| Primary | Percentage Change in LDL-C From Baseline to Day 330 (Part 1/Year 1) | Percentage change in low-density lipoprotein cholesterol (LDL-C) from baseline to Day 330 (Year 1) | Full Analysis Set (FAS) comprised all participants to whom study treatment had been assigned by randomization. | Posted | | Least Squares Mean | 95% Confidence Interval | percent change in LDL-C | | Baseline and Day 330 | | | | ID | Title | Description |
|---|
| OG000 | Part 1- Inclisiran | Inclisiran sodium 300 mg subcutaneous (sc) injection (given at Days 1, 90 and 270) | | OG001 | Part 1 - Placebo | Placebo sc injection (given at Day 1, 90 and 270) |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000-27.14(-32.04 to -22.24)
- OG0011.40(-3.97 to 6.78)
|
|
| | 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 |
|---|
| | ANCOVA | | <.0001 | | LS Mean | -28.54 | | | 2-Sided | 95 | -35.81 | -21.27 | | | | | Superiority | | |
|
| Secondary | Time-adjusted Percent Change in LDL-C From Baseline After Day 90 and up to Day 330 (Part 1/Year 1) | Time-adjusted percent change in LDL-C (after Day 90 and up to Day 330), calculated as the average of percent changes from baseline to Days 150, 270 and 330 | Full Analysis Set (FAS) comprised all participants to whom study treatment had been assigned by randomization | Posted | | Least Squares Mean | 95% Confidence Interval | Time-adjusted percent change in LDL-C | | Baseline, after Day 90 up to Day 330 | | | | ID | Title | Description |
|---|
| OG000 | Part 1- Inclisiran | Inclisiran sodium 300 mg subcutaneous (sc) injection (given at Days 1, 90 and 270) | | OG001 | Part 1 - Placebo | Placebo sc injection (given at Day 1, 90 and 270) |
| |
| Secondary | Absolute Change in LDL-C From Baseline to up Day 330 (Part 1/Year 1) | Absolute change in LDL-C from baseline to Day 330. | Full Analysis Set (FAS) comprised all participants to whom study treatment had been assigned by randomization | Posted | | Least Squares Mean | 95% Confidence Interval | mg/dL | | Baseline and Day 330 | | | | ID | Title | Description |
|---|
| OG000 | Part 1- Inclisiran | Inclisiran sodium 300 mg subcutaneous (sc) injection (given at Days 1, 90 and 270) | | OG001 | Part 1 - Placebo | Placebo sc injection (given at Day 1, 90 and 270) |
| |
| Secondary | Percent Change in Apo B From Baseline up to Day 330 (Part 1/Year 1) | Percentage change in apolipoprotein B (Apo B) from baseline to Day 330. | Full Analysis Set (FAS) comprised all participants to whom study treatment had been assigned by randomization | Posted | | Least Squares Mean | 95% Confidence Interval | Percent change in Apo B | | Baseline and Day 330 | | | | ID | Title | Description |
|---|
| OG000 | Part 1- Inclisiran | Inclisiran sodium 300 mg subcutaneous (sc) injection (given at Days 1, 90 and 270) | | OG001 | Part 1 - Placebo | Placebo sc injection (given at Day 1, 90 and 270) |
| |
| Secondary | Percent Change in Lp(a) From Baseline up to Day 330 (Part 1/Year 1) | Percentage change in lipoprotein (a) [Lp(a)] from baseline to Day 330. | Full Analysis Set (FAS) comprised all participants to whom study treatment had been assigned by randomization | Posted | | Least Squares Mean | 95% Confidence Interval | Percent change in Lp(a) | | Baseline and Day 330 | | | | ID | Title | Description |
|---|
| OG000 | Part 1- Inclisiran | Inclisiran sodium 300 mg subcutaneous (sc) injection (given at Days 1, 90 and 270) | | OG001 | Part 1 - Placebo | Placebo sc injection (given at Day 1, 90 and 270) |
| |
| Secondary | Percent Change in Non-HDL-C From Baseline up to Day 330 (Part 1/Year 1) | Percentage change in non-high density lipoprotein cholesterol (non-HDL-C) from baseline to Day 330. | Full Analysis Set (FAS) comprised all participants to whom study treatment had been assigned by randomization | Posted | | Least Squares Mean | 95% Confidence Interval | Percent change in non-HDL-C | | Baseline and Day 330 | | | | ID | Title | Description |
|---|
| OG000 | Part 1- Inclisiran | Inclisiran sodium 300 mg subcutaneous (sc) injection (given at Days 1, 90 and 270) | | OG001 | Part 1 - Placebo | Placebo sc injection (given at Day 1, 90 and 270) |
| |
| Secondary | Percent Change in Total Cholesterol From Baseline up to Day 330 (Part 1/Year 1) | Percentage change in total cholesterol from baseline to Day 330. | Full Analysis Set (FAS) comprised all participants to whom study treatment had been assigned by randomization | Posted | | Least Squares Mean | 95% Confidence Interval | Percent change in total cholesterol | | Baseline and Day 330 | | | | ID | Title | Description |
|---|
| OG000 | Part 1- Inclisiran | Inclisiran sodium 300 mg subcutaneous (sc) injection (given at Days 1, 90 and 270) | | OG001 | Part 1 - Placebo | Placebo sc injection (given at Day 1, 90 and 270) |
| |
| Secondary | Percent Change in LDL-C From Baseline up to Day 720 | Percentage change in LDL-C from baseline to each assessment time up to Day 720. | Full Analysis Set (FAS) comprised all participants to whom study treatment had been assigned by randomization. At each time point, only subjects with a value at both baseline and that time point are included. | Posted | | Mean | Standard Deviation | Percent change in LDL-C | | Baseline, up to Day 720 | | | | ID | Title | Description |
|---|
| OG000 | Part 1- Inclisiran | Inclisiran sodium 300 mg subcutaneous (sc) injection (given at Days 1, 90 and 270) | | OG001 | Part 1 - Placebo | Placebo sc injection (given at Day 1, 90 and 270) | | OG002 | Part 2 - Inclisiran (Total) | Inclisiran sodium 300 mg sc injection (given at Days 450 and 630). In addition, participants assigned to placebo in Part 1 received inclisiran sodium 300 mg sc injection on Day 360, while participants assigned to inclisiran in Part 1 received placebo sc injection on Day 360. |
| |
| Secondary | Absolute Change in LDL-C From Baseline up to Day 720 | Absolute change in LDL-C from baseline to each assessment time up to Day 720. | Full Analysis Set (FAS) comprised all participants to whom study treatment had been assigned by randomization. At each time point, only subjects with a value at both baseline and that time point are included. | Posted | | Mean | Standard Deviation | mg/dL | | Baseline, up to Day 720 | | | | ID | Title | Description |
|---|
| OG000 | Part 1- Inclisiran | Inclisiran sodium 300 mg subcutaneous (sc) injection (given at Days 1, 90 and 270) | | OG001 | Part 1 - Placebo | Placebo sc injection (given at Day 1, 90 and 270) | | OG002 | Part 2 - Inclisiran (Total) | Inclisiran sodium 300 mg sc injection (given at Days 450 and 630). In addition, participants assigned to placebo in Part 1 received inclisiran sodium 300 mg sc injection on Day 360, while participants assigned to inclisiran in Part 1 received placebo sc injection on Day 360. |
| |
| Secondary | Percent Change in Apo B From Baseline up to Day 720 | Percentage change in apolipoprotein B (Apo B) from baseline to each assessment time up to Day 720. | Full Analysis Set (FAS) comprised all participants to whom study treatment had been assigned by randomization. At each time point, only subjects with a value at both baseline and that time point are included. | Posted | | Mean | Standard Deviation | Percent change in Apo B | | Baseline, up to Day 720 | | | | ID | Title | Description |
|---|
| OG000 | Part 1- Inclisiran | Inclisiran sodium 300 mg subcutaneous (sc) injection (given at Days 1, 90 and 270) | | OG001 | Part 1 - Placebo | Placebo sc injection (given at Day 1, 90 and 270) | | OG002 | Part 2 - Inclisiran (Total) | Inclisiran sodium 300 mg sc injection (given at Days 450 and 630). In addition, participants assigned to placebo in Part 1 received inclisiran sodium 300 mg sc injection on Day 360, while participants assigned to inclisiran in Part 1 received placebo sc injection on Day 360. |
| |
| Secondary | Absolute Change in Apo B From Baseline up to Day 720 | Absolute change in apolipoprotein B (Apo B) from baseline to each assessment time up to Day 720. | Full Analysis Set (FAS) comprised all participants to whom study treatment had been assigned by randomization. At each time point, only subjects with a value at both baseline and that time point are included. | Posted | | Mean | Standard Deviation | mg/dL | | Baseline, up to Day 720 | | | | ID | Title | Description |
|---|
| OG000 | Part 1- Inclisiran | Inclisiran sodium 300 mg subcutaneous (sc) injection (given at Days 1, 90 and 270) | | OG001 | Part 1 - Placebo | Placebo sc injection (given at Day 1, 90 and 270) | | OG002 | Part 2 - Inclisiran (Total) | Inclisiran sodium 300 mg sc injection (given at Days 450 and 630). In addition, participants assigned to placebo in Part 1 received inclisiran sodium 300 mg sc injection on Day 360, while participants assigned to inclisiran in Part 1 received placebo sc injection on Day 360. |
| |
| Secondary | Percent Change in Lp(a) From Baseline up to Day 720 | Percentage change in lipoprotein (a) [Lp(a)] from baseline to each assessment time up to Day 720. | Full Analysis Set (FAS) comprised all participants to whom study treatment had been assigned by randomization. At each time point, only subjects with a value at both baseline and that time point are included. | Posted | | Mean | Standard Deviation | Percent change in Lp(a) | | Baseline, up to Day 720 | | | | ID | Title | Description |
|---|
| OG000 | Part 1- Inclisiran | Inclisiran sodium 300 mg subcutaneous (sc) injection (given at Days 1, 90 and 270) | | OG001 | Part 1 - Placebo | Placebo sc injection (given at Day 1, 90 and 270) | | OG002 | Part 2 - Inclisiran (Total) | Inclisiran sodium 300 mg sc injection (given at Days 450 and 630). In addition, participants assigned to placebo in Part 1 received inclisiran sodium 300 mg sc injection on Day 360, while participants assigned to inclisiran in Part 1 received placebo sc injection on Day 360. |
| |
| Secondary | Absolute Change in Lp(a) From Baseline up to Day 720 | Absolute change in lipoprotein (a) [Lp(a)] from baseline to each assessment time up to Day 720. | Full Analysis Set (FAS) comprised all participants to whom study treatment had been assigned by randomization. At each time point, only subjects with a value at both baseline and that time point are included. | Posted | | Mean | Standard Deviation | nmol/L | | Baseline, up to Day 720 | | | | ID | Title | Description |
|---|
| OG000 | Part 1- Inclisiran | Inclisiran sodium 300 mg subcutaneous (sc) injection (given at Days 1, 90 and 270) | | OG001 | Part 1 - Placebo | Placebo sc injection (given at Day 1, 90 and 270) | | OG002 | Part 2 - Inclisiran (Total) | Inclisiran sodium 300 mg sc injection (given at Days 450 and 630). In addition, participants assigned to placebo in Part 1 received inclisiran sodium 300 mg sc injection on Day 360, while participants assigned to inclisiran in Part 1 received placebo sc injection on Day 360. |
| |
| Secondary | Percent Change in Non-HDL-C From Baseline up to Day 720 | Percentage change in non-high density lipoprotein cholesterol (non-HDL-C) from baseline to each assessment time up to Day 720. | Full Analysis Set (FAS) comprised all participants to whom study treatment had been assigned by randomization. At each time point, only subjects with a value at both baseline and that time point are included. | Posted | | Mean | Standard Deviation | Percent change in non-HDL-C | | Baseline, up to Day 720 | | | | ID | Title | Description |
|---|
| OG000 | Part 1- Inclisiran | Inclisiran sodium 300 mg subcutaneous (sc) injection (given at Days 1, 90 and 270) | | OG001 | Part 1 - Placebo | Placebo sc injection (given at Day 1, 90 and 270) | | OG002 | Part 2 - Inclisiran (Total) | Inclisiran sodium 300 mg sc injection (given at Days 450 and 630). In addition, participants assigned to placebo in Part 1 received inclisiran sodium 300 mg sc injection on Day 360, while participants assigned to inclisiran in Part 1 received placebo sc injection on Day 360. |
| |
| Secondary | Absolute Change in Non-HDL-C From Baseline up to Day 720 | Absolute change in non-high density lipoprotein cholesterol (non-HDL-C) from baseline to each assessment time up to Day 720. | Full Analysis Set (FAS) comprised all participants to whom study treatment had been assigned by randomization. At each time point, only subjects with a value at both baseline and that time point are included. | Posted | | Mean | Standard Deviation | mg/dL | | Baseline, up to Day 720 | | | | ID | Title | Description |
|---|
| OG000 | Part 1- Inclisiran | Inclisiran sodium 300 mg subcutaneous (sc) injection (given at Days 1, 90 and 270) | | OG001 | Part 1 - Placebo | Placebo sc injection (given at Day 1, 90 and 270) | | OG002 | Part 2 - Inclisiran (Total) | Inclisiran sodium 300 mg sc injection (given at Days 450 and 630). In addition, participants assigned to placebo in Part 1 received inclisiran sodium 300 mg sc injection on Day 360, while participants assigned to inclisiran in Part 1 received placebo sc injection on Day 360. |
| |
| Secondary | Percent Change in Total Cholesterol From Baseline up to Day 720 | Percentage change in total cholesterol from baseline to each assessment time up to Day 720. | Full Analysis Set (FAS) comprised all participants to whom study treatment had been assigned by randomization. At each time point, only subjects with a value at both baseline and that time point are included. | Posted | | Mean | Standard Deviation | Percent change in total cholesterol | | Baseline, up to Day 720 | | | | ID | Title | Description |
|---|
| OG000 | Part 1- Inclisiran | Inclisiran sodium 300 mg subcutaneous (sc) injection (given at Days 1, 90 and 270) | | OG001 | Part 1 - Placebo | Placebo sc injection (given at Day 1, 90 and 270) | | OG002 | Part 2 - Inclisiran (Total) | Inclisiran sodium 300 mg sc injection (given at Days 450 and 630). In addition, participants assigned to placebo in Part 1 received inclisiran sodium 300 mg sc injection on Day 360, while participants assigned to inclisiran in Part 1 received placebo sc injection on Day 360. |
| |
| Secondary | Absolute Change in Total Cholesterol From Baseline up to Day 720 | Absolute change in total cholesterol from baseline to each assessment time up to Day 720. | Full Analysis Set (FAS) comprised all participants to whom study treatment had been assigned by randomization. At each time point, only subjects with a value at both baseline and that time point are included. | Posted | | Mean | Standard Deviation | mg/dL | | Baseline, up to Day 720 | | | | ID | Title | Description |
|---|
| OG000 | Part 1- Inclisiran | Inclisiran sodium 300 mg subcutaneous (sc) injection (given at Days 1, 90 and 270) | | OG001 | Part 1 - Placebo | Placebo sc injection (given at Day 1, 90 and 270) | | OG002 | Part 2 - Inclisiran (Total) | Inclisiran sodium 300 mg sc injection (given at Days 450 and 630). In addition, participants assigned to placebo in Part 1 received inclisiran sodium 300 mg sc injection on Day 360, while participants assigned to inclisiran in Part 1 received placebo sc injection on Day 360. |
| |
| Secondary | Percent Change in Triglycerides From Baseline up to Day 720 | Percentage change in triglycerides from baseline to each assessment time up to Day 720. | Full Analysis Set (FAS) comprised all participants to whom study treatment had been assigned by randomization. At each time point, only subjects with a value at both baseline and that time point are included. | Posted | | Mean | Standard Deviation | Percent change in triglycerides | | Baseline, up to Day 720 | | | | ID | Title | Description |
|---|
| OG000 | Part 1- Inclisiran | Inclisiran sodium 300 mg subcutaneous (sc) injection (given at Days 1, 90 and 270) | | OG001 | Part 1 - Placebo | Placebo sc injection (given at Day 1, 90 and 270) | | OG002 | Part 2 - Inclisiran (Total) | Inclisiran sodium 300 mg sc injection (given at Days 450 and 630). In addition, participants assigned to placebo in Part 1 received inclisiran sodium 300 mg sc injection on Day 360, while participants assigned to inclisiran in Part 1 received placebo sc injection on Day 360. |
| |
| Secondary | Absolute Change in Triglycerides From Baseline up to Day 720 | Absolute change in triglycerides from baseline to each assessment time up to Day 720. | Full Analysis Set (FAS) comprised all participants to whom study treatment had been assigned by randomization. At each time point, only subjects with a value at both baseline and that time point are included. | Posted | | Mean | Standard Deviation | mg/dL | | Baseline, up to Day 720 | | | | ID | Title | Description |
|---|
| OG000 | Part 1- Inclisiran | Inclisiran sodium 300 mg subcutaneous (sc) injection (given at Days 1, 90 and 270) | | OG001 | Part 1 - Placebo | Placebo sc injection (given at Day 1, 90 and 270) | | OG002 | Part 2 - Inclisiran (Total) | Inclisiran sodium 300 mg sc injection (given at Days 450 and 630). In addition, participants assigned to placebo in Part 1 received inclisiran sodium 300 mg sc injection on Day 360, while participants assigned to inclisiran in Part 1 received placebo sc injection on Day 360. |
| |
| Secondary | Percent Change in HDL-C From Baseline up to Day 720 | Percentage change in high density lipoprotein cholesterol (HDL-C) from baseline to each assessment time up to Day 720. | Full Analysis Set (FAS) comprised all participants to whom study treatment had been assigned by randomization. At each time point, only subjects with a value at both baseline and that time point are included. | Posted | | Mean | Standard Deviation | Percent change in HDL-C | | Baseline, up to Day 720 | | | | ID | Title | Description |
|---|
| OG000 | Part 1- Inclisiran | Inclisiran sodium 300 mg subcutaneous (sc) injection (given at Days 1, 90 and 270) | | OG001 | Part 1 - Placebo | Placebo sc injection (given at Day 1, 90 and 270) | | OG002 | Part 2 - Inclisiran (Total) | Inclisiran sodium 300 mg sc injection (given at Days 450 and 630). In addition, participants assigned to placebo in Part 1 received inclisiran sodium 300 mg sc injection on Day 360, while participants assigned to inclisiran in Part 1 received placebo sc injection on Day 360. |
| |
| Secondary | Absolute Change in HDL-C From Baseline up to Day 720 | Absolute change in high density lipoprotein cholesterol (HDL-C) from baseline to each assessment time up to Day 720. | Full Analysis Set (FAS) comprised all participants to whom study treatment had been assigned by randomization. At each time point, only subjects with a value at both baseline and that time point are included. | Posted | | Mean | Standard Deviation | mg/dL | | Baseline, up to Day 720 | | | | ID | Title | Description |
|---|
| OG000 | Part 1- Inclisiran | Inclisiran sodium 300 mg subcutaneous (sc) injection (given at Days 1, 90 and 270) | | OG001 | Part 1 - Placebo | Placebo sc injection (given at Day 1, 90 and 270) | | OG002 | Part 2 - Inclisiran (Total) | Inclisiran sodium 300 mg sc injection (given at Days 450 and 630). In addition, participants assigned to placebo in Part 1 received inclisiran sodium 300 mg sc injection on Day 360, while participants assigned to inclisiran in Part 1 received placebo sc injection on Day 360. |
| |
| Secondary | Percent Change in VLDL-C From Baseline up to Day 720 | Percentage change in very low density lipoprotein cholesterol (VLDL-C) from baseline to each assessment time up to Day 720. | Full Analysis Set (FAS) comprised all participants to whom study treatment had been assigned by randomization. At each time point, only subjects with a value at both baseline and that time point are included. | Posted | | Mean | Standard Deviation | Percent change in VLDL-C | | Baseline, up to Day 720 | | | | ID | Title | Description |
|---|
| OG000 | Part 1- Inclisiran | Inclisiran sodium 300 mg subcutaneous (sc) injection (given at Days 1, 90 and 270) | | OG001 | Part 1 - Placebo | Placebo sc injection (given at Day 1, 90 and 270) | | OG002 | Part 2 - Inclisiran (Total) | Inclisiran sodium 300 mg sc injection (given at Days 450 and 630). In addition, participants assigned to placebo in Part 1 received inclisiran sodium 300 mg sc injection on Day 360, while participants assigned to inclisiran in Part 1 received placebo sc injection on Day 360. |
| |
| Secondary | Absolut Change in VLDL-C From Baseline up to Day 720 | Absolute change in very low density lipoprotein cholesterol (VLDL-C) from baseline to each assessment time up to Day 720. | Full Analysis Set (FAS) comprised all participants to whom study treatment had been assigned by randomization. At each time point, only subjects with a value at both baseline and that time point are included. | Posted | | Mean | Standard Deviation | mg/dL | | Baseline, up to Day 720 | | | | ID | Title | Description |
|---|
| OG000 | Part 1- Inclisiran | Inclisiran sodium 300 mg subcutaneous (sc) injection (given at Days 1, 90 and 270) | | OG001 | Part 1 - Placebo | Placebo sc injection (given at Day 1, 90 and 270) | | OG002 | Part 2 - Inclisiran (Total) | Inclisiran sodium 300 mg sc injection (given at Days 450 and 630). In addition, participants assigned to placebo in Part 1 received inclisiran sodium 300 mg sc injection on Day 360, while participants assigned to inclisiran in Part 1 received placebo sc injection on Day 360. |
| |
| Secondary | Percent Change in Apo A1 From Baseline up to Day 720 | Percentage change in apolipoprotein A1 (Apo A1) from baseline to each assessment time up to Day 720. | Full Analysis Set (FAS) comprised all participants to whom study treatment had been assigned by randomization. At each time point, only subjects with a value at both baseline and that time point are included. | Posted | | Mean | Standard Deviation | Percent change in Apo A1 | | Baseline, up to Day 720 | | | | ID | Title | Description |
|---|
| OG000 | Part 1- Inclisiran | Inclisiran sodium 300 mg subcutaneous (sc) injection (given at Days 1, 90 and 270) | | OG001 | Part 1 - Placebo | Placebo sc injection (given at Day 1, 90 and 270) | | OG002 | Part 2 - Inclisiran (Total) | Inclisiran sodium 300 mg sc injection (given at Days 450 and 630). In addition, participants assigned to placebo in Part 1 received inclisiran sodium 300 mg sc injection on Day 360, while participants assigned to inclisiran in Part 1 received placebo sc injection on Day 360. |
| |
| Secondary | Absolute Change in Apo A1 From Baseline up to Day 720 | Absolute change in apolipoprotein A1 (Apo A1) from baseline to each assessment time up to Day 720. | Full Analysis Set (FAS) comprised all participants to whom study treatment had been assigned by randomization. At each time point, only subjects with a value at both baseline and that time point are included. | Posted | | Mean | Standard Deviation | mg/dL | | Baseline, up to Day 720 | | | | ID | Title | Description |
|---|
| OG000 | Part 1- Inclisiran | Inclisiran sodium 300 mg subcutaneous (sc) injection (given at Days 1, 90 and 270) | | OG001 | Part 1 - Placebo | Placebo sc injection (given at Day 1, 90 and 270) | | OG002 | Part 2 - Inclisiran (Total) | Inclisiran sodium 300 mg sc injection (given at Days 450 and 630). In addition, participants assigned to placebo in Part 1 received inclisiran sodium 300 mg sc injection on Day 360, while participants assigned to inclisiran in Part 1 received placebo sc injection on Day 360. |
| |
| Secondary | Percent Change in PCSK9 From Baseline up to Day 720 | Percentage change in proprotein convertase subtilisin/kexin type 9 (PCSK9) from baseline to each assessment time up to Day 720. | Full Analysis Set (FAS) comprised all participants to whom study treatment had been assigned by randomization. At each time point, only subjects with a value at both baseline and that time point are included. | Posted | | Mean | Standard Deviation | Percent change in PCSK9 | | Baseline, up to Day 720 | | | | ID | Title | Description |
|---|
| OG000 | Part 1- Inclisiran | Inclisiran sodium 300 mg subcutaneous (sc) injection (given at Days 1, 90 and 270) | | OG001 | Part 1 - Placebo | Placebo sc injection (given at Day 1, 90 and 270) | | OG002 | Part 2 - Inclisiran (Total) | Inclisiran sodium 300 mg sc injection (given at Days 450 and 630). In addition, participants assigned to placebo in Part 1 received inclisiran sodium 300 mg sc injection on Day 360, while participants assigned to inclisiran in Part 1 received placebo sc injection on Day 360. |
| |
| Secondary | Absolut Change in PCSK9 From Baseline up to Day 720 | Absolute change in proprotein convertase subtilisin/kexin type 9 (PCSK9) from baseline to each assessment time up to Day 720. | Full Analysis Set (FAS) comprised all participants to whom study treatment had been assigned by randomization. At each time point, only subjects with a value at both baseline and that time point are included. | Posted | | Mean | Standard Deviation | ng/mL | | Baseline, up to Day 720 | | | | ID | Title | Description |
|---|
| OG000 | Part 1- Inclisiran | Inclisiran sodium 300 mg subcutaneous (sc) injection (given at Days 1, 90 and 270) | | OG001 | Part 1 - Placebo | Placebo sc injection (given at Day 1, 90 and 270) | | OG002 | Part 2 - Inclisiran (Total) | Inclisiran sodium 300 mg sc injection (given at Days 450 and 630). In addition, participants assigned to placebo in Part 1 received inclisiran sodium 300 mg sc injection on Day 360, while participants assigned to inclisiran in Part 1 received placebo sc injection on Day 360. |
| |