| Primary | Percentage Change in Low-density Lipoprotein Cholesterol (LDL-C) (mg/dL) From Baseline at Day 150 - Core Analysis: Core Part | Low-density lipoprotein cholesterol is a type of lipoprotein in the blood. Lipoproteins are particles made of lipids(fats) and proteins that carry fats through the bloodstream. Because of their structure, fats can't move through the blood on their own. So, lipoproteins carry fats to various cells in the body. | Full analysis set - all treated participants | Posted | | Least Squares Mean | 95% Confidence Interval | % change in LDL-C | | Baseline, Day 150 | | | | ID | Title | Description |
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| OG000 | Inclisiran - Inclisiran | Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 1, 90, and 270, and with matching placebo s.c administered on Day 180 | | OG001 | Placebo- Inclisiran | Placebo s.c administered on Days 1 and 90 and Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 180 and 270 |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000-45.87(-49.33 to -42.42)
- OG0011.62(-1.77 to 5.02)
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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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| | ANCOVA | | <0.0001 | | LS Mean Difference | -47.50 | | | 2-Sided | 95 | -52.35 | -42.65 | | | | | Superiority | | |
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| Secondary | Absolute Change in LDL-C (mg/dL) From Baseline at Day 150 - Core Analysis: Core Part | Low-density lipoprotein cholesterol is a type of lipoprotein in the blood. Lipoproteins are particles made of lipids(fats) and proteins that carry fats through the bloodstream. Because of their structure, fats can't move through the blood on their own. So, lipoproteins carry fats to various cells in the body. | Full analysis set - all treated participants | Posted | | Least Squares Mean | 95% Confidence Interval | mg/dL | | Baseline, Day 150 | | | | ID | Title | Description |
|---|
| OG000 | Inclisiran - Inclisiran | Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 1, 90, and 270, and with matching placebo s.c administered on Day 180 | | OG001 | Placebo- Inclisiran | Placebo s.c administered on Days 1 and 90 and Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 180 and 270 |
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| Secondary | Percentage Change in Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) (ng/mL) From Baseline at Day 150 - Core Analysis: Core Part | Inclisiran is a double-stranded small interfering ribonucleic acid (siRNA) that causes degradation of protein convertase subtilisin/kexin type 9 (PCSK9) messenger RNA (mRNA) leading to the reduction of PCSK9 protein. The percentage change from baseline in PCSK9 at Day 150 was assessed. | Full analysis set - all treated participants | Posted | | Least Squares Mean | 95% Confidence Interval | % change in PCSK9 | | Baseline, Day 150 | | | | ID | Title | Description |
|---|
| OG000 | Inclisiran - Inclisiran | Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 1, 90, and 270, and with matching placebo s.c administered on Day 180 | | OG001 | Placebo- Inclisiran | Placebo s.c administered on Days 1 and 90 and Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 180 and 270 |
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| Secondary | Absolute Change in PCSK9 (ng/mL) From Baseline at Day 150 - Core Analysis: Core Part | Inclisiran is a double-stranded small interfering ribonucleic acid (siRNA) that causes degradation of protein convertase subtilisin/kexin type 9 (PCSK9) messenger RNA (mRNA) leading to the reduction of PCSK9 protein. | Full analysis set - all treated participants | Posted | | Least Squares Mean | 95% Confidence Interval | ng/mL | | Baseline, Day 150 | | | | ID | Title | Description |
|---|
| OG000 | Inclisiran - Inclisiran | Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 1, 90, and 270, and with matching placebo s.c administered on Day 180 | | OG001 | Placebo- Inclisiran | Placebo s.c administered on Days 1 and 90 and Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 180 and 270 |
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| Secondary | Percentage Change in Total Cholesterol (mg/dL) From Baseline at Day 150 - Core Analysis: Core Part | Total cholesterol is a measure of all the cholesterol in the blood. It includes low-density lipoprotein (LDL), high-density lipoprotein (HDL) and a portion of triglycerides. | Full analysis set - all treated participants | Posted | | Least Squares Mean | 95% Confidence Interval | % change in total cholesterol | | Baseline, Day 150 | | | | ID | Title | Description |
|---|
| OG000 | Inclisiran - Inclisiran | Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 1, 90, and 270, and with matching placebo s.c administered on Day 180 | | OG001 | Placebo- Inclisiran | Placebo s.c administered on Days 1 and 90 and Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 180 and 270 |
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| Secondary | Absolute Change in Total Cholesterol (mg/dL) From Baseline at Day 150 - Core Analysis: Core Part | Total cholesterol is a measure of all the cholesterol in the blood. It includes low-density lipoprotein (LDL), high-density lipoprotein (HDL) and a portion of triglycerides. | Full analysis set - all treated participants | Posted | | Least Squares Mean | 95% Confidence Interval | mg/dL | | Baseline, Day 150 | | | | ID | Title | Description |
|---|
| OG000 | Inclisiran - Inclisiran | Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 1, 90, and 270, and with matching placebo s.c administered on Day 180 | | OG001 | Placebo- Inclisiran | Placebo s.c administered on Days 1 and 90 and Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 180 and 270 |
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| Secondary | Percentage Change in High-density Lipoprotein Cholesterol (HDL-C) (mg/dL) From Baseline at Day 150 - Core Analysis: Core Part | HDL-C stands for high-density lipoprotein cholesterol, often referred to as the "good" cholesterol. This is because HDL cholesterol helps remove other forms of cholesterol from the bloodstream. It picks up excess cholesterol in the blood and carries it back to the liver, where it is broken down and flushed out of the body. | Full analysis set - all treated participants | Posted | | Least Squares Mean | 95% Confidence Interval | % change in HDL-C | | Baseline, Day 150 | | | | ID | Title | Description |
|---|
| OG000 | Inclisiran - Inclisiran | Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 1, 90, and 270, and with matching placebo s.c administered on Day 180 | | OG001 | Placebo- Inclisiran | Placebo s.c administered on Days 1 and 90 and Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 180 and 270 |
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| Secondary | Absolute Change in HDL-C (mg/dL) From Baseline at Day 150 - Core Analysis: Core Part | HDL-C stands for high-density lipoprotein cholesterol, often referred to as the "good" cholesterol. This is because HDL cholesterol helps remove other forms of cholesterol from the bloodstream. It picks up excess cholesterol in the blood and carries it back to the liver, where it is broken down and flushed out of the body. | Full analysis set - all treated participants | Posted | | Least Squares Mean | 95% Confidence Interval | mg/dL | | Baseline, Day 150 | | | | ID | Title | Description |
|---|
| OG000 | Inclisiran - Inclisiran | Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 1, 90, and 270, and with matching placebo s.c administered on Day 180 | | OG001 | Placebo- Inclisiran | Placebo s.c administered on Days 1 and 90 and Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 180 and 270 |
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| Secondary | Percentage Change in Non-HDL-C (mg/dL) From Baseline at Day 150 - Core Analysis: Core Part | Non-HDL cholesterol is a measure of all the "bad" types of cholesterol in the blood, excluding HDL cholesterol. It is calculated by subtracting HDL cholesterol from total cholesterol. Non-HDL cholesterol includes all the types of cholesterol other than HDL cholesterol, and higher levels of non-HDL cholesterol can increase the risk of cardiovascular disease. | Full analysis set - all treated participants | Posted | | Least Squares Mean | 95% Confidence Interval | % change in non-HDL-C | | Baseline, Day 150 | | | | ID | Title | Description |
|---|
| OG000 | Inclisiran - Inclisiran | Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 1, 90, and 270, and with matching placebo s.c administered on Day 180 | | OG001 | Placebo- Inclisiran | Placebo s.c administered on Days 1 and 90 and Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 180 and 270 |
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| Secondary | Absolute Change in Non-HDL-C (mg/dL) From Baseline at Day 150 - Core Analysis: Core Part | Non-HDL cholesterol is a measure of all the "bad" types of cholesterol in the blood, excluding HDL cholesterol. It is calculated by subtracting HDL cholesterol from total cholesterol. Non-HDL cholesterol includes all the types of cholesterol other than HDL cholesterol, and higher levels of non-HDL cholesterol can increase the risk of cardiovascular disease. | Full analysis set - all treated participants | Posted | | Least Squares Mean | 95% Confidence Interval | mg/dL | | Baseline, Day 150 | | | | ID | Title | Description |
|---|
| OG000 | Inclisiran - Inclisiran | Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 1, 90, and 270, and with matching placebo s.c administered on Day 180 | | OG001 | Placebo- Inclisiran | Placebo s.c administered on Days 1 and 90 and Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 180 and 270 |
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| Secondary | Percentage Change in Apolipoprotein B (ApoB) (mg/dL) From Baseline at Day 150 - Core Analysis: Core Part | Apolipoprotein B (ApoB) is a protein that helps carry fat and cholesterol through the body. It is encoded by the APOB gene. ApoB attaches to negative types of cholesterol that cause plaque buildup in blood vessels, which can lead to damage and heart disease. | Full analysis set - all treated participants | Posted | | Least Squares Mean | 95% Confidence Interval | % change in apolipoprotein B | | Baseline, Day 150 | | | | ID | Title | Description |
|---|
| OG000 | Inclisiran - Inclisiran | Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 1, 90, and 270, and with matching placebo s.c administered on Day 180 | | OG001 | Placebo- Inclisiran | Placebo s.c administered on Days 1 and 90 and Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 180 and 270 |
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| Secondary | Absolute Change in ApoB (mg/dL) From Baseline at Day 150 - Core Analysis: Core Part | Apolipoprotein B (ApoB) is a protein that helps carry fat and cholesterol through the body. It is encoded by the APOB gene. ApoB attaches to negative types of cholesterol that cause plaque buildup in blood vessels, which can lead to damage and heart disease. | Full analysis set - all treated participants | Posted | | Least Squares Mean | 95% Confidence Interval | mg/dL | | Baseline, Day 150 | | | | ID | Title | Description |
|---|
| OG000 | Inclisiran - Inclisiran | Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 1, 90, and 270, and with matching placebo s.c administered on Day 180 | | OG001 | Placebo- Inclisiran | Placebo s.c administered on Days 1 and 90 and Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 180 and 270 |
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| Secondary | Percentage Change in Apolipoprotein A-1 (ApoA-1) (mg/dL) From Baseline at Day 150 - Core Analysis: Core Part | Apolipoprotein A1 (ApoA1) is the primary protein associated with high-density lipoprotein (HDL) particles, and plays a central role in reverse cholesterol transport. HDL cholesterol (HDL-C) and ApoA1 concentrations are inversely related to the risk for coronary artery disease (CAD). | Full analysis set - all treated participants | Posted | | Least Squares Mean | 95% Confidence Interval | % change in apolipoprotein A-1 | | Baseline, Day 150 | | | | ID | Title | Description |
|---|
| OG000 | Inclisiran - Inclisiran | Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 1, 90, and 270, and with matching placebo s.c administered on Day 180 | | OG001 | Placebo- Inclisiran | Placebo s.c administered on Days 1 and 90 and Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 180 and 270 |
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| Secondary | Absolute Change in ApoA-1 (mg/dL) From Baseline at Day 150 - Core Analysis: Core Part | Apolipoprotein A1 (ApoA1) is the primary protein associated with high-density lipoprotein (HDL) particles, and plays a central role in reverse cholesterol transport. HDL cholesterol (HDL-C) and ApoA1 concentrations are inversely related to the risk for coronary artery disease (CAD). | Full analysis set - all treated participants | Posted | | Least Squares Mean | 95% Confidence Interval | mg/dL | | Baseline, Day 150 | | | | ID | Title | Description |
|---|
| OG000 | Inclisiran - Inclisiran | Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 1, 90, and 270, and with matching placebo s.c administered on Day 180 | | OG001 | Placebo- Inclisiran | Placebo s.c administered on Days 1 and 90 and Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 180 and 270 |
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| Secondary | Percentage Change in Lipoprotein (a) (Lp(a)) (Nmol/L) From Baseline at Day 150 - Core Analysis: Core Part | Often referred to as Lp(a), lipoprotein (a) is a type of lipoprotein that is genetically inherited and in high levels is a common independent risk factor for heart disease. | Full analysis set - all treated participants | Posted | | Least Squares Mean | 95% Confidence Interval | % change in lipoprotein (a) | | Baseline, Day 150 | | | | ID | Title | Description |
|---|
| OG000 | Inclisiran - Inclisiran | Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 1, 90, and 270, and with matching placebo s.c administered on Day 180 | | OG001 | Placebo- Inclisiran | Placebo s.c administered on Days 1 and 90 and Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 180 and 270 |
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| Secondary | Absolute Change in Log-transformed Lp(a) (Nmol/L) From Baseline at Day 150 - Core Analysis: Core Part | Often referred to as Lp(a), lipoprotein (a) is a type of lipoprotein that is genetically inherited and in high levels is a common independent risk factor for heart disease. | Full analysis set - all treated participants | Posted | | Least Squares Mean | 95% Confidence Interval | nmol/L | | Baseline, Day 150 | | | | ID | Title | Description |
|---|
| OG000 | Inclisiran - Inclisiran | Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 1, 90, and 270, and with matching placebo s.c administered on Day 180 | | OG001 | Placebo- Inclisiran | Placebo s.c administered on Days 1 and 90 and Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 180 and 270 |
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| Secondary | Percentage Change in Triglyceride (mg/dL) From Baseline at Day 150 - Core Analysis: Core Part | Triglycerides are fats from the food we eat. Most of the fats we eat (like butter) are in triglyceride form. Extra calories, alcohol and sugar in the body turn into triglycerides. The body stores them in fat cells throughout the body. | Full analysis set - all treated participants | Posted | | Least Squares Mean | 95% Confidence Interval | % change in Triglyceride | | Baseline, Day 150 | | | | ID | Title | Description |
|---|
| OG000 | Inclisiran - Inclisiran | Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 1, 90, and 270, and with matching placebo s.c administered on Day 180 | | OG001 | Placebo- Inclisiran | Placebo s.c administered on Days 1 and 90 and Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 180 and 270 |
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| Secondary | Absolute Change in Triglyceride (mg/dL) From Baseline at Day 150 - Core Analysis: Core Part | Triglycerides are fats from the food we eat. Most of the fats we eat (like butter) are in triglyceride form. Extra calories, alcohol and sugar in the body turn into triglycerides. The body stores them in fat cells throughout the body. | Full analysis set - all treated participants | Posted | | Least Squares Mean | 95% Confidence Interval | mg/dL | | Baseline, Day 150 | | | | ID | Title | Description |
|---|
| OG000 | Inclisiran - Inclisiran | Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 1, 90, and 270, and with matching placebo s.c administered on Day 180 | | OG001 | Placebo- Inclisiran | Placebo s.c administered on Days 1 and 90 and Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 180 and 270 |
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| Secondary | Percentage Change in LDL-C (mg/dL) From Baseline at Day 330 - Final Analysis: Core Part + Extension Part | Low-density lipoprotein cholesterol is a type of lipoprotein in the blood. Lipoproteins are particles made of lipids(fats) and proteins that carry fats through the bloodstream. Because of their structure, fats can't move through the blood on their own. So, lipoproteins carry fats to various cells in the body. | Full analysis set - all treated participants in the Inclisiran - Inclisiran group | Posted | | Least Squares Mean | 95% Confidence Interval | % change in LDL-C | | Baseline, Day 330 | | | | ID | Title | Description |
|---|
| OG000 | Inclisiran - Inclisiran | Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 1, 90, and 270, and with matching placebo s.c administered on Day 180 | | OG001 | Placebo- Inclisiran | Placebo s.c administered on Days 1 and 90 and Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 180 and 270 |
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| Secondary | Absolute Change in LDL-C (mg/dL) From Baseline at Day 330 - Final Analysis: Core Part + Extension Part | Low-density lipoprotein cholesterol is a type of lipoprotein in the blood. Lipoproteins are particles made of lipids(fats) and proteins that carry fats through the bloodstream. Because of their structure, fats can't move through the blood on their own. So, lipoproteins carry fats to various cells in the body. | Full analysis set - all treated participants in the Inclisiran - Inclisiran group | Posted | | Least Squares Mean | 95% Confidence Interval | mg/dL | | Baseline, Day 330 | | | | ID | Title | Description |
|---|
| OG000 | Inclisiran - Inclisiran | Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 1, 90, and 270, and with matching placebo s.c administered on Day 180 | | OG001 | Placebo- Inclisiran | Placebo s.c administered on Days 1 and 90 and Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 180 and 270 |
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| Secondary | Number of Participants With Adverse Events (AEs) During Core Part | An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a subject or clinical investigation subject | Safety set - all treated participants in the core part | Posted | | Count of Participants | | Participants | | Core part, from treatment start (Day 1) to Day 150 | | | | ID | Title | Description |
|---|
| OG000 | Inclisiran - Inclisiran | Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 1, 90, and 270, and with matching placebo s.c administered on Day 180 | | OG001 | Placebo- Inclisiran | Placebo s.c administered on Days 1 and 90 and Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 180 and 270 |
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| Secondary | Number of Participants With Adverse Events (AEs) During Extension Part | An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a subject or clinical investigation subject | Final analysis - all treated participants in the extension part | Posted | | Count of Participants | | Participants | | Extension part, from Day 181, up to Day 360 | | | | ID | Title | Description |
|---|
| OG000 | Inclisiran - Inclisiran | Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 1, 90, and 270, and with matching placebo s.c administered on Day 180 | | OG001 | Placebo- Inclisiran | Placebo s.c administered on Days 1 and 90 and Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 180 and 270 |
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| Secondary | Number of Participants With Adverse Events (AEs) - Cumulative Data (Core + Extension Part) | An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a subject or clinical investigation subject | Final analysis - all treated participants (Core + Extension part) | Posted | | Count of Participants | | Participants | | AEs are reported from first dose of study treatment until end of study treatment plus 30 days after the last study visit (or 90 days after the last administration of study drug, whichever is longer) up to a maximum timeframe of approximately 360 days | | | | ID | Title | Description |
|---|
| OG000 | Inclisiran - Inclisiran | Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 1, 90, and 270, and with matching placebo s.c administered on Day 180 | | OG001 | Placebo- Inclisiran | Placebo s.c administered on Days 1 and 90 and Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) s.c administered on Days 180 and 270 |
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