Trial · NCT03399370
Inclisiran for Participants With Atherosclerotic Cardiovascular Disease and Elevated Low-density Lipoprotein Cholesterol
NCT03399370, Phase 3, Completed, The Medicines Company; results first posted 2020-10-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Inclisiran for Participants With Atherosclerotic Cardiovascular Disease and Elevated Low-density Lipoprotein Cholesterol. Trials, record NCT03399370. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03399370
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Inclisiran for Participants With Atherosclerotic Cardiovascular Disease and Elevated Low-density Lipoprotein Cholesterol
- NCT number
- NCT03399370
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,561 participants, actual
- Lead sponsor
- The Medicines Company
- Conditions
- ASCVD, Elevated Cholesterol
- Interventions
- Inclisiran Sodium, Placebo
- First posted
- 2018-01-16
- Last updated
- 2020-10-05
- Results first posted
- 2020-10-05
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage Change in LDL-C From Baseline to Day 510 | Baseline, Day 510 | |
| Primary | Time-adjusted Percentage Change in LDL-C Levels From Baseline After Day 90 and up to Day 540 | Baseline, Day 90 to Day 540 | Assessments performed at Baseline, Day 90, Day 540, time-adjusted percent change at Day 540 reported |
| Secondary | Absolute Change in LDL-C From Baseline to Day 510 | Baseline, Day 510 | |
| Secondary | Time-adjusted Absolute Change in LDL-C From Baseline After Day 90 and up to Day 540 | Baseline, Day 90 to Day 540 | Assessments performed at Baseline, Day 90, Day 540, time-adjusted percent change at Day 540 reported |
| Secondary | Percentage Change in Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) From Baseline to Day 510 | Baseline, Day 510 | |
| Secondary | Percentage Change in Total Cholesterol From Baseline to Day 510 | Baseline, Day 510 | |
| Secondary | Percentage Change in Apolipoprotein B (ApoB) From Baseline to Day 510 | Baseline, Day 510 | |
| Secondary | Percentage Change in Non-HDL-C From Baseline to Day 510 | Baseline, Day 510 |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage Change in LDL-C From Baseline to Day 510 | Baseline, Day 510 | Intent-to-treat (ITT) population | percent change | LEAST_SQUARES_MEAN |
| PRIMARY | Time-adjusted Percentage Change in LDL-C Levels From Baseline After Day 90 and up to Day 540 | Baseline, Day 90 to Day 540 | Intent-to-treat (ITT) population | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Absolute Change in LDL-C From Baseline to Day 510 | Baseline, Day 510 | Intent-to-treat (ITT) population | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Time-adjusted Absolute Change in LDL-C From Baseline After Day 90 and up to Day 540 | Baseline, Day 90 to Day 540 | Intent-to-treat (ITT) population | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage Change in Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) From Baseline to Day 510 | Baseline, Day 510 | Intent-to-treat (ITT) population | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage Change in Total Cholesterol From Baseline to Day 510 | Baseline, Day 510 | Intent-to-treat (ITT) population | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage Change in Apolipoprotein B (ApoB) From Baseline to Day 510 | Baseline, Day 510 | Intent-to-treat (ITT) population | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage Change in Non-HDL-C From Baseline to Day 510 | Baseline, Day 510 | Intent-to-treat (ITT) population | percent change | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage Change in LDL-C From Baseline to Day 510 | Inclisiran | -56.34 | 95% Confidence Interval -58.35 to -54.34 | percent change | |
| Percentage Change in LDL-C From Baseline to Day 510 | Placebo | 1.30 | 95% Confidence Interval -1.24 to 3.83 | percent change | |
| Time-adjusted Percentage Change in LDL-C Levels From Baseline After Day 90 and up to Day 540 | Inclisiran | -51.27 | 95% Confidence Interval -53.00 to -49.54 | percent change | |
| Time-adjusted Percentage Change in LDL-C Levels From Baseline After Day 90 and up to Day 540 | Placebo | 2.51 | 95% Confidence Interval 0.77 to 4.25 | percent change | |
| Absolute Change in LDL-C From Baseline to Day 510 | Inclisiran | -56.18 | 95% Confidence Interval -58.47 to -53.90 | mg/dL | |
| Absolute Change in LDL-C From Baseline to Day 510 | Placebo | -2.06 | 95% Confidence Interval -4.36 to 0.24 | mg/dL | |
| Time-adjusted Absolute Change in LDL-C From Baseline After Day 90 and up to Day 540 | Inclisiran | -53.66 | 95% Confidence Interval -55.41 to -51.92 | mg/dL | |
| Time-adjusted Absolute Change in LDL-C From Baseline After Day 90 and up to Day 540 | Placebo | -0.39 | 95% Confidence Interval -2.14 to 1.37 | mg/dL | |
| Percentage Change in Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) From Baseline to Day 510 | Inclisiran | -69.78 | 95% Confidence Interval -73.88 to -65.67 | percent change | |
| Percentage Change in Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) From Baseline to Day 510 | Placebo | 13.52 | 95% Confidence Interval 9.28 to 17.77 | percent change |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Inclisiran | 781 | |
| Overall Study | STARTED | Saline Solution | 780 | |
| Overall Study | COMPLETED | Inclisiran | 721 | |
| Overall Study | COMPLETED | Saline Solution | 694 | |
| Overall Study | NOT COMPLETED | Inclisiran | 60 | |
| Overall Study | NOT COMPLETED | Saline Solution | 86 |
Source ClinicalTrials.gov
Adverse events476
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Bronchitis | Infections and infestations | Inclisiran | 46 | 781 | |
| other | Bronchitis | Infections and infestations | Saline Solution | 30 | 778 | |
| other | Diabetes mellitus | Metabolism and nutrition disorders | Inclisiran | 120 | 781 | |
| other | Diabetes mellitus | Metabolism and nutrition disorders | Saline Solution | 108 | 778 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | Inclisiran | 39 | 781 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | Saline Solution | 39 | 778 | |
| other | Hypertension | Vascular disorders | Inclisiran | 42 | 781 | |
| other | Hypertension | Vascular disorders | Saline Solution | 42 | 778 | |
| serious | Anaemia | Blood and lymphatic system disorders | Inclisiran | 3 | 781 | |
| serious | Anaemia | Blood and lymphatic system disorders | Saline Solution | 1 | 778 |
1 to 10 of 476Source ClinicalTrials.gov
See all 476 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Inclisiran | 12 | 781 |
| Total, all-cause mortality | Saline Solution | 11 | 778 |
| Total, other adverse events | Inclisiran | 247 | 781 |
| Total, other adverse events | Saline Solution | 219 | 778 |
| Total, serious adverse events | Inclisiran | 175 | 781 |
| Total, serious adverse events | Saline Solution | 205 | 778 |
Source ClinicalTrials.gov
Papers5
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Inclisiran vs Saline Solution: deaths from any cause | Trial comparisons |
| Inclisiran vs Saline Solution: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03399370
GET https://conductscience.org/api/trials/v1/NCT03399370/events?page=2