Trial Outcomes & Findings for Study of Efficacy and Safety of Inclisiran in Japanese Participants With High Cardiovascular Risk and Elevated LDL-C (NCT NCT04666298)
NCT ID: NCT04666298
Last Updated: 2024-06-20
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
312 participants
Primary outcome timeframe
Baseline, Day 180
Results posted on
2024-06-20
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo subcutaneous injection
|
100 mg Inclisiran Sodium
100 mg inclisiran sodium (equivalent to 94.5 mg inclisiran) subcutaneous injection
|
200 mg Inclisiran Sodium
200 mg inclisiran sodium (equivalent to 189 mg inclisiran) subcutaneous injection
|
300 mg Inclisiran Sodium
300 mg inclisiran sodium (equivalent to 284 mg inclisiran) subcutaneous injection
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
57
|
55
|
101
|
99
|
|
Overall Study
COMPLETED
|
55
|
55
|
100
|
95
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
1
|
4
|
Reasons for withdrawal
| Measure |
Placebo
Placebo subcutaneous injection
|
100 mg Inclisiran Sodium
100 mg inclisiran sodium (equivalent to 94.5 mg inclisiran) subcutaneous injection
|
200 mg Inclisiran Sodium
200 mg inclisiran sodium (equivalent to 189 mg inclisiran) subcutaneous injection
|
300 mg Inclisiran Sodium
300 mg inclisiran sodium (equivalent to 284 mg inclisiran) subcutaneous injection
|
|---|---|---|---|---|
|
Overall Study
Subject decision
|
1
|
0
|
0
|
2
|
|
Overall Study
Death
|
1
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
1
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
1
|
|
Overall Study
Protocol deviation
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Study of Efficacy and Safety of Inclisiran in Japanese Participants With High Cardiovascular Risk and Elevated LDL-C
Baseline characteristics by cohort
| Measure |
Placebo
n=57 Participants
Placebo subcutaneous injection
|
100 mg Inclisiran Sodium
n=55 Participants
100 mg inclisiran sodium (equivalent to 94.5 mg inclisiran) subcutaneous injection
|
200 mg Inclisiran Sodium
n=101 Participants
200 mg inclisiran sodium (equivalent to 189 mg inclisiran) subcutaneous injection
|
300 mg Inclisiran Sodium
n=99 Participants
300 mg inclisiran sodium (equivalent to 284 mg inclisiran) subcutaneous injection
|
Total
n=312 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
63.8 years
STANDARD_DEVIATION 11.12 • n=5 Participants
|
62.7 years
STANDARD_DEVIATION 9.25 • n=7 Participants
|
64.7 years
STANDARD_DEVIATION 10.57 • n=5 Participants
|
63.0 years
STANDARD_DEVIATION 10.66 • n=4 Participants
|
63.6 years
STANDARD_DEVIATION 10.46 • n=21 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
80 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
77 Participants
n=4 Participants
|
232 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Japanese
|
57 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
101 Participants
n=5 Participants
|
99 Participants
n=4 Participants
|
312 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline, Day 180Population: 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
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.
Outcome measures
| Measure |
Placebo
n=56 Participants
Placebo subcutaneous injection
|
100 mg Inclisiran Sodium
n=55 Participants
100 mg inclisiran sodium (equivalent to 94.5 mg inclisiran) subcutaneous injection
|
200 mg Inclisiran Sodium
n=101 Participants
200 mg inclisiran sodium (equivalent to 189 mg inclisiran) subcutaneous injection
|
300 mg Inclisiran Sodium
n=96 Participants
300 mg inclisiran sodium (equivalent to 284 mg inclisiran) subcutaneous injection
|
|---|---|---|---|---|
|
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) to Day 180
|
9.0 percent change in LDL-C
Interval 3.5 to 14.5
|
-47.6 percent change in LDL-C
Interval -53.4 to -41.8
|
-51.9 percent change in LDL-C
Interval -56.8 to -47.0
|
-56.3 percent change in LDL-C
Interval -61.1 to -51.4
|
SECONDARY outcome
Timeframe: Baseline, day 14, day 30, day 60, day 90, day 104, day 120, day 150, and day 180Population: 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.
Percent change from baseline in proprotein convertase subtilisin/kexin type 9 (PCSK9) was calculated to evaluate the effect of inclisiran over time.
Outcome measures
| Measure |
Placebo
n=57 Participants
Placebo subcutaneous injection
|
100 mg Inclisiran Sodium
n=55 Participants
100 mg inclisiran sodium (equivalent to 94.5 mg inclisiran) subcutaneous injection
|
200 mg Inclisiran Sodium
n=101 Participants
200 mg inclisiran sodium (equivalent to 189 mg inclisiran) subcutaneous injection
|
300 mg Inclisiran Sodium
n=98 Participants
300 mg inclisiran sodium (equivalent to 284 mg inclisiran) subcutaneous injection
|
|---|---|---|---|---|
|
Percent Change From Baseline in PCSK9 by Visit
Day 14
|
4.79 percent change in PCSK9
Standard Deviation 21.623
|
-55.42 percent change in PCSK9
Standard Deviation 19.980
|
-65.64 percent change in PCSK9
Standard Deviation 13.677
|
-69.56 percent change in PCSK9
Standard Deviation 11.387
|
|
Percent Change From Baseline in PCSK9 by Visit
Day 30
|
1.92 percent change in PCSK9
Standard Deviation 22.427
|
-66.45 percent change in PCSK9
Standard Deviation 12.341
|
-72.94 percent change in PCSK9
Standard Deviation 8.809
|
-76.46 percent change in PCSK9
Standard Deviation 8.561
|
|
Percent Change From Baseline in PCSK9 by Visit
Day 60
|
-0.16 percent change in PCSK9
Standard Deviation 22.656
|
-62.56 percent change in PCSK9
Standard Deviation 15.356
|
-73.23 percent change in PCSK9
Standard Deviation 10.692
|
-76.52 percent change in PCSK9
Standard Deviation 9.953
|
|
Percent Change From Baseline in PCSK9 by Visit
Day 90
|
2.12 percent change in PCSK9
Standard Deviation 21.447
|
-59.76 percent change in PCSK9
Standard Deviation 14.503
|
-70.49 percent change in PCSK9
Standard Deviation 10.806
|
-73.09 percent change in PCSK9
Standard Deviation 11.525
|
|
Percent Change From Baseline in PCSK9 by Visit
Day 104
|
2.65 percent change in PCSK9
Standard Deviation 28.624
|
-69.05 percent change in PCSK9
Standard Deviation 11.109
|
-76.23 percent change in PCSK9
Standard Deviation 9.017
|
-78.55 percent change in PCSK9
Standard Deviation 8.052
|
|
Percent Change From Baseline in PCSK9 by Visit
Day 120
|
0.99 percent change in PCSK9
Standard Deviation 21.572
|
-70.29 percent change in PCSK9
Standard Deviation 11.543
|
-77.03 percent change in PCSK9
Standard Deviation 8.206
|
-79.80 percent change in PCSK9
Standard Deviation 6.994
|
|
Percent Change From Baseline in PCSK9 by Visit
Day 150
|
2.34 percent change in PCSK9
Standard Deviation 23.353
|
-66.02 percent change in PCSK9
Standard Deviation 12.724
|
-73.94 percent change in PCSK9
Standard Deviation 17.139
|
-77.12 percent change in PCSK9
Standard Deviation 8.770
|
|
Percent Change From Baseline in PCSK9 by Visit
Day 180
|
2.78 percent change in PCSK9
Standard Deviation 21.226
|
-63.62 percent change in PCSK9
Standard Deviation 14.012
|
-70.99 percent change in PCSK9
Standard Deviation 10.495
|
-75.97 percent change in PCSK9
Standard Deviation 9.885
|
SECONDARY outcome
Timeframe: Baseline, day 14, day 30, day 60, day 90, day 104, day 120 and day 150Population: 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.
Percent change from baseline in low-density lipoprotein cholesterol (LDL-C) was calculated to evaluate the effect of inclisiran over time.
Outcome measures
| Measure |
Placebo
n=57 Participants
Placebo subcutaneous injection
|
100 mg Inclisiran Sodium
n=55 Participants
100 mg inclisiran sodium (equivalent to 94.5 mg inclisiran) subcutaneous injection
|
200 mg Inclisiran Sodium
n=101 Participants
200 mg inclisiran sodium (equivalent to 189 mg inclisiran) subcutaneous injection
|
300 mg Inclisiran Sodium
n=98 Participants
300 mg inclisiran sodium (equivalent to 284 mg inclisiran) subcutaneous injection
|
|---|---|---|---|---|
|
Percent Change From Baseline in LDL-C by Visit
Day 14
|
1.68 percent change in LDL-C
Standard Deviation 18.099
|
-37.15 percent change in LDL-C
Standard Deviation 21.855
|
-42.08 percent change in LDL-C
Standard Deviation 20.503
|
-47.60 percent change in LDL-C
Standard Deviation 19.889
|
|
Percent Change From Baseline in LDL-C by Visit
Day 30
|
1.29 percent change in LDL-C
Standard Deviation 13.068
|
-52.20 percent change in LDL-C
Standard Deviation 18.389
|
-55.54 percent change in LDL-C
Standard Deviation 17.501
|
-62.77 percent change in LDL-C
Standard Deviation 15.097
|
|
Percent Change From Baseline in LDL-C by Visit
Day 60
|
0.24 percent change in LDL-C
Standard Deviation 15.314
|
-50.06 percent change in LDL-C
Standard Deviation 19.173
|
-55.61 percent change in LDL-C
Standard Deviation 17.570
|
-62.35 percent change in LDL-C
Standard Deviation 13.976
|
|
Percent Change From Baseline in LDL-C by Visit
Day 90
|
2.69 percent change in LDL-C
Standard Deviation 14.332
|
-46.39 percent change in LDL-C
Standard Deviation 17.872
|
-53.92 percent change in LDL-C
Standard Deviation 17.186
|
-61.51 percent change in LDL-C
Standard Deviation 15.480
|
|
Percent Change From Baseline in LDL-C by Visit
Day 104
|
1.20 percent change in LDL-C
Standard Deviation 13.519
|
-53.00 percent change in LDL-C
Standard Deviation 19.001
|
-60.33 percent change in LDL-C
Standard Deviation 15.912
|
-65.68 percent change in LDL-C
Standard Deviation 15.321
|
|
Percent Change From Baseline in LDL-C by Visit
Day 120
|
2.26 percent change in LDL-C
Standard Deviation 14.854
|
-54.91 percent change in LDL-C
Standard Deviation 19.410
|
-62.04 percent change in LDL-C
Standard Deviation 16.742
|
-67.23 percent change in LDL-C
Standard Deviation 16.017
|
|
Percent Change From Baseline in LDL-C by Visit
Day 150
|
4.27 percent change in LDL-C
Standard Deviation 16.983
|
-55.46 percent change in LDL-C
Standard Deviation 18.817
|
-60.55 percent change in LDL-C
Standard Deviation 16.502
|
-66.15 percent change in LDL-C
Standard Deviation 15.197
|
SECONDARY outcome
Timeframe: Baseline, Day 180Population: 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
Absolute change from baseline in low-density lipoprotein cholesterol (LDL-C) was calculated to evaluate the effect of inclisiran until Day 180.
Outcome measures
| Measure |
Placebo
n=56 Participants
Placebo subcutaneous injection
|
100 mg Inclisiran Sodium
n=55 Participants
100 mg inclisiran sodium (equivalent to 94.5 mg inclisiran) subcutaneous injection
|
200 mg Inclisiran Sodium
n=101 Participants
200 mg inclisiran sodium (equivalent to 189 mg inclisiran) subcutaneous injection
|
300 mg Inclisiran Sodium
n=96 Participants
300 mg inclisiran sodium (equivalent to 284 mg inclisiran) subcutaneous injection
|
|---|---|---|---|---|
|
Absolute Change in LDL-C From Baseline at Day 180
|
13.2 mg/dL
Interval 6.6 to 19.8
|
-49.3 mg/dL
Interval -56.2 to -42.3
|
-53.9 mg/dL
Interval -59.8 to -48.0
|
-57.7 mg/dL
Interval -63.5 to -51.8
|
SECONDARY outcome
Timeframe: Baseline, Day 180Population: 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
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.
Outcome measures
| Measure |
Placebo
n=56 Participants
Placebo subcutaneous injection
|
100 mg Inclisiran Sodium
n=55 Participants
100 mg inclisiran sodium (equivalent to 94.5 mg inclisiran) subcutaneous injection
|
200 mg Inclisiran Sodium
n=101 Participants
200 mg inclisiran sodium (equivalent to 189 mg inclisiran) subcutaneous injection
|
300 mg Inclisiran Sodium
n=96 Participants
300 mg inclisiran sodium (equivalent to 284 mg inclisiran) subcutaneous injection
|
|---|---|---|---|---|
|
Proportion of Participants With LDL-C Greater Than 80% of Baseline Value at Day 180
|
35 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, day 14, day 30, day 60, day 90, day 104, day 120, day 150, and day 180Population: 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.
Proportion of participants with greater or equal to 50% LDL-C reduction from baseline was calculated to evaluate the effect of inclisiran over time.
Outcome measures
| Measure |
Placebo
n=57 Participants
Placebo subcutaneous injection
|
100 mg Inclisiran Sodium
n=55 Participants
100 mg inclisiran sodium (equivalent to 94.5 mg inclisiran) subcutaneous injection
|
200 mg Inclisiran Sodium
n=101 Participants
200 mg inclisiran sodium (equivalent to 189 mg inclisiran) subcutaneous injection
|
300 mg Inclisiran Sodium
n=98 Participants
300 mg inclisiran sodium (equivalent to 284 mg inclisiran) subcutaneous injection
|
|---|---|---|---|---|
|
Proportion of Participants With Greater or Equal to 50% LDL-C Reduction From Baseline by Visit
Day 14
|
1 Participants
|
17 Participants
|
40 Participants
|
45 Participants
|
|
Proportion of Participants With Greater or Equal to 50% LDL-C Reduction From Baseline by Visit
Day 30
|
0 Participants
|
31 Participants
|
63 Participants
|
83 Participants
|
|
Proportion of Participants With Greater or Equal to 50% LDL-C Reduction From Baseline by Visit
Day 60
|
0 Participants
|
26 Participants
|
64 Participants
|
75 Participants
|
|
Proportion of Participants With Greater or Equal to 50% LDL-C Reduction From Baseline by Visit
Day 90
|
0 Participants
|
22 Participants
|
58 Participants
|
76 Participants
|
|
Proportion of Participants With Greater or Equal to 50% LDL-C Reduction From Baseline by Visit
Day 104
|
0 Participants
|
32 Participants
|
77 Participants
|
82 Participants
|
|
Proportion of Participants With Greater or Equal to 50% LDL-C Reduction From Baseline by Visit
Day 120
|
0 Participants
|
37 Participants
|
72 Participants
|
82 Participants
|
|
Proportion of Participants With Greater or Equal to 50% LDL-C Reduction From Baseline by Visit
Day 150
|
0 Participants
|
35 Participants
|
73 Participants
|
78 Participants
|
|
Proportion of Participants With Greater or Equal to 50% LDL-C Reduction From Baseline by Visit
Day 180
|
0 Participants
|
33 Participants
|
68 Participants
|
73 Participants
|
SECONDARY outcome
Timeframe: Baseline, day 14, day 30, day 60, day 90, day 104, day 120, day 150, and day 180Population: 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.
Percent change from baseline in cholesterol by visit was calculated to evaluate the effect of inclisiran over time
Outcome measures
| Measure |
Placebo
n=57 Participants
Placebo subcutaneous injection
|
100 mg Inclisiran Sodium
n=55 Participants
100 mg inclisiran sodium (equivalent to 94.5 mg inclisiran) subcutaneous injection
|
200 mg Inclisiran Sodium
n=101 Participants
200 mg inclisiran sodium (equivalent to 189 mg inclisiran) subcutaneous injection
|
300 mg Inclisiran Sodium
n=98 Participants
300 mg inclisiran sodium (equivalent to 284 mg inclisiran) subcutaneous injection
|
|---|---|---|---|---|
|
Percent Change From Baseline in Cholesterol by Visit
Day 14
|
0.87 Percent change in cholesterol
Standard Deviation 10.399
|
-21.94 Percent change in cholesterol
Standard Deviation 14.034
|
-24.71 Percent change in cholesterol
Standard Deviation 12.917
|
-28.60 Percent change in cholesterol
Standard Deviation 12.476
|
|
Percent Change From Baseline in Cholesterol by Visit
Day 30
|
0.89 Percent change in cholesterol
Standard Deviation 9.003
|
-30.92 Percent change in cholesterol
Standard Deviation 12.558
|
-32.90 Percent change in cholesterol
Standard Deviation 11.739
|
-37.09 Percent change in cholesterol
Standard Deviation 10.227
|
|
Percent Change From Baseline in Cholesterol by Visit
Day 60
|
0.31 Percent change in cholesterol
Standard Deviation 8.885
|
-29.47 Percent change in cholesterol
Standard Deviation 13.426
|
-33.71 Percent change in cholesterol
Standard Deviation 12.291
|
-37.01 Percent change in cholesterol
Standard Deviation 9.948
|
|
Percent Change From Baseline in Cholesterol by Visit
Day 90
|
1.03 Percent change in cholesterol
Standard Deviation 8.952
|
-27.30 Percent change in cholesterol
Standard Deviation 13.127
|
-32.26 Percent change in cholesterol
Standard Deviation 12.103
|
-36.34 Percent change in cholesterol
Standard Deviation 10.655
|
|
Percent Change From Baseline in Cholesterol by Visit
Day 104
|
1.62 Percent change in cholesterol
Standard Deviation 10.178
|
-30.72 Percent change in cholesterol
Standard Deviation 13.239
|
-35.63 Percent change in cholesterol
Standard Deviation 11.875
|
-39.53 Percent change in cholesterol
Standard Deviation 10.468
|
|
Percent Change From Baseline in Cholesterol by Visit
Day 120
|
1.11 Percent change in cholesterol
Standard Deviation 10.860
|
-32.24 Percent change in cholesterol
Standard Deviation 13.575
|
-36.24 Percent change in cholesterol
Standard Deviation 12.995
|
-39.38 Percent change in cholesterol
Standard Deviation 10.165
|
|
Percent Change From Baseline in Cholesterol by Visit
Day 150
|
2.41 Percent change in cholesterol
Standard Deviation 10.801
|
-32.20 Percent change in cholesterol
Standard Deviation 14.246
|
-35.70 Percent change in cholesterol
Standard Deviation 11.980
|
-38.12 Percent change in cholesterol
Standard Deviation 10.850
|
|
Percent Change From Baseline in Cholesterol by Visit
Day 180
|
2.78 Percent change in cholesterol
Standard Deviation 10.272
|
-30.22 Percent change in cholesterol
Standard Deviation 12.468
|
-32.95 Percent change in cholesterol
Standard Deviation 12.540
|
-35.46 Percent change in cholesterol
Standard Deviation 11.941
|
SECONDARY outcome
Timeframe: Baseline, day 14, day 30, day 60, day 90, day 104, day 120, day 150, and day 180Population: 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.
Percent change from baseline in triglycerides by visit was calculated to evaluate the effect of inclisiran over time
Outcome measures
| Measure |
Placebo
n=57 Participants
Placebo subcutaneous injection
|
100 mg Inclisiran Sodium
n=55 Participants
100 mg inclisiran sodium (equivalent to 94.5 mg inclisiran) subcutaneous injection
|
200 mg Inclisiran Sodium
n=101 Participants
200 mg inclisiran sodium (equivalent to 189 mg inclisiran) subcutaneous injection
|
300 mg Inclisiran Sodium
n=98 Participants
300 mg inclisiran sodium (equivalent to 284 mg inclisiran) subcutaneous injection
|
|---|---|---|---|---|
|
Percent Change From Baseline in Triglycerides by Visit
Day 14
|
5.49 percent change in triglycerides
Standard Deviation 28.803
|
1.24 percent change in triglycerides
Standard Deviation 29.630
|
-1.16 percent change in triglycerides
Standard Deviation 51.241
|
-7.19 percent change in triglycerides
Standard Deviation 23.817
|
|
Percent Change From Baseline in Triglycerides by Visit
Day 30
|
7.76 percent change in triglycerides
Standard Deviation 35.248
|
-4.72 percent change in triglycerides
Standard Deviation 25.843
|
-8.69 percent change in triglycerides
Standard Deviation 25.450
|
-8.37 percent change in triglycerides
Standard Deviation 28.240
|
|
Percent Change From Baseline in Triglycerides by Visit
Day 60
|
9.68 percent change in triglycerides
Standard Deviation 37.000
|
-7.17 percent change in triglycerides
Standard Deviation 28.427
|
-9.26 percent change in triglycerides
Standard Deviation 27.598
|
-9.93 percent change in triglycerides
Standard Deviation 26.405
|
|
Percent Change From Baseline in Triglycerides by Visit
Day 90
|
6.83 percent change in triglycerides
Standard Deviation 33.204
|
-1.87 percent change in triglycerides
Standard Deviation 40.499
|
-12.17 percent change in triglycerides
Standard Deviation 26.204
|
-9.99 percent change in triglycerides
Standard Deviation 29.230
|
|
Percent Change From Baseline in Triglycerides by Visit
Day 104
|
11.86 percent change in triglycerides
Standard Deviation 37.365
|
-7.12 percent change in triglycerides
Standard Deviation 26.145
|
-5.81 percent change in triglycerides
Standard Deviation 55.419
|
-13.51 percent change in triglycerides
Standard Deviation 26.915
|
|
Percent Change From Baseline in Triglycerides by Visit
Day 120
|
3.57 percent change in triglycerides
Standard Deviation 33.870
|
-9.40 percent change in triglycerides
Standard Deviation 27.192
|
-9.32 percent change in triglycerides
Standard Deviation 33.471
|
-12.33 percent change in triglycerides
Standard Deviation 26.280
|
|
Percent Change From Baseline in Triglycerides by Visit
Day 150
|
3.33 percent change in triglycerides
Standard Deviation 32.023
|
-5.60 percent change in triglycerides
Standard Deviation 42.988
|
-12.65 percent change in triglycerides
Standard Deviation 24.766
|
-11.81 percent change in triglycerides
Standard Deviation 28.623
|
|
Percent Change From Baseline in Triglycerides by Visit
Day 180
|
-0.19 percent change in triglycerides
Standard Deviation 32.161
|
-2.34 percent change in triglycerides
Standard Deviation 33.783
|
-12.11 percent change in triglycerides
Standard Deviation 39.414
|
-13.67 percent change in triglycerides
Standard Deviation 27.307
|
SECONDARY outcome
Timeframe: Baseline, day 14, day 30, day 60, day 90, day 104, day 120, day 150, and day 180Population: 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.
Percent change from baseline in high-density lipoprotein cholesterol (HDL-C) by visit was calculated to evaluate the effect of inclisiran over time
Outcome measures
| Measure |
Placebo
n=57 Participants
Placebo subcutaneous injection
|
100 mg Inclisiran Sodium
n=55 Participants
100 mg inclisiran sodium (equivalent to 94.5 mg inclisiran) subcutaneous injection
|
200 mg Inclisiran Sodium
n=101 Participants
200 mg inclisiran sodium (equivalent to 189 mg inclisiran) subcutaneous injection
|
300 mg Inclisiran Sodium
n=98 Participants
300 mg inclisiran sodium (equivalent to 284 mg inclisiran) subcutaneous injection
|
|---|---|---|---|---|
|
Percent Change From Baseline in HDL Cholesterol by Visit
Day 14
|
1.73 percent change in HDL Cholesterol
Standard Deviation 8.765
|
3.00 percent change in HDL Cholesterol
Standard Deviation 10.745
|
5.93 percent change in HDL Cholesterol
Standard Deviation 12.164
|
4.38 percent change in HDL Cholesterol
Standard Deviation 10.727
|
|
Percent Change From Baseline in HDL Cholesterol by Visit
Day 30
|
1.94 percent change in HDL Cholesterol
Standard Deviation 11.259
|
4.86 percent change in HDL Cholesterol
Standard Deviation 10.450
|
9.89 percent change in HDL Cholesterol
Standard Deviation 13.656
|
8.43 percent change in HDL Cholesterol
Standard Deviation 12.740
|
|
Percent Change From Baseline in HDL Cholesterol by Visit
Day 60
|
0.57 percent change in HDL Cholesterol
Standard Deviation 10.677
|
6.80 percent change in HDL Cholesterol
Standard Deviation 15.222
|
8.02 percent change in HDL Cholesterol
Standard Deviation 15.411
|
9.15 percent change in HDL Cholesterol
Standard Deviation 14.984
|
|
Percent Change From Baseline in HDL Cholesterol by Visit
Day 90
|
0.56 percent change in HDL Cholesterol
Standard Deviation 11.543
|
6.51 percent change in HDL Cholesterol
Standard Deviation 16.297
|
10.86 percent change in HDL Cholesterol
Standard Deviation 16.359
|
8.59 percent change in HDL Cholesterol
Standard Deviation 16.546
|
|
Percent Change From Baseline in HDL Cholesterol by Visit
Day 104
|
1.35 percent change in HDL Cholesterol
Standard Deviation 14.817
|
8.69 percent change in HDL Cholesterol
Standard Deviation 15.303
|
11.04 percent change in HDL Cholesterol
Standard Deviation 16.443
|
8.99 percent change in HDL Cholesterol
Standard Deviation 17.280
|
|
Percent Change From Baseline in HDL Cholesterol by Visit
Day 120
|
4.20 percent change in HDL Cholesterol
Standard Deviation 13.747
|
8.84 percent change in HDL Cholesterol
Standard Deviation 13.432
|
12.65 percent change in HDL Cholesterol
Standard Deviation 16.777
|
11.97 percent change in HDL Cholesterol
Standard Deviation 18.300
|
|
Percent Change From Baseline in HDL Cholesterol by Visit
Day 150
|
5.12 percent change in HDL Cholesterol
Standard Deviation 13.587
|
7.51 percent change in HDL Cholesterol
Standard Deviation 17.455
|
12.80 percent change in HDL Cholesterol
Standard Deviation 16.337
|
11.68 percent change in HDL Cholesterol
Standard Deviation 18.486
|
|
Percent Change From Baseline in HDL Cholesterol by Visit
Day 180
|
8.25 percent change in HDL Cholesterol
Standard Deviation 12.940
|
6.89 percent change in HDL Cholesterol
Standard Deviation 17.051
|
15.95 percent change in HDL Cholesterol
Standard Deviation 17.025
|
14.26 percent change in HDL Cholesterol
Standard Deviation 20.158
|
SECONDARY outcome
Timeframe: Baseline, day 14, day 30, day 60, day 90, day 104, day 120, day 150, and day 180Population: 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.
Percent change from baseline in non-HDL Cholesterol by visit was calculated to evaluate the effect of inclisiran over time
Outcome measures
| Measure |
Placebo
n=57 Participants
Placebo subcutaneous injection
|
100 mg Inclisiran Sodium
n=55 Participants
100 mg inclisiran sodium (equivalent to 94.5 mg inclisiran) subcutaneous injection
|
200 mg Inclisiran Sodium
n=101 Participants
200 mg inclisiran sodium (equivalent to 189 mg inclisiran) subcutaneous injection
|
300 mg Inclisiran Sodium
n=98 Participants
300 mg inclisiran sodium (equivalent to 284 mg inclisiran) subcutaneous injection
|
|---|---|---|---|---|
|
Percent Change From Baseline in Non-HDL Cholesterol by Visit
Day 14
|
1.13 percent change in non-HDL Cholesterol
Standard Deviation 13.511
|
-31.37 percent change in non-HDL Cholesterol
Standard Deviation 19.592
|
-35.68 percent change in non-HDL Cholesterol
Standard Deviation 18.056
|
-41.16 percent change in non-HDL Cholesterol
Standard Deviation 17.005
|
|
Percent Change From Baseline in Non-HDL Cholesterol by Visit
Day 30
|
1.03 percent change in non-HDL Cholesterol
Standard Deviation 11.483
|
-44.72 percent change in non-HDL Cholesterol
Standard Deviation 16.270
|
-47.99 percent change in non-HDL Cholesterol
Standard Deviation 15.318
|
-54.17 percent change in non-HDL Cholesterol
Standard Deviation 12.815
|
|
Percent Change From Baseline in Non-HDL Cholesterol by Visit
Day 60
|
0.62 percent change in non-HDL Cholesterol
Standard Deviation 11.841
|
-43.39 percent change in non-HDL Cholesterol
Standard Deviation 16.505
|
-48.18 percent change in non-HDL Cholesterol
Standard Deviation 15.146
|
-54.10 percent change in non-HDL Cholesterol
Standard Deviation 12.034
|
|
Percent Change From Baseline in Non-HDL Cholesterol by Visit
Day 90
|
1.75 percent change in non-HDL Cholesterol
Standard Deviation 11.931
|
-39.83 percent change in non-HDL Cholesterol
Standard Deviation 16.485
|
-47.20 percent change in non-HDL Cholesterol
Standard Deviation 15.002
|
-53.18 percent change in non-HDL Cholesterol
Standard Deviation 13.236
|
|
Percent Change From Baseline in Non-HDL Cholesterol by Visit
Day 104
|
1.96 percent change in non-HDL Cholesterol
Standard Deviation 12.067
|
-46.10 percent change in non-HDL Cholesterol
Standard Deviation 17.006
|
-51.98 percent change in non-HDL Cholesterol
Standard Deviation 14.344
|
-57.74 percent change in non-HDL Cholesterol
Standard Deviation 12.513
|
|
Percent Change From Baseline in Non-HDL Cholesterol by Visit
Day 120
|
0.82 percent change in non-HDL Cholesterol
Standard Deviation 14.045
|
-48.22 percent change in non-HDL Cholesterol
Standard Deviation 17.301
|
-53.52 percent change in non-HDL Cholesterol
Standard Deviation 15.425
|
-58.67 percent change in non-HDL Cholesterol
Standard Deviation 12.175
|
|
Percent Change From Baseline in Non-HDL Cholesterol by Visit
Day 150
|
1.96 percent change in non-HDL Cholesterol
Standard Deviation 13.519
|
-47.90 percent change in non-HDL Cholesterol
Standard Deviation 17.495
|
-52.85 percent change in non-HDL Cholesterol
Standard Deviation 14.254
|
-56.82 percent change in non-HDL Cholesterol
Standard Deviation 12.997
|
|
Percent Change From Baseline in Non-HDL Cholesterol by Visit
Day 180
|
1.29 percent change in non-HDL Cholesterol
Standard Deviation 13.455
|
-44.83 percent change in non-HDL Cholesterol
Standard Deviation 15.558
|
-50.15 percent change in non-HDL Cholesterol
Standard Deviation 16.446
|
-54.04 percent change in non-HDL Cholesterol
Standard Deviation 14.230
|
SECONDARY outcome
Timeframe: Baseline, day 14, day 30, day 60, day 90, day 104, day 120, day 150, and day 180Population: 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.
Percent change from baseline in very low-density lipoprotein cholesterol (VLDL - C) by visit was calculated to evaluate the effect of inclisiran over time
Outcome measures
| Measure |
Placebo
n=57 Participants
Placebo subcutaneous injection
|
100 mg Inclisiran Sodium
n=55 Participants
100 mg inclisiran sodium (equivalent to 94.5 mg inclisiran) subcutaneous injection
|
200 mg Inclisiran Sodium
n=101 Participants
200 mg inclisiran sodium (equivalent to 189 mg inclisiran) subcutaneous injection
|
300 mg Inclisiran Sodium
n=98 Participants
300 mg inclisiran sodium (equivalent to 284 mg inclisiran) subcutaneous injection
|
|---|---|---|---|---|
|
Percent Change From Baseline in VLDL-C by Visit
Day 14
|
5.55 percent change in VLDL-C
Standard Deviation 28.428
|
-2.96 percent change in VLDL-C
Standard Deviation 31.885
|
-5.56 percent change in VLDL-C
Standard Deviation 43.055
|
-12.41 percent change in VLDL-C
Standard Deviation 25.589
|
|
Percent Change From Baseline in VLDL-C by Visit
Day 30
|
6.69 percent change in VLDL-C
Standard Deviation 33.655
|
-9.01 percent change in VLDL-C
Standard Deviation 28.560
|
-13.39 percent change in VLDL-C
Standard Deviation 28.081
|
-14.74 percent change in VLDL-C
Standard Deviation 30.582
|
|
Percent Change From Baseline in VLDL-C by Visit
Day 60
|
9.40 percent change in VLDL-C
Standard Deviation 36.824
|
-10.27 percent change in VLDL-C
Standard Deviation 32.555
|
-14.02 percent change in VLDL-C
Standard Deviation 28.944
|
-17.94 percent change in VLDL-C
Standard Deviation 25.358
|
|
Percent Change From Baseline in VLDL-C by Visit
Day 90
|
6.53 percent change in VLDL-C
Standard Deviation 33.387
|
-5.39 percent change in VLDL-C
Standard Deviation 41.490
|
-16.70 percent change in VLDL-C
Standard Deviation 26.127
|
-15.76 percent change in VLDL-C
Standard Deviation 27.957
|
|
Percent Change From Baseline in VLDL-C by Visit
Day 104
|
11.56 percent change in VLDL-C
Standard Deviation 37.588
|
-12.10 percent change in VLDL-C
Standard Deviation 28.575
|
-12.54 percent change in VLDL-C
Standard Deviation 45.978
|
-24.05 percent change in VLDL-C
Standard Deviation 26.076
|
|
Percent Change From Baseline in VLDL-C by Visit
Day 120
|
3.10 percent change in VLDL-C
Standard Deviation 33.707
|
-15.90 percent change in VLDL-C
Standard Deviation 30.271
|
-14.05 percent change in VLDL-C
Standard Deviation 36.083
|
-22.29 percent change in VLDL-C
Standard Deviation 24.030
|
|
Percent Change From Baseline in VLDL-C by Visit
Day 150
|
3.41 percent change in VLDL-C
Standard Deviation 31.791
|
-10.91 percent change in VLDL-C
Standard Deviation 45.835
|
-17.49 percent change in VLDL-C
Standard Deviation 27.270
|
-18.39 percent change in VLDL-C
Standard Deviation 30.321
|
|
Percent Change From Baseline in VLDL-C by Visit
Day 180
|
-0.30 percent change in VLDL-C
Standard Deviation 31.345
|
-7.30 percent change in VLDL-C
Standard Deviation 33.946
|
-17.89 percent change in VLDL-C
Standard Deviation 33.050
|
-21.74 percent change in VLDL-C
Standard Deviation 27.746
|
SECONDARY outcome
Timeframe: Baseline, day 14, day 30, day 60, day 90, day 104, day 120, day 150, and day 180Population: 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.
Percent change from baseline in Apolipoprotein A1 (Apo-A1) by visit was calculated to evaluate the effect of inclisiran over time
Outcome measures
| Measure |
Placebo
n=57 Participants
Placebo subcutaneous injection
|
100 mg Inclisiran Sodium
n=55 Participants
100 mg inclisiran sodium (equivalent to 94.5 mg inclisiran) subcutaneous injection
|
200 mg Inclisiran Sodium
n=101 Participants
200 mg inclisiran sodium (equivalent to 189 mg inclisiran) subcutaneous injection
|
300 mg Inclisiran Sodium
n=98 Participants
300 mg inclisiran sodium (equivalent to 284 mg inclisiran) subcutaneous injection
|
|---|---|---|---|---|
|
Percent Change From Baseline in Apo- A1 by Visit
Day 14
|
0.04 percent change in Apo-A1
Standard Deviation 8.872
|
3.64 percent change in Apo-A1
Standard Deviation 9.293
|
2.29 percent change in Apo-A1
Standard Deviation 7.659
|
3.98 percent change in Apo-A1
Standard Deviation 7.952
|
|
Percent Change From Baseline in Apo- A1 by Visit
Day 30
|
0.90 percent change in Apo-A1
Standard Deviation 9.713
|
2.70 percent change in Apo-A1
Standard Deviation 10.553
|
4.52 percent change in Apo-A1
Standard Deviation 9.302
|
4.35 percent change in Apo-A1
Standard Deviation 9.012
|
|
Percent Change From Baseline in Apo- A1 by Visit
Day 60
|
0.00 percent change in Apo-A1
Standard Deviation 8.501
|
4.71 percent change in Apo-A1
Standard Deviation 11.785
|
3.89 percent change in Apo-A1
Standard Deviation 10.196
|
5.18 percent change in Apo-A1
Standard Deviation 10.023
|
|
Percent Change From Baseline in Apo- A1 by Visit
Day 90
|
-0.35 percent change in Apo-A1
Standard Deviation 9.888
|
3.86 percent change in Apo-A1
Standard Deviation 11.353
|
5.71 percent change in Apo-A1
Standard Deviation 10.609
|
5.21 percent change in Apo-A1
Standard Deviation 10.383
|
|
Percent Change From Baseline in Apo- A1 by Visit
Day 104
|
0.14 percent change in Apo-A1
Standard Deviation 10.780
|
5.89 percent change in Apo-A1
Standard Deviation 13.922
|
5.66 percent change in Apo-A1
Standard Deviation 11.007
|
4.99 percent change in Apo-A1
Standard Deviation 10.061
|
|
Percent Change From Baseline in Apo- A1 by Visit
Day 120
|
1.79 percent change in Apo-A1
Standard Deviation 10.707
|
5.33 percent change in Apo-A1
Standard Deviation 12.293
|
6.49 percent change in Apo-A1
Standard Deviation 11.334
|
6.60 percent change in Apo-A1
Standard Deviation 11.152
|
|
Percent Change From Baseline in Apo- A1 by Visit
Day 150
|
3.70 percent change in Apo-A1
Standard Deviation 11.571
|
4.85 percent change in Apo-A1
Standard Deviation 14.330
|
7.46 percent change in Apo-A1
Standard Deviation 11.582
|
8.35 percent change in Apo-A1
Standard Deviation 12.564
|
|
Percent Change From Baseline in Apo- A1 by Visit
Day 180
|
6.09 percent change in Apo-A1
Standard Deviation 11.862
|
4.99 percent change in Apo-A1
Standard Deviation 14.170
|
10.26 percent change in Apo-A1
Standard Deviation 12.250
|
9.09 percent change in Apo-A1
Standard Deviation 13.871
|
SECONDARY outcome
Timeframe: Baseline, day 14, day 30, day 60, day 90, day 104, day 120, day 150, and day 180Population: 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.
Percent change from baseline in Apolipoprotein B (Apo-B) by visit was calculated to evaluate the effect of inclisiran over time
Outcome measures
| Measure |
Placebo
n=57 Participants
Placebo subcutaneous injection
|
100 mg Inclisiran Sodium
n=55 Participants
100 mg inclisiran sodium (equivalent to 94.5 mg inclisiran) subcutaneous injection
|
200 mg Inclisiran Sodium
n=101 Participants
200 mg inclisiran sodium (equivalent to 189 mg inclisiran) subcutaneous injection
|
300 mg Inclisiran Sodium
n=98 Participants
300 mg inclisiran sodium (equivalent to 284 mg inclisiran) subcutaneous injection
|
|---|---|---|---|---|
|
Percent Change From Baseline in Apo- B by Visit
Day 14
|
1.09 percent change in Apo-B
Standard Deviation 13.795
|
-28.16 percent change in Apo-B
Standard Deviation 16.442
|
-32.45 percent change in Apo-B
Standard Deviation 17.518
|
-37.12 percent change in Apo-B
Standard Deviation 16.743
|
|
Percent Change From Baseline in Apo- B by Visit
Day 30
|
2.16 percent change in Apo-B
Standard Deviation 12.904
|
-39.72 percent change in Apo-B
Standard Deviation 14.749
|
-43.99 percent change in Apo-B
Standard Deviation 15.185
|
-48.76 percent change in Apo-B
Standard Deviation 12.962
|
|
Percent Change From Baseline in Apo- B by Visit
Day 60
|
1.41 percent change in Apo-B
Standard Deviation 11.965
|
-39.94 percent change in Apo-B
Standard Deviation 13.996
|
-44.49 percent change in Apo-B
Standard Deviation 14.654
|
-48.53 percent change in Apo-B
Standard Deviation 12.005
|
|
Percent Change From Baseline in Apo- B by Visit
Day 90
|
2.76 percent change in Apo-B
Standard Deviation 12.882
|
-35.84 percent change in Apo-B
Standard Deviation 14.134
|
-42.04 percent change in Apo-B
Standard Deviation 14.319
|
-46.78 percent change in Apo-B
Standard Deviation 12.611
|
|
Percent Change From Baseline in Apo- B by Visit
Day 104
|
3.03 percent change in Apo-B
Standard Deviation 13.304
|
-40.86 percent change in Apo-B
Standard Deviation 14.578
|
-47.03 percent change in Apo-B
Standard Deviation 13.283
|
-51.93 percent change in Apo-B
Standard Deviation 12.390
|
|
Percent Change From Baseline in Apo- B by Visit
Day 120
|
2.05 percent change in Apo-B
Standard Deviation 14.719
|
-43.39 percent change in Apo-B
Standard Deviation 14.174
|
-48.18 percent change in Apo-B
Standard Deviation 14.142
|
-51.85 percent change in Apo-B
Standard Deviation 12.414
|
|
Percent Change From Baseline in Apo- B by Visit
Day 150
|
3.86 percent change in Apo-B
Standard Deviation 13.559
|
-42.82 percent change in Apo-B
Standard Deviation 14.799
|
-46.71 percent change in Apo-B
Standard Deviation 13.775
|
-50.41 percent change in Apo-B
Standard Deviation 12.411
|
|
Percent Change From Baseline in Apo- B by Visit
Day 180
|
3.82 percent change in Apo-B
Standard Deviation 14.649
|
-38.63 percent change in Apo-B
Standard Deviation 13.265
|
-44.50 percent change in Apo-B
Standard Deviation 14.685
|
-46.81 percent change in Apo-B
Standard Deviation 13.968
|
SECONDARY outcome
Timeframe: Baseline, day 14, day 30, day 60, day 90, day 104, day 120, day 150, and day 180Population: 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.
Percent change from baseline in Lipoprotein a (LP(a)) by visit was calculated to evaluate the effect of inclisiran over time
Outcome measures
| Measure |
Placebo
n=57 Participants
Placebo subcutaneous injection
|
100 mg Inclisiran Sodium
n=55 Participants
100 mg inclisiran sodium (equivalent to 94.5 mg inclisiran) subcutaneous injection
|
200 mg Inclisiran Sodium
n=101 Participants
200 mg inclisiran sodium (equivalent to 189 mg inclisiran) subcutaneous injection
|
300 mg Inclisiran Sodium
n=98 Participants
300 mg inclisiran sodium (equivalent to 284 mg inclisiran) subcutaneous injection
|
|---|---|---|---|---|
|
Percent Change From Baseline in Lipoprotein-a by Visit
Day 14
|
3.33 percent change in LP(a)
Standard Deviation 32.912
|
-21.77 percent change in LP(a)
Standard Deviation 24.909
|
-16.63 percent change in LP(a)
Standard Deviation 41.372
|
-22.84 percent change in LP(a)
Standard Deviation 22.934
|
|
Percent Change From Baseline in Lipoprotein-a by Visit
Day 30
|
0.92 percent change in LP(a)
Standard Deviation 31.643
|
-28.09 percent change in LP(a)
Standard Deviation 21.846
|
-22.80 percent change in LP(a)
Standard Deviation 46.679
|
-31.30 percent change in LP(a)
Standard Deviation 26.785
|
|
Percent Change From Baseline in Lipoprotein-a by Visit
Day 60
|
-4.29 percent change in LP(a)
Standard Deviation 30.944
|
-30.89 percent change in LP(a)
Standard Deviation 26.802
|
-26.11 percent change in LP(a)
Standard Deviation 45.964
|
-36.21 percent change in LP(a)
Standard Deviation 22.036
|
|
Percent Change From Baseline in Lipoprotein-a by Visit
Day 90
|
4.35 percent change in LP(a)
Standard Deviation 29.270
|
-27.08 percent change in LP(a)
Standard Deviation 25.260
|
-24.93 percent change in LP(a)
Standard Deviation 42.005
|
-34.26 percent change in LP(a)
Standard Deviation 25.027
|
|
Percent Change From Baseline in Lipoprotein-a by Visit
Day 104
|
-2.41 percent change in LP(a)
Standard Deviation 26.326
|
-32.02 percent change in LP(a)
Standard Deviation 30.286
|
-25.99 percent change in LP(a)
Standard Deviation 45.444
|
-37.92 percent change in LP(a)
Standard Deviation 30.801
|
|
Percent Change From Baseline in Lipoprotein-a by Visit
Day 120
|
0.22 percent change in LP(a)
Standard Deviation 23.786
|
-31.46 percent change in LP(a)
Standard Deviation 27.979
|
-30.26 percent change in LP(a)
Standard Deviation 37.382
|
-37.24 percent change in LP(a)
Standard Deviation 25.389
|
|
Percent Change From Baseline in Lipoprotein-a by Visit
Day 150
|
4.02 percent change in LP(a)
Standard Deviation 32.703
|
-32.21 percent change in LP(a)
Standard Deviation 26.140
|
-21.59 percent change in LP(a)
Standard Deviation 47.820
|
-38.11 percent change in LP(a)
Standard Deviation 24.508
|
|
Percent Change From Baseline in Lipoprotein-a by Visit
Day 180
|
5.45 percent change in LP(a)
Standard Deviation 36.446
|
-30.15 percent change in LP(a)
Standard Deviation 25.578
|
-25.46 percent change in LP(a)
Standard Deviation 48.279
|
-35.41 percent change in LP(a)
Standard Deviation 25.123
|
SECONDARY outcome
Timeframe: Day 180Population: 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
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.
Outcome measures
| Measure |
Placebo
n=56 Participants
Placebo subcutaneous injection
|
100 mg Inclisiran Sodium
n=55 Participants
100 mg inclisiran sodium (equivalent to 94.5 mg inclisiran) subcutaneous injection
|
200 mg Inclisiran Sodium
n=101 Participants
200 mg inclisiran sodium (equivalent to 189 mg inclisiran) subcutaneous injection
|
300 mg Inclisiran Sodium
n=96 Participants
300 mg inclisiran sodium (equivalent to 284 mg inclisiran) subcutaneous injection
|
|---|---|---|---|---|
|
Proportion of Participants Who Attain Lipid Control Target Pre-specified by JAS 2017 Guidelines for Their Level of Cardiovascular Risk at Day 180
|
5 Participants
|
50 Participants
|
87 Participants
|
91 Participants
|
SECONDARY outcome
Timeframe: Baseline, day 14, day 30, day 60, day 90, day 104, day 120, day 150, and day 180Population: 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.
Number of participants by LDL-C levels was calculated to evaluate the effect of inclisiran.
Outcome measures
| Measure |
Placebo
n=57 Participants
Placebo subcutaneous injection
|
100 mg Inclisiran Sodium
n=55 Participants
100 mg inclisiran sodium (equivalent to 94.5 mg inclisiran) subcutaneous injection
|
200 mg Inclisiran Sodium
n=101 Participants
200 mg inclisiran sodium (equivalent to 189 mg inclisiran) subcutaneous injection
|
300 mg Inclisiran Sodium
n=98 Participants
300 mg inclisiran sodium (equivalent to 284 mg inclisiran) subcutaneous injection
|
|---|---|---|---|---|
|
Number of Participants With LDL-C Levels of <25 mg/dL, <50 mg/dL, <70 mg/dL, and <100 mg/dL by Visit
Day 150: LDL-C <100 mg/dL
|
23 Participants
|
52 Participants
|
95 Participants
|
93 Participants
|
|
Number of Participants With LDL-C Levels of <25 mg/dL, <50 mg/dL, <70 mg/dL, and <100 mg/dL by Visit
Day 14: LDL-C <25 mg/dL
|
0 Participants
|
1 Participants
|
5 Participants
|
10 Participants
|
|
Number of Participants With LDL-C Levels of <25 mg/dL, <50 mg/dL, <70 mg/dL, and <100 mg/dL by Visit
Day 14: LDL-C <50 mg/dL
|
1 Participants
|
19 Participants
|
38 Participants
|
43 Participants
|
|
Number of Participants With LDL-C Levels of <25 mg/dL, <50 mg/dL, <70 mg/dL, and <100 mg/dL by Visit
Day 14: LDL-C <70 mg/dL
|
3 Participants
|
29 Participants
|
56 Participants
|
66 Participants
|
|
Number of Participants With LDL-C Levels of <25 mg/dL, <50 mg/dL, <70 mg/dL, and <100 mg/dL by Visit
Day 14: LDL-C <100 mg/dL
|
22 Participants
|
45 Participants
|
81 Participants
|
86 Participants
|
|
Number of Participants With LDL-C Levels of <25 mg/dL, <50 mg/dL, <70 mg/dL, and <100 mg/dL by Visit
Day 30: LDL-C <25 mg/dL
|
0 Participants
|
6 Participants
|
14 Participants
|
20 Participants
|
|
Number of Participants With LDL-C Levels of <25 mg/dL, <50 mg/dL, <70 mg/dL, and <100 mg/dL by Visit
Day 30: LDL-C <50 mg/dL
|
0 Participants
|
30 Participants
|
56 Participants
|
71 Participants
|
|
Number of Participants With LDL-C Levels of <25 mg/dL, <50 mg/dL, <70 mg/dL, and <100 mg/dL by Visit
Day 30: LDL-C <70 mg/dL
|
3 Participants
|
40 Participants
|
74 Participants
|
80 Participants
|
|
Number of Participants With LDL-C Levels of <25 mg/dL, <50 mg/dL, <70 mg/dL, and <100 mg/dL by Visit
Day 30: LDL-C <100 mg/dL
|
22 Participants
|
51 Participants
|
93 Participants
|
94 Participants
|
|
Number of Participants With LDL-C Levels of <25 mg/dL, <50 mg/dL, <70 mg/dL, and <100 mg/dL by Visit
Day 60: LDL-C <25 mg/dL
|
0 Participants
|
6 Participants
|
14 Participants
|
23 Participants
|
|
Number of Participants With LDL-C Levels of <25 mg/dL, <50 mg/dL, <70 mg/dL, and <100 mg/dL by Visit
Day 60: LDL-C <50 mg/dL
|
0 Participants
|
28 Participants
|
57 Participants
|
70 Participants
|
|
Number of Participants With LDL-C Levels of <25 mg/dL, <50 mg/dL, <70 mg/dL, and <100 mg/dL by Visit
Day 60: LDL-C <70 mg/dL
|
5 Participants
|
37 Participants
|
77 Participants
|
79 Participants
|
|
Number of Participants With LDL-C Levels of <25 mg/dL, <50 mg/dL, <70 mg/dL, and <100 mg/dL by Visit
Day 60: LDL-C <100 mg/dL
|
21 Participants
|
50 Participants
|
92 Participants
|
92 Participants
|
|
Number of Participants With LDL-C Levels of <25 mg/dL, <50 mg/dL, <70 mg/dL, and <100 mg/dL by Visit
Day 90: LDL-C <25 mg/dL
|
0 Participants
|
2 Participants
|
12 Participants
|
21 Participants
|
|
Number of Participants With LDL-C Levels of <25 mg/dL, <50 mg/dL, <70 mg/dL, and <100 mg/dL by Visit
Day 90: LDL-C <50 mg/dL
|
0 Participants
|
27 Participants
|
51 Participants
|
67 Participants
|
|
Number of Participants With LDL-C Levels of <25 mg/dL, <50 mg/dL, <70 mg/dL, and <100 mg/dL by Visit
Day 90: LDL-C <70 mg/dL
|
1 Participants
|
35 Participants
|
74 Participants
|
80 Participants
|
|
Number of Participants With LDL-C Levels of <25 mg/dL, <50 mg/dL, <70 mg/dL, and <100 mg/dL by Visit
Day 90: LDL-C <100 mg/dL
|
24 Participants
|
49 Participants
|
93 Participants
|
94 Participants
|
|
Number of Participants With LDL-C Levels of <25 mg/dL, <50 mg/dL, <70 mg/dL, and <100 mg/dL by Visit
Day 104: LDL-C <25 mg/dL
|
0 Participants
|
6 Participants
|
22 Participants
|
27 Participants
|
|
Number of Participants With LDL-C Levels of <25 mg/dL, <50 mg/dL, <70 mg/dL, and <100 mg/dL by Visit
Day 104: LDL-C <50 mg/dL
|
0 Participants
|
30 Participants
|
64 Participants
|
70 Participants
|
|
Number of Participants With LDL-C Levels of <25 mg/dL, <50 mg/dL, <70 mg/dL, and <100 mg/dL by Visit
Day 104: LDL-C <70 mg/dL
|
4 Participants
|
38 Participants
|
82 Participants
|
80 Participants
|
|
Number of Participants With LDL-C Levels of <25 mg/dL, <50 mg/dL, <70 mg/dL, and <100 mg/dL by Visit
Day 104: LDL-C <100 mg/dL
|
25 Participants
|
52 Participants
|
95 Participants
|
92 Participants
|
|
Number of Participants With LDL-C Levels of <25 mg/dL, <50 mg/dL, <70 mg/dL, and <100 mg/dL by Visit
Day 120: LDL-C <25 mg/dL
|
0 Participants
|
9 Participants
|
25 Participants
|
32 Participants
|
|
Number of Participants With LDL-C Levels of <25 mg/dL, <50 mg/dL, <70 mg/dL, and <100 mg/dL by Visit
Day 120: LDL-C <50 mg/dL
|
0 Participants
|
32 Participants
|
64 Participants
|
70 Participants
|
|
Number of Participants With LDL-C Levels of <25 mg/dL, <50 mg/dL, <70 mg/dL, and <100 mg/dL by Visit
Day 120: LDL-C <70 mg/dL
|
3 Participants
|
39 Participants
|
82 Participants
|
81 Participants
|
|
Number of Participants With LDL-C Levels of <25 mg/dL, <50 mg/dL, <70 mg/dL, and <100 mg/dL by Visit
Day 120: LDL-C <100 mg/dL
|
24 Participants
|
53 Participants
|
95 Participants
|
91 Participants
|
|
Number of Participants With LDL-C Levels of <25 mg/dL, <50 mg/dL, <70 mg/dL, and <100 mg/dL by Visit
Day 150: LDL-C <25 mg/dL
|
0 Participants
|
5 Participants
|
24 Participants
|
31 Participants
|
|
Number of Participants With LDL-C Levels of <25 mg/dL, <50 mg/dL, <70 mg/dL, and <100 mg/dL by Visit
Day 150: LDL-C <50 mg/dL
|
0 Participants
|
32 Participants
|
67 Participants
|
71 Participants
|
|
Number of Participants With LDL-C Levels of <25 mg/dL, <50 mg/dL, <70 mg/dL, and <100 mg/dL by Visit
Day 150: LDL-C <70 mg/dL
|
2 Participants
|
41 Participants
|
81 Participants
|
81 Participants
|
|
Number of Participants With LDL-C Levels of <25 mg/dL, <50 mg/dL, <70 mg/dL, and <100 mg/dL by Visit
Day 180: LDL-C <25 mg/dL
|
0 Participants
|
7 Participants
|
13 Participants
|
26 Participants
|
|
Number of Participants With LDL-C Levels of <25 mg/dL, <50 mg/dL, <70 mg/dL, and <100 mg/dL by Visit
Day 180: LDL-C <50 mg/dL
|
0 Participants
|
30 Participants
|
56 Participants
|
65 Participants
|
|
Number of Participants With LDL-C Levels of <25 mg/dL, <50 mg/dL, <70 mg/dL, and <100 mg/dL by Visit
Day 180: LDL-C <70 mg/dL
|
2 Participants
|
40 Participants
|
78 Participants
|
80 Participants
|
|
Number of Participants With LDL-C Levels of <25 mg/dL, <50 mg/dL, <70 mg/dL, and <100 mg/dL by Visit
Day 180: LDL-C <100 mg/dL
|
22 Participants
|
54 Participants
|
94 Participants
|
90 Participants
|
Adverse Events
Placebo
Serious events: 6 serious events
Other events: 32 other events
Deaths: 1 deaths
Inclisiran 100 mg
Serious events: 2 serious events
Other events: 38 other events
Deaths: 0 deaths
Inclisiran 200 mg
Serious events: 7 serious events
Other events: 59 other events
Deaths: 0 deaths
Inclisiran 300 mg
Serious events: 7 serious events
Other events: 59 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=57 participants at risk
Placebo subcutaneous injection
|
Inclisiran 100 mg
n=55 participants at risk
100 mg inclisiran sodium (equivalent to 94.5 mg inclisiran) subcutaneous injection
|
Inclisiran 200 mg
n=101 participants at risk
200 mg inclisiran sodium (equivalent to 189 mg inclisiran) subcutaneous injection
|
Inclisiran 300 mg
n=99 participants at risk
300 mg inclisiran sodium (equivalent to 284 mg inclisiran) subcutaneous injection
|
|---|---|---|---|---|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/57 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
0.99%
1/101 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
0.00%
0/99 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
|
Cardiac disorders
Angina unstable
|
1.8%
1/57 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
1.8%
1/55 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
0.00%
0/101 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
1.0%
1/99 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/57 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
0.00%
0/101 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
1.0%
1/99 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/57 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
0.00%
0/101 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
1.0%
1/99 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
|
Eye disorders
Epiretinal membrane
|
0.00%
0/57 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
0.99%
1/101 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
0.00%
0/99 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
|
Eye disorders
Vitreous haemorrhage
|
1.8%
1/57 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
0.00%
0/101 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
0.00%
0/99 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/57 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
0.00%
0/101 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
1.0%
1/99 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
|
General disorders
Death
|
1.8%
1/57 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
0.00%
0/101 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
0.00%
0/99 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
|
General disorders
Vascular stent stenosis
|
0.00%
0/57 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
0.00%
0/101 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
1.0%
1/99 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
|
Infections and infestations
COVID-19
|
0.00%
0/57 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
0.99%
1/101 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
0.00%
0/99 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/57 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
0.00%
0/101 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
1.0%
1/99 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
|
Infections and infestations
Infection
|
0.00%
0/57 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
0.00%
0/101 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
1.0%
1/99 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/57 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
1.8%
1/55 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
0.00%
0/101 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
0.00%
0/99 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
1.8%
1/57 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
0.00%
0/101 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
0.00%
0/99 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
1.8%
1/57 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
0.00%
0/101 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
0.00%
0/99 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
1.8%
1/57 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
0.99%
1/101 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
0.00%
0/99 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.00%
0/57 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
0.00%
0/101 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
1.0%
1/99 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/57 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
0.99%
1/101 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
0.00%
0/99 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
|
Musculoskeletal and connective tissue disorders
Fracture pain
|
0.00%
0/57 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
0.99%
1/101 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
0.00%
0/99 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
1.8%
1/57 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
0.00%
0/101 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
0.00%
0/99 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/57 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
0.00%
0/101 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
1.0%
1/99 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/57 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
0.00%
0/101 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
1.0%
1/99 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
|
Nervous system disorders
Embolic cerebral infarction
|
1.8%
1/57 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
0.00%
0/101 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
0.00%
0/99 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
|
Vascular disorders
Peripheral artery occlusion
|
0.00%
0/57 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
0.99%
1/101 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
0.00%
0/99 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
Other adverse events
| Measure |
Placebo
n=57 participants at risk
Placebo subcutaneous injection
|
Inclisiran 100 mg
n=55 participants at risk
100 mg inclisiran sodium (equivalent to 94.5 mg inclisiran) subcutaneous injection
|
Inclisiran 200 mg
n=101 participants at risk
200 mg inclisiran sodium (equivalent to 189 mg inclisiran) subcutaneous injection
|
Inclisiran 300 mg
n=99 participants at risk
300 mg inclisiran sodium (equivalent to 284 mg inclisiran) subcutaneous injection
|
|---|---|---|---|---|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
8.8%
5/57 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
20.0%
11/55 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
11.9%
12/101 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
12.1%
12/99 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
|
Gastrointestinal disorders
Diarrhoea
|
1.8%
1/57 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
7.3%
4/55 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
5.0%
5/101 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
1.0%
1/99 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
|
General disorders
Injection site reaction
|
3.5%
2/57 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
5.5%
3/55 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
11.9%
12/101 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
6.1%
6/99 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
|
General disorders
Malaise
|
10.5%
6/57 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
1.8%
1/55 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
2.0%
2/101 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
7.1%
7/99 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
|
General disorders
Pyrexia
|
12.3%
7/57 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
14.5%
8/55 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
11.9%
12/101 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
18.2%
18/99 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
|
General disorders
Vaccination site pain
|
14.0%
8/57 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
1.8%
1/55 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
5.0%
5/101 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
5.1%
5/99 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
|
Infections and infestations
COVID-19
|
3.5%
2/57 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
14.5%
8/55 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
5.0%
5/101 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
6.1%
6/99 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
|
Infections and infestations
Herpes zoster
|
5.3%
3/57 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
1.8%
1/55 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
3.0%
3/101 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
0.00%
0/99 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
|
Infections and infestations
Nasopharyngitis
|
5.3%
3/57 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
7.3%
4/55 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
5.9%
6/101 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
7.1%
7/99 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
|
Injury, poisoning and procedural complications
Contusion
|
5.3%
3/57 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
7.3%
4/55 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
3.0%
3/101 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
3.0%
3/99 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
|
Investigations
Blood creatine phosphokinase increased
|
7.0%
4/57 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
1.8%
1/55 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
3.0%
3/101 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
5.1%
5/99 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
|
Investigations
C-reactive protein increased
|
0.00%
0/57 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
1.8%
1/55 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
0.99%
1/101 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
5.1%
5/99 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
15.8%
9/57 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
12.7%
7/55 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
9.9%
10/101 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
15.2%
15/99 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.0%
4/57 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
1.8%
1/55 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
2.0%
2/101 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
2.0%
2/99 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.8%
5/57 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
10.9%
6/55 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
3.0%
3/101 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
8.1%
8/99 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/57 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
1.8%
1/55 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
2.0%
2/101 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
5.1%
5/99 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
|
Nervous system disorders
Headache
|
8.8%
5/57 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
5.5%
3/55 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
3.0%
3/101 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
3.0%
3/99 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
|
Nervous system disorders
Hypoaesthesia
|
7.0%
4/57 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
0.00%
0/55 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
0.00%
0/101 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
0.00%
0/99 • Adverse events were reported from first dose of study treatment up to a maximum duration of 360 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER