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Study of Efficacy and Safety of Inclisiran in Japanese Participants With High Cardiovascular Risk and Elevated LDL-C (ORION-15)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04666298
Recruitment Status : Completed
First Posted : December 14, 2020
Results First Posted : May 10, 2023
Last Update Posted : May 10, 2023
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Hypercholesterolemia
Heterozygous Familial Hypercholesterolemia
Interventions Drug: Inclisiran sodium
Drug: Placebo
Enrollment 312
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo 100 mg Inclisiran Sodium 200 mg Inclisiran Sodium 300 mg Inclisiran Sodium
Hide Arm/Group Description Placebo subcutaneous injection 100 mg inclisiran sodium (equivalent to 94.5 mg inclisiran) subcutaneous injection 200 mg inclisiran sodium (equivalent to 189 mg inclisiran) subcutaneous injection 300 mg inclisiran sodium (equivalent to 284 mg inclisiran) subcutaneous injection
Period Title: Overall Study
Started 57 55 101 99
Completed 55 55 100 95
Not Completed 2 0 1 4
Reason Not Completed
Subject decision             1             0             0             2
Death             1             0             0             0
Lost to Follow-up             0             0             0             1
Physician Decision             0             0             0             1
Protocol deviation             0             0             1             0
Arm/Group Title Placebo 100 mg Inclisiran Sodium 200 mg Inclisiran Sodium 300 mg Inclisiran Sodium Total
Hide Arm/Group Description Placebo subcutaneous injection 100 mg inclisiran sodium (equivalent to 94.5 mg inclisiran) subcutaneous injection 200 mg inclisiran sodium (equivalent to 189 mg inclisiran) subcutaneous injection 300 mg inclisiran sodium (equivalent to 284 mg inclisiran) subcutaneous injection Total of all reporting groups
Overall Number of Baseline Participants 57 55 101 99 312
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 57 participants 55 participants 101 participants 99 participants 312 participants
63.8  (11.12) 62.7  (9.25) 64.7  (10.57) 63.0  (10.66) 63.6  (10.46)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 57 participants 55 participants 101 participants 99 participants 312 participants
Female
18
  31.6%
19
  34.5%
21
  20.8%
22
  22.2%
80
  25.6%
Male
39
  68.4%
36
  65.5%
80
  79.2%
77
  77.8%
232
  74.4%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 57 participants 55 participants 101 participants 99 participants 312 participants
Japanese
57
 100.0%
55
 100.0%
101
 100.0%
99
 100.0%
312
 100.0%
1.Primary Outcome
Title Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) to Day 180
Hide Description

Percent change from baseline in LDL-C was calculated to evaluate the effect of inclisiran at Day 180.

Difference between different inclisiran dose groups and the placebo group in percentage change in LDL-C levels from baseline to Day 180 were calculated to capture both, the effect of the study drug and the effect of additional medications, mirroring the conditions in clinical practice.

An MMRM (Mixed-effect Model with Repeated Measurement) was used as the primary analysis model, with treatment group, visits, interaction between visits and treatment groups, current use of statins or other lipid-modifying therapies as fixed effects, and baseline LDL-C as a continuous covariate.

Time Frame Baseline, Day 180
Hide Outcome Measure Data
Hide Analysis Population Description

The FAS comprised all participants to whom study treatment had been assigned by randomization.

The overall number of participants analyzed represents the participants in the Full Analysis Set (FAS) who had valid LDL-C value for both, baseline and day 180

Arm/Group Title Placebo 100 mg Inclisiran Sodium 200 mg Inclisiran Sodium 300 mg Inclisiran Sodium
Hide Arm/Group Description:
Placebo subcutaneous injection
100 mg inclisiran sodium (equivalent to 94.5 mg inclisiran) subcutaneous injection
200 mg inclisiran sodium (equivalent to 189 mg inclisiran) subcutaneous injection
300 mg inclisiran sodium (equivalent to 284 mg inclisiran) subcutaneous injection
Overall Number of Participants Analyzed 56 55 101 96
Least Squares Mean (95% Confidence Interval)
Unit of Measure: percent change in LDL-C
9.0
(3.5 to 14.5)
-47.6
(-53.4 to -41.8)
-51.9
(-56.8 to -47.0)
-56.3
(-61.1 to -51.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, 100 mg Inclisiran Sodium
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments One-sided adjusted p-value for multiple comparisons using Dunnett´s multiple t-test
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -56.6
Confidence Interval (2-Sided) 95%
-64.2 to -49.0
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.24
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, 200 mg Inclisiran Sodium
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments One-sided adjusted p-value for multiple comparisons using Dunnett´s multiple t-test
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -60.9
Confidence Interval (2-Sided) 95%
-67.6 to -54.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.84
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, 300 mg Inclisiran Sodium
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments One-sided adjusted p-value for multiple comparisons using Dunnett´s multiple t-test
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -65.3
Confidence Interval (2-Sided) 95%
-72.0 to -58.6
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.86
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percent Change From Baseline in PCSK9 by Visit
Hide Description Percent change from baseline in proprotein convertase subtilisin/kexin type 9 (PCSK9) was calculated to evaluate the effect of inclisiran over time.
Time Frame Baseline, day 14, day 30, day 60, day 90, day 104, day 120, day 150, and day 180
Hide Outcome Measure Data
Hide Analysis Population Description

The overall number of participants analyzed represents the participants in the Full Analysis Set (FAS) who had at least one valid measurement of PCSK9.

The number analyzed per row represents the participants with a valid PCSK9 value for both, baseline and that particular visit.

Arm/Group Title Placebo 100 mg Inclisiran Sodium 200 mg Inclisiran Sodium 300 mg Inclisiran Sodium
Hide Arm/Group Description:
Placebo subcutaneous injection
100 mg inclisiran sodium (equivalent to 94.5 mg inclisiran) subcutaneous injection
200 mg inclisiran sodium (equivalent to 189 mg inclisiran) subcutaneous injection
300 mg inclisiran sodium (equivalent to 284 mg inclisiran) subcutaneous injection
Overall Number of Participants Analyzed 57 55 101 98
Mean (Standard Deviation)
Unit of Measure: percent change in PCSK9
Day 14 Number Analyzed 57 participants 55 participants 101 participants 98 participants
4.79  (21.623) -55.42  (19.980) -65.64  (13.677) -69.56  (11.387)
Day 30 Number Analyzed 57 participants 55 participants 101 participants 98 participants
1.92  (22.427) -66.45  (12.341) -72.94  (8.809) -76.46  (8.561)
Day 60 Number Analyzed 57 participants 55 participants 101 participants 98 participants
-0.16  (22.656) -62.56  (15.356) -73.23  (10.692) -76.52  (9.953)
Day 90 Number Analyzed 57 participants 55 participants 101 participants 97 participants
2.12  (21.447) -59.76  (14.503) -70.49  (10.806) -73.09  (11.525)
Day 104 Number Analyzed 57 participants 55 participants 101 participants 96 participants
2.65  (28.624) -69.05  (11.109) -76.23  (9.017) -78.55  (8.052)
Day 120 Number Analyzed 55 participants 55 participants 101 participants 95 participants
0.99  (21.572) -70.29  (11.543) -77.03  (8.206) -79.80  (6.994)
Day 150 Number Analyzed 56 participants 55 participants 101 participants 96 participants
2.34  (23.353) -66.02  (12.724) -73.94  (17.139) -77.12  (8.770)
Day 180 Number Analyzed 56 participants 55 participants 101 participants 96 participants
2.78  (21.226) -63.62  (14.012) -70.99  (10.495) -75.97  (9.885)
3.Secondary Outcome
Title Percent Change From Baseline in LDL-C by Visit
Hide Description Percent change from baseline in low-density lipoprotein cholesterol (LDL-C) was calculated to evaluate the effect of inclisiran over time.
Time Frame Baseline, day 14, day 30, day 60, day 90, day 104, day 120 and day 150
Hide Outcome Measure Data
Hide Analysis Population Description

The overall number of participants analyzed represents the participants in the Full Analysis Set (FAS) who had at least one valid measurement of LDL-C.

The number analyzed per row represents the participants with a valid LDL-C value for both, baseline and that particular visit.

Arm/Group Title Placebo 100 mg Inclisiran Sodium 200 mg Inclisiran Sodium 300 mg Inclisiran Sodium
Hide Arm/Group Description:
Placebo subcutaneous injection
100 mg inclisiran sodium (equivalent to 94.5 mg inclisiran) subcutaneous injection
200 mg inclisiran sodium (equivalent to 189 mg inclisiran) subcutaneous injection
300 mg inclisiran sodium (equivalent to 284 mg inclisiran) subcutaneous injection
Overall Number of Participants Analyzed 57 55 101 98
Mean (Standard Deviation)
Unit of Measure: percent change in LDL-C
Day 14 Number Analyzed 57 participants 55 participants 101 participants 98 participants
1.68  (18.099) -37.15  (21.855) -42.08  (20.503) -47.60  (19.889)
Day 30 Number Analyzed 57 participants 55 participants 101 participants 98 participants
1.29  (13.068) -52.20  (18.389) -55.54  (17.501) -62.77  (15.097)
Day 60 Number Analyzed 57 participants 55 participants 101 participants 98 participants
0.24  (15.314) -50.06  (19.173) -55.61  (17.570) -62.35  (13.976)
Day 90 Number Analyzed 57 participants 55 participants 101 participants 97 participants
2.69  (14.332) -46.39  (17.872) -53.92  (17.186) -61.51  (15.480)
Day 104 Number Analyzed 57 participants 55 participants 101 participants 96 participants
1.20  (13.519) -53.00  (19.001) -60.33  (15.912) -65.68  (15.321)
Day 120 Number Analyzed 55 participants 55 participants 101 participants 95 participants
2.26  (14.854) -54.91  (19.410) -62.04  (16.742) -67.23  (16.017)
Day 150 Number Analyzed 56 participants 55 participants 101 participants 96 participants
4.27  (16.983) -55.46  (18.817) -60.55  (16.502) -66.15  (15.197)
4.Secondary Outcome
Title Absolute Change in LDL-C From Baseline at Day 180
Hide Description Absolute change from baseline in low-density lipoprotein cholesterol (LDL-C) was calculated to evaluate the effect of inclisiran until Day 180.
Time Frame Baseline, Day 180
Hide Outcome Measure Data
Hide Analysis Population Description
The overall number of participants analyzed represents the participants in the Full Analysis Set (FAS) who had valid LDL-C value for both, baseline and day 180
Arm/Group Title Placebo 100 mg Inclisiran Sodium 200 mg Inclisiran Sodium 300 mg Inclisiran Sodium
Hide Arm/Group Description:
Placebo subcutaneous injection
100 mg inclisiran sodium (equivalent to 94.5 mg inclisiran) subcutaneous injection
200 mg inclisiran sodium (equivalent to 189 mg inclisiran) subcutaneous injection
300 mg inclisiran sodium (equivalent to 284 mg inclisiran) subcutaneous injection
Overall Number of Participants Analyzed 56 55 101 96
Least Squares Mean (95% Confidence Interval)
Unit of Measure: mg/dL
13.2
(6.6 to 19.8)
-49.3
(-56.2 to -42.3)
-53.9
(-59.8 to -48.0)
-57.7
(-63.5 to -51.8)
5.Secondary Outcome
Title Proportion of Participants With LDL-C Greater Than 80% of Baseline Value at Day 180
Hide Description

Proportion of participants with LDL-C greater than 80% of baseline value at Day 180 was calculated to evaluate the effect of inclisiran until Day 180.

Subjects are counted if the LDL-C value is greater than '0.8*(LDL-C at Baseline - LDL-C at Day180) + LDL-C at Day180', or the LDL-C value is greater than or equal to the LDL-C at Baseline.

Time Frame Baseline, Day 180
Hide Outcome Measure Data
Hide Analysis Population Description
The overall number of participants analyzed represents the participants in the Full Analysis Set (FAS) who had valid LDL-C value for both, baseline and day 180
Arm/Group Title Placebo 100 mg Inclisiran Sodium 200 mg Inclisiran Sodium 300 mg Inclisiran Sodium
Hide Arm/Group Description:
Placebo subcutaneous injection
100 mg inclisiran sodium (equivalent to 94.5 mg inclisiran) subcutaneous injection
200 mg inclisiran sodium (equivalent to 189 mg inclisiran) subcutaneous injection
300 mg inclisiran sodium (equivalent to 284 mg inclisiran) subcutaneous injection
Overall Number of Participants Analyzed 56 55 101 96
Measure Type: Count of Participants
Unit of Measure: Participants
35
  62.5%
0
   0.0%
0
   0.0%
0
   0.0%
6.Secondary Outcome
Title Proportion of Participants With Greater or Equal to 50% LDL-C Reduction From Baseline by Visit
Hide Description Proportion of participants with greater or equal to 50% LDL-C reduction from baseline was calculated to evaluate the effect of inclisiran over time.
Time Frame Baseline, day 14, day 30, day 60, day 90, day 104, day 120, day 150, and day 180
Hide Outcome Measure Data
Hide Analysis Population Description

The overall number of participants analyzed represents the participants in the Full Analysis Set (FAS) who had at least one valid measurement of LDL-C.

The number analyzed per row represents the participants with a valid LDL-C value for both, baseline and that particular visit.

Arm/Group Title Placebo 100 mg Inclisiran Sodium 200 mg Inclisiran Sodium 300 mg Inclisiran Sodium
Hide Arm/Group Description:
Placebo subcutaneous injection
100 mg inclisiran sodium (equivalent to 94.5 mg inclisiran) subcutaneous injection
200 mg inclisiran sodium (equivalent to 189 mg inclisiran) subcutaneous injection
300 mg inclisiran sodium (equivalent to 284 mg inclisiran) subcutaneous injection
Overall Number of Participants Analyzed 57 55 101 98
Measure Type: Count of Participants
Unit of Measure: Participants
Day 14 Number Analyzed 57 participants 55 participants 101 participants 98 participants
1
   1.8%
17
  30.9%
40
  39.6%
45
  45.9%
Day 30 Number Analyzed 57 participants 55 participants 101 participants 98 participants
0
   0.0%
31
  56.4%
63
  62.4%
83
  84.7%
Day 60 Number Analyzed 57 participants 55 participants 101 participants 98 participants
0
   0.0%
26
  47.3%
64
  63.4%
75
  76.5%
Day 90 Number Analyzed 57 participants 55 participants 101 participants 97 participants
0
   0.0%
22
  40.0%
58
  57.4%
76
  78.4%
Day 104 Number Analyzed 57 participants 55 participants 101 participants 96 participants
0
   0.0%
32
  58.2%
77
  76.2%
82
  85.4%
Day 120 Number Analyzed 55 participants 55 participants 101 participants 95 participants
0
   0.0%
37
  67.3%
72
  71.3%
82
  86.3%
Day 150 Number Analyzed 56 participants 55 participants 101 participants 96 participants
0
   0.0%
35
  63.6%
73
  72.3%
78
  81.3%
Day 180 Number Analyzed 56 participants 55 participants 101 participants 96 participants
0
   0.0%
33
  60.0%
68
  67.3%
73
  76.0%
7.Secondary Outcome
Title Percent Change From Baseline in Cholesterol by Visit
Hide Description Percent change from baseline in cholesterol by visit was calculated to evaluate the effect of inclisiran over time
Time Frame Baseline, day 14, day 30, day 60, day 90, day 104, day 120, day 150, and day 180
Hide Outcome Measure Data
Hide Analysis Population Description

The overall number of participants analyzed represents the participants in the Full Analysis Set (FAS) who had at least one valid measurement of cholesterol.

The number analyzed per row represents the participants with a valid cholesterol value for both, baseline and that particular visit.

Arm/Group Title Placebo 100 mg Inclisiran Sodium 200 mg Inclisiran Sodium 300 mg Inclisiran Sodium
Hide Arm/Group Description:
Placebo subcutaneous injection
100 mg inclisiran sodium (equivalent to 94.5 mg inclisiran) subcutaneous injection
200 mg inclisiran sodium (equivalent to 189 mg inclisiran) subcutaneous injection
300 mg inclisiran sodium (equivalent to 284 mg inclisiran) subcutaneous injection
Overall Number of Participants Analyzed 57 55 101 98
Mean (Standard Deviation)
Unit of Measure: Percent change in cholesterol
Day 14 Number Analyzed 57 participants 55 participants 101 participants 98 participants
0.87  (10.399) -21.94  (14.034) -24.71  (12.917) -28.60  (12.476)
Day 30 Number Analyzed 57 participants 55 participants 101 participants 98 participants
0.89  (9.003) -30.92  (12.558) -32.90  (11.739) -37.09  (10.227)
Day 60 Number Analyzed 57 participants 55 participants 101 participants 98 participants
0.31  (8.885) -29.47  (13.426) -33.71  (12.291) -37.01  (9.948)
Day 90 Number Analyzed 57 participants 55 participants 101 participants 97 participants
1.03  (8.952) -27.30  (13.127) -32.26  (12.103) -36.34  (10.655)
Day 104 Number Analyzed 57 participants 55 participants 101 participants 96 participants
1.62  (10.178) -30.72  (13.239) -35.63  (11.875) -39.53  (10.468)
Day 120 Number Analyzed 55 participants 55 participants 101 participants 95 participants
1.11  (10.860) -32.24  (13.575) -36.24  (12.995) -39.38  (10.165)
Day 150 Number Analyzed 56 participants 55 participants 101 participants 96 participants
2.41  (10.801) -32.20  (14.246) -35.70  (11.980) -38.12  (10.850)
Day 180 Number Analyzed 56 participants 55 participants 101 participants 96 participants
2.78  (10.272) -30.22  (12.468) -32.95  (12.540) -35.46  (11.941)
8.Secondary Outcome
Title Percent Change From Baseline in Triglycerides by Visit
Hide Description Percent change from baseline in triglycerides by visit was calculated to evaluate the effect of inclisiran over time
Time Frame Baseline, day 14, day 30, day 60, day 90, day 104, day 120, day 150, and day 180
Hide Outcome Measure Data
Hide Analysis Population Description

The overall number of participants analyzed represents the participants in the Full Analysis Set (FAS) who had at least one valid measurement of triglycerides.

The number analyzed per row represents the participants with a valid triglycerides value for both, baseline and that particular visit.

Arm/Group Title Placebo 100 mg Inclisiran Sodium 200 mg Inclisiran Sodium 300 mg Inclisiran Sodium
Hide Arm/Group Description:
Placebo subcutaneous injection
100 mg inclisiran sodium (equivalent to 94.5 mg inclisiran) subcutaneous injection
200 mg inclisiran sodium (equivalent to 189 mg inclisiran) subcutaneous injection
300 mg inclisiran sodium (equivalent to 284 mg inclisiran) subcutaneous injection
Overall Number of Participants Analyzed 57 55 101 98
Mean (Standard Deviation)
Unit of Measure: percent change in triglycerides
Day 14 Number Analyzed 57 participants 55 participants 101 participants 98 participants
5.49  (28.803) 1.24  (29.630) -1.16  (51.241) -7.19  (23.817)
Day 30 Number Analyzed 57 participants 55 participants 101 participants 98 participants
7.76  (35.248) -4.72  (25.843) -8.69  (25.450) -8.37  (28.240)
Day 60 Number Analyzed 57 participants 55 participants 101 participants 98 participants
9.68  (37.000) -7.17  (28.427) -9.26  (27.598) -9.93  (26.405)
Day 90 Number Analyzed 57 participants 55 participants 101 participants 97 participants
6.83  (33.204) -1.87  (40.499) -12.17  (26.204) -9.99  (29.230)
Day 104 Number Analyzed 57 participants 55 participants 101 participants 96 participants
11.86  (37.365) -7.12  (26.145) -5.81  (55.419) -13.51  (26.915)
Day 120 Number Analyzed 55 participants 55 participants 101 participants 95 participants
3.57  (33.870) -9.40  (27.192) -9.32  (33.471) -12.33  (26.280)
Day 150 Number Analyzed 56 participants 55 participants 101 participants 96 participants
3.33  (32.023) -5.60  (42.988) -12.65  (24.766) -11.81  (28.623)
Day 180 Number Analyzed 56 participants 55 participants 101 participants 96 participants
-0.19  (32.161) -2.34  (33.783) -12.11  (39.414) -13.67  (27.307)
9.Secondary Outcome
Title Percent Change From Baseline in HDL Cholesterol by Visit
Hide Description Percent change from baseline in high-density lipoprotein cholesterol (HDL-C) by visit was calculated to evaluate the effect of inclisiran over time
Time Frame Baseline, day 14, day 30, day 60, day 90, day 104, day 120, day 150, and day 180
Hide Outcome Measure Data
Hide Analysis Population Description

The overall number of participants analyzed represents the participants in the Full Analysis Set (FAS) who had at least one valid measurement of HDL Cholesterol.

The number analyzed per row represents the participants with a valid HDL Cholesterol value for both, baseline and that particular visit.

Arm/Group Title Placebo 100 mg Inclisiran Sodium 200 mg Inclisiran Sodium 300 mg Inclisiran Sodium
Hide Arm/Group Description:
Placebo subcutaneous injection
100 mg inclisiran sodium (equivalent to 94.5 mg inclisiran) subcutaneous injection
200 mg inclisiran sodium (equivalent to 189 mg inclisiran) subcutaneous injection
300 mg inclisiran sodium (equivalent to 284 mg inclisiran) subcutaneous injection
Overall Number of Participants Analyzed 57 55 101 98
Mean (Standard Deviation)
Unit of Measure: percent change in HDL Cholesterol
Day 14 Number Analyzed 57 participants 55 participants 101 participants 98 participants
1.73  (8.765) 3.00  (10.745) 5.93  (12.164) 4.38  (10.727)
Day 30 Number Analyzed 57 participants 55 participants 101 participants 98 participants
1.94  (11.259) 4.86  (10.450) 9.89  (13.656) 8.43  (12.740)
Day 60 Number Analyzed 57 participants 55 participants 101 participants 98 participants
0.57  (10.677) 6.80  (15.222) 8.02  (15.411) 9.15  (14.984)
Day 90 Number Analyzed 57 participants 55 participants 101 participants 97 participants
0.56  (11.543) 6.51  (16.297) 10.86  (16.359) 8.59  (16.546)
Day 104 Number Analyzed 57 participants 55 participants 101 participants 96 participants
1.35  (14.817) 8.69  (15.303) 11.04  (16.443) 8.99  (17.280)
Day 120 Number Analyzed 55 participants 55 participants 101 participants 95 participants
4.20  (13.747) 8.84  (13.432) 12.65  (16.777) 11.97  (18.300)
Day 150 Number Analyzed 56 participants 55 participants 101 participants 96 participants
5.12  (13.587) 7.51  (17.455) 12.80  (16.337) 11.68  (18.486)
Day 180 Number Analyzed 56 participants 55 participants 101 participants 96 participants
8.25  (12.940) 6.89  (17.051) 15.95  (17.025) 14.26  (20.158)
10.Secondary Outcome
Title Percent Change From Baseline in Non-HDL Cholesterol by Visit
Hide Description Percent change from baseline in non-HDL Cholesterol by visit was calculated to evaluate the effect of inclisiran over time
Time Frame Baseline, day 14, day 30, day 60, day 90, day 104, day 120, day 150, and day 180
Hide Outcome Measure Data
Hide Analysis Population Description

The overall number of participants analyzed represents the participants in the Full Analysis Set (FAS) who had at least one valid measurement of non-HDL Cholesterol.

The number analyzed per row represents the participants with a valid non-HDL Cholesterol value for both, baseline and that particular visit.

Arm/Group Title Placebo 100 mg Inclisiran Sodium 200 mg Inclisiran Sodium 300 mg Inclisiran Sodium
Hide Arm/Group Description:
Placebo subcutaneous injection
100 mg inclisiran sodium (equivalent to 94.5 mg inclisiran) subcutaneous injection
200 mg inclisiran sodium (equivalent to 189 mg inclisiran) subcutaneous injection
300 mg inclisiran sodium (equivalent to 284 mg inclisiran) subcutaneous injection
Overall Number of Participants Analyzed 57 55 101 98
Mean (Standard Deviation)
Unit of Measure: percent change in non-HDL Cholesterol
Day 14 Number Analyzed 57 participants 55 participants 101 participants 98 participants
1.13  (13.511) -31.37  (19.592) -35.68  (18.056) -41.16  (17.005)
Day 30 Number Analyzed 57 participants 55 participants 101 participants 98 participants
1.03  (11.483) -44.72  (16.270) -47.99  (15.318) -54.17  (12.815)
Day 60 Number Analyzed 57 participants 55 participants 101 participants 98 participants
0.62  (11.841) -43.39  (16.505) -48.18  (15.146) -54.10  (12.034)
Day 90 Number Analyzed 57 participants 55 participants 101 participants 97 participants
1.75  (11.931) -39.83  (16.485) -47.20  (15.002) -53.18  (13.236)
Day 104 Number Analyzed 57 participants 55 participants 101 participants 96 participants
1.96  (12.067) -46.10  (17.006) -51.98  (14.344) -57.74  (12.513)
Day 120 Number Analyzed 55 participants 55 participants 101 participants 95 participants
0.82  (14.045) -48.22  (17.301) -53.52  (15.425) -58.67  (12.175)
Day 150 Number Analyzed 56 participants 55 participants 101 participants 96 participants
1.96  (13.519) -47.90  (17.495) -52.85  (14.254) -56.82  (12.997)
Day 180 Number Analyzed 56 participants 55 participants 101 participants 96 participants
1.29  (13.455) -44.83  (15.558) -50.15  (16.446) -54.04  (14.230)
11.Secondary Outcome
Title Percent Change From Baseline in VLDL-C by Visit
Hide Description Percent change from baseline in very low-density lipoprotein cholesterol (VLDL - C) by visit was calculated to evaluate the effect of inclisiran over time
Time Frame Baseline, day 14, day 30, day 60, day 90, day 104, day 120, day 150, and day 180
Hide Outcome Measure Data
Hide Analysis Population Description

The overall number of participants analyzed represents the participants in the Full Analysis Set (FAS) who had at least one valid measurement of VLDL-C.

The number analyzed per row represents the participants with a valid VLDL-C value for both, baseline and that particular visit.

Arm/Group Title Placebo 100 mg Inclisiran Sodium 200 mg Inclisiran Sodium 300 mg Inclisiran Sodium
Hide Arm/Group Description:
Placebo subcutaneous injection
100 mg inclisiran sodium (equivalent to 94.5 mg inclisiran) subcutaneous injection
200 mg inclisiran sodium (equivalent to 189 mg inclisiran) subcutaneous injection
300 mg inclisiran sodium (equivalent to 284 mg inclisiran) subcutaneous injection
Overall Number of Participants Analyzed 57 55 101 98
Mean (Standard Deviation)
Unit of Measure: percent change in VLDL-C
Day 14 Number Analyzed 57 participants 55 participants 101 participants 98 participants
5.55  (28.428) -2.96  (31.885) -5.56  (43.055) -12.41  (25.589)
Day 30 Number Analyzed 57 participants 55 participants 101 participants 98 participants
6.69  (33.655) -9.01  (28.560) -13.39  (28.081) -14.74  (30.582)
Day 60 Number Analyzed 57 participants 55 participants 101 participants 98 participants
9.40  (36.824) -10.27  (32.555) -14.02  (28.944) -17.94  (25.358)
Day 90 Number Analyzed 57 participants 55 participants 101 participants 97 participants
6.53  (33.387) -5.39  (41.490) -16.70  (26.127) -15.76  (27.957)
Day 104 Number Analyzed 57 participants 55 participants 101 participants 96 participants
11.56  (37.588) -12.10  (28.575) -12.54  (45.978) -24.05  (26.076)
Day 120 Number Analyzed 55 participants 55 participants 101 participants 95 participants
3.10  (33.707) -15.90  (30.271) -14.05  (36.083) -22.29  (24.030)
Day 150 Number Analyzed 56 participants 55 participants 101 participants 96 participants
3.41  (31.791) -10.91  (45.835) -17.49  (27.270) -18.39  (30.321)
Day 180 Number Analyzed 56 participants 55 participants 101 participants 96 participants
-0.30  (31.345) -7.30  (33.946) -17.89  (33.050) -21.74  (27.746)
12.Secondary Outcome
Title Percent Change From Baseline in Apo- A1 by Visit
Hide Description Percent change from baseline in Apolipoprotein A1 (Apo-A1) by visit was calculated to evaluate the effect of inclisiran over time
Time Frame Baseline, day 14, day 30, day 60, day 90, day 104, day 120, day 150, and day 180
Hide Outcome Measure Data
Hide Analysis Population Description

The overall number of participants analyzed represents the participants in the Full Analysis Set (FAS) who had at least one valid measurement of Apo-A1.

The number analyzed per row represents the participants with a valid Apo-A1 value for both, baseline and that particular visit.

Arm/Group Title Placebo 100 mg Inclisiran Sodium 200 mg Inclisiran Sodium 300 mg Inclisiran Sodium
Hide Arm/Group Description:
Placebo subcutaneous injection
100 mg inclisiran sodium (equivalent to 94.5 mg inclisiran) subcutaneous injection
200 mg inclisiran sodium (equivalent to 189 mg inclisiran) subcutaneous injection
300 mg inclisiran sodium (equivalent to 284 mg inclisiran) subcutaneous injection
Overall Number of Participants Analyzed 57 55 101 98
Mean (Standard Deviation)
Unit of Measure: percent change in Apo-A1
Day 14 Number Analyzed 57 participants 55 participants 101 participants 98 participants
0.04  (8.872) 3.64  (9.293) 2.29  (7.659) 3.98  (7.952)
Day 30 Number Analyzed 57 participants 55 participants 101 participants 98 participants
0.90  (9.713) 2.70  (10.553) 4.52  (9.302) 4.35  (9.012)
Day 60 Number Analyzed 57 participants 55 participants 101 participants 98 participants
0.00  (8.501) 4.71  (11.785) 3.89  (10.196) 5.18  (10.023)
Day 90 Number Analyzed 57 participants 55 participants 101 participants 97 participants
-0.35  (9.888) 3.86  (11.353) 5.71  (10.609) 5.21  (10.383)
Day 104 Number Analyzed 57 participants 55 participants 101 participants 96 participants
0.14  (10.780) 5.89  (13.922) 5.66  (11.007) 4.99  (10.061)
Day 120 Number Analyzed 55 participants 55 participants 101 participants 95 participants
1.79  (10.707) 5.33  (12.293) 6.49  (11.334) 6.60  (11.152)
Day 150 Number Analyzed 56 participants 55 participants 101 participants 96 participants
3.70  (11.571) 4.85  (14.330) 7.46  (11.582) 8.35  (12.564)
Day 180 Number Analyzed 56 participants 55 participants 101 participants 96 participants
6.09  (11.862) 4.99  (14.170) 10.26  (12.250) 9.09  (13.871)
13.Secondary Outcome
Title Percent Change From Baseline in Apo- B by Visit
Hide Description Percent change from baseline in Apolipoprotein B (Apo-B) by visit was calculated to evaluate the effect of inclisiran over time
Time Frame Baseline, day 14, day 30, day 60, day 90, day 104, day 120, day 150, and day 180
Hide Outcome Measure Data
Hide Analysis Population Description

The overall number of participants analyzed represents the participants in the Full Analysis Set (FAS) who had at least one valid measurement of Apo-B.

The number analyzed per row represents the participants with a valid Apo-B value for both, baseline and that particular visit.

Arm/Group Title Placebo 100 mg Inclisiran Sodium 200 mg Inclisiran Sodium 300 mg Inclisiran Sodium
Hide Arm/Group Description:
Placebo subcutaneous injection
100 mg inclisiran sodium (equivalent to 94.5 mg inclisiran) subcutaneous injection
200 mg inclisiran sodium (equivalent to 189 mg inclisiran) subcutaneous injection
300 mg inclisiran sodium (equivalent to 284 mg inclisiran) subcutaneous injection
Overall Number of Participants Analyzed 57 55 101 98
Mean (Standard Deviation)
Unit of Measure: percent change in Apo-B
Day 14 Number Analyzed 57 participants 55 participants 101 participants 98 participants
1.09  (13.795) -28.16  (16.442) -32.45  (17.518) -37.12  (16.743)
Day 30 Number Analyzed 57 participants 55 participants 101 participants 98 participants
2.16  (12.904) -39.72  (14.749) -43.99  (15.185) -48.76  (12.962)
Day 60 Number Analyzed 57 participants 55 participants 101 participants 98 participants
1.41  (11.965) -39.94  (13.996) -44.49  (14.654) -48.53  (12.005)
Day 90 Number Analyzed 57 participants 55 participants 101 participants 97 participants
2.76  (12.882) -35.84  (14.134) -42.04  (14.319) -46.78  (12.611)
Day 104 Number Analyzed 57 participants 55 participants 101 participants 96 participants
3.03  (13.304) -40.86  (14.578) -47.03  (13.283) -51.93  (12.390)
Day 120 Number Analyzed 55 participants 55 participants 101 participants 95 participants
2.05  (14.719) -43.39  (14.174) -48.18  (14.142) -51.85  (12.414)
Day 150 Number Analyzed 56 participants 55 participants 101 participants 96 participants
3.86  (13.559) -42.82  (14.799) -46.71  (13.775) -50.41  (12.411)
Day 180 Number Analyzed 56 participants 55 participants 101 participants 96 participants
3.82  (14.649) -38.63  (13.265) -44.50  (14.685) -46.81  (13.968)
14.Secondary Outcome
Title Percent Change From Baseline in Lipoprotein-a by Visit
Hide Description Percent change from baseline in Lipoprotein a (LP(a)) by visit was calculated to evaluate the effect of inclisiran over time
Time Frame Baseline, day 14, day 30, day 60, day 90, day 104, day 120, day 150, and day 180
Hide Outcome Measure Data
Hide Analysis Population Description

The overall number of participants analyzed represents the participants in the Full Analysis Set (FAS) who had at least one valid measurement of LP(a).

The number analyzed per row represents the participants with a valid LP(a) value for both, baseline and that particular visit.

Arm/Group Title Placebo 100 mg Inclisiran Sodium 200 mg Inclisiran Sodium 300 mg Inclisiran Sodium
Hide Arm/Group Description:
Placebo subcutaneous injection
100 mg inclisiran sodium (equivalent to 94.5 mg inclisiran) subcutaneous injection
200 mg inclisiran sodium (equivalent to 189 mg inclisiran) subcutaneous injection
300 mg inclisiran sodium (equivalent to 284 mg inclisiran) subcutaneous injection
Overall Number of Participants Analyzed 57 55 101 98
Mean (Standard Deviation)
Unit of Measure: percent change in LP(a)
Day 14 Number Analyzed 57 participants 55 participants 101 participants 98 participants
3.33  (32.912) -21.77  (24.909) -16.63  (41.372) -22.84  (22.934)
Day 30 Number Analyzed 57 participants 55 participants 101 participants 98 participants
0.92  (31.643) -28.09  (21.846) -22.80  (46.679) -31.30  (26.785)
Day 60 Number Analyzed 57 participants 55 participants 101 participants 98 participants
-4.29  (30.944) -30.89  (26.802) -26.11  (45.964) -36.21  (22.036)
Day 90 Number Analyzed 57 participants 55 participants 101 participants 97 participants
4.35  (29.270) -27.08  (25.260) -24.93  (42.005) -34.26  (25.027)
Day 104 Number Analyzed 57 participants 55 participants 101 participants 96 participants
-2.41  (26.326) -32.02  (30.286) -25.99  (45.444) -37.92  (30.801)
Day 120 Number Analyzed 55 participants 55 participants 101 participants 95 participants
0.22  (23.786) -31.46  (27.979) -30.26  (37.382) -37.24  (25.389)
Day 150 Number Analyzed 56 participants 55 participants 101 participants 96 participants
4.02  (32.703) -32.21  (26.140) -21.59  (47.820) -38.11  (24.508)
Day 180 Number Analyzed 56 participants 55 participants 101 participants 96 participants
5.45  (36.446) -30.15  (25.578) -25.46  (48.279) -35.41  (25.123)
15.Secondary Outcome
Title Proportion of Participants Who Attain Lipid Control Target Pre-specified by JAS 2017 Guidelines for Their Level of Cardiovascular Risk at Day 180
Hide Description Proportion of participants who attain lipid control target pre-specified by Japan Atherosclerosis Society(JAS) 2017 guidelines for their level of cardiovascular risk at Day 180 was calculated to evaluate the effect of inclisiran.
Time Frame Day 180
Hide Outcome Measure Data
Hide Analysis Population Description
The overall number of participants analyzed represents the participants in the Full Analysis Set (FAS) who had at least one valid measurement of LDL-C at Day 180
Arm/Group Title Placebo 100 mg Inclisiran Sodium 200 mg Inclisiran Sodium 300 mg Inclisiran Sodium
Hide Arm/Group Description:
Placebo subcutaneous injection
100 mg inclisiran sodium (equivalent to 94.5 mg inclisiran) subcutaneous injection
200 mg inclisiran sodium (equivalent to 189 mg inclisiran) subcutaneous injection
300 mg inclisiran sodium (equivalent to 284 mg inclisiran) subcutaneous injection
Overall Number of Participants Analyzed 56 55 101 96
Measure Type: Count of Participants
Unit of Measure: Participants
5
   8.9%
50
  90.9%
87
  86.1%
91
  94.8%
16.Secondary Outcome
Title Number of Participants With LDL-C Levels of <25 mg/dL, <50 mg/dL, <70 mg/dL, and <100 mg/dL by Visit
Hide Description Number of participants by LDL-C levels was calculated to evaluate the effect of inclisiran.
Time Frame Baseline, day 14, day 30, day 60, day 90, day 104, day 120, day 150, and day 180
Hide Outcome Measure Data
Hide Analysis Population Description

The overall number of participants analyzed represents the participants in the Full Analysis Set (FAS) who had at least one valid measurement of LDL-C.

The number analyzed per row represents the participants with a valid LDL-C at that particular visit.

Arm/Group Title Placebo 100 mg Inclisiran Sodium 200 mg Inclisiran Sodium 300 mg Inclisiran Sodium
Hide Arm/Group Description:
Placebo subcutaneous injection
100 mg inclisiran sodium (equivalent to 94.5 mg inclisiran) subcutaneous injection
200 mg inclisiran sodium (equivalent to 189 mg inclisiran) subcutaneous injection
300 mg inclisiran sodium (equivalent to 284 mg inclisiran) subcutaneous injection
Overall Number of Participants Analyzed 57 55 101 98
Measure Type: Count of Participants
Unit of Measure: Participants
Day 14: LDL-C <25 mg/dL Number Analyzed 57 participants 55 participants 101 participants 98 participants
0
   0.0%
1
   1.8%
5
   5.0%
10
  10.2%
Day 14: LDL-C <50 mg/dL Number Analyzed 57 participants 55 participants 101 participants 98 participants
1
   1.8%
19
  34.5%
38
  37.6%
43
  43.9%
Day 14: LDL-C <70 mg/dL Number Analyzed 57 participants 55 participants 101 participants 98 participants
3
   5.3%
29
  52.7%
56
  55.4%
66
  67.3%
Day 14: LDL-C <100 mg/dL Number Analyzed 57 participants 55 participants 101 participants 98 participants
22
  38.6%
45
  81.8%
81
  80.2%
86
  87.8%
Day 30: LDL-C <25 mg/dL Number Analyzed 57 participants 55 participants 101 participants 98 participants
0
   0.0%
6
  10.9%
14
  13.9%
20
  20.4%
Day 30: LDL-C <50 mg/dL Number Analyzed 57 participants 55 participants 101 participants 98 participants
0
   0.0%
30
  54.5%
56
  55.4%
71
  72.4%
Day 30: LDL-C <70 mg/dL Number Analyzed 57 participants 55 participants 101 participants 98 participants
3
   5.3%
40
  72.7%
74
  73.3%
80
  81.6%
Day 30: LDL-C <100 mg/dL Number Analyzed 57 participants 55 participants 101 participants 98 participants
22
  38.6%
51
  92.7%
93
  92.1%
94
  95.9%
Day 60: LDL-C <25 mg/dL Number Analyzed 57 participants 55 participants 101 participants 98 participants
0
   0.0%
6
  10.9%
14
  13.9%
23
  23.5%
Day 60: LDL-C <50 mg/dL Number Analyzed 57 participants 55 participants 101 participants 98 participants
0
   0.0%
28
  50.9%
57
  56.4%
70
  71.4%
Day 60: LDL-C <70 mg/dL Number Analyzed 57 participants 55 participants 101 participants 98 participants
5
   8.8%
37
  67.3%
77
  76.2%
79
  80.6%
Day 60: LDL-C <100 mg/dL Number Analyzed 57 participants 55 participants 101 participants 98 participants
21
  36.8%
50
  90.9%
92
  91.1%
92
  93.9%
Day 90: LDL-C <25 mg/dL Number Analyzed 57 participants 55 participants 101 participants 97 participants
0
   0.0%
2
   3.6%
12
  11.9%
21
  21.6%
Day 90: LDL-C <50 mg/dL Number Analyzed 57 participants 55 participants 101 participants 97 participants
0
   0.0%
27
  49.1%
51
  50.5%
67
  69.1%
Day 90: LDL-C <70 mg/dL Number Analyzed 57 participants 55 participants 101 participants 97 participants
1
   1.8%
35
  63.6%
74
  73.3%
80
  82.5%
Day 90: LDL-C <100 mg/dL Number Analyzed 57 participants 55 participants 101 participants 97 participants
24
  42.1%
49
  89.1%
93
  92.1%
94
  96.9%
Day 104: LDL-C <25 mg/dL Number Analyzed 57 participants 55 participants 101 participants 96 participants
0
   0.0%
6
  10.9%
22
  21.8%
27
  28.1%
Day 104: LDL-C <50 mg/dL Number Analyzed 57 participants 55 participants 101 participants 96 participants
0
   0.0%
30
  54.5%
64
  63.4%
70
  72.9%
Day 104: LDL-C <70 mg/dL Number Analyzed 57 participants 55 participants 101 participants 96 participants
4
   7.0%
38
  69.1%
82
  81.2%
80
  83.3%
Day 104: LDL-C <100 mg/dL Number Analyzed 57 participants 55 participants 101 participants 96 participants
25
  43.9%
52
  94.5%
95
  94.1%
92
  95.8%
Day 120: LDL-C <25 mg/dL Number Analyzed 55 participants 55 participants 101 participants 95 participants
0
   0.0%
9
  16.4%
25
  24.8%
32
  33.7%
Day 120: LDL-C <50 mg/dL Number Analyzed 55 participants 55 participants 101 participants 95 participants
0
   0.0%
32
  58.2%
64
  63.4%
70
  73.7%
Day 120: LDL-C <70 mg/dL Number Analyzed 55 participants 55 participants 101 participants 95 participants
3
   5.5%
39
  70.9%
82
  81.2%
81
  85.3%
Day 120: LDL-C <100 mg/dL Number Analyzed 55 participants 55 participants 101 participants 95 participants
24
  43.6%
53
  96.4%
95
  94.1%
91
  95.8%
Day 150: LDL-C <25 mg/dL Number Analyzed 56 participants 55 participants 101 participants 96 participants
0
   0.0%
5
   9.1%
24
  23.8%
31
  32.3%
Day 150: LDL-C <50 mg/dL Number Analyzed 56 participants 55 participants 101 participants 96 participants
0
   0.0%
32
  58.2%
67
  66.3%
71
  74.0%
Day 150: LDL-C <70 mg/dL Number Analyzed 56 participants 55 participants 101 participants 96 participants
2
   3.6%
41
  74.5%
81
  80.2%
81
  84.4%
Day 150: LDL-C <100 mg/dL Number Analyzed 56 participants 55 participants 101 participants 96 participants
23
  41.1%
52
  94.5%
95
  94.1%
93
  96.9%
Day 180: LDL-C <25 mg/dL Number Analyzed 56 participants 55 participants 101 participants 96 participants
0
   0.0%
7
  12.7%
13
  12.9%
26
  27.1%
Day 180: LDL-C <50 mg/dL Number Analyzed 56 participants 55 participants 101 participants 96 participants
0
   0.0%
30
  54.5%
56
  55.4%
65
  67.7%
Day 180: LDL-C <70 mg/dL Number Analyzed 56 participants 55 participants 101 participants 96 participants
2
   3.6%
40
  72.7%
78
  77.2%
80
  83.3%
Day 180: LDL-C <100 mg/dL Number Analyzed 56 participants 55 participants 101 participants 96 participants
22
  39.3%
54
  98.2%
94
  93.1%
90
  93.8%
Time Frame Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Inclisiran 100 mg Inclisiran 200 mg Inclisiran 300 mg
Hide Arm/Group Description Placebo subcutaneous injection 100 mg inclisiran sodium (equivalent to 94.5 mg inclisiran) subcutaneous injection 200 mg inclisiran sodium (equivalent to 189 mg inclisiran) subcutaneous injection 300 mg inclisiran sodium (equivalent to 284 mg inclisiran) subcutaneous injection
All-Cause Mortality
Placebo Inclisiran 100 mg Inclisiran 200 mg Inclisiran 300 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/57 (1.75%)   0/55 (0.00%)   0/101 (0.00%)   0/99 (0.00%) 
Hide Serious Adverse Events
Placebo Inclisiran 100 mg Inclisiran 200 mg Inclisiran 300 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   6/57 (10.53%)   2/55 (3.64%)   7/101 (6.93%)   7/99 (7.07%) 
Cardiac disorders         
Angina pectoris  1  0/57 (0.00%)  0/55 (0.00%)  1/101 (0.99%)  0/99 (0.00%) 
Angina unstable  1  1/57 (1.75%)  1/55 (1.82%)  0/101 (0.00%)  1/99 (1.01%) 
Cardiac failure congestive  1  0/57 (0.00%)  0/55 (0.00%)  0/101 (0.00%)  1/99 (1.01%) 
Ventricular extrasystoles  1  0/57 (0.00%)  0/55 (0.00%)  0/101 (0.00%)  1/99 (1.01%) 
Eye disorders         
Epiretinal membrane  1  0/57 (0.00%)  0/55 (0.00%)  1/101 (0.99%)  0/99 (0.00%) 
Vitreous haemorrhage  1  1/57 (1.75%)  0/55 (0.00%)  0/101 (0.00%)  0/99 (0.00%) 
Gastrointestinal disorders         
Pancreatitis acute  1  0/57 (0.00%)  0/55 (0.00%)  0/101 (0.00%)  1/99 (1.01%) 
General disorders         
Death  1  1/57 (1.75%)  0/55 (0.00%)  0/101 (0.00%)  0/99 (0.00%) 
Vascular stent stenosis  1  0/57 (0.00%)  0/55 (0.00%)  0/101 (0.00%)  1/99 (1.01%) 
Infections and infestations         
COVID-19  1  0/57 (0.00%)  0/55 (0.00%)  1/101 (0.99%)  0/99 (0.00%) 
COVID-19 pneumonia  1  0/57 (0.00%)  0/55 (0.00%)  0/101 (0.00%)  1/99 (1.01%) 
Infection  1  0/57 (0.00%)  0/55 (0.00%)  0/101 (0.00%)  1/99 (1.01%) 
Injury, poisoning and procedural complications         
Radius fracture  1  0/57 (0.00%)  1/55 (1.82%)  0/101 (0.00%)  0/99 (0.00%) 
Toxicity to various agents  1  1/57 (1.75%)  0/55 (0.00%)  0/101 (0.00%)  0/99 (0.00%) 
Wound dehiscence  1  1/57 (1.75%)  0/55 (0.00%)  0/101 (0.00%)  0/99 (0.00%) 
Metabolism and nutrition disorders         
Diabetes mellitus inadequate control  1  1/57 (1.75%)  0/55 (0.00%)  1/101 (0.99%)  0/99 (0.00%) 
Electrolyte imbalance  1  0/57 (0.00%)  0/55 (0.00%)  0/101 (0.00%)  1/99 (1.01%) 
Hyperglycaemia  1  0/57 (0.00%)  0/55 (0.00%)  1/101 (0.99%)  0/99 (0.00%) 
Musculoskeletal and connective tissue disorders         
Fracture pain  1  0/57 (0.00%)  0/55 (0.00%)  1/101 (0.99%)  0/99 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Bladder neoplasm  1  1/57 (1.75%)  0/55 (0.00%)  0/101 (0.00%)  0/99 (0.00%) 
Breast cancer  1  0/57 (0.00%)  0/55 (0.00%)  0/101 (0.00%)  1/99 (1.01%) 
Prostate cancer  1  0/57 (0.00%)  0/55 (0.00%)  0/101 (0.00%)  1/99 (1.01%) 
Nervous system disorders         
Embolic cerebral infarction  1  1/57 (1.75%)  0/55 (0.00%)  0/101 (0.00%)  0/99 (0.00%) 
Vascular disorders         
Peripheral artery occlusion  1  0/57 (0.00%)  0/55 (0.00%)  1/101 (0.99%)  0/99 (0.00%) 
1
Term from vocabulary, MedDRA (25.1)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Inclisiran 100 mg Inclisiran 200 mg Inclisiran 300 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   32/57 (56.14%)   38/55 (69.09%)   59/101 (58.42%)   59/99 (59.60%) 
Gastrointestinal disorders         
Diarrhoea  1  1/57 (1.75%)  4/55 (7.27%)  5/101 (4.95%)  1/99 (1.01%) 
General disorders         
Injection site reaction  1  2/57 (3.51%)  3/55 (5.45%)  12/101 (11.88%)  6/99 (6.06%) 
Malaise  1  6/57 (10.53%)  1/55 (1.82%)  2/101 (1.98%)  7/99 (7.07%) 
Pyrexia  1  7/57 (12.28%)  8/55 (14.55%)  12/101 (11.88%)  18/99 (18.18%) 
Vaccination site pain  1  8/57 (14.04%)  1/55 (1.82%)  5/101 (4.95%)  5/99 (5.05%) 
Infections and infestations         
COVID-19  1  2/57 (3.51%)  8/55 (14.55%)  5/101 (4.95%)  6/99 (6.06%) 
Herpes zoster  1  3/57 (5.26%)  1/55 (1.82%)  3/101 (2.97%)  0/99 (0.00%) 
Nasopharyngitis  1  3/57 (5.26%)  4/55 (7.27%)  6/101 (5.94%)  7/99 (7.07%) 
Injury, poisoning and procedural complications         
Contusion  1  3/57 (5.26%)  4/55 (7.27%)  3/101 (2.97%)  3/99 (3.03%) 
Investigations         
Blood creatine phosphokinase increased  1  4/57 (7.02%)  1/55 (1.82%)  3/101 (2.97%)  5/99 (5.05%) 
C-reactive protein increased  1  0/57 (0.00%)  1/55 (1.82%)  1/101 (0.99%)  5/99 (5.05%) 
Metabolism and nutrition disorders         
Diabetes mellitus  1  5/57 (8.77%)  11/55 (20.00%)  12/101 (11.88%)  12/99 (12.12%) 
Diabetes mellitus inadequate control  1  9/57 (15.79%)  7/55 (12.73%)  10/101 (9.90%)  15/99 (15.15%) 
Musculoskeletal and connective tissue disorders         
Arthralgia  1  4/57 (7.02%)  1/55 (1.82%)  2/101 (1.98%)  2/99 (2.02%) 
Back pain  1  5/57 (8.77%)  6/55 (10.91%)  3/101 (2.97%)  8/99 (8.08%) 
Pain in extremity  1  0/57 (0.00%)  1/55 (1.82%)  2/101 (1.98%)  5/99 (5.05%) 
Nervous system disorders         
Headache  1  5/57 (8.77%)  3/55 (5.45%)  3/101 (2.97%)  3/99 (3.03%) 
Hypoaesthesia  1  4/57 (7.02%)  0/55 (0.00%)  0/101 (0.00%)  0/99 (0.00%) 
1
Term from vocabulary, MedDRA (25.1)
Indicates events were collected by systematic assessment
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.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
Results Point of Contact
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Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: + 1 862 778 8300
EMail: Novartis.email@Novartis.com
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Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT04666298    
Other Study ID Numbers: CKJX839A11201
First Submitted: December 7, 2020
First Posted: December 14, 2020
Results First Submitted: April 17, 2023
Results First Posted: May 10, 2023
Last Update Posted: May 10, 2023