A Study of Inclisiran in Participants With Homozygous Fam... | NCT03851705

ID	Type	Description	Link
CKJX839A12302	Other Identifier	Novartis Pharmaceuticals
2018-000893-31	EudraCT Number

Label	Type	Description	Intervention Names
Part 1 - Inclisiran	Experimental	Participants who received a dose of 300 milligram (mg) inclisiran sodium for injection administered by SC injection on Day 1 and Day 90.	Drug: Inclisiran Sodium for injection
Part 1 - Placebo	Placebo Comparator	Participants who received a dose of placebos administered by SC injection on Day 1 and Day 90.	Drug: Placebo Drug: Placebos
Part 2 - Inclisiran	Experimental	Participants who received a dose of 300 mg inclisiran sodium for injection administered by SC injection on Day 270, Day 450 and Day 630. In addition, participants who were assigned to the placebo arm in Part 1 will receive a dose of 300 mg inclisiran sodium administered by SC injection on Day 180 after completion of Part 1.	Drug: Inclisiran Sodium for injection

Name	Type	Description	Arm Group Labels	Other Names
Inclisiran Sodium for injection	Drug	Inclisiran is a synthetic, chemically modified small interfering ribonucleic acid (siRNA) targeting proprotein convertase subtilisin kexin type 9 (PCSK9) messenger ribonucleic acid (mRNA) with a covalently attached triantennary N-acetylgalactosamine (GalNAc) ligand.

Measure	Description	Time Frame
Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 150	Percentage Change in LDL-C levels from Baseline to Day 150	Baseline, Day 150

Measure	Description	Time Frame
Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 150	Absolute Change in LDL-C levels (mg/dL) from baseline to Day 150	Baseline, Day 150
Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Subsequent Visits up to Day 180

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of HoFH by genetic confirmation or a clinical diagnosis based on a history of an untreated LDL-C concentration >500 mg/dL (13 mmol/L) together with either xanthoma before 10 years of age or evidence of heterozygous familial hypercholesterolemia in both parents
Stable on a low-fat diet.
Subjects on statins should be receiving a maximally tolerated dose. Maximum tolerated dose is defined as the maximum dose of statin that can be taken on a regular basis without intolerable adverse events.
Subjects not receiving statins must have documented evidence of intolerance to at least two different statins.
Subjects on lipid-lower therapies (such as statin and/or ezetimibe) should be on a stable dose for ≥30 days before screening with no planned medication or dose change during study participation.
Fasting central laboratory LDL-C concentration ≥130 mg/dL (3.4 mmol/L).
Triglyceride concentration <400 mg/dL (4.5 mmol/L)
No current or planned renal dialysis or renal transplantation
Subjects on a documented regimen of LDL or plasma apheresis will be allowed to continue the apheresis during the study, if needed.
Subjects must be willing and able to give written informed consent before initiation of any study-related procedures. The subject should be willing to comply with all required study procedures.
Willing to follow all study procedures including adherence to dietary guidelines, study visits, fasting blood draws, and compliance with study treatment regimens.

Exclusion Criteria:

Use of Mipomersen or Lomitapide therapy within 5 months of screening
Treatment (within 90 days of screening) with monoclonal antibodies directed towards PCSK9
New York Heart Association (NYHA) class IV heart failure or last known left ventricular ejection fraction <25%
Major adverse cardiovascular event within 3 months prior to randomization
Planned cardiac surgery or revascularization
Uncontrolled severe hypertension: systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg prior to randomization despite anti-hypertensive therapy
Active liver disease defined as any known current infectious, neoplastic, or metabolic pathology of the liver or unexplained alanine aminotransferase (ALT), aspartate aminotransferase (AST), elevation >3x ULN, or total bilirubin >2x upper limit of normal (ULN) at screening confirmed by a repeat measurement at least 1 week apart
Severe concomitant noncardiovascular disease that carries the risk of reducing life expectancy to less than the duration of the trial
History of malignancy that required surgery (excluding local and wide-local excision), radiation therapy and/or commencement of systemic therapy as treatment during the 3 years prior to randomization
Females who are pregnant or nursing, or who are of childbearing potential and unwilling to use at least one acceptable effective method of contraception (eg, oral contraceptives, barrier methods, approved contraceptive implant, long- term injectable contraception, intrauterine device) for the entire duration of the study. Exemptions from this criterion:
1. Women >2 years postmenopausal (defined as 1 year or longer since their last menstrual period) AND more than 55 years of age
2. Postmenopausal women (as defined above) and less than 55 years of age with a negative pregnancy test within 24 hours of enrolment
3. Women who are surgically sterilized at least 3 months prior to enrolment
Known history of alcohol and/or drug abuse within 5 years
Any condition that according to the investigator could interfere with the conduct of the study, such as but not limited to:
1. Subjects who are unable to communicate or to cooperate with the investigator.
2. Unable to understand the protocol requirements, instructions and study-related restrictions, the nature, scope, and possible consequences of the study (including subjects whose cooperation is doubtful due to drug abuse or alcohol dependency)
3. Unlikely to comply with the protocol requirements, instructions, and study-related restrictions (eg, uncooperative attitude, inability to return for follow-up visits, and improbability of completing the study)
4. Have any medical or surgical condition, which in the opinion of the investigator would put the subject at increased risk from participating in the study
5. Persons directly involved in the conduct of the study
Any uncontrolled or serious disease, or any medical or surgical condition, that may either interfere with participation in the clinical study, and/or put the subject at significant risk (according to investigator's [or delegate] judgment) if he/she participates in the clinical study
Any underlying known disease, or surgical, physical, or medical condition that, in the opinion of the Investigator, might interfere with the interpretation of clinical study results
Treatment with other investigational medicinal products or devices within 30 days or 5 half-lives of the screening visit, whichever is longer
Previous participation in the study
Hypersensitivity to any of the ingredients of Inclisiran

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Facility	Status	City	State	ZIP	Country	Contacts
(50852-001) Queen Mary Hospital		Hong Kong			Hong Kong
(50972-001) Hadassah Hospital Lipid Research Ein Kerem

PubMed Identifier	Type	Citation	Retractions
37850379	Derived	Raal F, Durst R, Bi R, Talloczy Z, Maheux P, Lesogor A, Kastelein JJP; ORION-5 Study Investigators. Efficacy, Safety, and Tolerability of Inclisiran in Patients With Homozygous Familial Hypercholesterolemia: Results From the ORION-5 Randomized Clinical Trial. Circulation. 2024 Jan 30;149(5):354-362. doi: 10.1161/CIRCULATIONAHA.122.063460. Epub 2023 Oct 18.
33990512

Label	URL
A Plain Language Trial Summary is available on novctrd.com	View source

ID	Title	Description
FG000	Part 1 - Inclisiran	Participants who received a dose of 300 milligram (mg) inclisiran sodium for injection administered by SC injection on Day 1 and Day 90.
FG001	Part 1 - Placebo

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Oct 8, 2020	Sep 6, 2022

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 150

Percentage Change in LDL-C levels from Baseline to Day 150

ITT Population: All participants randomized into the study comprised the intent-to-treat (ITT) population.

Posted

Least Squares Mean

95% Confidence Interval

Percentage change

Baseline, Day 150

ID	Title	Description
OG000	Part 1 - Placebo	Participants who received a dose of placebos administered by SC injection on Day 1 and Day 90.
OG001	Part 1 - Inclisiran	Participants who received a dose of 300 milligram (mg) inclisiran sodium for injection administered by SC injection on Day 1 and Day 90.

Units	Counts
Participants	OG00019 OG00137

Title

Denominators

Categories

Title	Measurements
	OG0002.39(-19.98 to 24.75) OG0010.70(-14.03 to 15.44)

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
OG000 OG001		ANCOVA		0.9047	The a priori threshold for statistical significance was <0.05 (two-sided)	Mean Difference (Final Values)	-1.68			2-Sided	95	-29.19	25.83					Superiority

Secondary

Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 150

Absolute Change in LDL-C levels (mg/dL) from baseline to Day 150

ITT Population: All participants randomized into the study comprised the intent-to-treat (ITT) population.

Posted

Least Squares Mean

95% Confidence Interval

mg/dL

Baseline, Day 150

ID	Title	Description
OG000	Part 1 - Placebo	Participants who received a dose of placebos administered by SC injection on Day 1 and Day 90.
OG001	Part 1 - Inclisiran	Participants who received a dose of 300 milligram (mg) inclisiran sodium for injection administered by SC injection on Day 1 and Day 90.

Units	Counts
Participants	OG000

Secondary

Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Subsequent Visits up to Day 180

Percentage Change in LDL-C levels from baseline to subsequent visits on Days 90, 150, and 180

ITT Population: All participants randomized into the study comprised the intent-to-treat (ITT) population.

Posted

Least Squares Mean

95% Confidence Interval

Percentage change

Baseline, Days 90, 150, 180

ID	Title	Description
OG000	Part 1 - Placebo	Participants who received a dose of placebos administered by SC injection on Day 1 and Day 90.
OG001	Part 1 - Inclisiran	Participants who received a dose of 300 milligram (mg) inclisiran sodium for injection administered by SC injection on Day 1 and Day 90.

Units	Counts
Participants	OG000

Secondary

Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Subsequent Visits up to Day 720

Percentage Change in LDL-C levels from baseline to subsequent visits up to Day 720

ITT Population (Part 2): The overall number of participants analyzed represents the intent-to-treat (ITT) population. The number analyzed per row represents participants with data at each time point.

Posted

Mean

Standard Deviation

Percentage change

Baseline, Days 270, 330, 450, 510, 630, 690, and 720

ID	Title	Description
OG000	Part 2 - Placebo-Inclisiran	Participants who received a dose of 300 mg inclisiran sodium for injection administered by SC injection on Day 270, Day 450 and Day 630. In addition, participants who were assigned to the placebo arm in Part 1 received a dose of 300 mg inclisiran administered by SC injection on Day 180 after completion of Part 1.
OG001	Part 2 - Inclisiran-Inclisiran	Participants who received a dose of 300 mg inclisiran sodium for injection administered by SC injection on Day 270, Day 450 and Day 630. In addition, participants who were assigned to the placebo arm in Part 1 received a dose of 300 mg inclisiran administered by SC injection on Day 180 after completion of Part 1.

Secondary

Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Subsequent Visits up to Day 180

Absolute change in LDL-C levels (mg/dL) from baseline to subsequent visits on Days 90, 150 and 180 based on the

ITT Population: All participants randomized into the study comprised the intent-to-treat (ITT) population.

Posted

Least Squares Mean

95% Confidence Interval

mg/dL

Baseline, Days 90, 150, 180

ID	Title	Description
OG000	Part 1 - Placebo	Participants who received a dose of placebos administered by SC injection on Day 1 and Day 90.
OG001	Part 1 - Inclisiran	Participants who received a dose of 300 milligram (mg) inclisiran sodium for injection administered by SC injection on Day 1 and Day 90.

Units	Counts
Participants	OG000

Secondary

Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Subsequent Visits up to Day 720

Absolute change in LDL-C levels from Baseline to Subsequent Visits up to Day 720

ITT Population (Part 2): The overall number of participants analyzed represents the intent-to-treat (ITT) population. The number analyzed per row represents participants with data at each time point.

Posted

Mean

Standard Deviation

mg/dL

Baseline, Days 270, 330, 450, 510, 630, 690, and 720

ID	Title	Description
OG000	Part 2 - Placebo-Inclisiran	Participants who received a dose of 300 mg inclisiran sodium for injection administered by SC injection on Day 270, Day 450 and Day 630. In addition, participants who were assigned to the placebo arm in Part 1 received a dose of 300 mg inclisiran administered by SC injection on Day 180 after completion of Part 1.
OG001	Part 2 - Inclisiran-Inclisiran	Participants who received a dose of 300 mg inclisiran sodium for injection administered by SC injection on Day 270, Day 450 and Day 630. In addition, participants who were assigned to the placebo arm in Part 1 received a dose of 300 mg inclisiran administered by SC injection on Day 180 after completion of Part 1.

Secondary

Percent Change in Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) From Baseline to Subsequent Visits up to Day 180

Percentage Change in PCSK9 from baseline to subsequent visits up to Day 180

ITT Population: All participants randomized into the study comprised the intent-to-treat (ITT) population.

Posted

Least Squares Mean

95% Confidence Interval

Percentage change

Baseline, Days 90, 150, 180

ID	Title	Description
OG000	Part 1 - Placebo	Participants who received a dose of placebos administered by SC injection on Day 1 and Day 90.
OG001	Part 1 - Inclisiran	Participants who received a dose of 300 milligram (mg) inclisiran sodium for injection administered by SC injection on Day 1 and Day 90.

Units	Counts
Participants	OG000

Secondary

Percent Change in Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) From Baseline to Subsequent Visits up to Day 720

Percentage Change in PCSK9 from baseline to subsequent visits up to Day 720

ITT Population (Part 2): The overall number of participants analyzed represents the intent-to-treat (ITT) population. The number analyzed per row represents participants with data at each time point.

Posted

Mean

Standard Deviation

Percentage Change

Baseline, Days 270, 330, 450, 510, 630, 690, and 720

ID	Title	Description
OG000	Part 2 - Placebo-Inclisiran	Participants who received a dose of 300 mg inclisiran sodium for injection administered by SC injection on Day 270, Day 450 and Day 630. In addition, participants who were assigned to the placebo arm in Part 1 received a dose of 300 mg inclisiran administered by SC injection on Day 180 after completion of Part 1.
OG001	Part 2 - Inclisiran-Inclisiran	Participants who received a dose of 300 mg inclisiran sodium for injection administered by SC injection on Day 270, Day 450 and Day 630. In addition, participants who were assigned to the placebo arm in Part 1 received a dose of 300 mg inclisiran administered by SC injection on Day 180 after completion of Part 1.

Secondary

Absolute Change in Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) From Baseline to Subsequent Visits up to Day 180

Absolute Change in PCSK9 from baseline to subsequent visits up to Day 180

ITT Population: All participants randomized into the study comprised the intent-to-treat (ITT) population.

Posted

Least Squares Mean

95% Confidence Interval

ug/L

Baseline, Days 90, 150, 180

ID	Title	Description
OG000	Part 1 - Placebo	Participants will receive a dose of placebos administered by SC injection on Day 1 and Day 90.
OG001	Part 1 - Inclisiran	Participants who received a dose of 300 milligram (mg) inclisiran sodium for injection administered by SC injection on Day 1 and Day 90.

Units	Counts
Participants	OG000

Secondary

Absolute Change in Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) From Baseline to Subsequent Visits up to Day 720

Absolute Change in PCSK9 from baseline to subsequent visits up to Day 720

ITT Population (Part 2): The overall number of participants analyzed represents the intent-to-treat (ITT) population. The number analyzed per row represents participants with data at each time point.

Posted

Mean

Standard Deviation

ug/L

Baseline, Days 270, 330, 450, 510, 630, 690, and 720

ID	Title	Description
OG000	Part 2 - Placebo-Inclisiran	Participants who received a dose of 300 mg inclisiran sodium for injection administered by SC injection on Day 270, Day 450 and Day 630. In addition, participants who were assigned to the placebo arm in Part 1 received a dose of 300 mg inclisiran administered by SC injection on Day 180 after completion of Part 1.
OG001	Part 2 - Inclisiran-Inclisiran	Participants who received a dose of 300 mg inclisiran sodium for injection administered by SC injection on Day 270, Day 450 and Day 630. In addition, participants who were assigned to the placebo arm in Part 1 received a dose of 300 mg inclisiran administered by SC injection on Day 180 after completion of Part 1.

Secondary

Percent Change in Total Cholesterol From Baseline to Subsequent Visits up to Day 180

Percentage change in total cholesterol from baseline to subsequent visits up to Day 180

ITT Population: All participants randomized into the study comprised the intent-to-treat (ITT) population.

Posted

Least Squares Mean

95% Confidence Interval

Percentage Change

Baseline, Days 90, 150 and 180

ID	Title	Description
OG000	Part 1 - Placebo	Participants who received a dose of placebos administered by SC injection on Day 1 and Day 90.
OG001	Part 1 - Inclisiran	Participants who received a dose of 300 milligram (mg) inclisiran sodium for injection administered by SC injection on Day 1 and Day 90.

Units	Counts
Participants	OG000

Secondary

Absolute Change in Total Cholesterol From Baseline to Subsequent Visits up to Day 180

Absolute Change in total cholesterol from baseline to subsequent visits up to Day 180

ITT Population: All participants randomized into the study comprised the intent-to-treat (ITT) population.

Posted

Least Squares Mean

95% Confidence Interval

mg/dL

Baseline, Days 90, 150, 180

ID	Title	Description
OG000	Part 1 - Placebo	Participants who received a dose of placebos administered by SC injection on Day 1 and Day 90.
OG001	Part 1 - Inclisiran	Participants who received a dose of 300 milligram (mg) inclisiran sodium for injection administered by SC injection on Day 1 and Day 90.

Units	Counts
Participants	OG000

Secondary

Percent Change in Total Cholesterol From Baseline to Subsequent Visits up to Day 720

Percentage change in total cholesterol from baseline to subsequent visits up to Day 720

ITT Population (Part 2): The overall number of participants analyzed represents the intent-to-treat (ITT) population. The number analyzed per row represents participants with data at each time point.

Posted

Mean

Standard Deviation

Percentage Change

Baseline, Days 270, 330, 450, 510, 630, 690, and 720

ID	Title	Description
OG000	Part 2 - Placebo-Inclisiran	Participants who received a dose of 300 mg inclisiran sodium for injection administered by SC injection on Day 270, Day 450 and Day 630. In addition, participants who were assigned to the placebo arm in Part 1 received a dose of 300 mg inclisiran administered by SC injection on Day 180 after completion of Part 1.
OG001	Part 2 - Inclisiran-Inclisiran	Participants who received a dose of 300 mg inclisiran sodium for injection administered by SC injection on Day 270, Day 450 and Day 630. In addition, participants who were assigned to the placebo arm in Part 1 received a dose of 300 mg inclisiran administered by SC injection on Day 180 after completion of Part 1.

Secondary

Absolute Change in Total Cholesterol From Baseline to Subsequent Visits up to Day 720

Absolute Change in total cholesterol from baseline to subsequent visits up to Day 720

ITT Population (Part 2): The overall number of participants analyzed represents the intent-to-treat (ITT) population. The number analyzed per row represents participants with data at each time point.

Posted

Mean

Standard Deviation

mg/dL

Baseline, Days 270, 330, 450, 510, 630, 690, and 720

ID	Title	Description
OG000	Part 2 - Placebo-Inclisiran	Participants who received a dose of 300 mg inclisiran sodium for injection administered by SC injection on Day 270, Day 450 and Day 630. In addition, participants who were assigned to the placebo arm in Part 1 received a dose of 300 mg inclisiran administered by SC injection on Day 180 after completion of Part 1.
OG001	Part 2 - Inclisiran-Inclisiran	Participants who received a dose of 300 mg inclisiran sodium for injection administered by SC injection on Day 270, Day 450 and Day 630. In addition, participants who were assigned to the placebo arm in Part 1 received a dose of 300 mg inclisiran administered by SC injection on Day 180 after completion of Part 1.

Units

Secondary

Percent Change in Apolipoprotein B (apoB) From Baseline to Subsequent Visits up to Day 180

Percentage change in Apolipoprotein B (apoB) from baseline to subsequent visits up to Day 180 demonstrated by Mixed Model Repeated Measures statisitical method.

ITT Population: All participants randomized into the study comprised the intent-to-treat (ITT) population

Posted

Least Squares Mean

95% Confidence Interval

Percentage change

Baseline, Days 90, 150, 180

ID	Title	Description
OG000	Part 1 - Placebo	Participants will receive a dose of placebos administered by SC injection on Day 1 and Day 90.
OG001	Part 1 - Inclisiran	Participants who received a dose of 300 milligram (mg) inclisiran sodium for injection administered by SC injection on Day 1 and Day 90.

Units	Counts
Participants	OG000

Secondary

Percent Change in Apolipoprotein B (apoB) From Baseline to Subsequent Visits up to Day 720

Percentage Change in Apolipoprotein B (apoB) from baseline to subsequent visits up to Day 720

ITT Population (Part 2): The overall number of participants analyzed represents the intent-to-treat (ITT) population. The number analyzed per row represents participants with data at each time point.

Posted

Mean

Standard Deviation

Percentage Change

Baseline, Days 270, 330, 450, 510, 630, 690, and 720

ID	Title	Description
OG000	Part 2 - Placebo-Inclisiran	Participants who received a dose of 300 mg inclisiran sodium for injection administered by SC injection on Day 270, Day 450 and Day 630. In addition, participants who were assigned to the placebo arm in Part 1 received a dose of 300 mg inclisiran administered by SC injection on Day 180 after completion of Part 1.
OG001	Part 2 - Inclisiran-Inclisiran	Participants who received a dose of 300 mg inclisiran sodium for injection administered by SC injection on Day 270, Day 450 and Day 630. In addition, participants who were assigned to the placebo arm in Part 1 received a dose of 300 mg inclisiran administered by SC injection on Day 180 after completion of Part 1.

Secondary

Absolute Change in Apolipoprotein B (apoB) From Baseline to Subsequent Visits up to Day 180

Absolute change in Apolipoprotein B (apoB) from baseline to subsequent visits up to Day 180

ITT Population: All participants randomized into the study comprised the intent-to-treat (ITT) population.

Posted

Least Squares Mean

95% Confidence Interval

mg/dL

Baseline, Days 90, 150, 180

ID	Title	Description
OG000	Part 1 - Placebo	Participants who received a dose of placebos administered by SC injection on Day 1 and Day 90.
OG001	Part 1 - Inclisiran	Participants who received a dose of 300 milligram (mg) inclisiran sodium for injection administered by SC injection on Day 1 and Day 90.

Units	Counts
Participants	OG000

Secondary

Absolute Change in Apolipoprotein B (Apo B) From Baseline to Subsequent Visits up to Day 720

Absolute Change in Apolipoprotein B (Apo B) from baseline to subsequent visits up to Day 720

ITT Population (Part 2): The overall number of participants analyzed represents the intent-to-treat (ITT) population. The number analyzed per row represents participants with data at each time point.

Posted

Mean

Standard Deviation

mg/dL

Baseline, Days 270, 330, 450, 510, 630, 690, and 720

ID	Title	Description
OG000	Part 2 - Placebo-Inclisiran	Participants who received a dose of 300 mg inclisiran sodium for injection administered by SC injection on Day 270, Day 450 and Day 630. In addition, participants who were assigned to the placebo arm in Part 1 received a dose of 300 mg inclisiran administered by SC injection on Day 180 after completion of Part 1.
OG001	Part 2 - Inclisiran-Inclisiran	Participants who received a dose of 300 mg inclisiran sodium for injection administered by SC injection on Day 270, Day 450 and Day 630. In addition, participants who were assigned to the placebo arm in Part 1 received a dose of 300 mg inclisiran administered by SC injection on Day 180 after completion of Part 1.

Secondary

Percent Change in Non-HDL Cholesterol (Non-HDL-C) From Baseline to Subsequent Visits up to Day 180

Percentage change in non-HDL-C levels from baseline to subsequent visits up to Day 180

ITT Population: All participants randomized into the study comprised the intent-to-treat (ITT) population.

Posted

Least Squares Mean

95% Confidence Interval

Percentage change

Baseline, Days 90, 150, 180

ID	Title	Description
OG000	Part 1 - Placebo	Participants will receive a dose of placebos administered by SC injection on Day 1 and Day 90.
OG001	Part 1 - Inclisiran	Participants who received a dose of 300 milligram (mg) inclisiran sodium for injection administered by SC injection on Day 1 and Day 90.

Units	Counts
Participants	OG000

Secondary

Percent Change in Non-HDL Cholesterol (Non-HDL-C) From Baseline to Subsequent Visits up to Day 720

Percentage Change in non-HDL-C from Baseline to subsequent visits up to Day 720

ITT Population (Part 2): The overall number of participants analyzed represents the intent-to-treat (ITT) population. The number analyzed per row represents participants with data at each time point.

Posted

Mean

Standard Deviation

Percentage Change

Baseline, Days 270, 330, 450, 510, 630, 690, and 720

ID	Title	Description
OG000	Part 2 - Placebo-Inclisiran	Participants who received a dose of 300 mg inclisiran sodium for injection administered by SC injection on Day 270, Day 450 and Day 630. In addition, participants who were assigned to the placebo arm in Part 1 received a dose of 300 mg inclisiran administered by SC injection on Day 180 after completion of Part 1.
OG001	Part 2 - Inclisiran-Inclisiran	Participants who received a dose of 300 mg inclisiran sodium for injection administered by SC injection on Day 270, Day 450 and Day 630. In addition, participants who were assigned to the placebo arm in Part 1 received a dose of 300 mg inclisiran administered by SC injection on Day 180 after completion of Part 1.

Secondary

Absolute Change in Non-HDL Cholesterol (Non-HDL-C) From Baseline to Subsequent Visits up to Day 180

Absolute change in non-HDL-C levels from Baseline to subsequent visits up to Day 180

ITT Population: All participants randomized into the study comprised the intent-to-treat (ITT) population.

Posted

Least Squares Mean

95% Confidence Interval

mg/dL

Baseline, Days 90, 150, 180

ID	Title	Description
OG000	Part 1 - Placebo	Participants will receive a dose of placebos administered by SC injection on Day 1 and Day 90.
OG001	Part 1 - Inclisiran	Participants who received a dose of 300 milligram (mg) inclisiran sodium for injection administered by SC injection on Day 1 and Day 90.

Units	Counts
Participants	OG000

Secondary

Absolute Change in Non-HDL Cholesterol (Non-HDL-C) From Baseline to Subsequent Visits up to Day 720

Absolute Change in non-HDL Cholesterol (non-HDL-C) from Baseline to Subsequent Visits up to Day 720

ITT Population (Part 2): The overall number of participants analyzed represents the intent-to-treat (ITT) population. The number analyzed per row represents participants with data at each time point.

Posted

Mean

Standard Deviation

mg/dL

Baseline, Days 270, 330, 450, 510, 630, 690, and 720

ID	Title	Description
OG000	Part 2 - Placebo-Inclisiran	Participants who received a dose of 300 mg inclisiran sodium for injection administered by SC injection on Day 270, Day 450 and Day 630. In addition, participants who were assigned to the placebo arm in Part 1 received a dose of 300 mg inclisiran administered by SC injection on Day 180 after completion of Part 1.
OG001	Part 2 - Inclisiran-Inclisiran	Participants who received a dose of 300 mg inclisiran sodium for injection administered by SC injection on Day 270, Day 450 and Day 630. In addition, participants who were assigned to the placebo arm in Part 1 received a dose of 300 mg inclisiran administered by SC injection on Day 180 after completion of Part 1.

Secondary

Individual Responsiveness of Subjects: Part 1

Individual Responsiveness of Subjects defined as the number of subjects reaching on treatment LDL-C levels of <25 mg/dL, <50 mg/dL, <70 mg/dL, and <100 mg/dL up to Day 180

ITT Population: All participants randomized into the study comprised the intent-to-treat (ITT) population. The number analyzed per row represents participants with data at each time point.

Posted

Count of Participants

Participants

Days 150, 180

ID	Title	Description
OG000	Part 1 - Placebo	Participants who received a dose of placebos administered by SC injection on Day 1 and Day 90.
OG001	Part 1 - Inclisiran	Participants who received a dose of 300 milligram (mg) inclisiran sodium for injection administered by SC injection on Day 1 and Day 90.

Units	Counts
Participants	OG000

Secondary

Individual Responsiveness of Subjects: Part 2

Individual Responsiveness of Subjects defined as the number of subjects reaching on treatment LDL-C levels of <25 mg/dL, <50 mg/dL, <70 mg/dL, and <100 mg/dL up to Day 720

ITT Population (Part 2): The overall number of participants analyzed represents the intent-to-treat (ITT) population. The number analyzed per row represents participants with data at each time point.

Posted

Count of Participants

Participants

Days 330, 510, 690 and 720

ID	Title	Description
OG000	Part 2 - Placebo-Inclisiran	Participants who received a dose of 300 mg inclisiran sodium for injection administered by SC injection on Day 270, Day 450 and Day 630. In addition, participants who were assigned to the placebo arm in Part 1 received a dose of 300 mg inclisiran administered by SC injection on Day 180 after completion of Part 1.
OG001	Part 2 - Inclisiran-Inclisiran	Participants who received a dose of 300 mg inclisiran sodium for injection administered by SC injection on Day 270, Day 450 and Day 630. In addition, participants who were assigned to the placebo arm in Part 1 received a dose of 300 mg inclisiran administered by SC injection on Day 180 after completion of Part 1.

Secondary

Proportional Responsiveness: Part 1

Number of participants in each group who attain global lipid targets for their indication

ITT Population: All participants randomized into the study comprised the intent-to-treat (ITT) population. The number analyzed per row represents participants with data at each time point.

Posted

Count of Participants

Participants

Days 150, 180

ID	Title	Description
OG000	Part 1 - Placebo	Participants who received a dose of placebos administered by SC injection on Day 1 and Day 90.
OG001	Part 1 - Inclisiran	Participants who received a dose of 300 milligram (mg) inclisiran sodium for injection administered by SC injection on Day 1 and Day 90.

Units	Counts
Participants	OG000

Secondary

Proportional Responsiveness of Subjects: Part 2

Number of participants in each group who attain global lipid targets for their indication

ITT Population (Part 2): The overall number of participants analyzed represents the intent-to-treat (ITT) population. The number analyzed per row represents participants with data at each time point.

Posted

Count of Participants

Participants

Days 330, 510, 690 and 720

ID	Title	Description
OG000	Part 2 - Placebo-Inclisiran	Participants who received a dose of 300 mg inclisiran sodium for injection administered by SC injection on Day 270, Day 450 and Day 630. In addition, participants who were assigned to the placebo arm in Part 1 received a dose of 300 mg inclisiran administered by SC injection on Day 180 after completion of Part 1.
OG001	Part 2 - Inclisiran-Inclisiran	Participants who received a dose of 300 mg inclisiran sodium for injection administered by SC injection on Day 270, Day 450 and Day 630. In addition, participants who were assigned to the placebo arm in Part 1 received a dose of 300 mg inclisiran administered by SC injection on Day 180 after completion of Part 1.

Units	Counts

Secondary

LDL-C Reduction ≥20% or ≥30% From Baseline: Part 1

Proportion of subjects in each group with ≥20% or ≥30% LDL-C reduction from Baseline in Part 1 (Days 90, 150, 180)

ITT Population: All participants randomized into the study comprised the intent-to-treat (ITT) population. The number analyzed per row represents participants with data at each time point.

Posted

Count of Participants

Participants

Baseline, Days 90, 150, 180

ID	Title	Description
OG000	Part 1 - Inclisiran	Participants who received a dose of 300 milligram (mg) inclisiran sodium for injection administered by SC injection on Day 1 and Day 90.
OG001	Part 1 - Placebo	Participants who received a dose of placebos administered by SC injection on Day 1 and Day 90.

Units	Counts
Participants	OG000

Secondary

LDL-C Reduction ≥20% or ≥30% From Baseline: Part 2

Proportion of subjects in each group with ≥20% or ≥30% LDL-C reduction from Baseline in Part 2 (Days 330, 510, 690, and 720)

ITT Population: All participants randomized into the study comprised the intent-to-treat (ITT) population. The number analyzed per row represents participants with data at each time point.

Posted

Count of Participants

Participants

Baseline, Days 330, 510, 690, and 720

ID	Title	Description
OG000	Part 2 - Placebo-Inclisiran	Participants who received a dose of 300 mg inclisiran sodium for injection administered by SC injection on Day 270, Day 450 and Day 630. In addition, participants who were assigned to the placebo arm in Part 1 received a dose of 300 mg inclisiran administered by SC injection on Day 180 after completion of Part 1.
OG001	Part 2 - Inclisiran-Inclisiran	Participants who received a dose of 300 mg inclisiran sodium for injection administered by SC injection on Day 270, Day 450 and Day 630. In addition, participants who were assigned to the placebo arm in Part 1 received a dose of 300 mg inclisiran administered by SC injection on Day 180 after completion of Part 1.

Units

Secondary

Percent Change in High-Density Lipoprotein Cholesterol Levels (HDL-C) From Baseline to Subsequent Visits up to Day 180

Percentage Change in HDL-C levels (mg/dL) from baseline to subsequent visits on Day 90, 150, and 180

ITT Population: All participants randomized into the study comprised the intent-to-treat (ITT) population.

Posted

Least Squares Mean

95% Confidence Interval

Percentage change

Baseline, Days 90, 150, 180

ID	Title	Description
OG000	Part 1 - Placebo	Participants who received a dose of placebos administered by SC injection on Day 1 and Day 90.
OG001	Part 1 - Inclisiran	Participants who received a dose of 300 milligram (mg) inclisiran sodium for injection administered by SC injection on Day 1 and Day 90.

Units	Counts
Participants	OG000

Secondary

Percent Change in High-Density Lipoprotein Cholesterol Levels (HDL-C) From Baseline to Subsequent Visits up to Day 720

Percentage change in LDL-C levels from Baseline to Subsequent Visits up to Day 720

ITT Population (Part 2): The overall number of participants analyzed represents the intent-to-treat (ITT) population. The number analyzed per row represents participants with data at each time point.

Posted

Mean

Standard Deviation

Percentage change

Baseline, Days 330, 450, 510, 630, 690, and 720

ID	Title	Description
OG000	Part 2 - Placebo-Inclisiran	Participants who received a dose of 300 mg inclisiran sodium for injection administered by SC injection on Day 270, Day 450 and Day 630. In addition, participants who were assigned to the placebo arm in Part 1 received a dose of 300 mg inclisiran administered by SC injection on Day 180 after completion of Part 1.
OG001	Part 2 - Inclisiran-Inclisiran	Participants who received a dose of 300 mg inclisiran sodium for injection administered by SC injection on Day 270, Day 450 and Day 630. In addition, participants who were assigned to the placebo arm in Part 1 received a dose of 300 mg inclisiran administered by SC injection on Day 180 after completion of Part 1.

Secondary

Absolute Change in High-Density Lipoprotein Cholesterol Levels (HDL-C) From Baseline to Subsequent Visits up to Day 180

Absolute Change in HDL-C levels (mg/dL) from baseline to subsequent visits on Day 90, 150, and 180

ITT Population: All participants randomized into the study comprised the intent-to-treat (ITT) population.

Posted

Least Squares Mean

95% Confidence Interval

mg/dL

Baseline, Days 90, 150, 180

ID	Title	Description
OG000	Part 1 - Placebo	Participants who received a dose of placebos administered by SC injection on Day 1 and Day 90.
OG001	Part 1 - Inclisiran	Participants who received a dose of 300 milligram (mg) inclisiran sodium for injection administered by SC injection on Day 1 and Day 90.

Units	Counts
Participants	OG000

Secondary

Absolute Change in High-Density Lipoprotein Cholesterol Levels (HDL-C) From Baseline to Subsequent Visits up to Day 720

Absolute change in LDL-C levels from Baseline to Subsequent Visits up to Day 720

ITT Population (Part 2): The overall number of participants analyzed represents the intent-to-treat (ITT) population. The number analyzed per row represents participants with data at each time point.

Posted

Mean

Standard Deviation

mg/dL

Baseline, Days 330, 450, 510, 630, 690, and 720

ID	Title	Description
OG000	Part 2 - Placebo-Inclisiran	Participants who received a dose of 300 mg inclisiran sodium for injection administered by SC injection on Day 270, Day 450 and Day 630. In addition, participants who were assigned to the placebo arm in Part 1 received a dose of 300 mg inclisiran administered by SC injection on Day 180 after completion of Part 1.
OG001	Part 2 - Inclisiran-Inclisiran	Participants who received a dose of 300 mg inclisiran sodium for injection administered by SC injection on Day 270, Day 450 and Day 630. In addition, participants who were assigned to the placebo arm in Part 1 received a dose of 300 mg inclisiran administered by SC injection on Day 180 after completion of Part 1.

Secondary

Absolute Change in Very-Low-Density Lipoprotein Cholesterol (VLDL-C) From Baseline to Subsequent Visits up to Day 180

Absolute Change in VLDL-C levels from baseline to subsequent visits on Days 90, 150, and 180

ITT Population: All participants randomized into the study comprised the intent-to-treat (ITT) population.

Posted

Least Squares Mean

95% Confidence Interval

mg/dL

Baseline, Days 90, 150, 180

ID	Title	Description
OG000	Part 1 - Placebo	Participants who received a dose of placebos administered by SC injection on Day 1 and Day 90.
OG001	Part 1 - Inclisiran	Participants who received a dose of 300 milligram (mg) inclisiran sodium for injection administered by SC injection on Day 1 and Day 90.

Units	Counts
Participants	OG000

Secondary

Absolute Change in Very-Low-Density-Lipoprotein Cholesterol Levels (VLDL-C) From Baseline to Subsequent Visits up to Day 720

Absolute change in VLDL-C levels from Baseline to Subsequent Visits up to Day 720

ITT Population (Part 2): The overall number of participants analyzed represents the intent-to-treat (ITT) population. The number analyzed per row represents participants with data at each time point.

Posted

Mean

Standard Deviation

mg/dL

Baseline, Days 330, 450, 510, 630, 690, and 720

ID	Title	Description
OG000	Part 2 - Placebo-Inclisiran	Participants who received a dose of 300 mg inclisiran sodium for injection administered by SC injection on Day 270, Day 450 and Day 630. In addition, participants who were assigned to the placebo arm in Part 1 received a dose of 300 mg inclisiran administered by SC injection on Day 180 after completion of Part 1.
OG001	Part 2 - Inclisiran-Inclisiran	Participants who received a dose of 300 mg inclisiran sodium for injection administered by SC injection on Day 270, Day 450 and Day 630. In addition, participants who were assigned to the placebo arm in Part 1 received a dose of 300 mg inclisiran administered by SC injection on Day 180 after completion of Part 1.

Secondary

Percent Change in Very-Low-Density Lipoprotein Cholesterol (VLDL-C) From Baseline to Subsequent Visits up to Day 180

Percentage Change in VLDL-C levels (mg/dL) from baseline to subsequent visits on Days 90, 150, and 180

ITT Population: All participants randomized into the study comprised the intent-to-treat (ITT) population.

Posted

Least Squares Mean

95% Confidence Interval

Percentage change

Baseline, Days 90, 150, 180

ID	Title	Description
OG000	Part 1 - Placebo	Participants who received a dose of placebos administered by SC injection on Day 1 and Day 90.
OG001	Part 1 - Inclisiran	Participants who received a dose of 300 milligram (mg) inclisiran sodium for injection administered by SC injection on Day 1 and Day 90.

Units	Counts
Participants	OG000

Secondary

Percent Change in Very-Low-Density-Lipoprotein Cholesterol Levels (VLDL-C) From Baseline to Subsequent Visits up to Day 720

Percentage change in VLDL-C levels from Baseline to Subsequent Visits up to Day 720

ITT Population (Part 2): The overall number of participants analyzed represents the intent-to-treat (ITT) population. The number analyzed per row represents participants with data at each time point.

Posted

Mean

Standard Deviation

Percentage Change

Baseline, Days 330, 450, 510, 630, 690, and 720

ID	Title	Description
OG000	Part 2 - Placebo-Inclisiran	Participants who received a dose of 300 mg inclisiran sodium for injection administered by SC injection on Day 270, Day 450 and Day 630. In addition, participants who were assigned to the placebo arm in Part 1 received a dose of 300 mg inclisiran administered by SC injection on Day 180 after completion of Part 1.
OG001	Part 2 - Inclisiran-Inclisiran	Participants who received a dose of 300 mg inclisiran sodium for injection administered by SC injection on Day 270, Day 450 and Day 630. In addition, participants who were assigned to the placebo arm in Part 1 received a dose of 300 mg inclisiran administered by SC injection on Day 180 after completion of Part 1.

Secondary

Absolute Change in Apolipoprotein A-1 (Apo-A1) mg/dL From Baseline to Subsequent Visits up to Day 180

Absolute Change in Apolipoprotein A-1 (Apo-A1) from baseline to subsequent visits on Days 90, 150, and 180

ITT Population: All participants randomized into the study comprised the intent-to-treat (ITT) population.

Posted

Least Squares Mean

95% Confidence Interval

mg/dL

Baseline, Days 90, 150, 180

ID	Title	Description
OG000	Part 1 - Placebo	Participants who received a dose of placebos administered by SC injection on Day 1 and Day 90.
OG001	Part 1 - Inclisiran	Participants who received a dose of 300 milligram (mg) inclisiran sodium for injection administered by SC injection on Day 1 and Day 90.

Units	Counts
Participants	OG000

Secondary

Absolute Change Apolipoprotein A-1 (Apo-A1) From Baseline to Subsequent Visits up to Day 720

Absolute change in Apolipoprotein A-1 (Apo-A1) from Baseline to Subsequent Visits up to Day 720

ITT Population (Part 2): The overall number of participants analyzed represents the intent-to-treat (ITT) population. The number analyzed per row represents participants with data at each time point.

Posted

Mean

Standard Deviation

mg/dL

Baseline, Days 330, 450, 510, 630, 690, and 720

ID	Title	Description
OG000	Part 2 - Placebo-Inclisiran	Participants who received a dose of 300 mg inclisiran sodium for injection administered by SC injection on Day 270, Day 450 and Day 630. In addition, participants who were assigned to the placebo arm in Part 1 received a dose of 300 mg inclisiran administered by SC injection on Day 180 after completion of Part 1.
OG001	Part 2 - Inclisiran-Inclisiran	Participants who received a dose of 300 mg inclisiran sodium for injection administered by SC injection on Day 270, Day 450 and Day 630. In addition, participants who were assigned to the placebo arm in Part 1 received a dose of 300 mg inclisiran administered by SC injection on Day 180 after completion of Part 1.

Secondary

Percent Change in Apolipoprotein A-1 (Apo-A1) From Baseline to Subsequent Visits up to Day 180

Percentage Change in Apolipoprotein A-1 (Apo-A1) from baseline to subsequent visits on Day 90, 150, and 180

ITT Population: All participants randomized into the study comprised the intent-to-treat (ITT) population.

Posted

Least Squares Mean

95% Confidence Interval

Percentage change

Baseline, Days 90, 150, 180

ID	Title	Description
OG000	Part 1 - Placebo	Participants who received a dose of placebos administered by SC injection on Day 1 and Day 90.
OG001	Part 1 - Inclisiran	Participants who received a dose of 300 milligram (mg) inclisiran sodium for injection administered by SC injection on Day 1 and Day 90.

Units	Counts
Participants	OG000

Secondary

Percent Change Apolipoprotein A-1 (Apo-A1) From Baseline to Subsequent Visits up to Day 720

Percentage change in Apolipoprotein A-1 (Apo-A1) from Baseline to Subsequent Visits up to Day 720

ITT Population (Part 2): The overall number of participants analyzed represents the intent-to-treat (ITT) population. The number analyzed per row represents participants with data at each time point.

Posted

Mean

Standard Deviation

Percentage change

Baseline, Days 330, 450, 510, 630, 690, and 720

ID	Title	Description
OG000	Part 2 - Placebo-Inclisiran	Participants who received a dose of 300 mg inclisiran sodium for injection administered by SC injection on Day 270, Day 450 and Day 630. In addition, participants who were assigned to the placebo arm in Part 1 received a dose of 300 mg inclisiran administered by SC injection on Day 180 after completion of Part 1.
OG001	Part 2 - Inclisiran-Inclisiran	Participants who received a dose of 300 mg inclisiran sodium for injection administered by SC injection on Day 270, Day 450 and Day 630. In addition, participants who were assigned to the placebo arm in Part 1 received a dose of 300 mg inclisiran administered by SC injection on Day 180 after completion of Part 1.

Secondary

Percent Change in Lipoprotein(a) [Lp(a)] From Baseline to Subsequent Visits up to Day 180

Percentage Change in Lp(a) from Baseline to Subsequent Visits up to Day 180

ITT Population: All participants randomized into the study comprised the intent-to-treat (ITT) population.

Posted

Least Squares Mean

95% Confidence Interval

Percentage change

Baseline, Days 90, 150, 180

ID	Title	Description
OG000	Part 1 - Placebo	Participants who received a dose of placebos administered by SC injection on Day 1 and Day 90.
OG001	Part 1 - Inclisiran	Participants who received a dose of 300 milligram (mg) inclisiran sodium for injection administered by SC injection on Day 1 and Day 90.

Units	Counts
Participants	OG000

Secondary

Percent Change in Lipoprotein(a) [Lp(a)] From Baseline to Subsequent Visits up to Day 720

Percentage change in Lp(a) from Baseline to Subsequent Visits up to Day 720

ITT Population (Part 2): The overall number of participants analyzed represents the intent-to-treat (ITT) population. The number analyzed per row represents participants with data at each time point.

Posted

Mean

Standard Deviation

Percentage change

Baseline, Days 330, 450, 510, 630, 690, and 720

ID	Title	Description
OG000	Part 2 - Placebo-Inclisiran	Participants who received a dose of 300 mg inclisiran sodium for injection administered by SC injection on Day 270, Day 450 and Day 630. In addition, participants who were assigned to the placebo arm in Part 1 received a dose of 300 mg inclisiran administered by SC injection on Day 180 after completion of Part 1.
OG001	Part 2 - Inclisiran-Inclisiran	Participants who received a dose of 300 mg inclisiran sodium for injection administered by SC injection on Day 270, Day 450 and Day 630. In addition, participants who were assigned to the placebo arm in Part 1 received a dose of 300 mg inclisiran administered by SC injection on Day 180 after completion of Part 1.

Units

Secondary

Absolute Change in Lipoprotein(a) [Lp(a)] From Baseline to Subsequent Visits up to Day 180

Absolute Change in Lp(a) from baseline to subsequent visits up to Day 180

ITT Population: All participants randomized into the study comprised the intent-to-treat (ITT) population.

Posted

Least Squares Mean

95% Confidence Interval

nmol/L

Baseline, Days 90, 150, 180

ID	Title	Description
OG000	Part 1 - Placebo	Participants who received a dose of placebos administered by SC injection on Day 1 and Day 90.
OG001	Part 1 - Inclisiran	Participants who received a dose of 300 milligram (mg) inclisiran sodium for injection administered by SC injection on Day 1 and Day 90.

Units	Counts
Participants	OG000

Secondary

Absolute Change in Lipoprotein(a) [Lp(a)] From Baseline to Subsequent Visits up to Day 720

Absolute change in Lp(a) from Baseline to Subsequent Visits up to Day 720

ITT Population (Part 2): The overall number of participants analyzed represents the intent-to-treat (ITT) population. The number analyzed per row represents participants with data at each time point.

Posted

Mean

Standard Deviation

nmol/L

Baseline, Days 330, 450, 510, 630, 690, and 720

ID	Title	Description
OG000	Part 2 - Placebo-Inclisiran	Participants who received a dose of 300 mg inclisiran sodium for injection administered by SC injection on Day 270, Day 450 and Day 630. In addition, participants who were assigned to the placebo arm in Part 1 received a dose of 300 mg inclisiran administered by SC injection on Day 180 after completion of Part 1.
OG001	Part 2 - Inclisiran-Inclisiran	Participants who received a dose of 300 mg inclisiran sodium for injection administered by SC injection on Day 270, Day 450 and Day 630. In addition, participants who were assigned to the placebo arm in Part 1 received a dose of 300 mg inclisiran administered by SC injection on Day 180 after completion of Part 1.

Units

Secondary

Percent Change in High-Sensitivity C-Reactive Protein (hsCRP) From Baseline to Subsequent Visits up to Day 180: Part 1

Percent change in hsCRP from Baseline to subsequent visits up to Day 180

ITT Population (Part 1): The overall number of participants analyzed represents the intent-to-treat (ITT) population. The number analyzed per row represents participants with data at each time point.

Posted

Mean

Standard Deviation

Percentage Change

Baseline, Days 90, 150, 180

ID	Title	Description
OG000	Part 1 - Inclisiran	Participants who received a dose of 300 milligram (mg) inclisiran sodium for injection administered by SC injection on Day 1 and Day 90.
OG001	Part 1 - Placebo	Participants who received a dose of placebos administered by SC injection on Day 1 and Day 90.

Units	Counts
Participants	OG000

Secondary

Percent Change in High-Sensitivity C-Reactive Protein (hsCRP) From Baseline to Subsequent Visits up to Day 720: Part 2

Percentage change in hsCRP from baseline to subsequent visits up to Day 720

ITT Population (Part 2): The overall number of participants analyzed represents the intent-to-treat (ITT) population. The number analyzed per row represents participants with data at each time point.

Posted

Mean

Standard Deviation

Percentage Change

Baseline, Days 330, 510 ,690, 720

ID	Title	Description
OG000	Part 2 - Placebo-Inclisiran	Participants who received a dose of 300 mg inclisiran sodium for injection administered by SC injection on Day 270, Day 450 and Day 630. In addition, participants who were assigned to the placebo arm in Part 1 received a dose of 300 mg inclisiran administered by SC injection on Day 180 after completion of Part 1.
OG001	Part 2 - Inclisiran-Inclisiran	Participants who received a dose of 300 mg inclisiran sodium for injection administered by SC injection on Day 270, Day 450 and Day 630. In addition, participants who were assigned to the placebo arm in Part 1 received a dose of 300 mg inclisiran administered by SC injection on Day 180 after completion of Part 1.

Secondary

Absolute Change in High-Sensitivity C-Reactive Protein (hsCRP) From Baseline to Subsequent Visits up to Day 180: Part 1

Absolute Change in High-Sensitivity C-Reactive Protein (hsCRP) from Baseline to subsequent visits up to Day 180

ITT Population (Part 1): The overall number of participants analyzed represents the intent-to-treat (ITT) population. The number analyzed per row represents participants with data at each time point.

Posted

Mean

Standard Deviation

mg/L

Baseline, Days 90, 150, 180

ID	Title	Description
OG000	Part 1 - Placebo	Participants who received a dose of placebos administered by SC injection on Day 1 and Day 90.
OG001	Part 1 - Inclisiran	Participants who received a dose of 300 milligram (mg) inclisiran sodium for injection administered by SC injection on Day 1 and Day 90.

Units	Counts
Participants	OG000

Secondary

Absolute Change in High-Sensitivity C-Reactive Protein (hsCRP) From Baseline to Subsequent Visits up to Day 720: Part 2

Absolute Change in High-Sensitivity C-Reactive Protein (hsCRP) from baseline to subsequent visits up to Day 720

ITT Population (Part 2): The overall number of participants analyzed represents the intent-to-treat (ITT) population. The number analyzed per row represents participants with data at each time point.

Posted

Mean

Standard Deviation

mg/L

Baseline, Days 330, 510, 690, 720

ID	Title	Description
OG000	Part 2 - Placebo-Inclisiran	Participants who received a dose of 300 mg inclisiran sodium for injection administered by SC injection on Day 270, Day 450 and Day 630. In addition, participants who were assigned to the placebo arm in Part 1 received a dose of 300 mg inclisiran administered by SC injection on Day 180 after completion of Part 1.
OG001	Part 2 - Inclisiran-Inclisiran	Participants who received a dose of 300 mg inclisiran sodium for injection administered by SC injection on Day 270, Day 450 and Day 630. In addition, participants who were assigned to the placebo arm in Part 1 received a dose of 300 mg inclisiran administered by SC injection on Day 180 after completion of Part 1.

Secondary

Percent Change in Apo-B From Baseline to Day 150

Percentage change in Apo-B from baseline to Day 150 as demonstrated using the ANCOVA statisitical model.

ITT Population: All participants randomized into the study comprised the intent-to-treat (ITT) population.

Posted

Least Squares Mean

95% Confidence Interval

Percentage change

Baseline, Day 150

ID	Title	Description
OG000	Part 1 - Placebo	Participants who received a dose of placebos administered by SC injection on Day 1 and Day 90.
OG001	Part 1 - Inclisiran	Participants who received a dose of 300 milligram (mg) inclisiran sodium for injection administered by SC injection on Day 1 and Day 90.

Units	Counts
Participants	OG000

Secondary

Percent Change in Non-HDL-C From Baseline to Day 150

Percentage Change in non-HDL-C from baseline to Day 150 as demonstrated using the ANCOVA statisitical model.

ITT Population: All participants randomized into the study comprised the intent-to-treat (ITT) population.

Posted

Least Squares Mean

95% Confidence Interval

Percentage Change

Baseline, Day 150

ID	Title	Description
OG000	Part 1 - Placebo	Participants who received a dose of placebos administered by SC injection on Day 1 and Day 90.
OG001	Part 1 - Inclisiran	Participants who received a dose of 300 milligram (mg) inclisiran sodium for injection administered by SC injection on Day 1 and Day 90.

Units	Counts
Participants	OG000

Secondary

Percent Change in Total Cholesterol From Baseline to Day 150

Percentage change in total cholesterol from baseline to Day 150 as demonstrated using the ANCOVA statisitical model.

ITT Population: All participants randomized into the study comprised the intent-to-treat (ITT) population.

Posted

Least Squares Mean

95% Confidence Interval

Percentage Change

Baseline, Day 150

ID	Title	Description
OG000	Part 1 - Placebo	Participants who received a dose of placebos administered by SC injection on Day 1 and Day 90.
OG001	Part 1 - Inclisiran	Participants who received a dose of 300 milligram (mg) inclisiran sodium for injection administered by SC injection on Day 1 and Day 90.

Units	Counts
Participants	OG000

Secondary

Proportion of Subjects With ≥30% LDL-C Reduction of From Baseline at Day 150

Number of participants in each group with ≥30% LDL-C reduction from baseline at Day 150 using the Regression Logistic Statistical Model

ITT Population: All participants randomized into the study comprised the intent-to-treat (ITT) population.

Posted

Count of Participants

Participants

Baseline, Day 150

ID	Title	Description
OG000	Part 1 - Placebo	Participants who received a dose of placebos administered by SC injection on Day 1 and Day 90.
OG001	Part 1 - Inclisiran	Participants who received a dose of 300 milligram (mg) inclisiran sodium for injection administered by SC injection on Day 1 and Day 90.

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Angina unstable	Cardiac disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0010 affected19 at risk EG0020 affected56 at risk EG0031 affected53 at risk
Aortic valve stenosis	Cardiac disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0010 affected19 at risk EG0020 affected56 at risk EG003
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0010 affected19 at risk EG0020 affected56 at risk EG003
Cardiac failure	Cardiac disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0010 affected19 at risk EG0020 affected56 at risk EG003
Coronary artery disease	Cardiac disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0010 affected19 at risk EG0020 affected56 at risk EG003
Multiple organ dysfunction syndrome	General disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0010 affected19 at risk EG0020 affected56 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected37 at risk EG0010 affected19 at risk EG0021 affected56 at risk EG003
Sudden cardiac death	General disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0010 affected19 at risk EG0020 affected56 at risk EG003
Cholecystitis	Hepatobiliary disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0010 affected19 at risk EG0020 affected56 at risk EG003
Endocarditis	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0001 affected37 at risk EG0010 affected19 at risk EG0021 affected56 at risk EG003
Pelvic inflammatory disease	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0010 affected19 at risk EG0020 affected56 at risk EG003
Pneumonia	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0010 affected19 at risk EG0020 affected56 at risk EG003
Pneumonia bacterial	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0010 affected19 at risk EG0020 affected56 at risk EG003
Pneumonia viral	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0010 affected19 at risk EG0020 affected56 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0010 affected19 at risk EG0020 affected56 at risk EG003
Overdose	Injury, poisoning and procedural complications	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0010 affected19 at risk EG0020 affected56 at risk EG003
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (22.0)	Systematic Assessment	EG0001 affected37 at risk EG0010 affected19 at risk EG0021 affected56 at risk EG003
Leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0010 affected19 at risk EG0020 affected56 at risk EG003
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0010 affected19 at risk EG0020 affected56 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0010 affected19 at risk EG0020 affected56 at risk EG003
Ovarian cyst ruptured	Reproductive system and breast disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0010 affected19 at risk EG0020 affected56 at risk EG003
Chronic respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0010 affected19 at risk EG0020 affected56 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0010 affected19 at risk EG0020 affected56 at risk EG003
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0010 affected19 at risk EG0020 affected56 at risk EG003
Family stress	Social circumstances	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0011 affected19 at risk EG0021 affected56 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected37 at risk EG0011 affected19 at risk EG0022 affected56 at risk EG0031 affected53 at risk
Angina pectoris	Cardiac disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected37 at risk EG0010 affected19 at risk EG0021 affected56 at risk EG003
Aortic valve incompetence	Cardiac disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0010 affected19 at risk EG0020 affected56 at risk EG003
Aortic valve stenosis	Cardiac disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0010 affected19 at risk EG0020 affected56 at risk EG003
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0010 affected19 at risk EG0020 affected56 at risk EG003
Cardiac disorder	Cardiac disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0010 affected19 at risk EG0020 affected56 at risk EG003
Goitre	Endocrine disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0010 affected19 at risk EG0020 affected56 at risk EG003
Scleral haemorrhage	Eye disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected37 at risk EG0010 affected19 at risk EG0021 affected56 at risk EG003
Abdominal discomfort	Gastrointestinal disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0010 affected19 at risk EG0020 affected56 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected37 at risk EG0010 affected19 at risk EG0021 affected56 at risk EG003
Chronic gastritis	Gastrointestinal disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0010 affected19 at risk EG0020 affected56 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA (22.0)	Systematic Assessment	EG0002 affected37 at risk EG0010 affected19 at risk EG0022 affected56 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0010 affected19 at risk EG0020 affected56 at risk EG003
Gastrooesophageal sphincter insufficiency	Gastrointestinal disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0010 affected19 at risk EG0020 affected56 at risk EG003
Hiatus hernia	Gastrointestinal disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0010 affected19 at risk EG0020 affected56 at risk EG003
Mouth ulceration	Gastrointestinal disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected37 at risk EG0010 affected19 at risk EG0021 affected56 at risk EG003
Oesophagitis	Gastrointestinal disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0010 affected19 at risk EG0020 affected56 at risk EG003
Toothache	Gastrointestinal disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0010 affected19 at risk EG0020 affected56 at risk EG003
Asthenia	General disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0011 affected19 at risk EG0021 affected56 at risk EG003
Chest discomfort	General disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0010 affected19 at risk EG0020 affected56 at risk EG003
Inflammation	General disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0010 affected19 at risk EG0020 affected56 at risk EG003
Injection site erythema	General disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0010 affected19 at risk EG0020 affected56 at risk EG003
Pyrexia	General disorders	MedDRA (22.0)	Systematic Assessment	EG0002 affected37 at risk EG0010 affected19 at risk EG0022 affected56 at risk EG003
Biliary dyskinesia	Hepatobiliary disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0010 affected19 at risk EG0020 affected56 at risk EG003
Allergy to arthropod bite	Immune system disorders	MedDRA (22.0)	Systematic Assessment	EG0001 affected37 at risk EG0010 affected19 at risk EG0021 affected56 at risk EG003
Bacterial vulvovaginitis	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0010 affected19 at risk EG0020 affected56 at risk EG003
Corona virus infection	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0010 affected19 at risk EG0020 affected56 at risk EG003
Genitourinary chlamydia infection	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0010 affected19 at risk EG0020 affected56 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0001 affected37 at risk EG0010 affected19 at risk EG0021 affected56 at risk EG003
Pharyngitis	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0011 affected19 at risk EG0021 affected56 at risk EG003
Pneumonia	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0010 affected19 at risk EG0020 affected56 at risk EG003
Respiratory tract infection viral	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0002 affected37 at risk EG0012 affected19 at risk EG0024 affected56 at risk EG003
Rhinitis	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0010 affected19 at risk EG0020 affected56 at risk EG003
Sinusitis	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0010 affected19 at risk EG0020 affected56 at risk EG003
Tonsillitis	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0001 affected37 at risk EG0011 affected19 at risk EG0022 affected56 at risk EG003
Tracheitis	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0010 affected19 at risk EG0020 affected56 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0001 affected37 at risk EG0010 affected19 at risk EG0021 affected56 at risk EG003
Ureaplasma infection	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0010 affected19 at risk EG0020 affected56 at risk EG003
Viral upper respiratory tract infection	Infections and infestations	MedDRA (22.0)	Systematic Assessment	EG0001 affected37 at risk EG0010 affected19 at risk EG0021 affected56 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0010 affected19 at risk EG0020 affected56 at risk EG003
Activated partial thromboplastin time prolonged	Investigations	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0010 affected19 at risk EG0020 affected56 at risk EG003
Alanine aminotransferase abnormal	Investigations	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0010 affected19 at risk EG0020 affected56 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0011 affected19 at risk EG0021 affected56 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0011 affected19 at risk EG0021 affected56 at risk EG003
Blood 25-hydroxycholecalciferol decreased	Investigations	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0010 affected19 at risk EG0020 affected56 at risk EG003
Blood pressure increased	Investigations	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0010 affected19 at risk EG0020 affected56 at risk EG003
Glycosylated haemoglobin increased	Investigations	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0010 affected19 at risk EG0020 affected56 at risk EG003
International normalised ratio increased	Investigations	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0010 affected19 at risk EG0020 affected56 at risk EG003
Liver function test abnormal	Investigations	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0010 affected19 at risk EG0020 affected56 at risk EG003
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0010 affected19 at risk EG0020 affected56 at risk EG003
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0010 affected19 at risk EG0020 affected56 at risk EG003
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0010 affected19 at risk EG0020 affected56 at risk EG003
Leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0010 affected19 at risk EG0020 affected56 at risk EG003
Anosmia	Nervous system disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0010 affected19 at risk EG0020 affected56 at risk EG003
Carotid arteriosclerosis	Nervous system disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0010 affected19 at risk EG0020 affected56 at risk EG003
Dizziness	Nervous system disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0011 affected19 at risk EG0021 affected56 at risk EG003
Headache	Nervous system disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0010 affected19 at risk EG0020 affected56 at risk EG003
Neuralgia	Nervous system disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0010 affected19 at risk EG0020 affected56 at risk EG003
Neuropathy peripheral	Nervous system disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0010 affected19 at risk EG0020 affected56 at risk EG003
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	MedDRA (22.0)	Systematic Assessment	EG0001 affected37 at risk EG0010 affected19 at risk EG0021 affected56 at risk EG003
Depression	Psychiatric disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0011 affected19 at risk EG0021 affected56 at risk EG003
Haemorrhage urinary tract	Renal and urinary disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0010 affected19 at risk EG0020 affected56 at risk EG003
Renal impairment	Renal and urinary disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0010 affected19 at risk EG0020 affected56 at risk EG003
Menstrual disorder	Reproductive system and breast disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0010 affected19 at risk EG0020 affected56 at risk EG003
Ovarian cyst	Reproductive system and breast disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0010 affected19 at risk EG0020 affected56 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0010 affected19 at risk EG0020 affected56 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0010 affected19 at risk EG0020 affected56 at risk EG003
Pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0010 affected19 at risk EG0020 affected56 at risk EG003
Respiratory disorder	Respiratory, thoracic and mediastinal disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0010 affected19 at risk EG0020 affected56 at risk EG003
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0011 affected19 at risk EG0021 affected56 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0010 affected19 at risk EG0020 affected56 at risk EG003
Cardiac valve prosthesis user	Social circumstances	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0010 affected19 at risk EG0020 affected56 at risk EG003
Aortic arteriosclerosis	Vascular disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0010 affected19 at risk EG0020 affected56 at risk EG003
Hypertension	Vascular disorders	MedDRA (22.0)	Systematic Assessment	EG0000 affected37 at risk EG0010 affected19 at risk EG0020 affected56 at risk EG003

ID	Term
D006938	Hyperlipoproteinemia Type II
D008052	Lipid Metabolism, Inborn Errors
D008661	Metabolism, Inborn Errors
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D006951	Hyperlipoproteinemias
D006949	Hyperlipidemias
D050171	Dyslipidemias
D052439	Lipid Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

ID	Term
D007267	Injections
C585830	ALN-PCS

ID	Term
D004333	Drug Administration Routes
D004358	Drug Therapy
D013812	Therapeutics

ID	Title	Description
BG000	Inclisiran	Participants who received a dose of inclisiran sodium for injection administered by sub-cutaneous (SC) injection
BG001	Placebo	Participants who received a dose of placebo administered by sub-cutaneous (SC) injection
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Part 1: Inclisiran	Participants who received a dose of 300 milligram (mg) Inclisiran for injection administered by SC injection on Day 1 and Day 90.	0	37	2	37	12	37
EG001	Part 1: Placebo	Participants who received a dose of placebos administered by SC injection on Day 1 and Day 90.	0	19	1	19	6	19
EG002	Part 1:All Patients	Total of all patients	0	56	3	56	18	56
EG003	Part 2: Inclisiran	Participants who received a dose of 300 mg inclisiran for injection administered by SC injection on Day 270, Day 450 and Day 630.	3	53	11	53	29	53