Trial to Evaluate the Effect of Inclisiran Treatment on Low Density Lipoprotein Cholesterol (LDL-C) in Subjects With Heterozygous Familial Hypercholesterolemia (HeFH) (ORION-9)

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ClinicalTrials.gov Identifier: NCT03397121

Recruitment Status : Completed

First Posted : January 11, 2018

Results First Posted : October 28, 2020

Last Update Posted : October 28, 2020

View this study on the modernized ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

The Medicines Company

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Care Provider); Primary Purpose: Treatment
Conditions	Heterozygous Familial Hypercholesterolemia Elevated Cholesterol
Interventions	Drug: Inclisiran Drug: Placebo
Enrollment	482

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	Inclisiran	Placebo
Arm/Group Description	Inclisiran sodium 300 milligrams (m...	Placebo will be administered as SC ...
Arm/Group Description	Inclisiran sodium 300 milligrams (mg) will be administered as a SC injection on Day 1, Day 90 then every 6 months. Inclisiran: Inclisiran is a small interfering ribonucleic acid (RNA) that inhibits PCSK9 synthesis.	Placebo will be administered as SC injections of saline solution on Day 1, Day 90 then every 6 months. Placebo: Placebo will be supplied as sterile normal saline (0.9% sodium chloride in water for injection).
Period Title: Overall Study
Started	242	240
Completed	235	231
Not Completed	7	9

Baseline Characteristics

Arm/Group Title		Inclisiran	Placebo	Total
Arm/Group Description		Inclisiran sodium 300 milligrams (m...	Placebo will be administered as SC ...	Total of all reporting groups
Arm/Group Description		Inclisiran sodium 300 milligrams (mg) will be administered as a SC injection on Day 1, Day 90 then every 6 months. Inclisiran: Inclisiran is a small interfering ribonucleic acid (RNA) that inhibits PCSK9 synthesis.	Placebo will be administered as SC injections of saline solution on Day 1, Day 90 then every 6 months. Placebo: Placebo will be supplied as sterile normal saline (0.9% sodium chloride in water for injection).	Total of all reporting groups
Overall Number of Baseline Participants		242	240	482
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Categorical Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	242 participants	240 participants	482 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	189 78.1%	185 77.1%	374 77.6%
	>=65 years	53 21.9%	55 22.9%	108 22.4%
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	242 participants	240 participants	482 participants
		54.4 (12.48)	55.0 (11.81)	54.7 (12.14)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	242 participants	240 participants	482 participants
	Female	130 53.7%	125 52.1%	255 52.9%
	Male	112 46.3%	115 47.9%	227 47.1%
Ethnicity (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	242 participants	240 participants	482 participants
	Hispanic or Latino	7 2.9%	8 3.3%	15 3.1%
	Not Hispanic or Latino	235 97.1%	232 96.7%	467 96.9%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%
Race (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	242 participants	240 participants	482 participants
	American Indian or Alaska Native	1 0.4%	0 0.0%	1 0.2%
	Asian	7 2.9%	5 2.1%	12 2.5%
	Native Hawaiian or Other Pacific Islander	0 0.0%	1 0.4%	1 0.2%
	Black or African American	8 3.3%	7 2.9%	15 3.1%
	White	226 93.4%	227 94.6%	453 94.0%
	More than one race	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%
Region of Enrollment Measure Type: Number Unit of measure: Participants	Number Analyzed	242 participants	240 participants	482 participants
Canada		12	11	23
Netherlands		19	19	38
Sweden		18	16	34
United States		33	32	65
Czechia		7	5	12
Denmark		23	26	49
South Africa		88	89	177
Spain		42	42	84

Outcome Measures

1.Primary Outcome


Title	Percent Change in LDL-C From Baseline To Day 510
Description	[Not Specified]
Description	[Not Specified]
Time Frame	Baseline, Day 510

Outcome Measure Data

Analysis Population Description

ITT (intent-to-treat) Population


Arm/Group Title	Inclisiran	Placebo
Arm/Group Description:	Inclisiran sodium 300 milligrams (m...	Placebo administered as a subcutane...
Arm/Group Description:	Inclisiran sodium 300 milligrams (mg) (equivalent to 284 mg inclisiran) administered as a subcutaneous injection on Day 1, Day 90, and then every 6 months.	Placebo administered as a subcutaneous injection of sterile saline solution (0.9% sodium chloride in water for injection) on Day 1, Day 90, and then every 6 months.
Overall Number of Participants Analyzed	242	240
Least Squares Mean (95% Confidence Interval) Unit of Measure: percent change
	-41.15 (-44.52 to -37.77)	8.37 (3.96 to 12.77)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Inclisiran, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	<.0001
	Comments	The a priori threshold for statistical significance was <0.05
	Method	ANCOVA
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-49.52
	Confidence Interval	(2-Sided) 95% -55.04 to -43.99
	Estimation Comments	Represents the least squares mean difference from Placebo

2.Primary Outcome


Title	Time-adjusted Percent Change in LDL-C From Baseline After Day 90 and up to Day 540
Description	Assessments performed at Baseline, Day 90, Day 540, time-adjusted perc...
Description	Assessments performed at Baseline, Day 90, Day 540, time-adjusted percent change at Day 90 reported
Time Frame	Baseline, Day 90

Outcome Measure Data

Analysis Population Description

ITT (intent-to-treat) Population


Arm/Group Title	Inclisiran	Placebo
Arm/Group Description:	Inclisiran sodium 300 milligrams (m...	Placebo administered as a subcutane...
Arm/Group Description:	Inclisiran sodium 300 milligrams (mg) (equivalent to 284 mg inclisiran) administered as a subcutaneous injection on Day 1, Day 90, and then every 6 months.	Placebo administered as a subcutaneous injection of sterile saline solution (0.9% sodium chloride in water for injection) on Day 1, Day 90, and then every 6 months.
Overall Number of Participants Analyzed	242	240
Least Squares Mean (95% Confidence Interval) Unit of Measure: percent change
	-38.08 (-41.03 to -35.14)	6.22 (3.26 to 9.17)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Inclisiran, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	The a priori threshold for statistical significance was <0.05
	Method	ANCOVA
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-44.30
	Confidence Interval	(2-Sided) 95% -48.48 to -40.12
	Estimation Comments	Represents the least squares mean difference from Placebo

3.Secondary Outcome


Title	Absolute Change in LDL-C From Baseline to Day 510
Description	[Not Specified]
Description	[Not Specified]
Time Frame	Baseline, Day 510

Outcome Measure Data

Analysis Population Description

ITT (intent-to-treat) Population


Arm/Group Title	Inclisiran	Placebo
Arm/Group Description:	Inclisiran sodium 300 milligrams (m...	Placebo administered as a subcutane...
Arm/Group Description:	Inclisiran sodium 300 milligrams (mg) (equivalent to 284 mg inclisiran) administered as a subcutaneous injection on Day 1, Day 90, and then every 6 months.	Placebo administered as a subcutaneous injection of sterile saline solution (0.9% sodium chloride in water for injection) on Day 1, Day 90, and then every 6 months.
Overall Number of Participants Analyzed	242	240
Least Squares Mean (95% Confidence Interval) Unit of Measure: mg/dL
	-58.95 (-64.75 to -53.15)	9.94 (4.10 to 15.78)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Inclisiran, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	The a priori threshold for statistical significance was <0.05
	Method	ANCOVA
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-68.89
	Confidence Interval	(2-Sided) 95% -77.11 to -60.67
	Estimation Comments	Represents the least squares mean difference from Placebo

4.Secondary Outcome


Title	Time-adjusted Absolute Change in LDL-C From Baseline After Day 90 and up to Day 540
Description	Assessments performed at Baseline, Day 90, Day 540, absolute change at...
Description	Assessments performed at Baseline, Day 90, Day 540, absolute change at Day 90 reported
Time Frame	Baseline, Day 90

Outcome Measure Data

Analysis Population Description

ITT (intent-to-treat) Population


Arm/Group Title	Inclisiran	Placebo
Arm/Group Description:	Inclisiran sodium 300 milligrams (m...	Placebo administered as a subcutane...
Arm/Group Description:	Inclisiran sodium 300 milligrams (mg) (equivalent to 284 mg inclisiran) administered as a subcutaneous injection on Day 1, Day 90, and then every 6 months.	Placebo administered as a subcutaneous injection of sterile saline solution (0.9% sodium chloride in water for injection) on Day 1, Day 90, and then every 6 months.
Overall Number of Participants Analyzed	242	240
Least Squares Mean (95% Confidence Interval) Unit of Measure: mg/dL
	-56.58 (-60.98 to -52.17)	6.17 (1.72 to 10.62)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Inclisiran, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	The a priori threshold for statistical significance was <0.05
	Method	ANCOVA
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-62.74
	Confidence Interval	(2-Sided) 95% -69.01 to -56.48
	Estimation Comments	Represents the least squares mean difference from Placebo

5.Secondary Outcome


Title	Percentage Change in Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) From Baseline to Day 510
Description	[Not Specified]
Description	[Not Specified]
Time Frame	Baseline, Day 510

Outcome Measure Data

Analysis Population Description

ITT (intent-to-treat) Population


Arm/Group Title	Inclisiran	Placebo
Arm/Group Description:	Inclisiran sodium 300 milligrams (m...	Placebo administered as a subcutane...
Arm/Group Description:	Inclisiran sodium 300 milligrams (mg) (equivalent to 284 mg inclisiran) administered as a subcutaneous injection on Day 1, Day 90, and then every 6 months.	Placebo administered as a subcutaneous injection of sterile saline solution (0.9% sodium chloride in water for injection) on Day 1, Day 90, and then every 6 months.
Overall Number of Participants Analyzed	242	240
Least Squares Mean (95% Confidence Interval) Unit of Measure: percent change
	-60.68 (-64.40 to -56.96)	17.66 (13.91 to 21.42)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Inclisiran, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	The a priori threshold for statistical significance was <0.05
	Method	ANCOVA
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-78.34
	Confidence Interval	(2-Sided) 95% -83.65 to -73.04
	Estimation Comments	Represents the least squares mean difference from Placebo

6.Secondary Outcome


Title	Percentage Change in Total Cholesterol From Baseline to Day 510
Description	[Not Specified]
Description	[Not Specified]
Time Frame	Baseline, Day 510

Outcome Measure Data

Analysis Population Description

ITT (intent-to-treat) Population


Arm/Group Title	Inclisiran	Placebo
Arm/Group Description:	Inclisiran sodium 300 milligrams (m...	Placebo administered as a subcutane...
Arm/Group Description:	Inclisiran sodium 300 milligrams (mg) (equivalent to 284 mg inclisiran) administered as a subcutaneous injection on Day 1, Day 90, and then every 6 months.s.	Placebo administered as a subcutaneous injection of sterile saline solution (0.9% sodium chloride in water for injection) on Day 1, Day 90, and then every 6 months.
Overall Number of Participants Analyzed	242	240
Least Squares Mean (95% Confidence Interval) Unit of Measure: percent change
	-25.11 (-27.83 to -22.39)	6.66 (3.96 to 9.36)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Inclisiran, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	LS Mean Difference (95% CI) from Placebo

Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	The a priori threshold for statistical significance was <0.05
	Method	ANCOVA
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-31.77
	Confidence Interval	(2-Sided) 95% -35.59 to -27.94
	Estimation Comments	Represents the least squares mean difference from Placebo

7.Secondary Outcome


Title	Percent Change in Apolipoprotein B (Apo-B) From Baseline To Day 510
Description	[Not Specified]
Description	[Not Specified]
Time Frame	Baseline, Day 510

Outcome Measure Data

Analysis Population Description

ITT (intent-to-treat) Population


Arm/Group Title	Inclisiran	Placebo
Arm/Group Description:	Inclisiran sodium 300 milligrams (m...	Placebo administered as a subcutane...
Arm/Group Description:	Inclisiran sodium 300 milligrams (mg) (equivalent to 284 mg inclisiran) administered as a subcutaneous injection on Day 1, Day 90, and then every 6 months.	Placebo administered as a subcutaneous injection of sterile saline solution (0.9% sodium chloride in water for injection) on Day 1, Day 90, and then every 6 months.
Overall Number of Participants Analyzed	242	240
Least Squares Mean (95% Confidence Interval) Unit of Measure: percent change
	-33.14 (-35.91 to -30.36)	2.93 (0.14 to 5.71)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Inclisiran, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	The a priori threshold for statistical significance was <0.05
	Method	ANCOVA
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-36.06
	Confidence Interval	(2-Sided) 95% -39.99 to -32.14
	Estimation Comments	Represents the least squares mean difference from Placebo

8.Secondary Outcome


Title	Percent Change in Non-high-density Lipoprotein (HDL)-C From Baseline To Day 510
Description	[Not Specified]
Description	[Not Specified]
Time Frame	Baseline, Day 510

Outcome Measure Data

Analysis Population Description

ITT (intent-to-treat) Population


Arm/Group Title	Inclisiran	Placebo
Arm/Group Description:	Inclisiran sodium 300 milligrams (m...	Placebo administered as a subcutane...
Arm/Group Description:	Inclisiran sodium 300 milligrams (mg) (equivalent to 284 mg inclisiran) administered as a subcutaneous injection on Day 1, Day 90, and then every 6 months.	Placebo administered as a subcutaneous injection of sterile saline solution (0.9% sodium chloride in water for injection) on Day 1, Day 90, and then every 6 months.
Overall Number of Participants Analyzed	242	240
Least Squares Mean (95% Confidence Interval) Unit of Measure: percent change
	-34.93 (-38.46 to -31.40)	7.43 (3.93 to 10.92)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Inclisiran, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	The a priori threshold for statistical significance was <0.05
	Method	ANCOVA
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-42.36
	Confidence Interval	(2-Sided) 95% -47.32 to -37.40
	Estimation Comments	Represents the least squares mean difference from Placebo

Adverse Events

Time Frame	Day 0 - 510
Adverse Event Reporting Description	The safety population for adverse event collection was 481 subjects which is different from the Intent-to-Treat (ITT) population used in efficacy analysis (482 subjects). One subject was randomized in the Inclisiran arm, but never received study drug, therefore this subject not included in the safety population.

Arm/Group Title	Inclisiran	Placebo
Arm/Group Description	Inclisiran sodium 300 milligrams (m...	Placebo will be administered as SC ...
Arm/Group Description	Inclisiran sodium 300 milligrams (mg) will be administered as a SC injection on Day 1, Day 90 then every 6 months. Inclisiran: Inclisiran is a small interfering ribonucleic acid (RNA) that inhibits PCSK9 synthesis.	Placebo will be administered as SC injections of saline solution on Day 1, Day 90 then every 6 months. Placebo: Placebo will be supplied as sterile normal saline (0.9% sodium chloride in water for injection).
All-Cause Mortality
	Inclisiran	Placebo
	Affected / at Risk (%)	Affected / at Risk (%)
Total	1/241 (0.41%)	1/240 (0.42%)
Serious Adverse Events Serious Adverse Events
	Inclisiran	Placebo
	Affected / at Risk (%)	Affected / at Risk (%)
Total	18/241 (7.47%)	33/240 (13.75%)
Cardiac disorders
Acute myocardial infarction ^* 1	2/241 (0.83%)	1/240 (0.42%)
Angina Pectoris ^* 1	1/241 (0.41%)	0/240 (0.00%)
Angina unstable ^* 1	1/241 (0.41%)	4/240 (1.67%)
Aortic valve stenosis ^* 1	2/241 (0.83%)	0/240 (0.00%)
Arteriosclerosis coronary artery ^* 1	0/241 (0.00%)	1/240 (0.42%)
Atrial fibrillation ^* 1	0/241 (0.00%)	1/240 (0.42%)
Cardiac arrest ^* 1	1/241 (0.41%)	0/240 (0.00%)
Cardiac failure ^* 1	1/241 (0.41%)	0/240 (0.00%)
Cardiac failure acute ^* 1	1/241 (0.41%)	0/240 (0.00%)
Coronary artery disease ^* 1	1/241 (0.41%)	0/240 (0.00%)
Myocardial infarction ^* 1	1/241 (0.41%)	0/240 (0.00%)
Myocardial ischaemia ^* 1	1/241 (0.41%)	3/240 (1.25%)
Supraventricular tachycardia ^* 1	0/241 (0.00%)	1/240 (0.42%)
Eye disorders
Optic ischaemic neuropathy ^* 1	0/241 (0.00%)	2/240 (0.83%)
Gastrointestinal disorders
Gastritis erosive ^* 1	0/241 (0.00%)	1/240 (0.42%)
Pancreatitis acute ^* 1	0/241 (0.00%)	1/240 (0.42%)
General disorders
Hernia ^* 1	0/241 (0.00%)	1/240 (0.42%)
Non-cardiac chest pain ^* 1	0/241 (0.00%)	1/240 (0.42%)
Hepatobiliary disorders
Biliary colic ^* 1	0/241 (0.00%)	1/240 (0.42%)
Infections and infestations
Cellulitis ^* 1	1/241 (0.41%)	0/240 (0.00%)
Diverticulitis ^* 1	0/241 (0.00%)	1/240 (0.42%)
Infective tenosynovitis ^* 1	1/241 (0.41%)	0/240 (0.00%)
Influenza ^* 1	0/241 (0.00%)	1/240 (0.42%)
Pneumonia ^* 1	1/241 (0.41%)	1/240 (0.42%)
Post procedural infection ^* 1	0/241 (0.00%)	1/240 (0.42%)
Pyelitis ^* 1	0/241 (0.00%)	1/240 (0.42%)
Pyelonephritis ^* 1	0/241 (0.00%)	1/240 (0.42%)
Tick-borne fever ^* 1	0/241 (0.00%)	1/240 (0.42%)
Viral upper respiratory tract infection ^* 1	0/241 (0.00%)	1/240 (0.42%)
Wound sepsis ^* 1	0/241 (0.00%)	1/240 (0.42%)
Injury, poisoning and procedural complications
Limb injury ^* 1	0/241 (0.00%)	1/240 (0.42%)
Post procedural haematuria ^* 1	0/241 (0.00%)	1/240 (0.42%)
Road traffic accident ^* 1	0/241 (0.00%)	1/240 (0.42%)
Soft tissue injury ^* 1	0/241 (0.00%)	1/240 (0.42%)
Spinal compression fracture ^* 1	1/241 (0.41%)	0/240 (0.00%)
Musculoskeletal and connective tissue disorders
Back pain ^* 1	0/241 (0.00%)	2/240 (0.83%)
Myalgia ^* 1	0/241 (0.00%)	1/240 (0.42%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma ^* 1	0/241 (0.00%)	1/240 (0.42%)
Malignant melanoma in situ ^* 1	0/241 (0.00%)	1/240 (0.42%)
Prostate cancer ^* 1	1/241 (0.41%)	0/240 (0.00%)
Squamous cell carcinoma of skin ^* 1	1/241 (0.41%)	1/240 (0.42%)
Nervous system disorders
Sensory disturbance ^* 1	0/241 (0.00%)	1/240 (0.42%)
Trigeminal neuralgia ^* 1	0/241 (0.00%)	1/240 (0.42%)
Product Issues
Device loosening ^* 1	1/241 (0.41%)	0/240 (0.00%)
Psychiatric disorders
Anxiety ^* 1	1/241 (0.41%)	0/240 (0.00%)
Depression ^* 1	0/241 (0.00%)	1/240 (0.42%)
Major depression ^* 1	0/241 (0.00%)	1/240 (0.42%)
Renal and urinary disorders
Hydronephrosis ^* 1	0/241 (0.00%)	1/240 (0.42%)
Nephrolithiasis ^* 1	0/241 (0.00%)	1/240 (0.42%)
Respiratory, thoracic and mediastinal disorders
Asthma ^* 1	0/241 (0.00%)	1/240 (0.42%)
Chronic obstructive pulmonary disease ^* 1	0/241 (0.00%)	1/240 (0.42%)
1 Term from vocabulary, MedDRA (20.1) * Indicates events were collected by non-systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Inclisiran	Placebo
	Affected / at Risk (%)	Affected / at Risk (%)
Total	96/241 (39.83%)	67/240 (27.92%)
General disorders
Injection site reaction ^* 1	22/241 (9.13%)	0/240 (0.00%)
Infections and infestations
Influenza ^* 1	13/241 (5.39%)	21/240 (8.75%)
Nasopharyngitis ^* 1	28/241 (11.62%)	20/240 (8.33%)
Upper respiratory tract infection ^* 1	16/241 (6.64%)	16/240 (6.67%)
Musculoskeletal and connective tissue disorders
Back pain ^* 1	17/241 (7.05%)	10/240 (4.17%)
1 Term from vocabulary, MedDRA (20.1) * Indicates events were collected by non-systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	Vice President - Regulatory Operations
Organization:	The Medicines Company
Phone:	973-985-0597
EMail:	frank.bosley@novartis.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Raal FJ, Kallend D, Ray KK, Turner T, Koenig W, Wright RS, Wijngaard PLJ, Curcio D, Jaros MJ, Leiter LA, Kastelein JJP; ORION-9 Investigators. Inclisiran for the Treatment of Heterozygous Familial Hypercholesterolemia. N Engl J Med. 2020 Apr 16;382(16):1520-1530. doi: 10.1056/NEJMoa1913805. Epub 2020 Mar 18.

Layout table for additonal information

Responsible Party:	The Medicines Company
ClinicalTrials.gov Identifier:	NCT03397121
Other Study ID Numbers:	MDCO-PCS-17-03 2017-002472-30 ( EudraCT Number )
First Submitted:	January 2, 2018
First Posted:	January 11, 2018
Results First Submitted:	August 27, 2020
Results First Posted:	October 28, 2020
Last Update Posted:	October 28, 2020

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