This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Inclisiran for Participants With Atherosclerotic Cardiovascular Disease and Elevated Low-density Lipoprotein Cholesterol (NCT03399370), a randomized phase 3 study. The primary outcome is Percentage Change in LDL-C From Baseline to Day 510.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03399370 |
| Phase | Phase 3 |
| Condition | ASCVD, Elevated Cholesterol |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Double |
| Enrollment | 1561 |
| Arms in the primary outcome | 2 |
| Lead sponsor | The Medicines Company |
| Results posted | Yes |
2. Clinical Question
Population
Participants had atherosclerotic cardiovascular disease and elevated LDL-C despite receiving the maximum tolerated dose of LDL-C-lowering therapies. The primary endpoint was assessed in the intent-to-treat population. The registry describes the study as multicenter and conducted in the United States.
Intervention
Participants assigned to inclisiran received inclisiran sodium 300 mg as a subcutaneous injection on Day 1, Day 90, and then every 6 months. The primary question concerns the percentage change in LDL-C from baseline to Day 510.
Comparator
The comparator was a saline-solution placebo, administered as a subcutaneous injection on Day 1, Day 90, and then every 6 months. The study was randomized, double-blind, and parallel-group.
Primary question
Among participants in the intent-to-treat population, how did the mean percentage change in LDL-C from baseline to Day 510 compare between the inclisiran and placebo groups? The registry reports group estimates and a sponsor analysis of the between-group mean difference. This is a question about the measured trial outcome and its statistical precision, not a recommendation about treatment.
3. Trial Design
This was a randomized, double-blind, parallel-group, placebo-controlled Phase III study. The registry records total enrollment of 1561 participants. The study was completed, with a start date of 2017-12-21 and a primary completion date of 2019-09-10. The sponsor was The Medicines Company.
The trial compared subcutaneous inclisiran sodium with a saline-solution placebo. Both were scheduled on Day 1, Day 90, and then every 6 months. The registry describes the participants as having atherosclerotic cardiovascular disease and elevated LDL-C despite the maximum tolerated dose of LDL-C-lowering therapies. The study is described as multicenter and conducted in the United States.
The primary outcome was percentage change in LDL-C from baseline to Day 510, assessed in the intent-to-treat population. The registry lists least-squares means with 95% confidence intervals for each group. The primary outcome's stated timeframe is baseline and Day 510. Several secondary outcomes are also listed, including absolute and time-adjusted LDL-C change and percentage changes in PCSK9, total cholesterol, apolipoprotein B, and non-HDL-C.
The registry reports 781 participants in the inclisiran group and 780 in the placebo group for the primary endpoint estimates. The safety record uses different group denominators, which are described with the adverse-event results. The reason for differences in denominators is not reported in the registry record. Details about the randomization procedure, allocation concealment, and the specific implementation of masking are not reported in the registry record.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | Inclisiran | Saline Solution |
|---|---|---|
| STARTED | 781 | 780 |
| COMPLETED | 721 | 694 |
| NOT COMPLETED | 60 | 86 |
Analysis population for the primary outcome, as defined in the registry: Intent-to-treat (ITT) population
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | Inclisiran | Placebo | Total |
|---|---|---|---|---|
| Participants analysed | 781 | 780 | 1561 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 297 | 333 | 630 |
| Age, Categorical: >=65 years | Participants | 484 | 447 | 931 |
| Age, Continuous | years | 66.4 (SD 8.90) | 65.7 (SD 8.89) | 66.0 (SD 8.90) |
| Sex: Female, Male: Female | Participants | 246 | 232 | 478 |
| Sex: Female, Male: Male | Participants | 535 | 548 | 1083 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 2 | 4 | 6 |
| Race (NIH/OMB): Asian | Participants | 9 | 1 | 10 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 7 | 3 | 10 |
| Race (NIH/OMB): Black or African American | Participants | 110 | 87 | 197 |
| Race (NIH/OMB): White | Participants | 653 | 685 | 1338 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Region of Enrollment: United States | participants | 781 | 780 | 1561 |
6. Primary Endpoint
The registry lists the primary outcome as Percentage Change in LDL-C From Baseline to Day 510, measured over Baseline, Day 510.
| Element | Registry entry |
|---|---|
| Result type | Least Squares Mean |
| Measure of spread | 95% Confidence Interval |
| Unit | percent change |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is percentage change in LDL-C from baseline to Day 510. It describes the relative change in the measured LDL-C level over the stated period, with negative values indicating a decline from baseline and positive values indicating an increase. The registry presents the endpoint as a continuous measure and reports least-squares means for each group, alongside 95% confidence intervals.
LDL-C is the biomarker selected for the trial's primary comparison. Measuring change from baseline makes the endpoint a comparison of how the recorded level shifted over the study period rather than simply a comparison of final measurements without baseline context. The Day 510 assessment supplies a fixed time point for this primary outcome. The registry also includes other lipid-related outcomes, but they are distinct from the primary endpoint.
The primary endpoint was assessed in the intent-to-treat population. The registry does not describe the exact handling of missing baseline or Day 510 measurements, nor does it state whether any particular transformation was applied. Those details are not reported in the registry record. Interpretation should therefore remain tied to the stated measure, population, time point, group estimates, and reported between-group analysis.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
At Day 510, the registry reports a least-squares mean percentage change in LDL-C of -56.34 for inclisiran, with a 95% confidence interval from -58.35 to -54.34. For placebo, the reported estimate is 1.3, with a 95% confidence interval from -1.24 to 3.83. These are group-level estimates for the intent-to-treat population, not individual participant outcomes.
The sponsor's reported ANCOVA analysis gives a mean difference in final values of -57.64, with a 95% confidence interval from -60.86 to -54.43 and p < 0.001. The groups are listed in the order inclisiran and placebo. The reported contrast is negative, consistent with the lower percentage-change estimate in the inclisiran group and the higher estimate in the placebo group. The interval for the reported contrast lies below zero. The p-value is reported for the sponsor's analysis and should be read in the context of that model and its assumptions.
A confidence interval describes the precision of an estimate under the statistical model: it gives a range of values compatible with the data and model at the stated confidence level. It is not a range containing a fixed proportion of individual participants' results, and it does not account for every possible source of bias or uncertainty. The interval around the between-group estimate is relatively narrow in relation to the magnitude of that estimate, but statistical precision does not by itself establish clinical importance.
The group estimates and the between-group contrast are related but are not interchangeable. The group estimates describe each arm; the ANCOVA result describes the modeled comparison between arms. The registry names ANCOVA and identifies the contrast as a mean difference in final values. It does not report all model details, such as the exact covariates included or the assumptions diagnostics. The interpretation of the contrast should therefore stay within the reported analysis description.
The registry lists 1561 enrolled participants, while the primary endpoint estimates use 781 participants in the inclisiran group and 780 in the placebo group. These figures describe different aspects of the record and do not, on their own, explain whether all enrolled participants contributed a Day 510 measurement. Missing-data handling is not reported in the registry record. The endpoint estimates should not be read as proof that every participant had complete outcome data.
The posted statistical result addresses the measured LDL-C outcome at the specified time point. It does not establish effects on cardiovascular events, long-term outcomes beyond the recorded follow-up, or outcomes that were not reported. It also does not determine whether the size of the biomarker change is meaningful for an individual participant. Those questions require evidence beyond this endpoint estimate.
9. Statistical Methods Explained
The primary endpoint is continuous: each participant's LDL-C change is represented on a numeric scale, and the registry reports group means rather than event counts. For continuous outcomes, the analysis commonly compares average values between groups. A mean summarizes the center of a distribution, but it does not describe the full spread of participant measurements. The registry does not provide a dispersion estimate for individual outcomes in the primary result; it reports confidence intervals for the least-squares means.
What does a least-squares mean represent?
A least-squares mean is a model-based group estimate. It is also called an adjusted mean when the model accounts for other variables. The registry labels the endpoint estimates as least-squares means, but it does not specify which covariates were included in their calculation. It is therefore safest to describe them as the reported model-based means, without assuming a particular adjustment set. They differ conceptually from a simple arithmetic average calculated directly from all observed participant values.
The reported group estimates are -56.34 for inclisiran and 1.3 for placebo. Their 95% confidence intervals are -58.35 to -54.34 and -1.24 to 3.83, respectively. A confidence interval communicates sampling uncertainty around an estimate under the assumptions of the analysis. Narrower intervals generally indicate greater precision, while wider intervals indicate less precision. The interval is not a guarantee that the underlying value lies within its limits, and it does not include uncertainty arising from unmeasured bias, poor measurement, or an incorrect model.
How should the between-group analysis be read?
The registry reports an ANCOVA analysis, with the parameter described as a mean difference in final values. ANCOVA, or analysis of covariance, compares group outcomes using a regression model that can account for specified covariates. In clinical trials, baseline values may be among the covariates, but the exact terms used in this trial's model are not reported in the registry record. The method's name alone does not establish which covariates were included.
The reported mean difference is -57.64, with a 95% confidence interval from -60.86 to -54.43. The p-value is reported as p < 0.001. A p-value measures how incompatible the observed data, or more extreme data, would be with a stated null hypothesis under the model assumptions. It is not the probability that the null hypothesis is true, nor does it measure the clinical importance of the estimated difference. The registry identifies the analysis as a superiority comparison; the p-value and interval are the reported statistical evidence for that comparison.
Why can the arm estimates and contrast differ in form?
The least-squares means are group-specific estimates, whereas the ANCOVA mean difference is a model-based contrast between groups. A contrast combines estimates according to the analysis model and may account for covariates. Thus, the contrast should not be treated as a simple subtraction of the displayed group estimates. The registry's analysis result is the appropriate source for the stated sponsor comparison. No separate unadjusted recalculation is specified in the registry record.
General statistical principle: over-dispersion occurs when outcomes vary more than a model assumes. For a continuous endpoint, extra variability can make standard errors and confidence intervals too small if the model does not accommodate it. The registry does not report a diagnostic assessment for over-dispersion or any adjustment made for it. This is a general consideration, not a finding that over-dispersion occurred in this trial.
What do the planning illustrations mean?
Sample-size planning illustrations are calculations about how many participants might be needed under stated assumptions; they are not observed trial results. The illustrations associated with these results use a two-sided significance level of 0.05, equal allocation, and a normal approximation. Their target effects are stated fractions of the observed effect. For non-time-to-event outcomes, the illustrations are expressed as participants per arm. They are planning exercises, not the trial's original design justification and not observed power. The sample-size justification used for the trial is not reported in the registry record.
Observed power is not an additional measure of how convincing the result is after data collection. A post hoc calculation based on the observed effect largely reflects the same information as the test and confidence interval. Planning illustrations instead show how sample-size requirements depend on assumptions about the effect to detect and the chosen error rate. Their values should not be treated as the actual enrollment target unless the registry explicitly identifies them as such; it does not do so.
What analysis details remain unavailable?
The registry gives the endpoint population, time point, group estimates, confidence intervals, and sponsor analysis method. It does not report the full statistical analysis plan, exact covariates, model diagnostics, missing-data procedure, or whether interim analyses were conducted. These details can affect how a model-based estimate is interpreted. Their absence does not invalidate the posted result, but it limits independent assessment of the analysis choices and assumptions.
General statistical principle: randomization supports a fair comparison by balancing measured and unmeasured characteristics on average, but it does not ensure identical groups in every realized trial. Masking can reduce some forms of differential behavior or assessment, but the registry's double-blind designation does not describe which roles were masked or how masking was maintained. Both features inform interpretation, while the record's limited procedural detail constrains a fuller appraisal.
10. Analyses Reported by the Sponsor
| Method | Estimate | 95% CI | P-value |
|---|---|---|---|
| ANCOVA | Mean Difference (Final Values) -57.64 | -60.86 to -54.43 | < 0.001 |
The registry reports the sponsor's primary comparison as an ANCOVA mean difference in final values of -57.64, with a 95% confidence interval from -60.86 to -54.43 and p < 0.001. The group estimates are least-squares means: -56.34 for inclisiran and 1.3 for placebo. The group estimates and the ANCOVA contrast answer related but different statistical questions. The contrast is the reported between-group result and should be cited as such, rather than represented as a simple calculation from the two displayed group means.
The registry does not provide a separate numerical recalculation of the between-group contrast or enough model detail to reproduce the ANCOVA independently. It also does not report the covariates used in the model. Consequently, the sponsor's analysis is the stated inferential comparison, while the arm-level estimates offer descriptive context. The registry records no discrepancy between the sponsor analysis and any recalculation. No conclusion about independent replication of the sponsor's model can be made from the information recorded.
The confidence interval and p-value belong to the sponsor's analysis as reported. They convey precision and statistical evidence under that analysis; they do not resolve questions about missing data, model specification, clinical importance, or outcomes beyond the primary endpoint.
11. Multiplicity, Missing Data and Analysis Populations
The registry names six secondary outcomes, including LDL-C change at other time summaries and percentage changes in PCSK9, total cholesterol, apolipoprotein B, and non-HDL-C. It records eight outcome measures and eight analyses overall. The registry record does not describe how many hypotheses were treated as confirmatory, whether a hierarchy was used, or whether any adjustment for multiple comparisons was applied. A multiplicity strategy is not reported in the registry record.
Multiplicity matters when several outcomes, time points, or comparisons are tested. In general, as the number of statistical tests increases, the chance of at least one apparently significant result can increase if no adjustment or prespecified testing structure is used. This general concern does not establish that the trial's conclusions are incorrect; it means that individual secondary p-values, if considered, need to be interpreted in light of the analysis plan. The registry does not give enough detail to determine how the secondary outcomes were handled inferentially.
The primary endpoint population is identified as intent-to-treat. The registry does not explain how participants with missing baseline or Day 510 data were handled, how withdrawals were treated, or whether imputation or another missing-data method was used. These details are not reported in the registry record. The available endpoint group sizes alone cannot establish the number or pattern of missing measurements.
The registry also does not report interim analyses, stopping rules, or the complete prespecified statistical plan. The existence, timing, and consequences of any interim analyses are therefore not reported in the registry record. Without those details, readers cannot assess whether the reported testing strategy accounted for repeated looks at accumulating data. This is a limitation of the information recorded, not evidence that an unreported procedure occurred.
These uncertainties are relevant when interpreting the primary result and especially when considering secondary outcomes. The primary estimate remains the result reported for the stated endpoint and population, but the registry does not document every decision needed to reconstruct the full analysis pathway.
12. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Inclisiran | 175 | 781 | 22.4% |
| Saline Solution | 205 | 778 | 26.3% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Inclisiran | 12 of 781 |
| Saline Solution | 11 of 778 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Inclisiran | 247 of 781 |
| Saline Solution | 219 of 778 |
Most frequent serious adverse event terms
| Event term | Organ system | Inclisiran | Saline Solution |
|---|---|---|---|
| Coronary artery disease | Cardiac disorders | 15 of 781 | 22 of 778 |
| Cardiac failure congestive | Cardiac disorders | 7 of 781 | 20 of 778 |
| Acute myocardial infarction | Cardiac disorders | 14 of 781 | 12 of 778 |
| Pneumonia | Infections and infestations | 11 of 781 | 9 of 778 |
| Non-cardiac chest pain | General disorders | 10 of 781 | 9 of 778 |
| Atrial fibrillation | Cardiac disorders | 10 of 781 | 8 of 778 |
| Angina unstable | Cardiac disorders | 4 of 781 | 10 of 778 |
| Angina pectoris | Cardiac disorders | 6 of 781 | 7 of 778 |
| Myocardial infarction | Cardiac disorders | 6 of 781 | 6 of 778 |
| Ischaemic stroke | Nervous system disorders | 7 of 781 | 4 of 778 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Inclisiran | Saline Solution |
|---|---|---|---|
| Diabetes mellitus | Metabolism and nutrition disorders | 120 of 781 | 108 of 778 |
| Hypertension | Vascular disorders | 42 of 781 | 42 of 778 |
| Back pain | Musculoskeletal and connective tissue disorders | 39 of 781 | 39 of 778 |
| Bronchitis | Infections and infestations | 46 of 781 | 30 of 778 |
Serious events with the highest arm-level rate: coronary artery disease (2.8%), cardiac failure congestive (2.6%), acute myocardial infarction (1.8%), pneumonia (1.4%), angina unstable (1.3%).
The registry records serious adverse events affecting 175 of 781 participants in the inclisiran safety group and 205 of 778 participants in the saline-solution safety group. It records other adverse events affecting 247 of 781 participants and 219 of 778 participants, respectively. Deaths are recorded for 12 participants in the inclisiran group and 11 in the saline-solution group. These are counts and denominators as recorded; they are not, by themselves, adjusted comparisons or evidence about causation.
The safety denominators differ from the primary endpoint denominators, which are 781 for inclisiran and 780 for placebo. The reason for the difference is not reported in the registry record. The record does not specify in these figures whether events were judged related to study treatment, how long each participant was observed for safety, or how repeated events in a participant were counted.
The listed serious-event terms include coronary artery disease at 2.8%, cardiac failure congestive at 2.6%, acute myocardial infarction at 1.8%, pneumonia at 1.4%, angina unstable at 1.3%, and atrial fibrillation at 1.3%. The registry list does not identify a treatment group for these term percentages, so they should not be attributed to either group. Event descriptions and counts require context about ascertainment, exposure time, severity, and relatedness. The figures alone do not establish whether an event was caused by treatment.
13. What the Result Does, and Does Not, Mean
The primary result describes the trial's measured LDL-C endpoint at Day 510. The reported least-squares mean percentage change was -56.34 in the inclisiran group and 1.3 in the placebo group. The sponsor's ANCOVA comparison was -57.64, with a 95% confidence interval from -60.86 to -54.43 and p < 0.001. These results indicate that the recorded groups had different modeled mean changes in this biomarker at the specified time point.
The result does not, on its own, establish the size of any change in cardiovascular events or other clinical outcomes. The registry lists several secondary lipid-related outcomes, but the primary endpoint is specifically percentage change in LDL-C. A biomarker result cannot be substituted for an outcome that was not measured or reported. The registry record does not provide results for every possible clinical endpoint.
A statistically strong result is not automatically a measure of clinical importance. Clinical importance depends on the outcome, the size and durability of the change, participant context, benefits and harms, and other evidence. The posted estimate and confidence interval describe statistical magnitude and precision under the reported analysis; they do not settle those broader questions. No medical advice follows from the statistical comparison alone.
The registry's intent-to-treat designation identifies the population for the primary outcome, but missing-data methods are not reported. The record also does not provide the full analysis plan or all model details. These omissions limit how fully the result can be independently reconstructed. They should be kept distinct from the reported numerical result rather than used to assume a particular analysis procedure.
Finally, the study's recorded period and Day 510 endpoint do not establish effects beyond the time points reported. The registry's stated primary completion date is 2019-09-10. Longer-term outcomes, outcomes in populations outside the stated eligibility description, and treatment comparisons outside this placebo-controlled trial are not established by this result.
14. Why This Trial Matters Statistically
This trial illustrates how a clinical study can report more than one layer of statistical information for a continuous endpoint. The least-squares means describe the estimated change within each group, while the ANCOVA result gives the reported between-group comparison. Keeping those quantities distinct avoids treating an adjusted model contrast as though it were simply a subtraction of displayed group summaries.
The confidence intervals add information beyond a point estimate. They indicate the precision of the estimates under the model and help readers judge the range of values compatible with the reported data and assumptions. The p-value addresses a different question about compatibility with a null hypothesis; it does not describe the magnitude or practical importance of the effect. Considering the estimate, interval, analysis method, and endpoint together gives a more complete statistical reading than focusing on the p-value alone.
The record also makes important limits visible. It identifies the intent-to-treat population, time point, group estimates, and ANCOVA comparison, but does not report the exact model covariates, missing-data methods, multiplicity strategy, or complete statistical plan. Such details are central to reproducibility and to understanding what assumptions support a model-based result.
Safety interpretation offers another statistical lesson: denominators can differ between efficacy and safety results, and event counts need context. The recorded serious and other adverse-event figures should not be treated as causal comparisons without information about observation time, event definitions, and relatedness. Likewise, percentages for listed serious-event terms cannot be assigned to a group when the record does not identify one.
Overall, the statistical value of the record lies in the clearly specified primary biomarker endpoint and its reported between-group estimate, alongside a transparent view of the information gaps that limit further assessment.
15. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The registry identifies the primary endpoint and the sponsor's ANCOVA method, but it does not report the full model specification. In particular, the covariates included in the analysis, the handling of baseline values, and any model diagnostics are not reported in the registry record. This limits independent reproduction of the reported contrast.
Missing-data procedures are not described. The registry does not state how many participants lacked a Day 510 measurement, whether missing outcomes were imputed, or how withdrawals were handled. The reported group denominators therefore do not explain the completeness or pattern of outcome data. No assumptions about missingness can be inferred from the endpoint estimates alone.
The multiplicity approach for the secondary outcomes is not reported. The record lists six secondary outcomes, eight outcome measures, and eight analyses, but does not state whether testing was hierarchical or adjusted for multiple comparisons. The status of interim analyses and any associated statistical safeguards is also not reported in the registry record.
The safety record reports event counts and denominators, but it does not provide the information needed to interpret them as treatment-attributable risks. Observation time, event relatedness, and the method used to handle repeated events are not described in these figures. The reason the safety denominators differ from the primary endpoint denominators is not reported in the registry record. The serious-event term percentages are listed without a group assignment.
Additional design details, including the specific randomization procedure and how masking was maintained, are not reported in the registry record. The results also concern the stated population, comparison, and recorded endpoint; they do not by themselves establish results for other populations or outcomes beyond those reported.
16. Related Tutorials
17. Related Statistical Calculators
18. Sources
- ClinicalTrials.gov: Inclisiran for Participants With Atherosclerotic Cardiovascular Disease and Elevated Low-density Lipoprotein Cholesterol — NCT03399370.
- Registry record last updated 2020-10-05; status last verified 2020-09.
- Results first posted 2020-10-05.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
Continue through the Clinical Biostats statistical pathway
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19. Record Summary
The registry records NCT03399370 as a completed Phase III, randomized, double-blind, parallel-group, placebo-controlled study sponsored by The Medicines Company. Enrollment was 1561. The study began on 2017-12-21, and primary completion was recorded on 2019-09-10.
Participants with atherosclerotic cardiovascular disease and elevated LDL-C received inclisiran sodium 300 mg or saline-solution placebo by subcutaneous injection on Day 1, Day 90, and then every 6 months. The primary outcome was percentage change in LDL-C from baseline to Day 510 in the intent-to-treat population.
The registry reports least-squares mean estimates of -56.34 for inclisiran and 1.3 for placebo. The sponsor's ANCOVA mean difference in final values was -57.64, with a 95% confidence interval from -60.86 to -54.43 and p < 0.001. The record also includes adverse-event counts and lists six secondary outcomes. It does not report several details needed for full reproduction of the statistical plan, including missing-data handling and the multiplicity strategy.