| Primary | Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Week 12 (Intent-to-Treat [ITT] Estimand) | The percent change in LDL-C from baseline to week 12 is defined as: 100x (LDL-C value at week 12 - LDL-C value at baseline) / LDL-C value at baseline. | ITT estimand (All randomized participants who had at least 1 measurement value for LDL-C before the first dose of double blind investigational study drug) | Posted | | Least Squares Mean | Standard Error | Percentage of change | | Baseline to Week 12 | | | | ID | Title | Description |
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| OG000 | Placebo in DBTP | Participants received matching placebo subcutaneously (SC) every 2 weeks (Q2W) from baseline (Day 1) through Week 10 during the double-blind treatment period. Starting at Week 12, and continuing through Week 22, all participants received open-label alirocumab SC Q2W | | OG001 | Alirocumab 150 mg SC Q2W | Participants in this arm received alirocumab 150 milligrams (mg) SC Q2W from baseline (Day 1) through Week 10 during the double-blind treatment period. Starting at Week 12, and continuing through Week 22, all participants received open-label alirocumab SC Q2W |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG0008.6± 6.3
- OG001-26.9± 4.6
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | MMRM | | <0.0001 | P-value taken from MMRM (mixed-effect model with repeated measures) analysis | Least squares (LS) mean difference | -35.6 | Standard Error of the Mean | 7.8 | 2-Sided | 95 | -51.2 | -19.9 | | | | | Superiority | | |
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| Secondary | Percent Change in Apolipoprotein (Apo) B From Baseline to Week 12 (ITT Estimand) | ITT estimand; The percent change in Apo B from baseline to week 12 is defined as: 100x (Apo B value at week 12 - Apo B value at baseline) / Apo B value at baseline. | | Posted | | Least Squares Mean | Standard Error | Percentage of change | | Baseline to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo in DBTP | Participants received matching placebo subcutaneously (SC) every 2 weeks (Q2W) from baseline (Day 1) through Week 10 during the double-blind treatment period. Starting at Week 12, and continuing through Week 22, all participants received open-label alirocumab SC Q2W | | OG001 | Alirocumab 150 mg SC Q2W | Participants in this arm received alirocumab 150 milligrams (mg) SC Q2W from baseline (Day 1) through Week 10 during the double-blind treatment period. Starting at Week 12, and continuing through Week 22, all participants received open-label alirocumab SC Q2W |
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| Secondary | Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Week 12 | ITT estimand; The percent change in non-HDL-C from baseline to week 12 is defined as: 100x (non-HDL-C value at week 12 - non-HDL-C value at baseline) / non-HDL-C value at baseline. | | Posted | | Least Squares Mean | Standard Error | Percentage of change | | Baseline to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo in DBTP | Participants received matching placebo subcutaneously (SC) every 2 weeks (Q2W) from baseline (Day 1) through Week 10 during the double-blind treatment period. Starting at Week 12, and continuing through Week 22, all participants received open-label alirocumab SC Q2W | | OG001 | Alirocumab 150 mg SC Q2W | Participants in this arm received alirocumab 150 milligrams (mg) SC Q2W from baseline (Day 1) through Week 10 during the double-blind treatment period. Starting at Week 12, and continuing through Week 22, all participants received open-label alirocumab SC Q2W |
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| Secondary | Percent Change in Total Cholesterol (TC) From Baseline to Week 12 | ITT estimand; The percent change in TC from baseline to week 12 is defined as: 100x (TC value at week 12 - TC value at baseline) / TC value at baseline. | | Posted | | Least Squares Mean | Standard Error | Percentage of change | | Baseline to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo in DBTP | Participants received matching placebo subcutaneously (SC) every 2 weeks (Q2W) from baseline (Day 1) through Week 10 during the double-blind treatment period. Starting at Week 12, and continuing through Week 22, all participants received open-label alirocumab SC Q2W | | OG001 | Alirocumab 150 mg SC Q2W | Participants in this arm received alirocumab 150 milligrams (mg) SC Q2W from baseline (Day 1) through Week 10 during the double-blind treatment period. Starting at Week 12, and continuing through Week 22, all participants received open-label alirocumab SC Q2W |
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| Secondary | Percentage of Participants With ≥15% Reduction in LDL-C at Week 12 | | | Posted | | Number | | Percentage of participants | | At Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo in DBTP | Participants received matching placebo subcutaneously (SC) every 2 weeks (Q2W) from baseline (Day 1) through Week 10 during the double-blind treatment period. Starting at Week 12, and continuing through Week 22, all participants received open-label alirocumab SC Q2W | | OG001 | Alirocumab 150 mg SC Q2W | Participants in this arm received alirocumab 150 milligrams (mg) SC Q2W from baseline (Day 1) through Week 10 during the double-blind treatment period. Starting at Week 12, and continuing through Week 22, all participants received open-label alirocumab SC Q2W |
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| Secondary | Percentage of Participants With ≥30% Reduction in LDL-C at Week 12 | | | Posted | | Number | | Percentage of participants | | At Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo in DBTP | Participants received matching placebo subcutaneously (SC) every 2 weeks (Q2W) from baseline (Day 1) through Week 10 during the double-blind treatment period. Starting at Week 12, and continuing through Week 22, all participants received open-label alirocumab SC Q2W | | OG001 | Alirocumab 150 mg SC Q2W | Participants in this arm received alirocumab 150 milligrams (mg) SC Q2W from baseline (Day 1) through Week 10 during the double-blind treatment period. Starting at Week 12, and continuing through Week 22, all participants received open-label alirocumab SC Q2W |
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| Secondary | Percent Change in Lipoprotein(a) [Lp(a)] From Baseline to Week 12 | ITT estimand; The percent change in Lp(a) from baseline to week 12 is defined as: 100x (Lp(a) value at week 12 - Lp(a) value at baseline) / Lp(a) value at baseline. | | Posted | | Least Squares Mean | Standard Error | Percentage of change | | Baseline to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo in DBTP | Participants received matching placebo subcutaneously (SC) every 2 weeks (Q2W) from baseline (Day 1) through Week 10 during the double-blind treatment period. Starting at Week 12, and continuing through Week 22, all participants received open-label alirocumab SC Q2W | | OG001 | Alirocumab 150 mg SC Q2W | Participants in this arm received alirocumab 150 milligrams (mg) SC Q2W from baseline (Day 1) through Week 10 during the double-blind treatment period. Starting at Week 12, and continuing through Week 22, all participants received open-label alirocumab SC Q2W |
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| Secondary | Percentage of Participants With ≥50% Reduction in LDL-C at Week 12 | | | Posted | | Number | | Percentage of participants | | At Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo in DBTP | Participants received matching placebo subcutaneously (SC) every 2 weeks (Q2W) from baseline (Day 1) through Week 10 during the double-blind treatment period. Starting at Week 12, and continuing through Week 22, all participants received open-label alirocumab SC Q2W | | OG001 | Alirocumab 150 mg SC Q2W | Participants in this arm received alirocumab 150 milligrams (mg) SC Q2W from baseline (Day 1) through Week 10 during the double-blind treatment period. Starting at Week 12, and continuing through Week 22, all participants received open-label alirocumab SC Q2W |
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| Secondary | Percent Change in HDL-C From Baseline to Week 12 - ITT Analysis | ITT estimand; The percent change in HDL-C from baseline to week 12 is defined as: 100x (HDL-C value at week 12 - HDL-C value at baseline) / HDL-C value at baseline. | | Posted | | Least Squares Mean | Standard Error | Percentage of change | | Baseline to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo in DBTP | Participants received matching placebo subcutaneously (SC) every 2 weeks (Q2W) from baseline (Day 1) through Week 10 during the double-blind treatment period. Starting at Week 12, and continuing through Week 22, all participants received open-label alirocumab SC Q2W | | OG001 | Alirocumab 150 mg SC Q2W | Participants in this arm received alirocumab 150 milligrams (mg) SC Q2W from baseline (Day 1) through Week 10 during the double-blind treatment period. Starting at Week 12, and continuing through Week 22, all participants received open-label alirocumab SC Q2W |
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| Secondary | Percent Change in Fasting Triglycerides (TG) From Baseline to Week 12 | ITT estimand; The percent change in TG from baseline to week 12 is defined as: 100x (TG value at week 12 - TG value at baseline) / TG value at baseline. | | Posted | | Least Squares Mean | Standard Error | Percentage of change | | Baseline to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo in DBTP | Participants received matching placebo subcutaneously (SC) every 2 weeks (Q2W) from baseline (Day 1) through Week 10 during the double-blind treatment period. Starting at Week 12, and continuing through Week 22, all participants received open-label alirocumab SC Q2W | | OG001 | Alirocumab 150 mg SC Q2W | Participants in this arm received alirocumab 150 milligrams (mg) SC Q2W from baseline (Day 1) through Week 10 during the double-blind treatment period. Starting at Week 12, and continuing through Week 22, all participants received open-label alirocumab SC Q2W |
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| Secondary | Percent Change in Apo A-1 From Baseline to Week 12 -- ITT Analysis | ITT estimand; The percent change in Apo A-1 from baseline to week 12 is defined as: 100x (Apo A-1 value at week 12 - Apo A-1 value at baseline) / Apo A-1 value at baseline. | | Posted | | Least Squares Mean | Standard Error | Percentage of change | | Baseline to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo in DBTP | Participants received matching placebo subcutaneously (SC) every 2 weeks (Q2W) from baseline (Day 1) through Week 10 during the double-blind treatment period. Starting at Week 12, and continuing through Week 22, all participants received open-label alirocumab SC Q2W | | OG001 | Alirocumab 150 mg SC Q2W | Participants in this arm received alirocumab 150 milligrams (mg) SC Q2W from baseline (Day 1) through Week 10 during the double-blind treatment period. Starting at Week 12, and continuing through Week 22, all participants received open-label alirocumab SC Q2W |
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| Secondary | Percent Change in LDL-C From Baseline to Week 12 (On-treatment Estimand) | Percent change for LDL-C from baseline to Week 12 during the efficacy treatment period, which is defined as the time from the first double-blind investigational study drug injection up to 21 days after the last double-blind investigational study drug injection, or the first dose of the open-label investigational study drug, whichever is earlier. | | Posted | | Least Squares Mean | Standard Error | Percentage of change | | Baseline to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo in DBTP | Participants received matching placebo subcutaneously (SC) every 2 weeks (Q2W) from baseline (Day 1) through Week 10 during the double-blind treatment period. Starting at Week 12, and continuing through Week 22, all participants received open-label alirocumab SC Q2W | | OG001 | Alirocumab 150 mg SC Q2W | Participants in this arm received alirocumab 150 milligrams (mg) SC Q2W from baseline (Day 1) through Week 10 during the double-blind treatment period. Starting at Week 12, and continuing through Week 22, all participants received open-label alirocumab SC Q2W |
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| Secondary | Percent Change in Apo B From Baseline to Week 12 (On-treatment Estimand) | Percent change for Apo B from baseline to Week 12 during the efficacy treatment period, which is defined as the time from the first double-blind investigational study drug injection up to 21 days after the last double-blind investigational study drug injection, or the first dose of the open-label nvestigational study drug, whichever is earlier. | | Posted | | Least Squares Mean | Standard Error | Percentage of change | | Baseline to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo in DBTP | Participants received matching placebo subcutaneously (SC) every 2 weeks (Q2W) from baseline (Day 1) through Week 10 during the double-blind treatment period. Starting at Week 12, and continuing through Week 22, all participants received open-label alirocumab SC Q2W | | OG001 | Alirocumab 150 mg SC Q2W | Participants in this arm received alirocumab 150 milligrams (mg) SC Q2W from baseline (Day 1) through Week 10 during the double-blind treatment period. Starting at Week 12, and continuing through Week 22, all participants received open-label alirocumab SC Q2W |
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| Secondary | Percent Change in Non-HDL-C From Baseline to Week 12 (On-treatment Estimand) | Percent change for non-HDL-C from baseline to Week 12 during the efficacy treatment period, which is defined as the time from the first double-blind investigational study drug injection up to 21 days after the last double-blind investigational study drug injection, or the first dose of the open-label investigational study drug, whichever is earlier. | | Posted | | Least Squares Mean | Standard Error | Percentage of change | | Baseline to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo in DBTP | Participants received matching placebo subcutaneously (SC) every 2 weeks (Q2W) from baseline (Day 1) through Week 10 during the double-blind treatment period. Starting at Week 12, and continuing through Week 22, all participants received open-label alirocumab SC Q2W | | OG001 | Alirocumab 150 mg SC Q2W | Participants in this arm received alirocumab 150 milligrams (mg) SC Q2W from baseline (Day 1) through Week 10 during the double-blind treatment period. Starting at Week 12, and continuing through Week 22, all participants received open-label alirocumab SC Q2W |
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| Secondary | Percent Change in TC From Baseline to Week 12 (On-treatment Estimand) | Percent change for TC from baseline to Week 12 during the efficacy treatment period, which is defined as the time from the first double-blind investigational study drug injection up to 21 days after the last double-blind investigational study drug injection, or the first dose of the open-label investigational study drug, whichever is earlier. | | Posted | | Least Squares Mean | Standard Error | Percentage of change | | Baseline to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo in DBTP | Participants received matching placebo subcutaneously (SC) every 2 weeks (Q2W) from baseline (Day 1) through Week 10 during the double-blind treatment period. Starting at Week 12, and continuing through Week 22, all participants received open-label alirocumab SC Q2W | | OG001 | Alirocumab 150 mg SC Q2W | Participants in this arm received alirocumab 150 milligrams (mg) SC Q2W from baseline (Day 1) through Week 10 during the double-blind treatment period. Starting at Week 12, and continuing through Week 22, all participants received open-label alirocumab SC Q2W |
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| Secondary | Percent Change in Lp(a) From Baseline to Week 12 (On-treatment Estimand) | Percent change for LP(a) from baseline to Week 12 during the efficacy treatment period, which is defined as the time from the first double-blind investigational study drug injection up to 21 days after the last double-blind investigational study drug injection, or the first dose of the open-label investigational study drug, whichever is earlier. | | Posted | | Least Squares Mean | Standard Error | Percentage of change | | Baseline to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo in DBTP | Participants received matching placebo subcutaneously (SC) every 2 weeks (Q2W) from baseline (Day 1) through Week 10 during the double-blind treatment period. Starting at Week 12, and continuing through Week 22, all participants received open-label alirocumab SC Q2W | | OG001 | Alirocumab 150 mg SC Q2W | Participants in this arm received alirocumab 150 milligrams (mg) SC Q2W from baseline (Day 1) through Week 10 during the double-blind treatment period. Starting at Week 12, and continuing through Week 22, all participants received open-label alirocumab SC Q2W |
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| Secondary | Percent Change in HDL-C From Baseline to Week 12 (On-treatment Estimand) | Percent change for HDL-C from baseline to Week 12 during the efficacy treatment period, which is defined as the time from the first double-blind investigational study drug injection up to 21 days after the last double-blind investigational study drug injection, or the first dose of the open-label investigational study drug, whichever is earlier. | | Posted | | Least Squares Mean | Standard Error | Percentage of change | | Baseline to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo in DBTP | Participants received matching placebo subcutaneously (SC) every 2 weeks (Q2W) from baseline (Day 1) through Week 10 during the double-blind treatment period. Starting at Week 12, and continuing through Week 22, all participants received open-label alirocumab SC Q2W | | OG001 | Alirocumab 150 mg SC Q2W | Participants in this arm received alirocumab 150 milligrams (mg) SC Q2W from baseline (Day 1) through Week 10 during the double-blind treatment period. Starting at Week 12, and continuing through Week 22, all participants received open-label alirocumab SC Q2W |
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| Secondary | Percent Change in Fasting TG From Baseline to Week 12 (On-treatment Estimand) | Percent change for fasting TG from baseline to Week 12 during the efficacy treatment period, which is defined as the time from the first double-blind investigational study drug injection up to 21 days after the last double-blind investigational study drug injection, or the first dose of the open-label investigational study drug, whichever is earlier. | | Posted | | Least Squares Mean | Standard Error | Percentage of change | | Baseline to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo in DBTP | Participants received matching placebo subcutaneously (SC) every 2 weeks (Q2W) from baseline (Day 1) through Week 10 during the double-blind treatment period. Starting at Week 12, and continuing through Week 22, all participants received open-label alirocumab SC Q2W | | OG001 | Alirocumab 150 mg SC Q2W | Participants in this arm received alirocumab 150 milligrams (mg) SC Q2W from baseline (Day 1) through Week 10 during the double-blind treatment period. Starting at Week 12, and continuing through Week 22, all participants received open-label alirocumab SC Q2W |
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| Secondary | Percent Change in Apo A-1 From Baseline to Week 12 (On-treatment Estimand) | Percent change for Apo A-1 from baseline to Week 12 during the efficacy treatment period, which is defined as the time from the first double-blind investigational study drug injection up to 21 days after the last double-blind investigational study drug injection, or the first dose of the open-label investigational study drug, whichever is earlier. | | Posted | | Least Squares Mean | Standard Error | Percentage of change | | Baseline to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo in DBTP | Participants received matching placebo subcutaneously (SC) every 2 weeks (Q2W) from baseline (Day 1) through Week 10 during the double-blind treatment period. Starting at Week 12, and continuing through Week 22, all participants received open-label alirocumab SC Q2W | | OG001 | Alirocumab 150 mg SC Q2W | Participants in this arm received alirocumab 150 milligrams (mg) SC Q2W from baseline (Day 1) through Week 10 during the double-blind treatment period. Starting at Week 12, and continuing through Week 22, all participants received open-label alirocumab SC Q2W |
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| Secondary | Percentage of Participants With ≥15% Reduction, ≥30% Reduction, and ≥50% Reduction in LDL-C at Week 12 (On-treatment Estimand) | | | Posted | | Number | | Percentage of participants | | At Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo in DBTP | Participants received matching placebo subcutaneously (SC) every 2 weeks (Q2W) from baseline (Day 1) through Week 10 during the double-blind treatment period. Starting at Week 12, and continuing through Week 22, all participants received open-label alirocumab SC Q2W | | OG001 | Alirocumab 150 mg SC Q2W | Participants in this arm received alirocumab 150 milligrams (mg) SC Q2W from baseline (Day 1) through Week 10 during the double-blind treatment period. Starting at Week 12, and continuing through Week 22, all participants received open-label alirocumab SC Q2W |
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| Secondary | Absolute Change in the Ratio of Apo B/Apo A-1 From Baseline to Week 12 (ITT Estimand) | Ratio of Apo B/Apo A1 at week 12 minus ratio of Apo B/Apo A1 at baseline | | Posted | | Least Squares Mean | Standard Error | Ratio of change | | Baseline to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo in DBTP | Participants received matching placebo subcutaneously (SC) every 2 weeks (Q2W) from baseline (Day 1) through Week 10 during the double-blind treatment period. Starting at Week 12, and continuing through Week 22, all participants received open-label alirocumab SC Q2W | | OG001 | Alirocumab 150 mg SC Q2W | Participants in this arm received alirocumab 150 milligrams (mg) SC Q2W from baseline (Day 1) through Week 10 during the double-blind treatment period. Starting at Week 12, and continuing through Week 22, all participants received open-label alirocumab SC Q2W |
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| Secondary | Number of Participants With Anti-Drug Antibodies (ADA) to REGN727 Over Time | | Here 'n' = number of evaluable participants at this time point | Posted | | Number | | Participants | | 26 weeks | | | | ID | Title | Description |
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| OG000 | Placebo in DBTP | Participants received matching placebo subcutaneously (SC) every 2 weeks (Q2W) from baseline (Day 1) through Week 10 during the double-blind treatment period. Starting at Week 12, and continuing through Week 22, all participants received open-label alirocumab SC Q2W | | OG001 | Alirocumab 150 mg SC Q2W | Participants in this arm received alirocumab 150 milligrams (mg) SC Q2W from baseline (Day 1) through Week 10 during the double-blind treatment period. Starting at Week 12, and continuing through Week 22, all participants received open-label alirocumab SC Q2W |
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| Secondary | Number of Participants With Adverse Events (AEs) | All AEs will be recorded from time of informed consent to end of study. Only treatment-emergent adverse events (TEAE) will be reported. Double-blind TEAE observation period is defined as time from first dose of double-blind study drug to last dose of double-blind study drug +70 days, or up to day before first dose of open-label study drug administration, whichever is earlier. Open-label TEAE observation period is defined as time from first open-label study treatment administration to last open-label study treatment administration +70 days. | | Posted | | Number | | Participants | | Baseline to week 32 (End of Study) | | | | ID | Title | Description |
|---|
| OG000 | Placebo in DBTP | Participants received matching placebo subcutaneously (SC) every 2 weeks (Q2W) from baseline (Day 1) through Week 10 during the double-blind treatment period. Starting at Week 12, and continuing through Week 22, all participants received open-label alirocumab SC Q2W | | OG001 | Alirocumab 150 mg SC Q2W | Participants in this arm received alirocumab 150 milligrams (mg) SC Q2W from baseline (Day 1) through Week 10 during the double-blind treatment period. Starting at Week 12, and continuing through Week 22, all participants received open-label alirocumab SC Q2W | | OG002 | Alirocumab 150 mg SC Q2W in OLTP | |
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