Week 82 (n= 4) | -18.98 Percent change | Standard Deviation 6.534 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Apo A-1: Percent change at Week 94 (n= 1) | -22.45 Percent change | — |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Apo A-1: Percent change at Week 106 (n= 1) | 3.06 Percent change | — |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Apo A-1: Percent change at ET (n= 8) | -9.63 Percent change | Standard Deviation 25.308 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Apo A-1: Percent change at EOS (n= 3) | 11.27 Percent change | Standard Deviation 25.093 |
Secondary
Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) Over Time in the Main Study Period
Percent change was reported in low-density lipoprotein cholesterol (LDL-C) from baseline (week 0) up to week 26. LDL-C was measured using conventional units mg/dL. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period.
Time frame: Baseline (Week 0) up to Week 26
Population: n = Number of participants who were evaluable for this endpoint at a given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) Over Time in the Main Study Period | Percent change at Day 4 (n= 9) | -12.76 Percent Change | Standard Deviation 11.086 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) Over Time in the Main Study Period | Percent change at Week 18 (n= 7) | -13.72 Percent Change | Standard Deviation 28.424 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) Over Time in the Main Study Period | Percent change at Week 1 (n= 9) | -24.00 Percent Change | Standard Deviation 21.078 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) Over Time in the Main Study Period | Percent change at Week 2 (n= 9) | -30.13 Percent Change | Standard Deviation 24.402 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) Over Time in the Main Study Period | Percent change at Week 3 (n= 9) | -41.38 Percent Change | Standard Deviation 24.986 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) Over Time in the Main Study Period | Percent change at Week 4 (n= 9) | -49.17 Percent Change | Standard Deviation 23.136 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) Over Time in the Main Study Period | Percent change at Week 5 (n= 8) | -46.88 Percent Change | Standard Deviation 14.507 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) Over Time in the Main Study Period | Percent change at Week 6 (n= 9) | -52.13 Percent Change | Standard Deviation 14.768 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) Over Time in the Main Study Period | Percent change at Week 8 (n= 9) | -51.59 Percent Change | Standard Deviation 17.91 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) Over Time in the Main Study Period | Percent change at Week 10 (n= 9) | -45.61 Percent Change | Standard Deviation 13.839 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) Over Time in the Main Study Period | Percent change at Week 12 (n= 9) | -36.54 Percent Change | Standard Deviation 19.281 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) Over Time in the Main Study Period | Percent change at Week 13 (n= 2) | -39.84 Percent Change | Standard Deviation 10.753 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) Over Time in the Main Study Period | Percent change at Week 14 (n= 9) | -33.02 Percent Change | Standard Deviation 18.538 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) Over Time in the Main Study Period | Percent change at Week 15 (n= 2) | -43.38 Percent Change | Standard Deviation 12.814 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) Over Time in the Main Study Period | Percent change at Week 16 (n= 9) | -24.98 Percent Change | Standard Deviation 25.441 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) Over Time in the Main Study Period | Percent change at Week 17 (n= 2) | -40.99 Percent Change | Standard Deviation 9.95 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) Over Time in the Main Study Period | Percent change at Week 20 (n= 2) | -37.17 Percent Change | Standard Deviation 5.503 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) Over Time in the Main Study Period | Percent change at Week 22 (n= 7) | -9.50 Percent Change | Standard Deviation 38.456 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) Over Time in the Main Study Period | Percent change at Week 23 (n= 2) | -37.37 Percent Change | Standard Deviation 5.217 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) Over Time in the Main Study Period | Percent change at Week 25 (n= 2) | -22.12 Percent Change | Standard Deviation 2.537 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) Over Time in the Main Study Period | Percent change at Week 26 (n= 6) | -10.27 Percent Change | Standard Deviation 25.806 |
Secondary
Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period
Percent change was reported in low-density lipoprotein cholesterol (LDL-C) from baseline (week 26) to week 214 in the OLE period. LDL-C was measured using conventional units mg/dL. The efficacy analysis set included all participants in the SAF who had at least 1 post-baseline measure of the lipid panel in the main study period. (ET= Early Termination; EOS = End of Study)
Time frame: Baseline (Week 26) up to Week 214
Population: n = Number of participants who were evaluable for this endpoint at a given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Percent change at ET (n= 8) | -17.65 Percent Change | Standard Deviation 28.813 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Percent change at EOS (n= 3) | 19.59 Percent Change | Standard Deviation 40.976 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Baseline (n= 8) | 261.34 Percent Change | Standard Deviation 178.792 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Percent change at Week 27 (n= 8) | -22.49 Percent Change | Standard Deviation 16.52 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Percent change at Week 28 (n= 8) | -36.74 Percent Change | Standard Deviation 20.931 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Percent change at Week 29 (n= 8) | -44.35 Percent Change | Standard Deviation 20.817 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Percent change at Week 30 (n= 7) | -37.37 Percent Change | Standard Deviation 31.297 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Percent change at Week 31 (n= 8) | -50.74 Percent Change | Standard Deviation 20.147 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Percent change at Week 32 (n= 8) | -60.03 Percent Change | Standard Deviation 18.502 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Percent change at Week 34 (n= 8) | -53.03 Percent Change | Standard Deviation 22.13 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Percent change at Week 36 (n= 8) | -47.90 Percent Change | Standard Deviation 21.623 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Percent change at Week 38 (n= 8) | -37.05 Percent Change | Standard Deviation 25.341 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Percent change at Week 39 (n= 6) | -59.83 Percent Change | Standard Deviation 22.22 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Percent change at Week 40 (n= 6) | -53.90 Percent Change | Standard Deviation 20.97 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Percent change at Week 41 (n= 6) | -66.28 Percent Change | Standard Deviation 18.555 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Percent change at Week 42 (n= 6) | -59.59 Percent Change | Standard Deviation 18.95 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Percent change at Week 44 (n= 8) | -57.64 Percent Change | Standard Deviation 18.599 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Percent change at Week 46 (n= 8) | -48.74 Percent Change | Standard Deviation 19.717 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Percent change at Week 50 (n= 8) | -42.31 Percent Change | Standard Deviation 23.194 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Percent change at Week 54 (n= 8) | -13.60 Percent Change | Standard Deviation 44.339 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Percent change at Week 58 (n= 6) | -12.86 Percent Change | Standard Deviation 27.645 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Percent change at Week 70 (n= 4) | -38.61 Percent Change | Standard Deviation 36.151 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Percent change at Week 82 (n= 4) | -24.68 Percent Change | Standard Deviation 30.789 |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Percent change at Week 94 (n= 1) | -81.67 Percent Change | — |
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period | Percent change at Week 106 (n= 1) | -64.03 Percent Change | — |
Secondary
Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Week 2 to Week 4 in the Main Study Period
Percent change was reported in low-density lipoprotein cholesterol (LDL-C) from week 2 to week 4. LDL-C was measured using conventional units mg/dL. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period.
Time frame: Week 2 to Week 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Week 2 to Week 4 in the Main Study Period | -30.05 Percent Change | Standard Deviation 18.503 |