Trial Outcomes & Findings for Inclisiran for Participants With Atherosclerotic Cardiovascular Disease and Elevated Low-density Lipoprotein Cholesterol (NCT NCT03399370)
NCT ID: NCT03399370
Last Updated: 2020-10-05
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1561 participants
Primary outcome timeframe
Baseline, Day 510
Results posted on
2020-10-05
Participant Flow
Participant milestones
| Measure |
Inclisiran
Inclisiran sodium 300 milligrams (mg) will be administered as a SC injection on Day 1, Day 90, then every 6 months.
Inclisiran Sodium: Inclisiran is a small interfering ribonucleic acid (RNA) that inhibits PCSK9 synthesis.
|
Saline Solution
Placebo will be administered as a SC injection 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).
|
|---|---|---|
|
Overall Study
STARTED
|
781
|
780
|
|
Overall Study
COMPLETED
|
721
|
694
|
|
Overall Study
NOT COMPLETED
|
60
|
86
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Inclisiran for Participants With Atherosclerotic Cardiovascular Disease and Elevated Low-density Lipoprotein Cholesterol
Baseline characteristics by cohort
| Measure |
Inclisiran
n=781 Participants
Inclisiran sodium 300 milligrams (mg) will be administered as a SC injection on Day 1, Day 90, then every 6 months.
Inclisiran Sodium: Inclisiran is a small interfering ribonucleic acid (RNA) that inhibits PCSK9 synthesis.
|
Placebo
n=780 Participants
Placebo will be administered as a SC injection of saline solution on Day 1, Day 90, then every 6 months.
Placebo will be supplied as sterile normal saline (0.9% sodium chloride in water for injection).
|
Total
n=1561 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
297 Participants
n=5 Participants
|
333 Participants
n=7 Participants
|
630 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
484 Participants
n=5 Participants
|
447 Participants
n=7 Participants
|
931 Participants
n=5 Participants
|
|
Age, Continuous
|
66.4 years
STANDARD_DEVIATION 8.90 • n=5 Participants
|
65.7 years
STANDARD_DEVIATION 8.89 • n=7 Participants
|
66.0 years
STANDARD_DEVIATION 8.90 • n=5 Participants
|
|
Sex: Female, Male
Female
|
246 Participants
n=5 Participants
|
232 Participants
n=7 Participants
|
478 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
535 Participants
n=5 Participants
|
548 Participants
n=7 Participants
|
1083 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
9 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
110 Participants
n=5 Participants
|
87 Participants
n=7 Participants
|
197 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
653 Participants
n=5 Participants
|
685 Participants
n=7 Participants
|
1338 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
781 participants
n=5 Participants
|
780 participants
n=7 Participants
|
1561 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Day 510Population: Intent-to-treat (ITT) population
Outcome measures
| Measure |
Inclisiran
n=781 Participants
Inclisiran sodium 300 milligrams (mg) will be administered as a SC injection on Day 1, Day 90, then every 6 months.
Inclisiran Sodium: Inclisiran is a small interfering ribonucleic acid (RNA) that inhibits PCSK9 synthesis.
|
Placebo
n=780 Participants
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.
|
|---|---|---|
|
Percentage Change in LDL-C From Baseline to Day 510
|
-56.34 percent change
Interval -58.35 to -54.34
|
1.30 percent change
Interval -1.24 to 3.83
|
PRIMARY outcome
Timeframe: Baseline, Day 90 to Day 540Population: Intent-to-treat (ITT) population
Assessments performed at Baseline, Day 90, Day 540, time-adjusted percent change at Day 540 reported
Outcome measures
| Measure |
Inclisiran
n=781 Participants
Inclisiran sodium 300 milligrams (mg) will be administered as a SC injection on Day 1, Day 90, then every 6 months.
Inclisiran Sodium: Inclisiran is a small interfering ribonucleic acid (RNA) that inhibits PCSK9 synthesis.
|
Placebo
n=790 Participants
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.
|
|---|---|---|
|
Time-adjusted Percentage Change in LDL-C Levels From Baseline After Day 90 and up to Day 540
|
-51.27 percent change
Interval -53.0 to -49.54
|
2.51 percent change
Interval 0.77 to 4.25
|
SECONDARY outcome
Timeframe: Baseline, Day 510Population: Intent-to-treat (ITT) population
Outcome measures
| Measure |
Inclisiran
n=781 Participants
Inclisiran sodium 300 milligrams (mg) will be administered as a SC injection on Day 1, Day 90, then every 6 months.
Inclisiran Sodium: Inclisiran is a small interfering ribonucleic acid (RNA) that inhibits PCSK9 synthesis.
|
Placebo
n=780 Participants
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.
|
|---|---|---|
|
Absolute Change in LDL-C From Baseline to Day 510
|
-56.18 mg/dL
Interval -58.47 to -53.9
|
-2.06 mg/dL
Interval -4.36 to 0.24
|
SECONDARY outcome
Timeframe: Baseline, Day 90 to Day 540Population: Intent-to-treat (ITT) population
Assessments performed at Baseline, Day 90, Day 540, time-adjusted percent change at Day 540 reported
Outcome measures
| Measure |
Inclisiran
n=781 Participants
Inclisiran sodium 300 milligrams (mg) will be administered as a SC injection on Day 1, Day 90, then every 6 months.
Inclisiran Sodium: Inclisiran is a small interfering ribonucleic acid (RNA) that inhibits PCSK9 synthesis.
|
Placebo
n=780 Participants
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.
|
|---|---|---|
|
Time-adjusted Absolute Change in LDL-C From Baseline After Day 90 and up to Day 540
|
-53.66 mg/dL
Interval -55.41 to -51.92
|
-0.39 mg/dL
Interval -2.14 to 1.37
|
SECONDARY outcome
Timeframe: Baseline, Day 510Population: Intent-to-treat (ITT) population
Outcome measures
| Measure |
Inclisiran
n=781 Participants
Inclisiran sodium 300 milligrams (mg) will be administered as a SC injection on Day 1, Day 90, then every 6 months.
Inclisiran Sodium: Inclisiran is a small interfering ribonucleic acid (RNA) that inhibits PCSK9 synthesis.
|
Placebo
n=780 Participants
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.
|
|---|---|---|
|
Percentage Change in Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) From Baseline to Day 510
|
-69.78 percent change
Interval -73.88 to -65.67
|
13.52 percent change
Interval 9.28 to 17.77
|
SECONDARY outcome
Timeframe: Baseline, Day 510Population: Intent-to-treat (ITT) population
Outcome measures
| Measure |
Inclisiran
n=781 Participants
Inclisiran sodium 300 milligrams (mg) will be administered as a SC injection on Day 1, Day 90, then every 6 months.
Inclisiran Sodium: Inclisiran is a small interfering ribonucleic acid (RNA) that inhibits PCSK9 synthesis.
|
Placebo
n=781 Participants
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.
|
|---|---|---|
|
Percentage Change in Total Cholesterol From Baseline to Day 510
|
-33.56 percent change
Interval -35.09 to -32.03
|
-0.42 percent change
Interval -1.95 to 1.11
|
SECONDARY outcome
Timeframe: Baseline, Day 510Population: Intent-to-treat (ITT) population
Outcome measures
| Measure |
Inclisiran
n=781 Participants
Inclisiran sodium 300 milligrams (mg) will be administered as a SC injection on Day 1, Day 90, then every 6 months.
Inclisiran Sodium: Inclisiran is a small interfering ribonucleic acid (RNA) that inhibits PCSK9 synthesis.
|
Placebo
n=780 Participants
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.
|
|---|---|---|
|
Percentage Change in Apolipoprotein B (ApoB) From Baseline to Day 510
|
-44.81 percent change
Interval -46.52 to -43.1
|
-1.72 percent change
Interval -3.46 to 0.02
|
SECONDARY outcome
Timeframe: Baseline, Day 510Population: Intent-to-treat (ITT) population
Outcome measures
| Measure |
Inclisiran
n=781 Participants
Inclisiran sodium 300 milligrams (mg) will be administered as a SC injection on Day 1, Day 90, then every 6 months.
Inclisiran Sodium: Inclisiran is a small interfering ribonucleic acid (RNA) that inhibits PCSK9 synthesis.
|
Placebo
n=780 Participants
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.
|
|---|---|---|
|
Percentage Change in Non-HDL-C From Baseline to Day 510
|
-47.41 percent change
Interval -49.44 to -45.38
|
-0.05 percent change
Interval -2.08 to 1.99
|
Adverse Events
Inclisiran
Serious events: 175 serious events
Other events: 247 other events
Deaths: 12 deaths
Saline Solution
Serious events: 205 serious events
Other events: 219 other events
Deaths: 11 deaths
Serious adverse events
| Measure |
Inclisiran
n=781 participants at risk
Inclisiran sodium 300 milligrams (mg) will be administered as a SC injection on Day 1, Day 90, then every 6 months.
Inclisiran Sodium: Inclisiran is a small interfering ribonucleic acid (RNA) that inhibits PCSK9 synthesis.
|
Saline Solution
n=778 participants at risk
Placebo will be administered as a SC injection 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).
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.38%
3/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.26%
2/781 • 18 months
|
0.00%
0/778 • 18 months
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.13%
1/781 • 18 months
|
0.00%
0/778 • 18 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.13%
1/781 • 18 months
|
0.00%
0/778 • 18 months
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/781 • 18 months
|
0.26%
2/778 • 18 months
|
|
Cardiac disorders
Acute myocardial infarction
|
1.8%
14/781 • 18 months
|
1.5%
12/778 • 18 months
|
|
Cardiac disorders
Angina pectoris
|
0.77%
6/781 • 18 months
|
0.90%
7/778 • 18 months
|
|
Cardiac disorders
Angina unstable
|
0.51%
4/781 • 18 months
|
1.3%
10/778 • 18 months
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.00%
0/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
Cardiac disorders
Atrial fibrillation
|
1.3%
10/781 • 18 months
|
1.0%
8/778 • 18 months
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
Cardiac disorders
Atrioventricular block
|
0.26%
2/781 • 18 months
|
0.00%
0/778 • 18 months
|
|
Cardiac disorders
Atrioventricular block complete
|
0.13%
1/781 • 18 months
|
0.00%
0/778 • 18 months
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.00%
0/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
Cardiac disorders
Bradycardia
|
0.13%
1/781 • 18 months
|
0.26%
2/778 • 18 months
|
|
Cardiac disorders
Cardiac arrest
|
0.13%
1/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
Cardiac disorders
Cardiac failure acute
|
0.13%
1/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
Cardiac disorders
Cardiac failure congestive
|
0.90%
7/781 • 18 months
|
2.6%
20/778 • 18 months
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.13%
1/781 • 18 months
|
0.00%
0/778 • 18 months
|
|
Cardiac disorders
Cardiomyopathy
|
0.26%
2/781 • 18 months
|
0.00%
0/778 • 18 months
|
|
Cardiac disorders
Coronary artery disease
|
1.9%
15/781 • 18 months
|
2.8%
22/778 • 18 months
|
|
Cardiac disorders
Coronary artery occlusion
|
0.13%
1/781 • 18 months
|
0.26%
2/778 • 18 months
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.13%
1/781 • 18 months
|
0.00%
0/778 • 18 months
|
|
Cardiac disorders
Left ventricular failure
|
0.38%
3/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/781 • 18 months
|
0.39%
3/778 • 18 months
|
|
Cardiac disorders
Myocardial infarction
|
0.77%
6/781 • 18 months
|
0.77%
6/778 • 18 months
|
|
Cardiac disorders
Nodal arrythmia
|
0.00%
0/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
Cardiac disorders
Palpitations
|
0.00%
0/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/781 • 18 months
|
0.26%
2/778 • 18 months
|
|
Cardiac disorders
Sinus node dysfunction
|
0.00%
0/781 • 18 months
|
0.26%
2/778 • 18 months
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/781 • 18 months
|
0.26%
2/778 • 18 months
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.13%
1/781 • 18 months
|
0.00%
0/778 • 18 months
|
|
Cardiac disorders
Ventricular fibrillation
|
0.00%
0/781 • 18 months
|
0.26%
2/778 • 18 months
|
|
Cardiac disorders
Ventricular tachyarrhythmia
|
0.13%
1/781 • 18 months
|
0.00%
0/778 • 18 months
|
|
Cardiac disorders
Ventricular tachycardia
|
0.26%
2/781 • 18 months
|
0.51%
4/778 • 18 months
|
|
Congenital, familial and genetic disorders
Atrial septal defect
|
0.00%
0/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
Endocrine disorders
Ectopic hyperthyroidism
|
0.13%
1/781 • 18 months
|
0.00%
0/778 • 18 months
|
|
Eye disorders
Ophthalmic vein thrombosis
|
0.00%
0/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
Eye disorders
Retinal artery occlusion
|
0.13%
1/781 • 18 months
|
0.00%
0/778 • 18 months
|
|
Eye disorders
Visual impairment
|
0.00%
0/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.13%
1/781 • 18 months
|
0.00%
0/778 • 18 months
|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.13%
1/781 • 18 months
|
0.26%
2/778 • 18 months
|
|
Gastrointestinal disorders
Constipation
|
0.13%
1/781 • 18 months
|
0.00%
0/778 • 18 months
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/781 • 18 months
|
0.26%
2/778 • 18 months
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.00%
0/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
Gastrointestinal disorders
Duodenal polyp
|
0.13%
1/781 • 18 months
|
0.00%
0/778 • 18 months
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.13%
1/781 • 18 months
|
0.00%
0/778 • 18 months
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/781 • 18 months
|
0.26%
2/778 • 18 months
|
|
Gastrointestinal disorders
Intestinal infarction
|
0.00%
0/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.00%
0/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
Gastrointestinal disorders
Larger intestine perforation
|
0.00%
0/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
0.13%
1/781 • 18 months
|
0.00%
0/778 • 18 months
|
|
Gastrointestinal disorders
Pancreatic mass
|
0.00%
0/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
Gastrointestinal disorders
Pancreatitis
|
0.13%
1/781 • 18 months
|
0.00%
0/778 • 18 months
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.00%
0/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.51%
4/781 • 18 months
|
0.00%
0/778 • 18 months
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.13%
1/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
General disorders
Asthenia
|
0.00%
0/781 • 18 months
|
0.39%
3/778 • 18 months
|
|
General disorders
Chest pain
|
0.26%
2/781 • 18 months
|
0.39%
3/778 • 18 months
|
|
General disorders
Death
|
0.26%
2/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
General disorders
Gait disturbance
|
0.00%
0/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
General disorders
Hypothermia
|
0.00%
0/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
General disorders
Non-cardiac chest pain
|
1.3%
10/781 • 18 months
|
1.2%
9/778 • 18 months
|
|
General disorders
Pyrexia
|
0.13%
1/781 • 18 months
|
0.00%
0/778 • 18 months
|
|
General disorders
Sensation of foreign body
|
0.13%
1/781 • 18 months
|
0.00%
0/778 • 18 months
|
|
General disorders
Ulcer haemorrhage
|
0.00%
0/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
General disorders
Vascular stent restenosis
|
0.00%
0/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
Hepatobiliary disorders
Bile duct stone
|
0.13%
1/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.13%
1/781 • 18 months
|
0.26%
2/778 • 18 months
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/781 • 18 months
|
0.26%
2/778 • 18 months
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.13%
1/781 • 18 months
|
0.00%
0/778 • 18 months
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
Infections and infestations
Anal abscess
|
0.13%
1/781 • 18 months
|
0.00%
0/778 • 18 months
|
|
Infections and infestations
Appendicitis
|
0.26%
2/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
Infections and infestations
Appendicitis perforated
|
0.13%
1/781 • 18 months
|
0.00%
0/778 • 18 months
|
|
Infections and infestations
Arthritis infective
|
0.13%
1/781 • 18 months
|
0.00%
0/778 • 18 months
|
|
Infections and infestations
Bacterial pyelonephritis
|
0.00%
0/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
Infections and infestations
Bronchitis
|
0.26%
2/781 • 18 months
|
0.26%
2/778 • 18 months
|
|
Infections and infestations
Cavernous sinus thrombosis
|
0.00%
0/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
Infections and infestations
Cellulitis
|
0.51%
4/781 • 18 months
|
0.26%
2/778 • 18 months
|
|
Infections and infestations
Clostridium difficile colitis
|
0.13%
1/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
Infections and infestations
Cystitis
|
0.13%
1/781 • 18 months
|
0.00%
0/778 • 18 months
|
|
Infections and infestations
Device related infection
|
0.13%
1/781 • 18 months
|
0.00%
0/778 • 18 months
|
|
Infections and infestations
Diabetic foot infection
|
0.13%
1/781 • 18 months
|
0.00%
0/778 • 18 months
|
|
Infections and infestations
Diverticultis
|
0.26%
2/781 • 18 months
|
0.26%
2/778 • 18 months
|
|
Infections and infestations
Escherichia bacteraemia
|
0.13%
1/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
Infections and infestations
Gangrene
|
0.00%
0/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
Infections and infestations
Gastroenteritis
|
0.26%
2/781 • 18 months
|
0.00%
0/778 • 18 months
|
|
Infections and infestations
Gastroenteritis norovirus
|
0.00%
0/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
Infections and infestations
Infectious colitis
|
0.00%
0/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
Infections and infestations
Influenza
|
0.26%
2/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
Infections and infestations
Localised infection
|
0.26%
2/781 • 18 months
|
0.00%
0/778 • 18 months
|
|
Infections and infestations
Osteomyelitis
|
0.13%
1/781 • 18 months
|
0.26%
2/778 • 18 months
|
|
Infections and infestations
Osteomyelitis acute
|
0.13%
1/781 • 18 months
|
0.00%
0/778 • 18 months
|
|
Infections and infestations
Periorbital cellulitis
|
0.13%
1/781 • 18 months
|
0.00%
0/778 • 18 months
|
|
Infections and infestations
Periotinitis
|
0.13%
1/781 • 18 months
|
0.00%
0/778 • 18 months
|
|
Infections and infestations
Pneumonia
|
1.4%
11/781 • 18 months
|
1.2%
9/778 • 18 months
|
|
Infections and infestations
Pneumonia bacterial
|
0.13%
1/781 • 18 months
|
0.00%
0/778 • 18 months
|
|
Infections and infestations
Pneumonia viral
|
0.13%
1/781 • 18 months
|
0.00%
0/778 • 18 months
|
|
Infections and infestations
Post procedural infection
|
0.13%
1/781 • 18 months
|
0.00%
0/778 • 18 months
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
Infections and infestations
Sepsis
|
0.77%
6/781 • 18 months
|
0.51%
4/778 • 18 months
|
|
Infections and infestations
Sepsis syndrome
|
0.00%
0/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
Infections and infestations
Septic shock
|
0.13%
1/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
Infections and infestations
Staphylococcal abscess
|
0.13%
1/781 • 18 months
|
0.00%
0/778 • 18 months
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/781 • 18 months
|
0.39%
3/778 • 18 months
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
Injury, poisoning and procedural complications
Cardiac contusion
|
0.00%
0/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
Injury, poisoning and procedural complications
Cardiac valve replacement complication
|
0.00%
0/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
Injury, poisoning and procedural complications
Chemical burn
|
0.13%
1/781 • 18 months
|
0.00%
0/778 • 18 months
|
|
Injury, poisoning and procedural complications
Contusion
|
0.13%
1/781 • 18 months
|
0.00%
0/778 • 18 months
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.00%
0/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
Injury, poisoning and procedural complications
Fall
|
0.26%
2/781 • 18 months
|
0.00%
0/778 • 18 months
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/781 • 18 months
|
0.26%
2/778 • 18 months
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.13%
1/781 • 18 months
|
0.00%
0/778 • 18 months
|
|
Injury, poisoning and procedural complications
Gun shot wound
|
0.00%
0/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
Injury, poisoning and procedural complications
Head injury
|
0.13%
1/781 • 18 months
|
0.00%
0/778 • 18 months
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
Injury, poisoning and procedural complications
Incisional hernia, obstructive
|
0.13%
1/781 • 18 months
|
0.00%
0/778 • 18 months
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.13%
1/781 • 18 months
|
0.00%
0/778 • 18 months
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.13%
1/781 • 18 months
|
0.00%
0/778 • 18 months
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.13%
1/781 • 18 months
|
0.00%
0/778 • 18 months
|
|
Injury, poisoning and procedural complications
Occupational exposure to product
|
0.13%
1/781 • 18 months
|
0.00%
0/778 • 18 months
|
|
Injury, poisoning and procedural complications
Post procedural haematuria
|
0.00%
0/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
Injury, poisoning and procedural complications
Post procedural hawmorrhage
|
0.13%
1/781 • 18 months
|
0.00%
0/778 • 18 months
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.13%
1/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.13%
1/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
Injury, poisoning and procedural complications
Subarachnoid haemorrhage
|
0.00%
0/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.00%
0/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.00%
0/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.13%
1/781 • 18 months
|
0.00%
0/778 • 18 months
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
Investigations
Blood pressure increased
|
0.00%
0/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/781 • 18 months
|
0.26%
2/778 • 18 months
|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
0.00%
0/781 • 18 months
|
0.26%
2/778 • 18 months
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/781 • 18 months
|
0.26%
2/778 • 18 months
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.13%
1/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.13%
1/781 • 18 months
|
0.00%
0/778 • 18 months
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/781 • 18 months
|
0.26%
2/778 • 18 months
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.13%
1/781 • 18 months
|
0.00%
0/778 • 18 months
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.38%
3/781 • 18 months
|
0.00%
0/778 • 18 months
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.13%
1/781 • 18 months
|
0.00%
0/778 • 18 months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.13%
1/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.13%
1/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.26%
2/781 • 18 months
|
0.00%
0/778 • 18 months
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.13%
1/781 • 18 months
|
0.26%
2/778 • 18 months
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.00%
0/781 • 18 months
|
0.39%
3/778 • 18 months
|
|
Musculoskeletal and connective tissue disorders
Fracture malunion
|
0.00%
0/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.13%
1/781 • 18 months
|
0.51%
4/778 • 18 months
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.26%
2/781 • 18 months
|
0.26%
2/778 • 18 months
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.13%
1/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/781 • 18 months
|
0.26%
2/778 • 18 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.13%
1/781 • 18 months
|
0.00%
0/778 • 18 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.00%
0/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.00%
0/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.13%
1/781 • 18 months
|
0.00%
0/778 • 18 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.00%
0/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
0.38%
3/781 • 18 months
|
0.00%
0/778 • 18 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.13%
1/781 • 18 months
|
0.00%
0/778 • 18 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer stage 1
|
0.00%
0/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoid tumour of the stomach
|
0.00%
0/781 • 18 months
|
0.26%
2/778 • 18 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Clear cell renal cell carcinoma
|
0.00%
0/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
0.00%
0/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.00%
0/781 • 18 months
|
0.26%
2/778 • 18 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal lymphoma
|
0.13%
1/781 • 18 months
|
0.00%
0/778 • 18 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrooesophageal cancer
|
0.00%
0/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer
|
0.13%
1/781 • 18 months
|
0.00%
0/778 • 18 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.00%
0/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Liposarcoma recurrent
|
0.00%
0/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/781 • 18 months
|
0.39%
3/778 • 18 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.00%
0/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.13%
1/781 • 18 months
|
0.00%
0/778 • 18 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.00%
0/781 • 18 months
|
0.26%
2/778 • 18 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodyplastic syndrome
|
0.00%
0/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.13%
1/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.00%
0/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.51%
4/781 • 18 months
|
0.26%
2/778 • 18 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer recurrent
|
0.13%
1/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.13%
1/781 • 18 months
|
0.00%
0/778 • 18 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.13%
1/781 • 18 months
|
0.00%
0/778 • 18 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.38%
3/781 • 18 months
|
0.26%
2/778 • 18 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of lung
|
0.26%
2/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.64%
5/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
Nervous system disorders
Carotid artery disease
|
0.13%
1/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
Nervous system disorders
Carotid artery stenosis
|
0.38%
3/781 • 18 months
|
0.26%
2/778 • 18 months
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.13%
1/781 • 18 months
|
0.00%
0/778 • 18 months
|
|
Nervous system disorders
Cerebral infarction
|
0.13%
1/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
Nervous system disorders
Cerebrovascular accident
|
0.51%
4/781 • 18 months
|
0.39%
3/778 • 18 months
|
|
Nervous system disorders
Cerebrovascular disorder
|
0.13%
1/781 • 18 months
|
0.00%
0/778 • 18 months
|
|
Nervous system disorders
Cervical radiculopathy
|
0.00%
0/781 • 18 months
|
0.26%
2/778 • 18 months
|
|
Nervous system disorders
Demetia
|
0.00%
0/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
Nervous system disorders
Dizziness
|
0.38%
3/781 • 18 months
|
0.00%
0/778 • 18 months
|
|
Nervous system disorders
Headache
|
0.13%
1/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
Nervous system disorders
Ischaemic stroke
|
0.90%
7/781 • 18 months
|
0.51%
4/778 • 18 months
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.00%
0/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
Nervous system disorders
Migraine
|
0.13%
1/781 • 18 months
|
0.00%
0/778 • 18 months
|
|
Nervous system disorders
Myelopathy
|
0.00%
0/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
Nervous system disorders
Nerve compression
|
0.00%
0/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
Nervous system disorders
Normal pressure hydrocephalus
|
0.00%
0/781 • 18 months
|
0.26%
2/778 • 18 months
|
|
Nervous system disorders
Presyncope
|
0.26%
2/781 • 18 months
|
0.00%
0/778 • 18 months
|
|
Nervous system disorders
Radiculopathy
|
0.00%
0/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
Nervous system disorders
Seizure
|
0.00%
0/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
Nervous system disorders
Spinal subdural haematoma
|
0.00%
0/781 • 18 months
|
0.13%
1/778 • 18 months
|
|
Nervous system disorders
Status migrainosus
|
0.13%
1/781 • 18 months
|
0.00%
0/778 • 18 months
|
|
Nervous system disorders
Syncope
|
0.51%
4/781 • 18 months
|
0.90%
7/778 • 18 months
|
Other adverse events
| Measure |
Inclisiran
n=781 participants at risk
Inclisiran sodium 300 milligrams (mg) will be administered as a SC injection on Day 1, Day 90, then every 6 months.
Inclisiran Sodium: Inclisiran is a small interfering ribonucleic acid (RNA) that inhibits PCSK9 synthesis.
|
Saline Solution
n=778 participants at risk
Placebo will be administered as a SC injection 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).
|
|---|---|---|
|
Infections and infestations
Bronchitis
|
5.9%
46/781 • 18 months
|
3.9%
30/778 • 18 months
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
15.4%
120/781 • 18 months
|
13.9%
108/778 • 18 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.0%
39/781 • 18 months
|
5.0%
39/778 • 18 months
|
|
Vascular disorders
Hypertension
|
5.4%
42/781 • 18 months
|
5.4%
42/778 • 18 months
|
Additional Information
Vice-President, Regulatory Operations
The Medicines Company
Phone: 973-985-0597
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place