| Primary | Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) to Day 180 | Percent change from baseline in LDL-C was calculated to evaluate the effect of inclisiran at Day 180. Difference between different inclisiran dose groups and the placebo group in percentage change in LDL-C levels from baseline to Day 180 were calculated to capture both, the effect of the study drug and the effect of additional medications, mirroring the conditions in clinical practice. An MMRM (Mixed-effect Model with Repeated Measurement) was used as the primary analysis model, with treatment group, visits, interaction between visits and treatment groups, current use of statins or other lipid-modifying therapies as fixed effects, and baseline LDL-C as a continuous covariate. | The FAS comprised all participants to whom study treatment had been assigned by randomization. The overall number of participants analyzed represents the participants in the Full Analysis Set (FAS) who had valid LDL-C value for both, baseline and day 180 | Posted | | Least Squares Mean | 95% Confidence Interval | percent change in LDL-C | | Baseline, Day 180 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo subcutaneous injection | | OG001 | 100 mg Inclisiran Sodium | 100 mg inclisiran sodium (equivalent to 94.5 mg inclisiran) subcutaneous injection | | OG002 | 200 mg Inclisiran Sodium | 200 mg inclisiran sodium (equivalent to 189 mg inclisiran) subcutaneous injection | | OG003 | 300 mg Inclisiran Sodium | 300 mg inclisiran sodium (equivalent to 284 mg inclisiran) subcutaneous injection |
| | Units | Counts |
|---|
| Participants | - OG00056
- OG00155
- OG002101
- OG003
|
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG0009.0(3.5 to 14.5)
- OG001-47.6(-53.4 to -41.8)
- OG002-51.9(-56.8 to -47.0)
- OG003
|
|
| | 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 |
|---|
| | Mixed Models Analysis | | <.0001 | One-sided adjusted p-value for multiple comparisons using Dunnett´s multiple t-test | Mean Difference (Net) | -56.6 | Standard Error of the Mean | 3.24 | 2-Sided | 95 | -64.2 | -49.0 | | | | | Superiority | | | | | Mixed Models Analysis |
|
| Secondary | Percent Change From Baseline in PCSK9 by Visit | Percent change from baseline in proprotein convertase subtilisin/kexin type 9 (PCSK9) was calculated to evaluate the effect of inclisiran over time. | The overall number of participants analyzed represents the participants in the Full Analysis Set (FAS) who had at least one valid measurement of PCSK9. The number analyzed per row represents the participants with a valid PCSK9 value for both, baseline and that particular visit. | Posted | | Mean | Standard Deviation | percent change in PCSK9 | | Baseline, day 14, day 30, day 60, day 90, day 104, day 120, day 150, and day 180 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo subcutaneous injection | | OG001 | 100 mg Inclisiran Sodium | 100 mg inclisiran sodium (equivalent to 94.5 mg inclisiran) subcutaneous injection | | OG002 | 200 mg Inclisiran Sodium | 200 mg inclisiran sodium (equivalent to 189 mg inclisiran) subcutaneous injection | | OG003 | 300 mg Inclisiran Sodium | |
|
| Secondary | Percent Change From Baseline in LDL-C by Visit | Percent change from baseline in low-density lipoprotein cholesterol (LDL-C) was calculated to evaluate the effect of inclisiran over time. | The overall number of participants analyzed represents the participants in the Full Analysis Set (FAS) who had at least one valid measurement of LDL-C. The number analyzed per row represents the participants with a valid LDL-C value for both, baseline and that particular visit. | Posted | | Mean | Standard Deviation | percent change in LDL-C | | Baseline, day 14, day 30, day 60, day 90, day 104, day 120 and day 150 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo subcutaneous injection | | OG001 | 100 mg Inclisiran Sodium | 100 mg inclisiran sodium (equivalent to 94.5 mg inclisiran) subcutaneous injection | | OG002 | 200 mg Inclisiran Sodium | 200 mg inclisiran sodium (equivalent to 189 mg inclisiran) subcutaneous injection | | OG003 | 300 mg Inclisiran Sodium | 300 mg inclisiran sodium (equivalent to 284 mg inclisiran) subcutaneous injection |
|
| Secondary | Absolute Change in LDL-C From Baseline at Day 180 | Absolute change from baseline in low-density lipoprotein cholesterol (LDL-C) was calculated to evaluate the effect of inclisiran until Day 180. | The overall number of participants analyzed represents the participants in the Full Analysis Set (FAS) who had valid LDL-C value for both, baseline and day 180 | Posted | | Least Squares Mean | 95% Confidence Interval | mg/dL | | Baseline, Day 180 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo subcutaneous injection | | OG001 | 100 mg Inclisiran Sodium | 100 mg inclisiran sodium (equivalent to 94.5 mg inclisiran) subcutaneous injection | | OG002 | 200 mg Inclisiran Sodium | 200 mg inclisiran sodium (equivalent to 189 mg inclisiran) subcutaneous injection | | OG003 | 300 mg Inclisiran Sodium | 300 mg inclisiran sodium (equivalent to 284 mg inclisiran) subcutaneous injection |
| |
| Secondary | Proportion of Participants With LDL-C Greater Than 80% of Baseline Value at Day 180 | Proportion of participants with LDL-C greater than 80% of baseline value at Day 180 was calculated to evaluate the effect of inclisiran until Day 180. Subjects are counted if the LDL-C value is greater than '0.8*(LDL-C at Baseline - LDL-C at Day180) + LDL-C at Day180', or the LDL-C value is greater than or equal to the LDL-C at Baseline. | The overall number of participants analyzed represents the participants in the Full Analysis Set (FAS) who had valid LDL-C value for both, baseline and day 180 | Posted | | Count of Participants | | Participants | | Baseline, Day 180 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo subcutaneous injection | | OG001 | 100 mg Inclisiran Sodium | 100 mg inclisiran sodium (equivalent to 94.5 mg inclisiran) subcutaneous injection | | OG002 | 200 mg Inclisiran Sodium | 200 mg inclisiran sodium (equivalent to 189 mg inclisiran) subcutaneous injection | | OG003 | 300 mg Inclisiran Sodium | |
|
| Secondary | Proportion of Participants With Greater or Equal to 50% LDL-C Reduction From Baseline by Visit | Proportion of participants with greater or equal to 50% LDL-C reduction from baseline was calculated to evaluate the effect of inclisiran over time. | The overall number of participants analyzed represents the participants in the Full Analysis Set (FAS) who had at least one valid measurement of LDL-C. The number analyzed per row represents the participants with a valid LDL-C value for both, baseline and that particular visit. | Posted | | Count of Participants | | Participants | | Baseline, day 14, day 30, day 60, day 90, day 104, day 120, day 150, and day 180 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo subcutaneous injection | | OG001 | 100 mg Inclisiran Sodium | 100 mg inclisiran sodium (equivalent to 94.5 mg inclisiran) subcutaneous injection | | OG002 | 200 mg Inclisiran Sodium | 200 mg inclisiran sodium (equivalent to 189 mg inclisiran) subcutaneous injection | | OG003 | 300 mg Inclisiran Sodium | |
|
| Secondary | Percent Change From Baseline in Cholesterol by Visit | Percent change from baseline in cholesterol by visit was calculated to evaluate the effect of inclisiran over time | The overall number of participants analyzed represents the participants in the Full Analysis Set (FAS) who had at least one valid measurement of cholesterol. The number analyzed per row represents the participants with a valid cholesterol value for both, baseline and that particular visit. | Posted | | Mean | Standard Deviation | Percent change in cholesterol | | Baseline, day 14, day 30, day 60, day 90, day 104, day 120, day 150, and day 180 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo subcutaneous injection | | OG001 | 100 mg Inclisiran Sodium | 100 mg inclisiran sodium (equivalent to 94.5 mg inclisiran) subcutaneous injection | | OG002 | 200 mg Inclisiran Sodium | 200 mg inclisiran sodium (equivalent to 189 mg inclisiran) subcutaneous injection | | OG003 | 300 mg Inclisiran Sodium | |
|
| Secondary | Percent Change From Baseline in Triglycerides by Visit | Percent change from baseline in triglycerides by visit was calculated to evaluate the effect of inclisiran over time | The overall number of participants analyzed represents the participants in the Full Analysis Set (FAS) who had at least one valid measurement of triglycerides. The number analyzed per row represents the participants with a valid triglycerides value for both, baseline and that particular visit. | Posted | | Mean | Standard Deviation | percent change in triglycerides | | Baseline, day 14, day 30, day 60, day 90, day 104, day 120, day 150, and day 180 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo subcutaneous injection | | OG001 | 100 mg Inclisiran Sodium | 100 mg inclisiran sodium (equivalent to 94.5 mg inclisiran) subcutaneous injection | | OG002 | 200 mg Inclisiran Sodium | 200 mg inclisiran sodium (equivalent to 189 mg inclisiran) subcutaneous injection | | OG003 | 300 mg Inclisiran Sodium | |
|
| Secondary | Percent Change From Baseline in HDL Cholesterol by Visit | Percent change from baseline in high-density lipoprotein cholesterol (HDL-C) by visit was calculated to evaluate the effect of inclisiran over time | The overall number of participants analyzed represents the participants in the Full Analysis Set (FAS) who had at least one valid measurement of HDL Cholesterol. The number analyzed per row represents the participants with a valid HDL Cholesterol value for both, baseline and that particular visit. | Posted | | Mean | Standard Deviation | percent change in HDL Cholesterol | | Baseline, day 14, day 30, day 60, day 90, day 104, day 120, day 150, and day 180 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo subcutaneous injection | | OG001 | 100 mg Inclisiran Sodium | 100 mg inclisiran sodium (equivalent to 94.5 mg inclisiran) subcutaneous injection | | OG002 | 200 mg Inclisiran Sodium | 200 mg inclisiran sodium (equivalent to 189 mg inclisiran) subcutaneous injection | | OG003 | 300 mg Inclisiran Sodium | |
|
| Secondary | Percent Change From Baseline in Non-HDL Cholesterol by Visit | Percent change from baseline in non-HDL Cholesterol by visit was calculated to evaluate the effect of inclisiran over time | The overall number of participants analyzed represents the participants in the Full Analysis Set (FAS) who had at least one valid measurement of non-HDL Cholesterol. The number analyzed per row represents the participants with a valid non-HDL Cholesterol value for both, baseline and that particular visit. | Posted | | Mean | Standard Deviation | percent change in non-HDL Cholesterol | | Baseline, day 14, day 30, day 60, day 90, day 104, day 120, day 150, and day 180 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo subcutaneous injection | | OG001 | 100 mg Inclisiran Sodium | 100 mg inclisiran sodium (equivalent to 94.5 mg inclisiran) subcutaneous injection | | OG002 | 200 mg Inclisiran Sodium | 200 mg inclisiran sodium (equivalent to 189 mg inclisiran) subcutaneous injection | | OG003 | 300 mg Inclisiran Sodium | |
|
| Secondary | Percent Change From Baseline in VLDL-C by Visit | Percent change from baseline in very low-density lipoprotein cholesterol (VLDL - C) by visit was calculated to evaluate the effect of inclisiran over time | The overall number of participants analyzed represents the participants in the Full Analysis Set (FAS) who had at least one valid measurement of VLDL-C. The number analyzed per row represents the participants with a valid VLDL-C value for both, baseline and that particular visit. | Posted | | Mean | Standard Deviation | percent change in VLDL-C | | Baseline, day 14, day 30, day 60, day 90, day 104, day 120, day 150, and day 180 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo subcutaneous injection | | OG001 | 100 mg Inclisiran Sodium | 100 mg inclisiran sodium (equivalent to 94.5 mg inclisiran) subcutaneous injection | | OG002 | 200 mg Inclisiran Sodium | 200 mg inclisiran sodium (equivalent to 189 mg inclisiran) subcutaneous injection | | OG003 | 300 mg Inclisiran Sodium | |
|
| Secondary | Percent Change From Baseline in Apo- A1 by Visit | Percent change from baseline in Apolipoprotein A1 (Apo-A1) by visit was calculated to evaluate the effect of inclisiran over time | The overall number of participants analyzed represents the participants in the Full Analysis Set (FAS) who had at least one valid measurement of Apo-A1. The number analyzed per row represents the participants with a valid Apo-A1 value for both, baseline and that particular visit. | Posted | | Mean | Standard Deviation | percent change in Apo-A1 | | Baseline, day 14, day 30, day 60, day 90, day 104, day 120, day 150, and day 180 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo subcutaneous injection | | OG001 | 100 mg Inclisiran Sodium | 100 mg inclisiran sodium (equivalent to 94.5 mg inclisiran) subcutaneous injection | | OG002 | 200 mg Inclisiran Sodium | 200 mg inclisiran sodium (equivalent to 189 mg inclisiran) subcutaneous injection | | OG003 | 300 mg Inclisiran Sodium | 300 mg inclisiran sodium (equivalent to 284 mg inclisiran) subcutaneous injection |
|
| Secondary | Percent Change From Baseline in Apo- B by Visit | Percent change from baseline in Apolipoprotein B (Apo-B) by visit was calculated to evaluate the effect of inclisiran over time | The overall number of participants analyzed represents the participants in the Full Analysis Set (FAS) who had at least one valid measurement of Apo-B. The number analyzed per row represents the participants with a valid Apo-B value for both, baseline and that particular visit. | Posted | | Mean | Standard Deviation | percent change in Apo-B | | Baseline, day 14, day 30, day 60, day 90, day 104, day 120, day 150, and day 180 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo subcutaneous injection | | OG001 | 100 mg Inclisiran Sodium | 100 mg inclisiran sodium (equivalent to 94.5 mg inclisiran) subcutaneous injection | | OG002 | 200 mg Inclisiran Sodium | 200 mg inclisiran sodium (equivalent to 189 mg inclisiran) subcutaneous injection | | OG003 | 300 mg Inclisiran Sodium | 300 mg inclisiran sodium (equivalent to 284 mg inclisiran) subcutaneous injection |
|
| Secondary | Percent Change From Baseline in Lipoprotein-a by Visit | Percent change from baseline in Lipoprotein a (LP(a)) by visit was calculated to evaluate the effect of inclisiran over time | The overall number of participants analyzed represents the participants in the Full Analysis Set (FAS) who had at least one valid measurement of LP(a). The number analyzed per row represents the participants with a valid LP(a) value for both, baseline and that particular visit. | Posted | | Mean | Standard Deviation | percent change in LP(a) | | Baseline, day 14, day 30, day 60, day 90, day 104, day 120, day 150, and day 180 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo subcutaneous injection | | OG001 | 100 mg Inclisiran Sodium | 100 mg inclisiran sodium (equivalent to 94.5 mg inclisiran) subcutaneous injection | | OG002 | 200 mg Inclisiran Sodium | 200 mg inclisiran sodium (equivalent to 189 mg inclisiran) subcutaneous injection | | OG003 | 300 mg Inclisiran Sodium | 300 mg inclisiran sodium (equivalent to 284 mg inclisiran) subcutaneous injection |
|
| Secondary | Proportion of Participants Who Attain Lipid Control Target Pre-specified by JAS 2017 Guidelines for Their Level of Cardiovascular Risk at Day 180 | Proportion of participants who attain lipid control target pre-specified by Japan Atherosclerosis Society(JAS) 2017 guidelines for their level of cardiovascular risk at Day 180 was calculated to evaluate the effect of inclisiran. | The overall number of participants analyzed represents the participants in the Full Analysis Set (FAS) who had at least one valid measurement of LDL-C at Day 180 | Posted | | Count of Participants | | Participants | | Day 180 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo subcutaneous injection | | OG001 | 100 mg Inclisiran Sodium | 100 mg inclisiran sodium (equivalent to 94.5 mg inclisiran) subcutaneous injection | | OG002 | 200 mg Inclisiran Sodium | 200 mg inclisiran sodium (equivalent to 189 mg inclisiran) subcutaneous injection | | OG003 | 300 mg Inclisiran Sodium | 300 mg inclisiran sodium (equivalent to 284 mg inclisiran) subcutaneous injection |
|
| Secondary | Number of Participants With LDL-C Levels of <25 mg/dL, <50 mg/dL, <70 mg/dL, and <100 mg/dL by Visit | Number of participants by LDL-C levels was calculated to evaluate the effect of inclisiran. | The overall number of participants analyzed represents the participants in the Full Analysis Set (FAS) who had at least one valid measurement of LDL-C. The number analyzed per row represents the participants with a valid LDL-C at that particular visit. | Posted | | Count of Participants | | Participants | | Baseline, day 14, day 30, day 60, day 90, day 104, day 120, day 150, and day 180 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Placebo subcutaneous injection | | OG001 | 100 mg Inclisiran Sodium | 100 mg inclisiran sodium (equivalent to 94.5 mg inclisiran) subcutaneous injection | | OG002 | 200 mg Inclisiran Sodium | 200 mg inclisiran sodium (equivalent to 189 mg inclisiran) subcutaneous injection | | OG003 | 300 mg Inclisiran Sodium | 300 mg inclisiran sodium (equivalent to 284 mg inclisiran) subcutaneous injection |
|