Trial Outcomes & Findings for Efficacy and Safety of Inclisiran as Monotherapy in Patients With Primary Hypercholesterolemia Not Receiving Lipid-lowering Therapy. (NCT NCT05763875)
NCT ID: NCT05763875
Last Updated: 2025-10-16
Results Overview
Percentage change in LDL-C from Baseline (day 1) to Day 150, Inclisiran arm versus Ezetimibe and placebo. There were two estimands of interest in comparing efficacy of inclisiran as monotherapy against that of placebo or ezetimibe that differ on the treatment of interest used for each and the management of intercurrent events as follows: * Monotherapy Estimand: Inclisiran as monotherapy compared to the use of comparator. This estimand uses a hypothetical strategy where participants who permanently discontinued treatment, died or used other LLTs were handled in a hypothetical scenario of what would have happened if the intercurrent event did not happen. * Treatment-policy Estimand: Inclisiran as monotherapy compared to the use of comparator with or without other lipid lowering therapies (LLTs) added. This estimand ignored the use of other LLTs and treatment discontinuation. Deaths (if any) were handled as an unfavorable outcome using a composite variable strategy.
COMPLETED
PHASE3
350 participants
Baseline, Day 150
2025-10-16
Participant Flow
Participants were enrolled at 42 investigative sites in 5 countries
There was a 14 day screening period
Participant milestones
| Measure |
Inclisiran
Inclisiran s.c and Placebo p.o
|
Ezetimibe
Placebo s.c. and Ezetimibe p.o.
|
Placebo
Placebo s.c. and Placebo p.o.
|
|---|---|---|---|
|
Overall Study
STARTED
|
174
|
89
|
87
|
|
Overall Study
COMPLETED
|
164
|
86
|
84
|
|
Overall Study
NOT COMPLETED
|
10
|
3
|
3
|
Reasons for withdrawal
| Measure |
Inclisiran
Inclisiran s.c and Placebo p.o
|
Ezetimibe
Placebo s.c. and Ezetimibe p.o.
|
Placebo
Placebo s.c. and Placebo p.o.
|
|---|---|---|---|
|
Overall Study
Subject decision
|
5
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
4
|
1
|
2
|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
Baseline Characteristics
Efficacy and Safety of Inclisiran as Monotherapy in Patients With Primary Hypercholesterolemia Not Receiving Lipid-lowering Therapy.
Baseline characteristics by cohort
| Measure |
Inclisiran
n=174 Participants
Inclisiran s.c and Placebo p.o
|
Ezetimibe
n=89 Participants
Placebo s.c. and Ezetimibe p.o.
|
Placebo
n=87 Participants
Placebo s.c. and Placebo p.o.
|
Total
n=350 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
168 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
337 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Age, Continuous
|
45.7 years
STANDARD_DEVIATION 11.74 • n=5 Participants
|
46.3 years
STANDARD_DEVIATION 10.90 • n=7 Participants
|
46.7 years
STANDARD_DEVIATION 11.55 • n=5 Participants
|
46.1 years
STANDARD_DEVIATION 11.46 • n=4 Participants
|
|
Sex: Female, Male
Female
|
104 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
219 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
70 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
131 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
20 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
140 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
278 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Baseline Low-Density Lipoprotein Cholesterol (LDL-C)
|
135.8 mg/dL
STANDARD_DEVIATION 27.01 • n=5 Participants
|
134.4 mg/dL
STANDARD_DEVIATION 25.82 • n=7 Participants
|
135.4 mg/dL
STANDARD_DEVIATION 28.69 • n=5 Participants
|
135.4 mg/dL
STANDARD_DEVIATION 27.07 • n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, Day 150Population: Full Analysis Set, all randomized participants.
Percentage change in LDL-C from Baseline (day 1) to Day 150, Inclisiran arm versus Ezetimibe and placebo. There were two estimands of interest in comparing efficacy of inclisiran as monotherapy against that of placebo or ezetimibe that differ on the treatment of interest used for each and the management of intercurrent events as follows: * Monotherapy Estimand: Inclisiran as monotherapy compared to the use of comparator. This estimand uses a hypothetical strategy where participants who permanently discontinued treatment, died or used other LLTs were handled in a hypothetical scenario of what would have happened if the intercurrent event did not happen. * Treatment-policy Estimand: Inclisiran as monotherapy compared to the use of comparator with or without other lipid lowering therapies (LLTs) added. This estimand ignored the use of other LLTs and treatment discontinuation. Deaths (if any) were handled as an unfavorable outcome using a composite variable strategy.
Outcome measures
| Measure |
Inclisiran
n=174 Participants
Inclisiran s.c and Placebo p.o
|
Ezetimibe
n=89 Participants
Placebo s.c. and Ezetimibe p.o.
|
Placebo
n=87 Participants
Placebo s.c. and Placebo p.o.
|
|---|---|---|---|
|
Percentage Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 150
LS Mean (Treatment Policy estimand)
|
-46.54 Percentage change from baseline
Interval -50.2 to -42.88
|
-11.17 Percentage change from baseline
Interval -15.34 to -7.0
|
1.37 Percentage change from baseline
Interval -3.07 to 5.8
|
|
Percentage Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 150
LS Mean (Monotherapy estimand)
|
-49.37 Percentage change from baseline
Interval -52.76 to -45.97
|
-11.92 Percentage change from baseline
Interval -15.87 to -7.98
|
-1.53 Percentage change from baseline
Interval -2.97 to 6.03
|
SECONDARY outcome
Timeframe: Baseline, Day 150Population: Full Analysis Set, all randomized participants.
Absolute change in LDL-C from Baseline (Day 1) to Day 150, Inclisiran arm versus Ezetimibe and placebo. There were two estimands of interest in comparing efficacy of inclisiran as monotherapy against that of placebo or ezetimibe that differ on the treatment of interest used for each and the management of intercurrent events as follows: * Monotherapy Estimand: Inclisiran as monotherapy compared to the use of comparator. This estimand uses a hypothetical strategy where participants who permanently discontinued treatment, died or used other LLTs were handled in a hypothetical scenario of what would have happened if the intercurrent event did not happen. * Treatment-policy Estimand: Inclisiran as monotherapy compared to the use of comparator with or without other lipid lowering therapies (LLTs) added. This estimand ignored the use of other LLTs and treatment discontinuation. Deaths (if any) were handled as an unfavorable outcome using a composite variable strategy.
Outcome measures
| Measure |
Inclisiran
n=174 Participants
Inclisiran s.c and Placebo p.o
|
Ezetimibe
n=89 Participants
Placebo s.c. and Ezetimibe p.o.
|
Placebo
n=87 Participants
Placebo s.c. and Placebo p.o.
|
|---|---|---|---|
|
Absolute Change in LDL-C From Baseline to Day 150
LS Mean (Treatment Policy estimand)
|
-64.86 mg/dL
Interval -69.27 to -60.46
|
-17.55 mg/dL
Interval -22.53 to -12.57
|
-1.29 mg/dL
Interval -6.4 to 3.82
|
|
Absolute Change in LDL-C From Baseline to Day 150
LS Mean (Monotherapy estimand)
|
-68.57 mg/dL
Interval -72.59 to -64.56
|
-18.52 mg/dL
Interval -23.16 to -13.89
|
-1.07 mg/dL
Interval -6.32 to 4.19
|
SECONDARY outcome
Timeframe: Baseline, Day 150Population: Full Analysis Set, all randomized participants with a valid assessment for the outcome measure.
Percentage change in PCSK9 from Baseline (Day 1) to Day 150 , Inclisiran arm versus Ezetimibe and placebo. There were two estimands of interest in comparing efficacy of inclisiran as monotherapy against that of placebo or ezetimibe that differ on the treatment of interest used for each and the management of intercurrent events as follows: * Monotherapy Estimand: Inclisiran as monotherapy compared to the use of comparator. This estimand uses a hypothetical strategy where participants who permanently discontinued treatment, died or used other LLTs were handled in a hypothetical scenario of what would have happened if the intercurrent event did not happen. * Treatment-policy Estimand: Inclisiran as monotherapy compared to the use of comparator with or without other lipid lowering therapies (LLTs) added. This estimand ignored the use of other LLTs and treatment discontinuation. Deaths (if any) were handled as an unfavorable outcome using a composite variable strategy.
Outcome measures
| Measure |
Inclisiran
n=172 Participants
Inclisiran s.c and Placebo p.o
|
Ezetimibe
n=89 Participants
Placebo s.c. and Ezetimibe p.o.
|
Placebo
n=87 Participants
Placebo s.c. and Placebo p.o.
|
|---|---|---|---|
|
Percentage Change in Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) From Baseline to Day 150
LS Mean (Treatment Policy estimand)
|
-67.12 Percentage change from baseline
Interval -73.21 to -61.03
|
6.04 Percentage change from baseline
Interval -0.1 to 12.18
|
7.82 Percentage change from baseline
Interval 0.35 to 15.29
|
|
Percentage Change in Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) From Baseline to Day 150
LS Mean (Monotherapy estimand)
|
-71.31 Percentage change from baseline
Interval -76.73 to -65.89
|
5.56 Percentage change from baseline
Interval -0.67 to 11.79
|
8.16 Percentage change from baseline
Interval 0.59 to 15.74
|
SECONDARY outcome
Timeframe: Baseline, Day 150Population: Full Analysis Set, all randomized participants.
Percentage change in non-HDL-C from Baseline (Day 1) to Day 150, Inclisiran arm versus Ezetimibe and placebo. There were two estimands of interest in comparing efficacy of inclisiran as monotherapy against that of placebo or ezetimibe that differ on the treatment of interest used for each and the management of intercurrent events as follows: * Monotherapy Estimand: Inclisiran as monotherapy compared to the use of comparator. This estimand uses a hypothetical strategy where participants who permanently discontinued treatment, died or used other LLTs were handled in a hypothetical scenario of what would have happened if the intercurrent event did not happen. * Treatment-policy Estimand: Inclisiran as monotherapy compared to the use of comparator with or without other lipid lowering therapies (LLTs) added. This estimand ignored the use of other LLTs and treatment discontinuation. Deaths (if any) were handled as an unfavorable outcome using a composite variable strategy.
Outcome measures
| Measure |
Inclisiran
n=174 Participants
Inclisiran s.c and Placebo p.o
|
Ezetimibe
n=89 Participants
Placebo s.c. and Ezetimibe p.o.
|
Placebo
n=87 Participants
Placebo s.c. and Placebo p.o.
|
|---|---|---|---|
|
Percentage Change in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Day 150
LS Mean (Treatment Policy estimand)
|
-40.45 Percentage change from baseline
Interval -43.5 to -37.4
|
-9.97 Percentage change from baseline
Interval -13.34 to -6.61
|
1.88 Percentage change from baseline
Interval -2.75 to 6.5
|
|
Percentage Change in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Day 150
LS Mean (Monotherapy estimand)
|
-42.82 Percentage change from baseline
Interval -45.62 to -40.02
|
-10.84 Percentage change from baseline
Interval -13.84 to -7.84
|
2.04 Percentage change from baseline
Interval -2.63 to 6.71
|
SECONDARY outcome
Timeframe: Baseline, Day 150Population: Full Analysis Set, all randomized participants.
Percentage change in total cholesterol/HDL-C ratio from Baseline (Day1) to Day 150, Inclisiran arm versus Ezetimibe and placebo. There were two estimands of interest in comparing efficacy of inclisiran as monotherapy against that of placebo or ezetimibe that differ on the treatment of interest used for each and the management of intercurrent events as follows: * Monotherapy Estimand: Inclisiran as monotherapy compared to the use of comparator. This estimand uses a hypothetical strategy where participants who permanently discontinued treatment, died or used other LLTs were handled in a hypothetical scenario of what would have happened if the intercurrent event did not happen. * Treatment-policy Estimand: Inclisiran as monotherapy compared to the use of comparator with or without other lipid lowering therapies (LLTs) added. This estimand ignored the use of other LLTs and treatment discontinuation. Deaths (if any) were handled as an unfavorable outcome using a composite variable strate
Outcome measures
| Measure |
Inclisiran
n=174 Participants
Inclisiran s.c and Placebo p.o
|
Ezetimibe
n=89 Participants
Placebo s.c. and Ezetimibe p.o.
|
Placebo
n=87 Participants
Placebo s.c. and Placebo p.o.
|
|---|---|---|---|
|
Percentage Change in Total Cholesterol (TC)/HDL-C Ratio From Baseline to Day 150
LS Mean (Treatment Policy estimand)
|
-31.54 Percentage change from baseline
Interval -35.43 to -27.65
|
-6.70 Percentage change from baseline
Interval -10.61 to -2.78
|
2.31 Percentage change from baseline
Interval -4.05 to 8.68
|
|
Percentage Change in Total Cholesterol (TC)/HDL-C Ratio From Baseline to Day 150
LS Mean (Monotherapy estimand)
|
-33.56 Percentage change from baseline
Interval -37.32 to -29.79
|
-6.98 Percentage change from baseline
Interval -10.99 to -2.97
|
2.51 Percentage change from baseline
Interval -3.9 to 8.91
|
SECONDARY outcome
Timeframe: Baseline, Day 150Population: Full Analysis Set, all randomized participants.
Percentage change in Apo B from Baseline (Day 1) to Day 150, Inclisiran arm versus Ezetimibe and placebo. There were two estimands of interest in comparing efficacy of inclisiran as monotherapy against that of placebo or ezetimibe that differ on the treatment of interest used for each and the management of intercurrent events as follows: * Monotherapy Estimand: Inclisiran as monotherapy compared to the use of comparator. This estimand uses a hypothetical strategy where participants who permanently discontinued treatment, died or used other LLTs were handled in a hypothetical scenario of what would have happened if the intercurrent event did not happen. * Treatment-policy Estimand: Inclisiran as monotherapy compared to the use of comparator with or without other lipid lowering therapies (LLTs) added. This estimand ignored the use of other LLTs and treatment discontinuation. Deaths (if any) were handled as an unfavorable outcome using a composite variable strategy.
Outcome measures
| Measure |
Inclisiran
n=174 Participants
Inclisiran s.c and Placebo p.o
|
Ezetimibe
n=89 Participants
Placebo s.c. and Ezetimibe p.o.
|
Placebo
n=87 Participants
Placebo s.c. and Placebo p.o.
|
|---|---|---|---|
|
Percentage Change in Apolipoprotein B (Apo B) From Baseline to Day 150
LS Mean (Treatment Policy estimand)
|
-37.39 Percentage change from baseline
Interval -40.25 to -34.54
|
-8.41 Percentage change from baseline
Interval -11.71 to -5.12
|
-0.73 Percentage change from baseline
Interval -4.18 to 2.72
|
|
Percentage Change in Apolipoprotein B (Apo B) From Baseline to Day 150
LS Mean (Monotherapy estimand)
|
-39.36 Percentage change from baseline
Interval -42.0 to -36.72
|
-9.20 Percentage change from baseline
Interval -12.13 to -6.28
|
-0.58 Percentage change from baseline
Interval -4.07 to 2.9
|
SECONDARY outcome
Timeframe: Baseline, Day 150Population: Full Analysis Set, all randomized participants.
Percentage change in Apo B/Apo A-1 ratio from baseline (Day 1) to Day 150, Inclisiran arm versus Ezetimibe and placebo. There were two estimands of interest in comparing efficacy of inclisiran as monotherapy against that of placebo or ezetimibe that differ on the treatment of interest used for each and the management of intercurrent events as follows: * Monotherapy Estimand: Inclisiran as monotherapy compared to the use of comparator. This estimand uses a hypothetical strategy where participants who permanently discontinued treatment, died or used other LLTs were handled in a hypothetical scenario of what would have happened if the intercurrent event did not happen. * Treatment-policy Estimand: Inclisiran as monotherapy compared to the use of comparator with or without other lipid lowering therapies (LLTs) added. This estimand ignored the use of other LLTs and treatment discontinuation. Deaths (if any) were handled as an unfavorable outcome using a composite variable strategy.
Outcome measures
| Measure |
Inclisiran
n=174 Participants
Inclisiran s.c and Placebo p.o
|
Ezetimibe
n=89 Participants
Placebo s.c. and Ezetimibe p.o.
|
Placebo
n=87 Participants
Placebo s.c. and Placebo p.o.
|
|---|---|---|---|
|
Percentage Change in Apo B/Apo A-1 Ratio From Baseline to Day 150
LS Mean (Treatment Policy estimand)
|
-37.79 Percentage change from baseline
Interval -43.03 to -32.55
|
-7.55 Percentage change from baseline
Interval -11.74 to -3.36
|
-2.65 Percentage change from baseline
Interval -5.69 to 0.39
|
|
Percentage Change in Apo B/Apo A-1 Ratio From Baseline to Day 150
LS Mean (Monotherapy estimand)
|
-40.03 Percentage change from baseline
Interval -45.25 to -34.82
|
-7.69 Percentage change from baseline
Interval -12.0 to -3.37
|
-2.65 Percentage change from baseline
Interval -5.81 to 0.5
|
SECONDARY outcome
Timeframe: Baseline, Day 150Population: Full Analysis Set, all randomized participants with a valid assessment for the outcome measure.
Day 150 / Baseline ratio in Lp(a) in Inclisiran arm versus Ezetimibe and placebo. There were two estimands of interest in comparing efficacy of inclisiran as monotherapy against that of placebo or ezetimibe that differ on the treatment of interest used for each and the management of intercurrent events as follows: * Monotherapy Estimand: Inclisiran as monotherapy compared to the use of comparator. This estimand uses a hypothetical strategy where participants who permanently discontinued treatment, died or used other LLTs were handled in a hypothetical scenario of what would have happened if the intercurrent event did not happen. * Treatment-policy Estimand: Inclisiran as monotherapy compared to the use of comparator with or without other lipid lowering therapies (LLTs) added. This estimand ignored the use of other LLTs and treatment discontinuation. Deaths (if any) were handled as an unfavorable outcome using a composite variable strategy.
Outcome measures
| Measure |
Inclisiran
n=173 Participants
Inclisiran s.c and Placebo p.o
|
Ezetimibe
n=88 Participants
Placebo s.c. and Ezetimibe p.o.
|
Placebo
n=87 Participants
Placebo s.c. and Placebo p.o.
|
|---|---|---|---|
|
Change in Lipoprotein (a) [Lp(a)] From Baseline to Day 150
LS Mean (Treatment Policy estimand)
|
0.690 Ratio from baseline
Interval 0.611 to 0.78
|
0.911 Ratio from baseline
Interval 0.83 to 1.0
|
0.923 Ratio from baseline
Interval 0.803 to 1.06
|
|
Change in Lipoprotein (a) [Lp(a)] From Baseline to Day 150
LS Mean (Monotherapy estimand)
|
0.687 Ratio from baseline
Interval 0.612 to 0.722
|
0.912 Ratio from baseline
Interval 0.836 to 0.95
|
0.922 Ratio from baseline
Interval 0.8 to 1.062
|
SECONDARY outcome
Timeframe: From first dose of study treatment on Day 1 up to Day 180Population: Safety Analysis Set, all participants who received at least one dose of study treatment.
Incidence of TEAEs (regardless of seriousness) and SAEs by treatment group, including changes in laboratory results qualifying and reported as AEs.
Outcome measures
| Measure |
Inclisiran
n=174 Participants
Inclisiran s.c and Placebo p.o
|
Ezetimibe
n=89 Participants
Placebo s.c. and Ezetimibe p.o.
|
Placebo
n=87 Participants
Placebo s.c. and Placebo p.o.
|
|---|---|---|---|
|
Incidence of Treatment Emergent Adverse Events (TEAE) and Serious Adverse Events (SAE)
AEs
|
54 Participants
|
27 Participants
|
25 Participants
|
|
Incidence of Treatment Emergent Adverse Events (TEAE) and Serious Adverse Events (SAE)
AEs related to s.c. treatment (Inclisiran or s.c. matching placebo)
|
11 Participants
|
4 Participants
|
0 Participants
|
|
Incidence of Treatment Emergent Adverse Events (TEAE) and Serious Adverse Events (SAE)
AEs related to p.o. treatment (ezetimibe or p.o. matching placebo)
|
3 Participants
|
2 Participants
|
2 Participants
|
|
Incidence of Treatment Emergent Adverse Events (TEAE) and Serious Adverse Events (SAE)
SAEs
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Treatment Emergent Adverse Events (TEAE) and Serious Adverse Events (SAE)
SAEs related to s.c. treatment (Inclisiran or s.c. matching placebo)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Treatment Emergent Adverse Events (TEAE) and Serious Adverse Events (SAE)
SAEs related to p.o. treatment (ezetimibe or p.o. matching placebo)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Treatment Emergent Adverse Events (TEAE) and Serious Adverse Events (SAE)
Fatal SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Treatment Emergent Adverse Events (TEAE) and Serious Adverse Events (SAE)
AEs leading to treatment discontinuation of inclisiran or s.c. matching placebo
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Treatment Emergent Adverse Events (TEAE) and Serious Adverse Events (SAE)
AEs leading to treatment discontinuation of ezetimibe or p.o. matching placebo
|
4 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Inclisiran
Ezetimibe
Placebo
Total
Serious adverse events
| Measure |
Inclisiran
n=174 participants at risk
Inclisiran s.c and Placebo p.o
|
Ezetimibe
n=89 participants at risk
Placebo s.c. and Ezetimibe p.o.
|
Placebo
n=87 participants at risk
Placebo s.c. and Placebo p.o.
|
Total
n=350 participants at risk
Total
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.57%
1/174 • From first dose of study treatment on Day 1 up to Day 180
|
0.00%
0/89 • From first dose of study treatment on Day 1 up to Day 180
|
0.00%
0/87 • From first dose of study treatment on Day 1 up to Day 180
|
0.29%
1/350 • From first dose of study treatment on Day 1 up to Day 180
|
Other adverse events
| Measure |
Inclisiran
n=174 participants at risk
Inclisiran s.c and Placebo p.o
|
Ezetimibe
n=89 participants at risk
Placebo s.c. and Ezetimibe p.o.
|
Placebo
n=87 participants at risk
Placebo s.c. and Placebo p.o.
|
Total
n=350 participants at risk
Total
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
1.1%
2/174 • From first dose of study treatment on Day 1 up to Day 180
|
1.1%
1/89 • From first dose of study treatment on Day 1 up to Day 180
|
2.3%
2/87 • From first dose of study treatment on Day 1 up to Day 180
|
1.4%
5/350 • From first dose of study treatment on Day 1 up to Day 180
|
|
Gastrointestinal disorders
Vomiting
|
1.1%
2/174 • From first dose of study treatment on Day 1 up to Day 180
|
2.2%
2/89 • From first dose of study treatment on Day 1 up to Day 180
|
0.00%
0/87 • From first dose of study treatment on Day 1 up to Day 180
|
1.1%
4/350 • From first dose of study treatment on Day 1 up to Day 180
|
|
Infections and infestations
COVID-19
|
0.57%
1/174 • From first dose of study treatment on Day 1 up to Day 180
|
2.2%
2/89 • From first dose of study treatment on Day 1 up to Day 180
|
3.4%
3/87 • From first dose of study treatment on Day 1 up to Day 180
|
1.7%
6/350 • From first dose of study treatment on Day 1 up to Day 180
|
|
Infections and infestations
Gastroenteritis
|
1.1%
2/174 • From first dose of study treatment on Day 1 up to Day 180
|
2.2%
2/89 • From first dose of study treatment on Day 1 up to Day 180
|
0.00%
0/87 • From first dose of study treatment on Day 1 up to Day 180
|
1.1%
4/350 • From first dose of study treatment on Day 1 up to Day 180
|
|
Infections and infestations
Nasopharyngitis
|
3.4%
6/174 • From first dose of study treatment on Day 1 up to Day 180
|
3.4%
3/89 • From first dose of study treatment on Day 1 up to Day 180
|
3.4%
3/87 • From first dose of study treatment on Day 1 up to Day 180
|
3.4%
12/350 • From first dose of study treatment on Day 1 up to Day 180
|
|
Infections and infestations
Upper respiratory tract infection
|
1.1%
2/174 • From first dose of study treatment on Day 1 up to Day 180
|
2.2%
2/89 • From first dose of study treatment on Day 1 up to Day 180
|
1.1%
1/87 • From first dose of study treatment on Day 1 up to Day 180
|
1.4%
5/350 • From first dose of study treatment on Day 1 up to Day 180
|
|
Infections and infestations
Urinary tract infection
|
1.7%
3/174 • From first dose of study treatment on Day 1 up to Day 180
|
2.2%
2/89 • From first dose of study treatment on Day 1 up to Day 180
|
2.3%
2/87 • From first dose of study treatment on Day 1 up to Day 180
|
2.0%
7/350 • From first dose of study treatment on Day 1 up to Day 180
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/174 • From first dose of study treatment on Day 1 up to Day 180
|
2.2%
2/89 • From first dose of study treatment on Day 1 up to Day 180
|
1.1%
1/87 • From first dose of study treatment on Day 1 up to Day 180
|
0.86%
3/350 • From first dose of study treatment on Day 1 up to Day 180
|
|
Investigations
Blood pressure increased
|
0.57%
1/174 • From first dose of study treatment on Day 1 up to Day 180
|
2.2%
2/89 • From first dose of study treatment on Day 1 up to Day 180
|
0.00%
0/87 • From first dose of study treatment on Day 1 up to Day 180
|
0.86%
3/350 • From first dose of study treatment on Day 1 up to Day 180
|
|
Nervous system disorders
Headache
|
3.4%
6/174 • From first dose of study treatment on Day 1 up to Day 180
|
0.00%
0/89 • From first dose of study treatment on Day 1 up to Day 180
|
0.00%
0/87 • From first dose of study treatment on Day 1 up to Day 180
|
1.7%
6/350 • From first dose of study treatment on Day 1 up to Day 180
|
|
Renal and urinary disorders
Hypertonic bladder
|
0.00%
0/174 • From first dose of study treatment on Day 1 up to Day 180
|
2.2%
2/89 • From first dose of study treatment on Day 1 up to Day 180
|
0.00%
0/87 • From first dose of study treatment on Day 1 up to Day 180
|
0.57%
2/350 • From first dose of study treatment on Day 1 up to Day 180
|
|
Vascular disorders
Hypertension
|
0.57%
1/174 • From first dose of study treatment on Day 1 up to Day 180
|
1.1%
1/89 • From first dose of study treatment on Day 1 up to Day 180
|
2.3%
2/87 • From first dose of study treatment on Day 1 up to Day 180
|
1.1%
4/350 • From first dose of study treatment on Day 1 up to Day 180
|
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