Heterozygous Familial Hypercholesterolemia, Hypercholesterolemia
Conditions
Keywords
inclisiran, siRNA, dyslipidemia, PCSK9, Hypercholesterolemia, LDL-C
Brief summary
This was a placebo-controlled, double-blind, randomized trial in Japanese participants with history of coronary artery disease (CAD) or participants categorized in 'high risk' by JAS 2017 guideline, or Japanese participants with heterozygous familial hypercholesterolemia (HeFH) and elevated Low-density lipoprotein cholesterol (LDL-C) despite maximum tolerated dose of statin(s) to evaluate the efficacy, safety, tolerability, and PK of subcutaneous inclisiran injection(s).
Detailed description
The expected duration of the participants' involvement in the study was approximately 374 days which included screening (up to 14 days), Day 1 study drug administration, two additional injections on Day 90 and Day 270, and the follow-up period to Day 360. The primary analysis was conducted after all participants had finished Day 180 visit assessments or discontinued before Day 180 visit. After the primary analysis, double-blind treatment period were maintained to Day 360, although specific sponsor members (except for blinded monitors) were unblinded for the regulatory submission in Japan.
Interventions
Subcutaneously injected on Day 1, 90 and 270.
DRUGPlacebo
Subcutaneously injected on Day 1, 90, and 270.
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants with history of CAD or participants categorized in 'high risk' by Japan Atherosclerosis Society (JAS) 2017 guidelines or participants with heterozygous familial hypercholesterolemia (HeFH) * As per the JAS 2017 guideline, participants not meeting the LDL-C management targets. * Participants on statins should be receiving a maximally tolerated dose. * Participants not receiving statins must have documented evidence of intolerance to at least one statin. * The lipid-lowering therapy should have remained stable for ≥ 30 days before screening with no planned medication/ dose change until Day 180
Exclusion criteria
* Participants diagnosed with homozygous familial hypercholesterolemia (HoFH). * Treatment (within 90 days of screening) with monoclonal antibodies directed towards PCSK9. * New York Heart Association (NYHA) class IV heart failure or last known left ventricular ejection fraction \<25%. * Cardiac arrhythmia within 3 months prior to randomization that is not controlled by medication or via ablation. * Uncontrolled hypertension: systolic blood pressure \>160 mmHg or diastolic blood pressure \>100 mmHg prior to randomization despite antihypertensive therapy. * Active liver disease defined as any known current infectious, neoplastic, or metabolic pathology of the liver or unexplained elevations in alanine aminotransferase (ALT), aspartate aminotransferase (AST), \>3x the upper limit of normal (ULN), or total bilirubin \>2x ULN at screening. * Severe concomitant non-cardiovascular disease that carries the risk of reducing life expectancy to less than 2 years.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) to Day 180 | Baseline, 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in LDL-C by Visit | Baseline, day 14, day 30, day 60, day 90, day 104, day 120 and day 150 | Percent change from baseline in low-density lipoprotein cholesterol (LDL-C) was calculated to evaluate the effect of inclisiran over time. |
| Absolute Change in LDL-C From Baseline at Day 180 | Baseline, Day 180 | Absolute change from baseline in low-density lipoprotein cholesterol (LDL-C) was calculated to evaluate the effect of inclisiran until Day 180. |
| Proportion of Participants With LDL-C Greater Than 80% of Baseline Value at Day 180 | Baseline, 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. |
| Proportion of Participants With Greater or Equal to 50% LDL-C Reduction From Baseline by Visit | Baseline, day 14, day 30, day 60, day 90, day 104, day 120, day 150, and day 180 | Proportion of participants with greater or equal to 50% LDL-C reduction from baseline was calculated to evaluate the effect of inclisiran over time. |
| Percent Change From Baseline in Cholesterol by Visit | Baseline, day 14, day 30, day 60, day 90, day 104, day 120, day 150, and day 180 | Percent change from baseline in cholesterol by visit was calculated to evaluate the effect of inclisiran over time |
| Percent Change From Baseline in Triglycerides by Visit | Baseline, day 14, day 30, day 60, day 90, day 104, day 120, day 150, and day 180 | Percent change from baseline in triglycerides by visit was calculated to evaluate the effect of inclisiran over time |
| Percent Change From Baseline in HDL Cholesterol by Visit | Baseline, day 14, day 30, day 60, day 90, day 104, day 120, day 150, and day 180 | Percent change from baseline in high-density lipoprotein cholesterol (HDL-C) by visit was calculated to evaluate the effect of inclisiran over time |
| Percent Change From Baseline in PCSK9 by Visit | Baseline, day 14, day 30, day 60, day 90, day 104, day 120, day 150, and day 180 | Percent change from baseline in proprotein convertase subtilisin/kexin type 9 (PCSK9) was calculated to evaluate the effect of inclisiran over time. |
| Percent Change From Baseline in VLDL-C by Visit | Baseline, day 14, day 30, day 60, day 90, day 104, day 120, day 150, and day 180 | Percent change from baseline in very low-density lipoprotein cholesterol (VLDL - C) by visit was calculated to evaluate the effect of inclisiran over time |
| Percent Change From Baseline in Apo- A1 by Visit | Baseline, day 14, day 30, day 60, day 90, day 104, day 120, day 150, and day 180 | Percent change from baseline in Apolipoprotein A1 (Apo-A1) by visit was calculated to evaluate the effect of inclisiran over time |
| Percent Change From Baseline in Apo- B by Visit | Baseline, day 14, day 30, day 60, day 90, day 104, day 120, day 150, and day 180 | Percent change from baseline in Apolipoprotein B (Apo-B) by visit was calculated to evaluate the effect of inclisiran over time |
| Percent Change From Baseline in Lipoprotein-a by Visit | Baseline, day 14, day 30, day 60, day 90, day 104, day 120, day 150, and day 180 | Percent change from baseline in Lipoprotein a (LP(a)) by visit was calculated to evaluate the effect of inclisiran over time |
| Proportion of Participants Who Attain Lipid Control Target Pre-specified by JAS 2017 Guidelines for Their Level of Cardiovascular Risk at Day 180 | 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. |
| Number of Participants With LDL-C Levels of <25 mg/dL, <50 mg/dL, <70 mg/dL, and <100 mg/dL by Visit | Baseline, day 14, day 30, day 60, day 90, day 104, day 120, day 150, and day 180 | Number of participants by LDL-C levels was calculated to evaluate the effect of inclisiran. |
| Percent Change From Baseline in Non-HDL Cholesterol by Visit | Baseline, day 14, day 30, day 60, day 90, day 104, day 120, day 150, and day 180 | Percent change from baseline in non-HDL Cholesterol by visit was calculated to evaluate the effect of inclisiran over time |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo subcutaneous injection | 57 |
| 100 mg Inclisiran Sodium 100 mg inclisiran sodium (equivalent to 94.5 mg inclisiran) subcutaneous injection | 55 |
| 200 mg Inclisiran Sodium 200 mg inclisiran sodium (equivalent to 189 mg inclisiran) subcutaneous injection | 101 |
| 300 mg Inclisiran Sodium 300 mg inclisiran sodium (equivalent to 284 mg inclisiran) subcutaneous injection | 99 |
| Total | 312 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| 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 |
| Overall Study | Subject decision | 1 | 0 | 0 | 2 |
Baseline characteristics
| Characteristic | Placebo | 100 mg Inclisiran Sodium | 200 mg Inclisiran Sodium | 300 mg Inclisiran Sodium | Total |
|---|---|---|---|---|---|
| Age, Continuous | 63.8 years STANDARD_DEVIATION 11.12 | 62.7 years STANDARD_DEVIATION 9.25 | 64.7 years STANDARD_DEVIATION 10.57 | 63.0 years STANDARD_DEVIATION 10.66 | 63.6 years STANDARD_DEVIATION 10.46 |
| Race/Ethnicity, Customized Japanese | 57 Participants | 55 Participants | 101 Participants | 99 Participants | 312 Participants |
| Sex: Female, Male Female | 18 Participants | 19 Participants | 21 Participants | 22 Participants | 80 Participants |
| Sex: Female, Male Male | 39 Participants | 36 Participants | 80 Participants | 77 Participants | 232 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 57 | 0 / 55 | 0 / 101 | 0 / 99 |
| other Total, other adverse events | 32 / 57 | 38 / 55 | 59 / 101 | 59 / 99 |
| serious Total, serious adverse events | 6 / 57 | 2 / 55 | 7 / 101 | 7 / 99 |
Outcome results
Primary
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) to 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.
Time frame: Baseline, Day 180
Population: The FAS comprised all participants to whom study treatment had been assigned by randomization.~The overall number of participants analyzed represents the participants in the Full Analysis Set (FAS) who had valid LDL-C value for both, baseline and day 180
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) to Day 180 | 9.0 percent change in LDL-C |
| 100 mg Inclisiran Sodium | Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) to Day 180 | -47.6 percent change in LDL-C |
| 200 mg Inclisiran Sodium | Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) to Day 180 | -51.9 percent change in LDL-C |
| 300 mg Inclisiran Sodium | Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) to Day 180 | -56.3 percent change in LDL-C |
p-value: <0.000195% CI: [-64.2, -49]Mixed Models Analysis
p-value: <0.000195% CI: [-67.6, -54.3]Mixed Models Analysis
p-value: <0.000195% CI: [-72, -58.6]Mixed Models Analysis
Secondary
Absolute Change in LDL-C From Baseline at Day 180
Absolute change from baseline in low-density lipoprotein cholesterol (LDL-C) was calculated to evaluate the effect of inclisiran until Day 180.
Time frame: Baseline, Day 180
Population: The overall number of participants analyzed represents the participants in the Full Analysis Set (FAS) who had valid LDL-C value for both, baseline and day 180
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Absolute Change in LDL-C From Baseline at Day 180 | 13.2 mg/dL |
| 100 mg Inclisiran Sodium | Absolute Change in LDL-C From Baseline at Day 180 | -49.3 mg/dL |
| 200 mg Inclisiran Sodium | Absolute Change in LDL-C From Baseline at Day 180 | -53.9 mg/dL |
| 300 mg Inclisiran Sodium | Absolute Change in LDL-C From Baseline at Day 180 | -57.7 mg/dL |
Secondary
Number of Participants With LDL-C Levels of <25 mg/dL, <50 mg/dL, <70 mg/dL, and <100 mg/dL by Visit
Number of participants by LDL-C levels was calculated to evaluate the effect of inclisiran.
Time frame: Baseline, day 14, day 30, day 60, day 90, day 104, day 120, day 150, and day 180
Population: The overall number of participants analyzed represents the participants in the Full Analysis Set (FAS) who had at least one valid measurement of LDL-C.~The number analyzed per row represents the participants with a valid LDL-C at that particular visit.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| 100 mg Inclisiran Sodium | 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 | 30 Participants |
| 100 mg Inclisiran Sodium | 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 | 19 Participants |
| 100 mg Inclisiran Sodium | 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 | 29 Participants |
| 100 mg Inclisiran Sodium | 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 | 45 Participants |
| 100 mg Inclisiran Sodium | 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 | 52 Participants |
| 100 mg Inclisiran Sodium | 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 | 9 Participants |
| 100 mg Inclisiran Sodium | 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 | 54 Participants |
| 100 mg Inclisiran Sodium | 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 | 1 Participants |
| 100 mg Inclisiran Sodium | 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 | 6 Participants |
| 100 mg Inclisiran Sodium | 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 | 40 Participants |
| 100 mg Inclisiran Sodium | 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 | 51 Participants |
| 100 mg Inclisiran Sodium | 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 | 6 Participants |
| 100 mg Inclisiran Sodium | 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 | 28 Participants |
| 100 mg Inclisiran Sodium | 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 | 37 Participants |
| 100 mg Inclisiran Sodium | 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 | 50 Participants |
| 100 mg Inclisiran Sodium | 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 | 2 Participants |
| 100 mg Inclisiran Sodium | 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 | 27 Participants |
| 100 mg Inclisiran Sodium | 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 | 35 Participants |
| 100 mg Inclisiran Sodium | 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 | 49 Participants |
| 100 mg Inclisiran Sodium | 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 | 6 Participants |
| 100 mg Inclisiran Sodium | 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 | 30 Participants |
| 100 mg Inclisiran Sodium | 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 | 38 Participants |
| 100 mg Inclisiran Sodium | 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 | 32 Participants |
| 100 mg Inclisiran Sodium | 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 | 39 Participants |
| 100 mg Inclisiran Sodium | 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 | 53 Participants |
| 100 mg Inclisiran Sodium | 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 | 5 Participants |
| 100 mg Inclisiran Sodium | 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 | 32 Participants |
| 100 mg Inclisiran Sodium | 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 | 41 Participants |
| 100 mg Inclisiran Sodium | 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 | 52 Participants |
| 100 mg Inclisiran Sodium | 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 | 7 Participants |
| 100 mg Inclisiran Sodium | 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 | 30 Participants |
| 100 mg Inclisiran Sodium | 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 | 40 Participants |
| 200 mg Inclisiran Sodium | 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 | 95 Participants |
| 200 mg Inclisiran Sodium | 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 | 81 Participants |
| 200 mg Inclisiran Sodium | 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 | 95 Participants |
| 200 mg Inclisiran Sodium | 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 | 93 Participants |
| 200 mg Inclisiran Sodium | 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 | 95 Participants |
| 200 mg Inclisiran Sodium | 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 | 94 Participants |
| 200 mg Inclisiran Sodium | 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 | 24 Participants |
| 200 mg Inclisiran Sodium | 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 | 82 Participants |
| 200 mg Inclisiran Sodium | 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 | 74 Participants |
| 200 mg Inclisiran Sodium | 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 | 56 Participants |
| 200 mg Inclisiran Sodium | 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 | 67 Participants |
| 200 mg Inclisiran Sodium | 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 | 5 Participants |
| 200 mg Inclisiran Sodium | 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 | 25 Participants |
| 200 mg Inclisiran Sodium | 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 | 14 Participants |
| 200 mg Inclisiran Sodium | 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 | 14 Participants |
| 200 mg Inclisiran Sodium | 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 | 93 Participants |
| 200 mg Inclisiran Sodium | 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 | 22 Participants |
| 200 mg Inclisiran Sodium | 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 | 57 Participants |
| 200 mg Inclisiran Sodium | 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 | 51 Participants |
| 200 mg Inclisiran Sodium | 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 | 13 Participants |
| 200 mg Inclisiran Sodium | 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 | 64 Participants |
| 200 mg Inclisiran Sodium | 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 | 77 Participants |
| 200 mg Inclisiran Sodium | 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 | 38 Participants |
| 200 mg Inclisiran Sodium | 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 | 74 Participants |
| 200 mg Inclisiran Sodium | 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 | 81 Participants |
| 200 mg Inclisiran Sodium | 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 | 92 Participants |
| 200 mg Inclisiran Sodium | 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 | 78 Participants |
| 200 mg Inclisiran Sodium | 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 | 56 Participants |
| 200 mg Inclisiran Sodium | 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 | 82 Participants |
| 200 mg Inclisiran Sodium | 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 | 12 Participants |
| 200 mg Inclisiran Sodium | 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 | 64 Participants |
| 200 mg Inclisiran Sodium | 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 | 56 Participants |
| 300 mg Inclisiran Sodium | 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 | 27 Participants |
| 300 mg Inclisiran Sodium | 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 | 67 Participants |
| 300 mg Inclisiran Sodium | 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 | 10 Participants |
| 300 mg Inclisiran Sodium | 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 | 80 Participants |
| 300 mg Inclisiran Sodium | 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 | 20 Participants |
| 300 mg Inclisiran Sodium | 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 | 94 Participants |
| 300 mg Inclisiran Sodium | 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 | 93 Participants |
| 300 mg Inclisiran Sodium | 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 | 86 Participants |
| 300 mg Inclisiran Sodium | 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 | 70 Participants |
| 300 mg Inclisiran Sodium | 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 | 90 Participants |
| 300 mg Inclisiran Sodium | 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 | 80 Participants |
| 300 mg Inclisiran Sodium | 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 | 32 Participants |
| 300 mg Inclisiran Sodium | 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 | 80 Participants |
| 300 mg Inclisiran Sodium | 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 | 70 Participants |
| 300 mg Inclisiran Sodium | 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 | 26 Participants |
| 300 mg Inclisiran Sodium | 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 | 81 Participants |
| 300 mg Inclisiran Sodium | 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 | 92 Participants |
| 300 mg Inclisiran Sodium | 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 | 43 Participants |
| 300 mg Inclisiran Sodium | 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 | 91 Participants |
| 300 mg Inclisiran Sodium | 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 | 31 Participants |
| 300 mg Inclisiran Sodium | 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 | 66 Participants |
| 300 mg Inclisiran Sodium | 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 | 94 Participants |
| 300 mg Inclisiran Sodium | 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 | 71 Participants |
| 300 mg Inclisiran Sodium | 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 | 23 Participants |
| 300 mg Inclisiran Sodium | 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 | 70 Participants |
| 300 mg Inclisiran Sodium | 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 | 80 Participants |
| 300 mg Inclisiran Sodium | 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 | 65 Participants |
| 300 mg Inclisiran Sodium | 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 | 79 Participants |
| 300 mg Inclisiran Sodium | 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 | 92 Participants |
| 300 mg Inclisiran Sodium | 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 | 71 Participants |
| 300 mg Inclisiran Sodium | 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 | 81 Participants |
| 300 mg Inclisiran Sodium | 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 | 21 Participants |
Secondary
Percent Change From Baseline in Apo- A1 by Visit
Percent change from baseline in Apolipoprotein A1 (Apo-A1) by visit was calculated to evaluate the effect of inclisiran over time
Time frame: Baseline, day 14, day 30, day 60, day 90, day 104, day 120, day 150, and day 180
Population: The overall number of participants analyzed represents the participants in the Full Analysis Set (FAS) who had at least one valid measurement of Apo-A1.~The number analyzed per row represents the participants with a valid Apo-A1 value for both, baseline and that particular visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percent Change From Baseline in Apo- A1 by Visit | Day 120 | 1.79 percent change in Apo-A1 | Standard Deviation 10.707 |
| Placebo | Percent Change From Baseline in Apo- A1 by Visit | Day 30 | 0.90 percent change in Apo-A1 | Standard Deviation 9.713 |
| Placebo | Percent Change From Baseline in Apo- A1 by Visit | Day 60 | 0.00 percent change in Apo-A1 | Standard Deviation 8.501 |
| Placebo | Percent Change From Baseline in Apo- A1 by Visit | Day 104 | 0.14 percent change in Apo-A1 | Standard Deviation 10.78 |
| Placebo | Percent Change From Baseline in Apo- A1 by Visit | Day 180 | 6.09 percent change in Apo-A1 | Standard Deviation 11.862 |
| Placebo | Percent Change From Baseline in Apo- A1 by Visit | Day 14 | 0.04 percent change in Apo-A1 | Standard Deviation 8.872 |
| Placebo | Percent Change From Baseline in Apo- A1 by Visit | Day 90 | -0.35 percent change in Apo-A1 | Standard Deviation 9.888 |
| Placebo | Percent Change From Baseline in Apo- A1 by Visit | Day 150 | 3.70 percent change in Apo-A1 | Standard Deviation 11.571 |
| 100 mg Inclisiran Sodium | Percent Change From Baseline in Apo- A1 by Visit | Day 90 | 3.86 percent change in Apo-A1 | Standard Deviation 11.353 |
| 100 mg Inclisiran Sodium | Percent Change From Baseline in Apo- A1 by Visit | Day 14 | 3.64 percent change in Apo-A1 | Standard Deviation 9.293 |
| 100 mg Inclisiran Sodium | Percent Change From Baseline in Apo- A1 by Visit | Day 104 | 5.89 percent change in Apo-A1 | Standard Deviation 13.922 |
| 100 mg Inclisiran Sodium | Percent Change From Baseline in Apo- A1 by Visit | Day 150 | 4.85 percent change in Apo-A1 | Standard Deviation 14.33 |
| 100 mg Inclisiran Sodium | Percent Change From Baseline in Apo- A1 by Visit | Day 120 | 5.33 percent change in Apo-A1 | Standard Deviation 12.293 |
| 100 mg Inclisiran Sodium | Percent Change From Baseline in Apo- A1 by Visit | Day 30 | 2.70 percent change in Apo-A1 | Standard Deviation 10.553 |
| 100 mg Inclisiran Sodium | Percent Change From Baseline in Apo- A1 by Visit | Day 60 | 4.71 percent change in Apo-A1 | Standard Deviation 11.785 |
| 100 mg Inclisiran Sodium | Percent Change From Baseline in Apo- A1 by Visit | Day 180 | 4.99 percent change in Apo-A1 | Standard Deviation 14.17 |
| 200 mg Inclisiran Sodium | Percent Change From Baseline in Apo- A1 by Visit | Day 14 | 2.29 percent change in Apo-A1 | Standard Deviation 7.659 |
| 200 mg Inclisiran Sodium | Percent Change From Baseline in Apo- A1 by Visit | Day 150 | 7.46 percent change in Apo-A1 | Standard Deviation 11.582 |
| 200 mg Inclisiran Sodium | Percent Change From Baseline in Apo- A1 by Visit | Day 180 | 10.26 percent change in Apo-A1 | Standard Deviation 12.25 |
| 200 mg Inclisiran Sodium | Percent Change From Baseline in Apo- A1 by Visit | Day 30 | 4.52 percent change in Apo-A1 | Standard Deviation 9.302 |
| 200 mg Inclisiran Sodium | Percent Change From Baseline in Apo- A1 by Visit | Day 60 | 3.89 percent change in Apo-A1 | Standard Deviation 10.196 |
| 200 mg Inclisiran Sodium | Percent Change From Baseline in Apo- A1 by Visit | Day 90 | 5.71 percent change in Apo-A1 | Standard Deviation 10.609 |
| 200 mg Inclisiran Sodium | Percent Change From Baseline in Apo- A1 by Visit | Day 104 | 5.66 percent change in Apo-A1 | Standard Deviation 11.007 |
| 200 mg Inclisiran Sodium | Percent Change From Baseline in Apo- A1 by Visit | Day 120 | 6.49 percent change in Apo-A1 | Standard Deviation 11.334 |
| 300 mg Inclisiran Sodium | Percent Change From Baseline in Apo- A1 by Visit | Day 180 | 9.09 percent change in Apo-A1 | Standard Deviation 13.871 |
| 300 mg Inclisiran Sodium | Percent Change From Baseline in Apo- A1 by Visit | Day 14 | 3.98 percent change in Apo-A1 | Standard Deviation 7.952 |
| 300 mg Inclisiran Sodium | Percent Change From Baseline in Apo- A1 by Visit | Day 30 | 4.35 percent change in Apo-A1 | Standard Deviation 9.012 |
| 300 mg Inclisiran Sodium | Percent Change From Baseline in Apo- A1 by Visit | Day 60 | 5.18 percent change in Apo-A1 | Standard Deviation 10.023 |
| 300 mg Inclisiran Sodium | Percent Change From Baseline in Apo- A1 by Visit | Day 90 | 5.21 percent change in Apo-A1 | Standard Deviation 10.383 |
| 300 mg Inclisiran Sodium | Percent Change From Baseline in Apo- A1 by Visit | Day 120 | 6.60 percent change in Apo-A1 | Standard Deviation 11.152 |
| 300 mg Inclisiran Sodium | Percent Change From Baseline in Apo- A1 by Visit | Day 150 | 8.35 percent change in Apo-A1 | Standard Deviation 12.564 |
| 300 mg Inclisiran Sodium | Percent Change From Baseline in Apo- A1 by Visit | Day 104 | 4.99 percent change in Apo-A1 | Standard Deviation 10.061 |
Secondary
Percent Change From Baseline in Apo- B by Visit
Percent change from baseline in Apolipoprotein B (Apo-B) by visit was calculated to evaluate the effect of inclisiran over time
Time frame: Baseline, day 14, day 30, day 60, day 90, day 104, day 120, day 150, and day 180
Population: The overall number of participants analyzed represents the participants in the Full Analysis Set (FAS) who had at least one valid measurement of Apo-B.~The number analyzed per row represents the participants with a valid Apo-B value for both, baseline and that particular visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percent Change From Baseline in Apo- B by Visit | Day 180 | 3.82 percent change in Apo-B | Standard Deviation 14.649 |
| Placebo | Percent Change From Baseline in Apo- B by Visit | Day 14 | 1.09 percent change in Apo-B | Standard Deviation 13.795 |
| Placebo | Percent Change From Baseline in Apo- B by Visit | Day 150 | 3.86 percent change in Apo-B | Standard Deviation 13.559 |
| Placebo | Percent Change From Baseline in Apo- B by Visit | Day 60 | 1.41 percent change in Apo-B | Standard Deviation 11.965 |
| Placebo | Percent Change From Baseline in Apo- B by Visit | Day 120 | 2.05 percent change in Apo-B | Standard Deviation 14.719 |
| Placebo | Percent Change From Baseline in Apo- B by Visit | Day 104 | 3.03 percent change in Apo-B | Standard Deviation 13.304 |
| Placebo | Percent Change From Baseline in Apo- B by Visit | Day 90 | 2.76 percent change in Apo-B | Standard Deviation 12.882 |
| Placebo | Percent Change From Baseline in Apo- B by Visit | Day 30 | 2.16 percent change in Apo-B | Standard Deviation 12.904 |
| 100 mg Inclisiran Sodium | Percent Change From Baseline in Apo- B by Visit | Day 60 | -39.94 percent change in Apo-B | Standard Deviation 13.996 |
| 100 mg Inclisiran Sodium | Percent Change From Baseline in Apo- B by Visit | Day 150 | -42.82 percent change in Apo-B | Standard Deviation 14.799 |
| 100 mg Inclisiran Sodium | Percent Change From Baseline in Apo- B by Visit | Day 30 | -39.72 percent change in Apo-B | Standard Deviation 14.749 |
| 100 mg Inclisiran Sodium | Percent Change From Baseline in Apo- B by Visit | Day 180 | -38.63 percent change in Apo-B | Standard Deviation 13.265 |
| 100 mg Inclisiran Sodium | Percent Change From Baseline in Apo- B by Visit | Day 120 | -43.39 percent change in Apo-B | Standard Deviation 14.174 |
| 100 mg Inclisiran Sodium | Percent Change From Baseline in Apo- B by Visit | Day 90 | -35.84 percent change in Apo-B | Standard Deviation 14.134 |
| 100 mg Inclisiran Sodium | Percent Change From Baseline in Apo- B by Visit | Day 14 | -28.16 percent change in Apo-B | Standard Deviation 16.442 |
| 100 mg Inclisiran Sodium | Percent Change From Baseline in Apo- B by Visit | Day 104 | -40.86 percent change in Apo-B | Standard Deviation 14.578 |
| 200 mg Inclisiran Sodium | Percent Change From Baseline in Apo- B by Visit | Day 104 | -47.03 percent change in Apo-B | Standard Deviation 13.283 |
| 200 mg Inclisiran Sodium | Percent Change From Baseline in Apo- B by Visit | Day 90 | -42.04 percent change in Apo-B | Standard Deviation 14.319 |
| 200 mg Inclisiran Sodium | Percent Change From Baseline in Apo- B by Visit | Day 14 | -32.45 percent change in Apo-B | Standard Deviation 17.518 |
| 200 mg Inclisiran Sodium | Percent Change From Baseline in Apo- B by Visit | Day 150 | -46.71 percent change in Apo-B | Standard Deviation 13.775 |
| 200 mg Inclisiran Sodium | Percent Change From Baseline in Apo- B by Visit | Day 120 | -48.18 percent change in Apo-B | Standard Deviation 14.142 |
| 200 mg Inclisiran Sodium | Percent Change From Baseline in Apo- B by Visit | Day 60 | -44.49 percent change in Apo-B | Standard Deviation 14.654 |
| 200 mg Inclisiran Sodium | Percent Change From Baseline in Apo- B by Visit | Day 30 | -43.99 percent change in Apo-B | Standard Deviation 15.185 |
| 200 mg Inclisiran Sodium | Percent Change From Baseline in Apo- B by Visit | Day 180 | -44.50 percent change in Apo-B | Standard Deviation 14.685 |
| 300 mg Inclisiran Sodium | Percent Change From Baseline in Apo- B by Visit | Day 180 | -46.81 percent change in Apo-B | Standard Deviation 13.968 |
| 300 mg Inclisiran Sodium | Percent Change From Baseline in Apo- B by Visit | Day 14 | -37.12 percent change in Apo-B | Standard Deviation 16.743 |
| 300 mg Inclisiran Sodium | Percent Change From Baseline in Apo- B by Visit | Day 30 | -48.76 percent change in Apo-B | Standard Deviation 12.962 |
| 300 mg Inclisiran Sodium | Percent Change From Baseline in Apo- B by Visit | Day 60 | -48.53 percent change in Apo-B | Standard Deviation 12.005 |
| 300 mg Inclisiran Sodium | Percent Change From Baseline in Apo- B by Visit | Day 90 | -46.78 percent change in Apo-B | Standard Deviation 12.611 |
| 300 mg Inclisiran Sodium | Percent Change From Baseline in Apo- B by Visit | Day 104 | -51.93 percent change in Apo-B | Standard Deviation 12.39 |
| 300 mg Inclisiran Sodium | Percent Change From Baseline in Apo- B by Visit | Day 120 | -51.85 percent change in Apo-B | Standard Deviation 12.414 |
| 300 mg Inclisiran Sodium | Percent Change From Baseline in Apo- B by Visit | Day 150 | -50.41 percent change in Apo-B | Standard Deviation 12.411 |
Secondary
Percent Change From Baseline in Cholesterol by Visit
Percent change from baseline in cholesterol by visit was calculated to evaluate the effect of inclisiran over time
Time frame: Baseline, day 14, day 30, day 60, day 90, day 104, day 120, day 150, and day 180
Population: The overall number of participants analyzed represents the participants in the Full Analysis Set (FAS) who had at least one valid measurement of cholesterol.~The number analyzed per row represents the participants with a valid cholesterol value for both, baseline and that particular visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percent Change From Baseline in Cholesterol by Visit | Day 14 | 0.87 Percent change in cholesterol | Standard Deviation 10.399 |
| Placebo | Percent Change From Baseline in Cholesterol by Visit | Day 30 | 0.89 Percent change in cholesterol | Standard Deviation 9.003 |
| Placebo | Percent Change From Baseline in Cholesterol by Visit | Day 60 | 0.31 Percent change in cholesterol | Standard Deviation 8.885 |
| Placebo | Percent Change From Baseline in Cholesterol by Visit | Day 90 | 1.03 Percent change in cholesterol | Standard Deviation 8.952 |
| Placebo | Percent Change From Baseline in Cholesterol by Visit | Day 104 | 1.62 Percent change in cholesterol | Standard Deviation 10.178 |
| Placebo | Percent Change From Baseline in Cholesterol by Visit | Day 120 | 1.11 Percent change in cholesterol | Standard Deviation 10.86 |
| Placebo | Percent Change From Baseline in Cholesterol by Visit | Day 150 | 2.41 Percent change in cholesterol | Standard Deviation 10.801 |
| Placebo | Percent Change From Baseline in Cholesterol by Visit | Day 180 | 2.78 Percent change in cholesterol | Standard Deviation 10.272 |
| 100 mg Inclisiran Sodium | Percent Change From Baseline in Cholesterol by Visit | Day 120 | -32.24 Percent change in cholesterol | Standard Deviation 13.575 |
| 100 mg Inclisiran Sodium | Percent Change From Baseline in Cholesterol by Visit | Day 104 | -30.72 Percent change in cholesterol | Standard Deviation 13.239 |
| 100 mg Inclisiran Sodium | Percent Change From Baseline in Cholesterol by Visit | Day 30 | -30.92 Percent change in cholesterol | Standard Deviation 12.558 |
| 100 mg Inclisiran Sodium | Percent Change From Baseline in Cholesterol by Visit | Day 180 | -30.22 Percent change in cholesterol | Standard Deviation 12.468 |
| 100 mg Inclisiran Sodium | Percent Change From Baseline in Cholesterol by Visit | Day 150 | -32.20 Percent change in cholesterol | Standard Deviation 14.246 |
| 100 mg Inclisiran Sodium | Percent Change From Baseline in Cholesterol by Visit | Day 90 | -27.30 Percent change in cholesterol | Standard Deviation 13.127 |
| 100 mg Inclisiran Sodium | Percent Change From Baseline in Cholesterol by Visit | Day 60 | -29.47 Percent change in cholesterol | Standard Deviation 13.426 |
| 100 mg Inclisiran Sodium | Percent Change From Baseline in Cholesterol by Visit | Day 14 | -21.94 Percent change in cholesterol | Standard Deviation 14.034 |
| 200 mg Inclisiran Sodium | Percent Change From Baseline in Cholesterol by Visit | Day 150 | -35.70 Percent change in cholesterol | Standard Deviation 11.98 |
| 200 mg Inclisiran Sodium | Percent Change From Baseline in Cholesterol by Visit | Day 60 | -33.71 Percent change in cholesterol | Standard Deviation 12.291 |
| 200 mg Inclisiran Sodium | Percent Change From Baseline in Cholesterol by Visit | Day 90 | -32.26 Percent change in cholesterol | Standard Deviation 12.103 |
| 200 mg Inclisiran Sodium | Percent Change From Baseline in Cholesterol by Visit | Day 104 | -35.63 Percent change in cholesterol | Standard Deviation 11.875 |
| 200 mg Inclisiran Sodium | Percent Change From Baseline in Cholesterol by Visit | Day 120 | -36.24 Percent change in cholesterol | Standard Deviation 12.995 |
| 200 mg Inclisiran Sodium | Percent Change From Baseline in Cholesterol by Visit | Day 180 | -32.95 Percent change in cholesterol | Standard Deviation 12.54 |
| 200 mg Inclisiran Sodium | Percent Change From Baseline in Cholesterol by Visit | Day 14 | -24.71 Percent change in cholesterol | Standard Deviation 12.917 |
| 200 mg Inclisiran Sodium | Percent Change From Baseline in Cholesterol by Visit | Day 30 | -32.90 Percent change in cholesterol | Standard Deviation 11.739 |
| 300 mg Inclisiran Sodium | Percent Change From Baseline in Cholesterol by Visit | Day 60 | -37.01 Percent change in cholesterol | Standard Deviation 9.948 |
| 300 mg Inclisiran Sodium | Percent Change From Baseline in Cholesterol by Visit | Day 90 | -36.34 Percent change in cholesterol | Standard Deviation 10.655 |
| 300 mg Inclisiran Sodium | Percent Change From Baseline in Cholesterol by Visit | Day 30 | -37.09 Percent change in cholesterol | Standard Deviation 10.227 |
| 300 mg Inclisiran Sodium | Percent Change From Baseline in Cholesterol by Visit | Day 14 | -28.60 Percent change in cholesterol | Standard Deviation 12.476 |
| 300 mg Inclisiran Sodium | Percent Change From Baseline in Cholesterol by Visit | Day 104 | -39.53 Percent change in cholesterol | Standard Deviation 10.468 |
| 300 mg Inclisiran Sodium | Percent Change From Baseline in Cholesterol by Visit | Day 180 | -35.46 Percent change in cholesterol | Standard Deviation 11.941 |
| 300 mg Inclisiran Sodium | Percent Change From Baseline in Cholesterol by Visit | Day 150 | -38.12 Percent change in cholesterol | Standard Deviation 10.85 |
| 300 mg Inclisiran Sodium | Percent Change From Baseline in Cholesterol by Visit | Day 120 | -39.38 Percent change in cholesterol | Standard Deviation 10.165 |
Secondary
Percent Change From Baseline in HDL Cholesterol by Visit
Percent change from baseline in high-density lipoprotein cholesterol (HDL-C) by visit was calculated to evaluate the effect of inclisiran over time
Time frame: Baseline, day 14, day 30, day 60, day 90, day 104, day 120, day 150, and day 180
Population: The overall number of participants analyzed represents the participants in the Full Analysis Set (FAS) who had at least one valid measurement of HDL Cholesterol.~The number analyzed per row represents the participants with a valid HDL Cholesterol value for both, baseline and that particular visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percent Change From Baseline in HDL Cholesterol by Visit | Day 14 | 1.73 percent change in HDL Cholesterol | Standard Deviation 8.765 |
| Placebo | Percent Change From Baseline in HDL Cholesterol by Visit | Day 30 | 1.94 percent change in HDL Cholesterol | Standard Deviation 11.259 |
| Placebo | Percent Change From Baseline in HDL Cholesterol by Visit | Day 60 | 0.57 percent change in HDL Cholesterol | Standard Deviation 10.677 |
| Placebo | Percent Change From Baseline in HDL Cholesterol by Visit | Day 90 | 0.56 percent change in HDL Cholesterol | Standard Deviation 11.543 |
| Placebo | Percent Change From Baseline in HDL Cholesterol by Visit | Day 104 | 1.35 percent change in HDL Cholesterol | Standard Deviation 14.817 |
| Placebo | Percent Change From Baseline in HDL Cholesterol by Visit | Day 120 | 4.20 percent change in HDL Cholesterol | Standard Deviation 13.747 |
| Placebo | Percent Change From Baseline in HDL Cholesterol by Visit | Day 150 | 5.12 percent change in HDL Cholesterol | Standard Deviation 13.587 |
| Placebo | Percent Change From Baseline in HDL Cholesterol by Visit | Day 180 | 8.25 percent change in HDL Cholesterol | Standard Deviation 12.94 |
| 100 mg Inclisiran Sodium | Percent Change From Baseline in HDL Cholesterol by Visit | Day 120 | 8.84 percent change in HDL Cholesterol | Standard Deviation 13.432 |
| 100 mg Inclisiran Sodium | Percent Change From Baseline in HDL Cholesterol by Visit | Day 104 | 8.69 percent change in HDL Cholesterol | Standard Deviation 15.303 |
| 100 mg Inclisiran Sodium | Percent Change From Baseline in HDL Cholesterol by Visit | Day 30 | 4.86 percent change in HDL Cholesterol | Standard Deviation 10.45 |
| 100 mg Inclisiran Sodium | Percent Change From Baseline in HDL Cholesterol by Visit | Day 180 | 6.89 percent change in HDL Cholesterol | Standard Deviation 17.051 |
| 100 mg Inclisiran Sodium | Percent Change From Baseline in HDL Cholesterol by Visit | Day 150 | 7.51 percent change in HDL Cholesterol | Standard Deviation 17.455 |
| 100 mg Inclisiran Sodium | Percent Change From Baseline in HDL Cholesterol by Visit | Day 90 | 6.51 percent change in HDL Cholesterol | Standard Deviation 16.297 |
| 100 mg Inclisiran Sodium | Percent Change From Baseline in HDL Cholesterol by Visit | Day 60 | 6.80 percent change in HDL Cholesterol | Standard Deviation 15.222 |
| 100 mg Inclisiran Sodium | Percent Change From Baseline in HDL Cholesterol by Visit | Day 14 | 3.00 percent change in HDL Cholesterol | Standard Deviation 10.745 |
| 200 mg Inclisiran Sodium | Percent Change From Baseline in HDL Cholesterol by Visit | Day 150 | 12.80 percent change in HDL Cholesterol | Standard Deviation 16.337 |
| 200 mg Inclisiran Sodium | Percent Change From Baseline in HDL Cholesterol by Visit | Day 60 | 8.02 percent change in HDL Cholesterol | Standard Deviation 15.411 |
| 200 mg Inclisiran Sodium | Percent Change From Baseline in HDL Cholesterol by Visit | Day 90 | 10.86 percent change in HDL Cholesterol | Standard Deviation 16.359 |
| 200 mg Inclisiran Sodium | Percent Change From Baseline in HDL Cholesterol by Visit | Day 104 | 11.04 percent change in HDL Cholesterol | Standard Deviation 16.443 |
| 200 mg Inclisiran Sodium | Percent Change From Baseline in HDL Cholesterol by Visit | Day 120 | 12.65 percent change in HDL Cholesterol | Standard Deviation 16.777 |
| 200 mg Inclisiran Sodium | Percent Change From Baseline in HDL Cholesterol by Visit | Day 180 | 15.95 percent change in HDL Cholesterol | Standard Deviation 17.025 |
| 200 mg Inclisiran Sodium | Percent Change From Baseline in HDL Cholesterol by Visit | Day 14 | 5.93 percent change in HDL Cholesterol | Standard Deviation 12.164 |
| 200 mg Inclisiran Sodium | Percent Change From Baseline in HDL Cholesterol by Visit | Day 30 | 9.89 percent change in HDL Cholesterol | Standard Deviation 13.656 |
| 300 mg Inclisiran Sodium | Percent Change From Baseline in HDL Cholesterol by Visit | Day 60 | 9.15 percent change in HDL Cholesterol | Standard Deviation 14.984 |
| 300 mg Inclisiran Sodium | Percent Change From Baseline in HDL Cholesterol by Visit | Day 90 | 8.59 percent change in HDL Cholesterol | Standard Deviation 16.546 |
| 300 mg Inclisiran Sodium | Percent Change From Baseline in HDL Cholesterol by Visit | Day 30 | 8.43 percent change in HDL Cholesterol | Standard Deviation 12.74 |
| 300 mg Inclisiran Sodium | Percent Change From Baseline in HDL Cholesterol by Visit | Day 14 | 4.38 percent change in HDL Cholesterol | Standard Deviation 10.727 |
| 300 mg Inclisiran Sodium | Percent Change From Baseline in HDL Cholesterol by Visit | Day 104 | 8.99 percent change in HDL Cholesterol | Standard Deviation 17.28 |
| 300 mg Inclisiran Sodium | Percent Change From Baseline in HDL Cholesterol by Visit | Day 180 | 14.26 percent change in HDL Cholesterol | Standard Deviation 20.158 |
| 300 mg Inclisiran Sodium | Percent Change From Baseline in HDL Cholesterol by Visit | Day 150 | 11.68 percent change in HDL Cholesterol | Standard Deviation 18.486 |
| 300 mg Inclisiran Sodium | Percent Change From Baseline in HDL Cholesterol by Visit | Day 120 | 11.97 percent change in HDL Cholesterol | Standard Deviation 18.3 |
Secondary
Percent Change From Baseline in LDL-C by Visit
Percent change from baseline in low-density lipoprotein cholesterol (LDL-C) was calculated to evaluate the effect of inclisiran over time.
Time frame: Baseline, day 14, day 30, day 60, day 90, day 104, day 120 and day 150
Population: The overall number of participants analyzed represents the participants in the Full Analysis Set (FAS) who had at least one valid measurement of LDL-C.~The number analyzed per row represents the participants with a valid LDL-C value for both, baseline and that particular visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percent Change From Baseline in LDL-C by Visit | Day 104 | 1.20 percent change in LDL-C | Standard Deviation 13.519 |
| Placebo | Percent Change From Baseline in LDL-C by Visit | Day 90 | 2.69 percent change in LDL-C | Standard Deviation 14.332 |
| Placebo | Percent Change From Baseline in LDL-C by Visit | Day 60 | 0.24 percent change in LDL-C | Standard Deviation 15.314 |
| Placebo | Percent Change From Baseline in LDL-C by Visit | Day 150 | 4.27 percent change in LDL-C | Standard Deviation 16.983 |
| Placebo | Percent Change From Baseline in LDL-C by Visit | Day 120 | 2.26 percent change in LDL-C | Standard Deviation 14.854 |
| Placebo | Percent Change From Baseline in LDL-C by Visit | Day 30 | 1.29 percent change in LDL-C | Standard Deviation 13.068 |
| Placebo | Percent Change From Baseline in LDL-C by Visit | Day 14 | 1.68 percent change in LDL-C | Standard Deviation 18.099 |
| 100 mg Inclisiran Sodium | Percent Change From Baseline in LDL-C by Visit | Day 150 | -55.46 percent change in LDL-C | Standard Deviation 18.817 |
| 100 mg Inclisiran Sodium | Percent Change From Baseline in LDL-C by Visit | Day 14 | -37.15 percent change in LDL-C | Standard Deviation 21.855 |
| 100 mg Inclisiran Sodium | Percent Change From Baseline in LDL-C by Visit | Day 30 | -52.20 percent change in LDL-C | Standard Deviation 18.389 |
| 100 mg Inclisiran Sodium | Percent Change From Baseline in LDL-C by Visit | Day 60 | -50.06 percent change in LDL-C | Standard Deviation 19.173 |
| 100 mg Inclisiran Sodium | Percent Change From Baseline in LDL-C by Visit | Day 90 | -46.39 percent change in LDL-C | Standard Deviation 17.872 |
| 100 mg Inclisiran Sodium | Percent Change From Baseline in LDL-C by Visit | Day 104 | -53.00 percent change in LDL-C | Standard Deviation 19.001 |
| 100 mg Inclisiran Sodium | Percent Change From Baseline in LDL-C by Visit | Day 120 | -54.91 percent change in LDL-C | Standard Deviation 19.41 |
| 200 mg Inclisiran Sodium | Percent Change From Baseline in LDL-C by Visit | Day 30 | -55.54 percent change in LDL-C | Standard Deviation 17.501 |
| 200 mg Inclisiran Sodium | Percent Change From Baseline in LDL-C by Visit | Day 150 | -60.55 percent change in LDL-C | Standard Deviation 16.502 |
| 200 mg Inclisiran Sodium | Percent Change From Baseline in LDL-C by Visit | Day 120 | -62.04 percent change in LDL-C | Standard Deviation 16.742 |
| 200 mg Inclisiran Sodium | Percent Change From Baseline in LDL-C by Visit | Day 104 | -60.33 percent change in LDL-C | Standard Deviation 15.912 |
| 200 mg Inclisiran Sodium | Percent Change From Baseline in LDL-C by Visit | Day 60 | -55.61 percent change in LDL-C | Standard Deviation 17.57 |
| 200 mg Inclisiran Sodium | Percent Change From Baseline in LDL-C by Visit | Day 90 | -53.92 percent change in LDL-C | Standard Deviation 17.186 |
| 200 mg Inclisiran Sodium | Percent Change From Baseline in LDL-C by Visit | Day 14 | -42.08 percent change in LDL-C | Standard Deviation 20.503 |
| 300 mg Inclisiran Sodium | Percent Change From Baseline in LDL-C by Visit | Day 30 | -62.77 percent change in LDL-C | Standard Deviation 15.097 |
| 300 mg Inclisiran Sodium | Percent Change From Baseline in LDL-C by Visit | Day 90 | -61.51 percent change in LDL-C | Standard Deviation 15.48 |
| 300 mg Inclisiran Sodium | Percent Change From Baseline in LDL-C by Visit | Day 104 | -65.68 percent change in LDL-C | Standard Deviation 15.321 |
| 300 mg Inclisiran Sodium | Percent Change From Baseline in LDL-C by Visit | Day 14 | -47.60 percent change in LDL-C | Standard Deviation 19.889 |
| 300 mg Inclisiran Sodium | Percent Change From Baseline in LDL-C by Visit | Day 150 | -66.15 percent change in LDL-C | Standard Deviation 15.197 |
| 300 mg Inclisiran Sodium | Percent Change From Baseline in LDL-C by Visit | Day 120 | -67.23 percent change in LDL-C | Standard Deviation 16.017 |
| 300 mg Inclisiran Sodium | Percent Change From Baseline in LDL-C by Visit | Day 60 | -62.35 percent change in LDL-C | Standard Deviation 13.976 |
Secondary
Percent Change From Baseline in Lipoprotein-a by Visit
Percent change from baseline in Lipoprotein a (LP(a)) by visit was calculated to evaluate the effect of inclisiran over time
Time frame: Baseline, day 14, day 30, day 60, day 90, day 104, day 120, day 150, and day 180
Population: The overall number of participants analyzed represents the participants in the Full Analysis Set (FAS) who had at least one valid measurement of LP(a).~The number analyzed per row represents the participants with a valid LP(a) value for both, baseline and that particular visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percent Change From Baseline in Lipoprotein-a by Visit | Day 14 | 3.33 percent change in LP(a) | Standard Deviation 32.912 |
| Placebo | Percent Change From Baseline in Lipoprotein-a by Visit | Day 30 | 0.92 percent change in LP(a) | Standard Deviation 31.643 |
| Placebo | Percent Change From Baseline in Lipoprotein-a by Visit | Day 60 | -4.29 percent change in LP(a) | Standard Deviation 30.944 |
| Placebo | Percent Change From Baseline in Lipoprotein-a by Visit | Day 90 | 4.35 percent change in LP(a) | Standard Deviation 29.27 |
| Placebo | Percent Change From Baseline in Lipoprotein-a by Visit | Day 104 | -2.41 percent change in LP(a) | Standard Deviation 26.326 |
| Placebo | Percent Change From Baseline in Lipoprotein-a by Visit | Day 120 | 0.22 percent change in LP(a) | Standard Deviation 23.786 |
| Placebo | Percent Change From Baseline in Lipoprotein-a by Visit | Day 150 | 4.02 percent change in LP(a) | Standard Deviation 32.703 |
| Placebo | Percent Change From Baseline in Lipoprotein-a by Visit | Day 180 | 5.45 percent change in LP(a) | Standard Deviation 36.446 |
| 100 mg Inclisiran Sodium | Percent Change From Baseline in Lipoprotein-a by Visit | Day 120 | -31.46 percent change in LP(a) | Standard Deviation 27.979 |
| 100 mg Inclisiran Sodium | Percent Change From Baseline in Lipoprotein-a by Visit | Day 104 | -32.02 percent change in LP(a) | Standard Deviation 30.286 |
| 100 mg Inclisiran Sodium | Percent Change From Baseline in Lipoprotein-a by Visit | Day 30 | -28.09 percent change in LP(a) | Standard Deviation 21.846 |
| 100 mg Inclisiran Sodium | Percent Change From Baseline in Lipoprotein-a by Visit | Day 180 | -30.15 percent change in LP(a) | Standard Deviation 25.578 |
| 100 mg Inclisiran Sodium | Percent Change From Baseline in Lipoprotein-a by Visit | Day 150 | -32.21 percent change in LP(a) | Standard Deviation 26.14 |
| 100 mg Inclisiran Sodium | Percent Change From Baseline in Lipoprotein-a by Visit | Day 90 | -27.08 percent change in LP(a) | Standard Deviation 25.26 |
| 100 mg Inclisiran Sodium | Percent Change From Baseline in Lipoprotein-a by Visit | Day 60 | -30.89 percent change in LP(a) | Standard Deviation 26.802 |
| 100 mg Inclisiran Sodium | Percent Change From Baseline in Lipoprotein-a by Visit | Day 14 | -21.77 percent change in LP(a) | Standard Deviation 24.909 |
| 200 mg Inclisiran Sodium | Percent Change From Baseline in Lipoprotein-a by Visit | Day 150 | -21.59 percent change in LP(a) | Standard Deviation 47.82 |
| 200 mg Inclisiran Sodium | Percent Change From Baseline in Lipoprotein-a by Visit | Day 60 | -26.11 percent change in LP(a) | Standard Deviation 45.964 |
| 200 mg Inclisiran Sodium | Percent Change From Baseline in Lipoprotein-a by Visit | Day 90 | -24.93 percent change in LP(a) | Standard Deviation 42.005 |
| 200 mg Inclisiran Sodium | Percent Change From Baseline in Lipoprotein-a by Visit | Day 104 | -25.99 percent change in LP(a) | Standard Deviation 45.444 |
| 200 mg Inclisiran Sodium | Percent Change From Baseline in Lipoprotein-a by Visit | Day 120 | -30.26 percent change in LP(a) | Standard Deviation 37.382 |
| 200 mg Inclisiran Sodium | Percent Change From Baseline in Lipoprotein-a by Visit | Day 180 | -25.46 percent change in LP(a) | Standard Deviation 48.279 |
| 200 mg Inclisiran Sodium | Percent Change From Baseline in Lipoprotein-a by Visit | Day 14 | -16.63 percent change in LP(a) | Standard Deviation 41.372 |
| 200 mg Inclisiran Sodium | Percent Change From Baseline in Lipoprotein-a by Visit | Day 30 | -22.80 percent change in LP(a) | Standard Deviation 46.679 |
| 300 mg Inclisiran Sodium | Percent Change From Baseline in Lipoprotein-a by Visit | Day 60 | -36.21 percent change in LP(a) | Standard Deviation 22.036 |
| 300 mg Inclisiran Sodium | Percent Change From Baseline in Lipoprotein-a by Visit | Day 90 | -34.26 percent change in LP(a) | Standard Deviation 25.027 |
| 300 mg Inclisiran Sodium | Percent Change From Baseline in Lipoprotein-a by Visit | Day 30 | -31.30 percent change in LP(a) | Standard Deviation 26.785 |
| 300 mg Inclisiran Sodium | Percent Change From Baseline in Lipoprotein-a by Visit | Day 14 | -22.84 percent change in LP(a) | Standard Deviation 22.934 |
| 300 mg Inclisiran Sodium | Percent Change From Baseline in Lipoprotein-a by Visit | Day 104 | -37.92 percent change in LP(a) | Standard Deviation 30.801 |
| 300 mg Inclisiran Sodium | Percent Change From Baseline in Lipoprotein-a by Visit | Day 180 | -35.41 percent change in LP(a) | Standard Deviation 25.123 |
| 300 mg Inclisiran Sodium | Percent Change From Baseline in Lipoprotein-a by Visit | Day 150 | -38.11 percent change in LP(a) | Standard Deviation 24.508 |
| 300 mg Inclisiran Sodium | Percent Change From Baseline in Lipoprotein-a by Visit | Day 120 | -37.24 percent change in LP(a) | Standard Deviation 25.389 |
Secondary
Percent Change From Baseline in Non-HDL Cholesterol by Visit
Percent change from baseline in non-HDL Cholesterol by visit was calculated to evaluate the effect of inclisiran over time
Time frame: Baseline, day 14, day 30, day 60, day 90, day 104, day 120, day 150, and day 180
Population: The overall number of participants analyzed represents the participants in the Full Analysis Set (FAS) who had at least one valid measurement of non-HDL Cholesterol.~The number analyzed per row represents the participants with a valid non-HDL Cholesterol value for both, baseline and that particular visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percent Change From Baseline in Non-HDL Cholesterol by Visit | Day 14 | 1.13 percent change in non-HDL Cholesterol | Standard Deviation 13.511 |
| Placebo | Percent Change From Baseline in Non-HDL Cholesterol by Visit | Day 30 | 1.03 percent change in non-HDL Cholesterol | Standard Deviation 11.483 |
| Placebo | Percent Change From Baseline in Non-HDL Cholesterol by Visit | Day 60 | 0.62 percent change in non-HDL Cholesterol | Standard Deviation 11.841 |
| Placebo | Percent Change From Baseline in Non-HDL Cholesterol by Visit | Day 90 | 1.75 percent change in non-HDL Cholesterol | Standard Deviation 11.931 |
| Placebo | Percent Change From Baseline in Non-HDL Cholesterol by Visit | Day 104 | 1.96 percent change in non-HDL Cholesterol | Standard Deviation 12.067 |
| Placebo | Percent Change From Baseline in Non-HDL Cholesterol by Visit | Day 120 | 0.82 percent change in non-HDL Cholesterol | Standard Deviation 14.045 |
| Placebo | Percent Change From Baseline in Non-HDL Cholesterol by Visit | Day 150 | 1.96 percent change in non-HDL Cholesterol | Standard Deviation 13.519 |
| Placebo | Percent Change From Baseline in Non-HDL Cholesterol by Visit | Day 180 | 1.29 percent change in non-HDL Cholesterol | Standard Deviation 13.455 |
| 100 mg Inclisiran Sodium | Percent Change From Baseline in Non-HDL Cholesterol by Visit | Day 120 | -48.22 percent change in non-HDL Cholesterol | Standard Deviation 17.301 |
| 100 mg Inclisiran Sodium | Percent Change From Baseline in Non-HDL Cholesterol by Visit | Day 104 | -46.10 percent change in non-HDL Cholesterol | Standard Deviation 17.006 |
| 100 mg Inclisiran Sodium | Percent Change From Baseline in Non-HDL Cholesterol by Visit | Day 30 | -44.72 percent change in non-HDL Cholesterol | Standard Deviation 16.27 |
| 100 mg Inclisiran Sodium | Percent Change From Baseline in Non-HDL Cholesterol by Visit | Day 180 | -44.83 percent change in non-HDL Cholesterol | Standard Deviation 15.558 |
| 100 mg Inclisiran Sodium | Percent Change From Baseline in Non-HDL Cholesterol by Visit | Day 150 | -47.90 percent change in non-HDL Cholesterol | Standard Deviation 17.495 |
| 100 mg Inclisiran Sodium | Percent Change From Baseline in Non-HDL Cholesterol by Visit | Day 90 | -39.83 percent change in non-HDL Cholesterol | Standard Deviation 16.485 |
| 100 mg Inclisiran Sodium | Percent Change From Baseline in Non-HDL Cholesterol by Visit | Day 60 | -43.39 percent change in non-HDL Cholesterol | Standard Deviation 16.505 |
| 100 mg Inclisiran Sodium | Percent Change From Baseline in Non-HDL Cholesterol by Visit | Day 14 | -31.37 percent change in non-HDL Cholesterol | Standard Deviation 19.592 |
| 200 mg Inclisiran Sodium | Percent Change From Baseline in Non-HDL Cholesterol by Visit | Day 150 | -52.85 percent change in non-HDL Cholesterol | Standard Deviation 14.254 |
| 200 mg Inclisiran Sodium | Percent Change From Baseline in Non-HDL Cholesterol by Visit | Day 60 | -48.18 percent change in non-HDL Cholesterol | Standard Deviation 15.146 |
| 200 mg Inclisiran Sodium | Percent Change From Baseline in Non-HDL Cholesterol by Visit | Day 90 | -47.20 percent change in non-HDL Cholesterol | Standard Deviation 15.002 |
| 200 mg Inclisiran Sodium | Percent Change From Baseline in Non-HDL Cholesterol by Visit | Day 104 | -51.98 percent change in non-HDL Cholesterol | Standard Deviation 14.344 |
| 200 mg Inclisiran Sodium | Percent Change From Baseline in Non-HDL Cholesterol by Visit | Day 120 | -53.52 percent change in non-HDL Cholesterol | Standard Deviation 15.425 |
| 200 mg Inclisiran Sodium | Percent Change From Baseline in Non-HDL Cholesterol by Visit | Day 180 | -50.15 percent change in non-HDL Cholesterol | Standard Deviation 16.446 |
| 200 mg Inclisiran Sodium | Percent Change From Baseline in Non-HDL Cholesterol by Visit | Day 14 | -35.68 percent change in non-HDL Cholesterol | Standard Deviation 18.056 |
| 200 mg Inclisiran Sodium | Percent Change From Baseline in Non-HDL Cholesterol by Visit | Day 30 | -47.99 percent change in non-HDL Cholesterol | Standard Deviation 15.318 |
| 300 mg Inclisiran Sodium | Percent Change From Baseline in Non-HDL Cholesterol by Visit | Day 60 | -54.10 percent change in non-HDL Cholesterol | Standard Deviation 12.034 |
| 300 mg Inclisiran Sodium | Percent Change From Baseline in Non-HDL Cholesterol by Visit | Day 90 | -53.18 percent change in non-HDL Cholesterol | Standard Deviation 13.236 |
| 300 mg Inclisiran Sodium | Percent Change From Baseline in Non-HDL Cholesterol by Visit | Day 30 | -54.17 percent change in non-HDL Cholesterol | Standard Deviation 12.815 |
| 300 mg Inclisiran Sodium | Percent Change From Baseline in Non-HDL Cholesterol by Visit | Day 14 | -41.16 percent change in non-HDL Cholesterol | Standard Deviation 17.005 |
| 300 mg Inclisiran Sodium | Percent Change From Baseline in Non-HDL Cholesterol by Visit | Day 104 | -57.74 percent change in non-HDL Cholesterol | Standard Deviation 12.513 |
| 300 mg Inclisiran Sodium | Percent Change From Baseline in Non-HDL Cholesterol by Visit | Day 180 | -54.04 percent change in non-HDL Cholesterol | Standard Deviation 14.23 |
| 300 mg Inclisiran Sodium | Percent Change From Baseline in Non-HDL Cholesterol by Visit | Day 150 | -56.82 percent change in non-HDL Cholesterol | Standard Deviation 12.997 |
| 300 mg Inclisiran Sodium | Percent Change From Baseline in Non-HDL Cholesterol by Visit | Day 120 | -58.67 percent change in non-HDL Cholesterol | Standard Deviation 12.175 |
Secondary
Percent Change From Baseline in PCSK9 by Visit
Percent change from baseline in proprotein convertase subtilisin/kexin type 9 (PCSK9) was calculated to evaluate the effect of inclisiran over time.
Time frame: Baseline, day 14, day 30, day 60, day 90, day 104, day 120, day 150, and day 180
Population: The overall number of participants analyzed represents the participants in the Full Analysis Set (FAS) who had at least one valid measurement of PCSK9.~The number analyzed per row represents the participants with a valid PCSK9 value for both, baseline and that particular visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percent Change From Baseline in PCSK9 by Visit | Day 14 | 4.79 percent change in PCSK9 | Standard Deviation 21.623 |
| Placebo | Percent Change From Baseline in PCSK9 by Visit | Day 30 | 1.92 percent change in PCSK9 | Standard Deviation 22.427 |
| Placebo | Percent Change From Baseline in PCSK9 by Visit | Day 60 | -0.16 percent change in PCSK9 | Standard Deviation 22.656 |
| Placebo | Percent Change From Baseline in PCSK9 by Visit | Day 90 | 2.12 percent change in PCSK9 | Standard Deviation 21.447 |
| Placebo | Percent Change From Baseline in PCSK9 by Visit | Day 104 | 2.65 percent change in PCSK9 | Standard Deviation 28.624 |
| Placebo | Percent Change From Baseline in PCSK9 by Visit | Day 120 | 0.99 percent change in PCSK9 | Standard Deviation 21.572 |
| Placebo | Percent Change From Baseline in PCSK9 by Visit | Day 150 | 2.34 percent change in PCSK9 | Standard Deviation 23.353 |
| Placebo | Percent Change From Baseline in PCSK9 by Visit | Day 180 | 2.78 percent change in PCSK9 | Standard Deviation 21.226 |
| 100 mg Inclisiran Sodium | Percent Change From Baseline in PCSK9 by Visit | Day 120 | -70.29 percent change in PCSK9 | Standard Deviation 11.543 |
| 100 mg Inclisiran Sodium | Percent Change From Baseline in PCSK9 by Visit | Day 104 | -69.05 percent change in PCSK9 | Standard Deviation 11.109 |
| 100 mg Inclisiran Sodium | Percent Change From Baseline in PCSK9 by Visit | Day 30 | -66.45 percent change in PCSK9 | Standard Deviation 12.341 |
| 100 mg Inclisiran Sodium | Percent Change From Baseline in PCSK9 by Visit | Day 180 | -63.62 percent change in PCSK9 | Standard Deviation 14.012 |
| 100 mg Inclisiran Sodium | Percent Change From Baseline in PCSK9 by Visit | Day 150 | -66.02 percent change in PCSK9 | Standard Deviation 12.724 |
| 100 mg Inclisiran Sodium | Percent Change From Baseline in PCSK9 by Visit | Day 90 | -59.76 percent change in PCSK9 | Standard Deviation 14.503 |
| 100 mg Inclisiran Sodium | Percent Change From Baseline in PCSK9 by Visit | Day 60 | -62.56 percent change in PCSK9 | Standard Deviation 15.356 |
| 100 mg Inclisiran Sodium | Percent Change From Baseline in PCSK9 by Visit | Day 14 | -55.42 percent change in PCSK9 | Standard Deviation 19.98 |
| 200 mg Inclisiran Sodium | Percent Change From Baseline in PCSK9 by Visit | Day 150 | -73.94 percent change in PCSK9 | Standard Deviation 17.139 |
| 200 mg Inclisiran Sodium | Percent Change From Baseline in PCSK9 by Visit | Day 60 | -73.23 percent change in PCSK9 | Standard Deviation 10.692 |
| 200 mg Inclisiran Sodium | Percent Change From Baseline in PCSK9 by Visit | Day 90 | -70.49 percent change in PCSK9 | Standard Deviation 10.806 |
| 200 mg Inclisiran Sodium | Percent Change From Baseline in PCSK9 by Visit | Day 104 | -76.23 percent change in PCSK9 | Standard Deviation 9.017 |
| 200 mg Inclisiran Sodium | Percent Change From Baseline in PCSK9 by Visit | Day 120 | -77.03 percent change in PCSK9 | Standard Deviation 8.206 |
| 200 mg Inclisiran Sodium | Percent Change From Baseline in PCSK9 by Visit | Day 180 | -70.99 percent change in PCSK9 | Standard Deviation 10.495 |
| 200 mg Inclisiran Sodium | Percent Change From Baseline in PCSK9 by Visit | Day 14 | -65.64 percent change in PCSK9 | Standard Deviation 13.677 |
| 200 mg Inclisiran Sodium | Percent Change From Baseline in PCSK9 by Visit | Day 30 | -72.94 percent change in PCSK9 | Standard Deviation 8.809 |
| 300 mg Inclisiran Sodium | Percent Change From Baseline in PCSK9 by Visit | Day 60 | -76.52 percent change in PCSK9 | Standard Deviation 9.953 |
| 300 mg Inclisiran Sodium | Percent Change From Baseline in PCSK9 by Visit | Day 90 | -73.09 percent change in PCSK9 | Standard Deviation 11.525 |
| 300 mg Inclisiran Sodium | Percent Change From Baseline in PCSK9 by Visit | Day 30 | -76.46 percent change in PCSK9 | Standard Deviation 8.561 |
| 300 mg Inclisiran Sodium | Percent Change From Baseline in PCSK9 by Visit | Day 14 | -69.56 percent change in PCSK9 | Standard Deviation 11.387 |
| 300 mg Inclisiran Sodium | Percent Change From Baseline in PCSK9 by Visit | Day 104 | -78.55 percent change in PCSK9 | Standard Deviation 8.052 |
| 300 mg Inclisiran Sodium | Percent Change From Baseline in PCSK9 by Visit | Day 180 | -75.97 percent change in PCSK9 | Standard Deviation 9.885 |
| 300 mg Inclisiran Sodium | Percent Change From Baseline in PCSK9 by Visit | Day 150 | -77.12 percent change in PCSK9 | Standard Deviation 8.77 |
| 300 mg Inclisiran Sodium | Percent Change From Baseline in PCSK9 by Visit | Day 120 | -79.80 percent change in PCSK9 | Standard Deviation 6.994 |
Secondary
Percent Change From Baseline in Triglycerides by Visit
Percent change from baseline in triglycerides by visit was calculated to evaluate the effect of inclisiran over time
Time frame: Baseline, day 14, day 30, day 60, day 90, day 104, day 120, day 150, and day 180
Population: The overall number of participants analyzed represents the participants in the Full Analysis Set (FAS) who had at least one valid measurement of triglycerides.~The number analyzed per row represents the participants with a valid triglycerides value for both, baseline and that particular visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percent Change From Baseline in Triglycerides by Visit | Day 14 | 5.49 percent change in triglycerides | Standard Deviation 28.803 |
| Placebo | Percent Change From Baseline in Triglycerides by Visit | Day 30 | 7.76 percent change in triglycerides | Standard Deviation 35.248 |
| Placebo | Percent Change From Baseline in Triglycerides by Visit | Day 60 | 9.68 percent change in triglycerides | Standard Deviation 37 |
| Placebo | Percent Change From Baseline in Triglycerides by Visit | Day 90 | 6.83 percent change in triglycerides | Standard Deviation 33.204 |
| Placebo | Percent Change From Baseline in Triglycerides by Visit | Day 104 | 11.86 percent change in triglycerides | Standard Deviation 37.365 |
| Placebo | Percent Change From Baseline in Triglycerides by Visit | Day 120 | 3.57 percent change in triglycerides | Standard Deviation 33.87 |
| Placebo | Percent Change From Baseline in Triglycerides by Visit | Day 150 | 3.33 percent change in triglycerides | Standard Deviation 32.023 |
| Placebo | Percent Change From Baseline in Triglycerides by Visit | Day 180 | -0.19 percent change in triglycerides | Standard Deviation 32.161 |
| 100 mg Inclisiran Sodium | Percent Change From Baseline in Triglycerides by Visit | Day 120 | -9.40 percent change in triglycerides | Standard Deviation 27.192 |
| 100 mg Inclisiran Sodium | Percent Change From Baseline in Triglycerides by Visit | Day 104 | -7.12 percent change in triglycerides | Standard Deviation 26.145 |
| 100 mg Inclisiran Sodium | Percent Change From Baseline in Triglycerides by Visit | Day 30 | -4.72 percent change in triglycerides | Standard Deviation 25.843 |
| 100 mg Inclisiran Sodium | Percent Change From Baseline in Triglycerides by Visit | Day 180 | -2.34 percent change in triglycerides | Standard Deviation 33.783 |
| 100 mg Inclisiran Sodium | Percent Change From Baseline in Triglycerides by Visit | Day 150 | -5.60 percent change in triglycerides | Standard Deviation 42.988 |
| 100 mg Inclisiran Sodium | Percent Change From Baseline in Triglycerides by Visit | Day 90 | -1.87 percent change in triglycerides | Standard Deviation 40.499 |
| 100 mg Inclisiran Sodium | Percent Change From Baseline in Triglycerides by Visit | Day 60 | -7.17 percent change in triglycerides | Standard Deviation 28.427 |
| 100 mg Inclisiran Sodium | Percent Change From Baseline in Triglycerides by Visit | Day 14 | 1.24 percent change in triglycerides | Standard Deviation 29.63 |
| 200 mg Inclisiran Sodium | Percent Change From Baseline in Triglycerides by Visit | Day 150 | -12.65 percent change in triglycerides | Standard Deviation 24.766 |
| 200 mg Inclisiran Sodium | Percent Change From Baseline in Triglycerides by Visit | Day 60 | -9.26 percent change in triglycerides | Standard Deviation 27.598 |
| 200 mg Inclisiran Sodium | Percent Change From Baseline in Triglycerides by Visit | Day 90 | -12.17 percent change in triglycerides | Standard Deviation 26.204 |
| 200 mg Inclisiran Sodium | Percent Change From Baseline in Triglycerides by Visit | Day 104 | -5.81 percent change in triglycerides | Standard Deviation 55.419 |
| 200 mg Inclisiran Sodium | Percent Change From Baseline in Triglycerides by Visit | Day 120 | -9.32 percent change in triglycerides | Standard Deviation 33.471 |
| 200 mg Inclisiran Sodium | Percent Change From Baseline in Triglycerides by Visit | Day 180 | -12.11 percent change in triglycerides | Standard Deviation 39.414 |
| 200 mg Inclisiran Sodium | Percent Change From Baseline in Triglycerides by Visit | Day 14 | -1.16 percent change in triglycerides | Standard Deviation 51.241 |
| 200 mg Inclisiran Sodium | Percent Change From Baseline in Triglycerides by Visit | Day 30 | -8.69 percent change in triglycerides | Standard Deviation 25.45 |
| 300 mg Inclisiran Sodium | Percent Change From Baseline in Triglycerides by Visit | Day 60 | -9.93 percent change in triglycerides | Standard Deviation 26.405 |
| 300 mg Inclisiran Sodium | Percent Change From Baseline in Triglycerides by Visit | Day 90 | -9.99 percent change in triglycerides | Standard Deviation 29.23 |
| 300 mg Inclisiran Sodium | Percent Change From Baseline in Triglycerides by Visit | Day 30 | -8.37 percent change in triglycerides | Standard Deviation 28.24 |
| 300 mg Inclisiran Sodium | Percent Change From Baseline in Triglycerides by Visit | Day 14 | -7.19 percent change in triglycerides | Standard Deviation 23.817 |
| 300 mg Inclisiran Sodium | Percent Change From Baseline in Triglycerides by Visit | Day 104 | -13.51 percent change in triglycerides | Standard Deviation 26.915 |
| 300 mg Inclisiran Sodium | Percent Change From Baseline in Triglycerides by Visit | Day 180 | -13.67 percent change in triglycerides | Standard Deviation 27.307 |
| 300 mg Inclisiran Sodium | Percent Change From Baseline in Triglycerides by Visit | Day 150 | -11.81 percent change in triglycerides | Standard Deviation 28.623 |
| 300 mg Inclisiran Sodium | Percent Change From Baseline in Triglycerides by Visit | Day 120 | -12.33 percent change in triglycerides | Standard Deviation 26.28 |
Secondary
Percent Change From Baseline in VLDL-C by 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
Time frame: Baseline, day 14, day 30, day 60, day 90, day 104, day 120, day 150, and day 180
Population: The overall number of participants analyzed represents the participants in the Full Analysis Set (FAS) who had at least one valid measurement of VLDL-C.~The number analyzed per row represents the participants with a valid VLDL-C value for both, baseline and that particular visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percent Change From Baseline in VLDL-C by Visit | Day 104 | 11.56 percent change in VLDL-C | Standard Deviation 37.588 |
| Placebo | Percent Change From Baseline in VLDL-C by Visit | Day 120 | 3.10 percent change in VLDL-C | Standard Deviation 33.707 |
| Placebo | Percent Change From Baseline in VLDL-C by Visit | Day 30 | 6.69 percent change in VLDL-C | Standard Deviation 33.655 |
| Placebo | Percent Change From Baseline in VLDL-C by Visit | Day 180 | -0.30 percent change in VLDL-C | Standard Deviation 31.345 |
| Placebo | Percent Change From Baseline in VLDL-C by Visit | Day 14 | 5.55 percent change in VLDL-C | Standard Deviation 28.428 |
| Placebo | Percent Change From Baseline in VLDL-C by Visit | Day 150 | 3.41 percent change in VLDL-C | Standard Deviation 31.791 |
| Placebo | Percent Change From Baseline in VLDL-C by Visit | Day 60 | 9.40 percent change in VLDL-C | Standard Deviation 36.824 |
| Placebo | Percent Change From Baseline in VLDL-C by Visit | Day 90 | 6.53 percent change in VLDL-C | Standard Deviation 33.387 |
| 100 mg Inclisiran Sodium | Percent Change From Baseline in VLDL-C by Visit | Day 60 | -10.27 percent change in VLDL-C | Standard Deviation 32.555 |
| 100 mg Inclisiran Sodium | Percent Change From Baseline in VLDL-C by Visit | Day 120 | -15.90 percent change in VLDL-C | Standard Deviation 30.271 |
| 100 mg Inclisiran Sodium | Percent Change From Baseline in VLDL-C by Visit | Day 14 | -2.96 percent change in VLDL-C | Standard Deviation 31.885 |
| 100 mg Inclisiran Sodium | Percent Change From Baseline in VLDL-C by Visit | Day 104 | -12.10 percent change in VLDL-C | Standard Deviation 28.575 |
| 100 mg Inclisiran Sodium | Percent Change From Baseline in VLDL-C by Visit | Day 150 | -10.91 percent change in VLDL-C | Standard Deviation 45.835 |
| 100 mg Inclisiran Sodium | Percent Change From Baseline in VLDL-C by Visit | Day 30 | -9.01 percent change in VLDL-C | Standard Deviation 28.56 |
| 100 mg Inclisiran Sodium | Percent Change From Baseline in VLDL-C by Visit | Day 180 | -7.30 percent change in VLDL-C | Standard Deviation 33.946 |
| 100 mg Inclisiran Sodium | Percent Change From Baseline in VLDL-C by Visit | Day 90 | -5.39 percent change in VLDL-C | Standard Deviation 41.49 |
| 200 mg Inclisiran Sodium | Percent Change From Baseline in VLDL-C by Visit | Day 60 | -14.02 percent change in VLDL-C | Standard Deviation 28.944 |
| 200 mg Inclisiran Sodium | Percent Change From Baseline in VLDL-C by Visit | Day 90 | -16.70 percent change in VLDL-C | Standard Deviation 26.127 |
| 200 mg Inclisiran Sodium | Percent Change From Baseline in VLDL-C by Visit | Day 104 | -12.54 percent change in VLDL-C | Standard Deviation 45.978 |
| 200 mg Inclisiran Sodium | Percent Change From Baseline in VLDL-C by Visit | Day 14 | -5.56 percent change in VLDL-C | Standard Deviation 43.055 |
| 200 mg Inclisiran Sodium | Percent Change From Baseline in VLDL-C by Visit | Day 30 | -13.39 percent change in VLDL-C | Standard Deviation 28.081 |
| 200 mg Inclisiran Sodium | Percent Change From Baseline in VLDL-C by Visit | Day 120 | -14.05 percent change in VLDL-C | Standard Deviation 36.083 |
| 200 mg Inclisiran Sodium | Percent Change From Baseline in VLDL-C by Visit | Day 150 | -17.49 percent change in VLDL-C | Standard Deviation 27.27 |
| 200 mg Inclisiran Sodium | Percent Change From Baseline in VLDL-C by Visit | Day 180 | -17.89 percent change in VLDL-C | Standard Deviation 33.05 |
| 300 mg Inclisiran Sodium | Percent Change From Baseline in VLDL-C by Visit | Day 30 | -14.74 percent change in VLDL-C | Standard Deviation 30.582 |
| 300 mg Inclisiran Sodium | Percent Change From Baseline in VLDL-C by Visit | Day 14 | -12.41 percent change in VLDL-C | Standard Deviation 25.589 |
| 300 mg Inclisiran Sodium | Percent Change From Baseline in VLDL-C by Visit | Day 180 | -21.74 percent change in VLDL-C | Standard Deviation 27.746 |
| 300 mg Inclisiran Sodium | Percent Change From Baseline in VLDL-C by Visit | Day 150 | -18.39 percent change in VLDL-C | Standard Deviation 30.321 |
| 300 mg Inclisiran Sodium | Percent Change From Baseline in VLDL-C by Visit | Day 104 | -24.05 percent change in VLDL-C | Standard Deviation 26.076 |
| 300 mg Inclisiran Sodium | Percent Change From Baseline in VLDL-C by Visit | Day 60 | -17.94 percent change in VLDL-C | Standard Deviation 25.358 |
| 300 mg Inclisiran Sodium | Percent Change From Baseline in VLDL-C by Visit | Day 90 | -15.76 percent change in VLDL-C | Standard Deviation 27.957 |
| 300 mg Inclisiran Sodium | Percent Change From Baseline in VLDL-C by Visit | Day 120 | -22.29 percent change in VLDL-C | Standard Deviation 24.03 |
Secondary
Proportion of Participants Who Attain Lipid Control Target Pre-specified by JAS 2017 Guidelines for Their Level of Cardiovascular Risk 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.
Time frame: Day 180
Population: The overall number of participants analyzed represents the participants in the Full Analysis Set (FAS) who had at least one valid measurement of LDL-C at Day 180
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | 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 |
| 100 mg Inclisiran Sodium | Proportion of Participants Who Attain Lipid Control Target Pre-specified by JAS 2017 Guidelines for Their Level of Cardiovascular Risk at Day 180 | 50 Participants |
| 200 mg Inclisiran Sodium | Proportion of Participants Who Attain Lipid Control Target Pre-specified by JAS 2017 Guidelines for Their Level of Cardiovascular Risk at Day 180 | 87 Participants |
| 300 mg Inclisiran Sodium | Proportion of Participants Who Attain Lipid Control Target Pre-specified by JAS 2017 Guidelines for Their Level of Cardiovascular Risk at Day 180 | 91 Participants |
Secondary
Proportion of Participants With Greater or Equal to 50% LDL-C Reduction From Baseline by 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.
Time frame: Baseline, day 14, day 30, day 60, day 90, day 104, day 120, day 150, and day 180
Population: The overall number of participants analyzed represents the participants in the Full Analysis Set (FAS) who had at least one valid measurement of LDL-C.~The number analyzed per row represents the participants with a valid LDL-C value for both, baseline and that particular visit.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Proportion of Participants With Greater or Equal to 50% LDL-C Reduction From Baseline by Visit | Day 120 | 0 Participants |
| Placebo | Proportion of Participants With Greater or Equal to 50% LDL-C Reduction From Baseline by Visit | Day 14 | 1 Participants |
| Placebo | Proportion of Participants With Greater or Equal to 50% LDL-C Reduction From Baseline by Visit | Day 104 | 0 Participants |
| Placebo | Proportion of Participants With Greater or Equal to 50% LDL-C Reduction From Baseline by Visit | Day 180 | 0 Participants |
| Placebo | Proportion of Participants With Greater or Equal to 50% LDL-C Reduction From Baseline by Visit | Day 30 | 0 Participants |
| Placebo | Proportion of Participants With Greater or Equal to 50% LDL-C Reduction From Baseline by Visit | Day 150 | 0 Participants |
| Placebo | Proportion of Participants With Greater or Equal to 50% LDL-C Reduction From Baseline by Visit | Day 60 | 0 Participants |
| Placebo | Proportion of Participants With Greater or Equal to 50% LDL-C Reduction From Baseline by Visit | Day 90 | 0 Participants |
| 100 mg Inclisiran Sodium | Proportion of Participants With Greater or Equal to 50% LDL-C Reduction From Baseline by Visit | Day 150 | 35 Participants |
| 100 mg Inclisiran Sodium | Proportion of Participants With Greater or Equal to 50% LDL-C Reduction From Baseline by Visit | Day 90 | 22 Participants |
| 100 mg Inclisiran Sodium | Proportion of Participants With Greater or Equal to 50% LDL-C Reduction From Baseline by Visit | Day 30 | 31 Participants |
| 100 mg Inclisiran Sodium | Proportion of Participants With Greater or Equal to 50% LDL-C Reduction From Baseline by Visit | Day 104 | 32 Participants |
| 100 mg Inclisiran Sodium | Proportion of Participants With Greater or Equal to 50% LDL-C Reduction From Baseline by Visit | Day 60 | 26 Participants |
| 100 mg Inclisiran Sodium | Proportion of Participants With Greater or Equal to 50% LDL-C Reduction From Baseline by Visit | Day 14 | 17 Participants |
| 100 mg Inclisiran Sodium | Proportion of Participants With Greater or Equal to 50% LDL-C Reduction From Baseline by Visit | Day 180 | 33 Participants |
| 100 mg Inclisiran Sodium | Proportion of Participants With Greater or Equal to 50% LDL-C Reduction From Baseline by Visit | Day 120 | 37 Participants |
| 200 mg Inclisiran Sodium | Proportion of Participants With Greater or Equal to 50% LDL-C Reduction From Baseline by Visit | Day 120 | 72 Participants |
| 200 mg Inclisiran Sodium | Proportion of Participants With Greater or Equal to 50% LDL-C Reduction From Baseline by Visit | Day 14 | 40 Participants |
| 200 mg Inclisiran Sodium | Proportion of Participants With Greater or Equal to 50% LDL-C Reduction From Baseline by Visit | Day 30 | 63 Participants |
| 200 mg Inclisiran Sodium | Proportion of Participants With Greater or Equal to 50% LDL-C Reduction From Baseline by Visit | Day 60 | 64 Participants |
| 200 mg Inclisiran Sodium | Proportion of Participants With Greater or Equal to 50% LDL-C Reduction From Baseline by Visit | Day 90 | 58 Participants |
| 200 mg Inclisiran Sodium | Proportion of Participants With Greater or Equal to 50% LDL-C Reduction From Baseline by Visit | Day 104 | 77 Participants |
| 200 mg Inclisiran Sodium | Proportion of Participants With Greater or Equal to 50% LDL-C Reduction From Baseline by Visit | Day 150 | 73 Participants |
| 200 mg Inclisiran Sodium | Proportion of Participants With Greater or Equal to 50% LDL-C Reduction From Baseline by Visit | Day 180 | 68 Participants |
| 300 mg Inclisiran Sodium | Proportion of Participants With Greater or Equal to 50% LDL-C Reduction From Baseline by Visit | Day 60 | 75 Participants |
| 300 mg Inclisiran Sodium | Proportion of Participants With Greater or Equal to 50% LDL-C Reduction From Baseline by Visit | Day 30 | 83 Participants |
| 300 mg Inclisiran Sodium | Proportion of Participants With Greater or Equal to 50% LDL-C Reduction From Baseline by Visit | Day 180 | 73 Participants |
| 300 mg Inclisiran Sodium | Proportion of Participants With Greater or Equal to 50% LDL-C Reduction From Baseline by Visit | Day 150 | 78 Participants |
| 300 mg Inclisiran Sodium | Proportion of Participants With Greater or Equal to 50% LDL-C Reduction From Baseline by Visit | Day 14 | 45 Participants |
| 300 mg Inclisiran Sodium | Proportion of Participants With Greater or Equal to 50% LDL-C Reduction From Baseline by Visit | Day 90 | 76 Participants |
| 300 mg Inclisiran Sodium | Proportion of Participants With Greater or Equal to 50% LDL-C Reduction From Baseline by Visit | Day 120 | 82 Participants |
| 300 mg Inclisiran Sodium | Proportion of Participants With Greater or Equal to 50% LDL-C Reduction From Baseline by Visit | Day 104 | 82 Participants |
Secondary
Proportion of Participants With LDL-C Greater Than 80% of Baseline Value at 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.
Time frame: Baseline, Day 180
Population: The overall number of participants analyzed represents the participants in the Full Analysis Set (FAS) who had valid LDL-C value for both, baseline and day 180
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Proportion of Participants With LDL-C Greater Than 80% of Baseline Value at Day 180 | 35 Participants |
| 100 mg Inclisiran Sodium | Proportion of Participants With LDL-C Greater Than 80% of Baseline Value at Day 180 | 0 Participants |
| 200 mg Inclisiran Sodium | Proportion of Participants With LDL-C Greater Than 80% of Baseline Value at Day 180 | 0 Participants |
| 300 mg Inclisiran Sodium | Proportion of Participants With LDL-C Greater Than 80% of Baseline Value at Day 180 | 0 Participants |