Trial · NCT03814187
Trial to Assess the Effect of Long Term Dosing of Inclisiran in Subjects With High CV Risk and Elevated LDL-C
NCT03814187, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2024-03-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Trial to Assess the Effect of Long Term Dosing of Inclisiran in Subjects With High CV Risk and Elevated LDL-C. Trials, record NCT03814187. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03814187
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trial to Assess the Effect of Long Term Dosing of Inclisiran in Subjects With High CV Risk and Elevated LDL-C
- NCT number
- NCT03814187
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 3,275 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- ASCVD, Elevated Cholesterol, Heterozygous Familial Hypercholesterolemia, Homozygous Familial Hypercholesterolemia
- Interventions
- Inclisiran Sodium
- First posted
- 2019-01-23
- Last updated
- 2024-03-06
- Other registries' IDs
- eudract:2017-003092-55
- Results first posted
- 2024-03-06
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Subjects Achieving Global Lipid Targets for Their Level of ASCVD Risk | From ORION-8 Day 1 to the end of study (up to 1080 days) | The primary objective of the study is to evaluate the effect of inclisiran treatment on the proportion of subjects achieving prespecified LDL-C targets at end of study (EOS). Target is \<70 mg/dL for atherosclerotic cardiovascular disease (ASCVD) subjects and \<100 mg/dL for ASCVD risk equivalent subjects. Risk equivalent subjects are defined as either type 2 diabetes, familial hypercholesterolemia or a 10-year risk of a cardiovascular event ≥20% as assessed by the Framingham Risk Score or equivalent; without a medical history of coronary heart disease , cerebrovascular disease or peripheral artery disease. |
| Primary | Incidence of Treatment-emergent Adverse Events (TEAEs) | From ORION-8 Day 1 to the end of study (up to 1080 days) | Safety assessments include adverse events and serious adverse events until the end of study. End of study visit occured at least 90 days following the last inclisiran dose once a decision was made to end the study (either by the subject, investigator or sponsor). For subjects prematurely and permanently discontinued from study treatment, who were not willing to return within the 90 day timeframe, the EOS visit was scheduled as soon as possible, or if decision to discontinue and not return was made at a specific visit, this visit became the EOS visit. |
| Secondary | Absolute Change in LDL-C From the Initial Feeder Study Baseline | Feeder study baseline, ORION-8 baseline, Day 1080/EOS (ORION-8) (up to a maximum of 2340 days) | Absolute change from baseline in low density lipoprotein cholesterol (LDL-C) was calculated to evaluate the effect of inclisiran on LDL-C levels. |
| Secondary | Percentage Change in LDL-C From the Initial Feeder Study Baseline | Feeder study baseline, ORION-8 baseline, Day 1080/EOS (ORION-8) (up to a maximum of 2340 days) | Percentage change from baseline in low density lipoprotein cholesterol (LDL-C) was calculated to evaluate the effect of inclisiran on LDL-C levels. |
| Secondary | Absolute Change From the Initial Feeder Study Baseline in Total Cholesterol, Triglycerides and HDL-C | Feeder study baseline, ORION-8 baseline, Day 1080/EOS (ORION-8) (up to a maximum of 2340 days) | Absolute change from baseline in total cholesterol, triglycerides and high density lipoprotein cholesterol (HDL-C) was calculated to evaluate the effect of inclisiran on other lipids and lipoproteins. |
| Secondary | Percentage Change From the Initial Feeder Study Baseline in Total Cholesterol, Triglycerides and HDL-C | Feeder study baseline, ORION-8 baseline, Day 1080/EOS (ORION-8) (up to a maximum of 2340 days) | Percentage change from baseline in total cholesterol (TC), triglycerides and high density lipoprotein cholesterol (HDL-C) was calculated to evaluate the effect of inclisiran on other lipids and lipoproteins. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Proportion of Subjects Achieving Global Lipid Targets for Their Level of ASCVD Risk | From ORION-8 Day 1 to the end of study (up to 1080 days) | Safety Population: All ORION-3 rollover subjects who signed the informed consent to Study ORION-8, and all ORION-9/ORION-10/ORION-11 rollover subjects with at least one study drug administration in Study. Only participants with valid LDL-C measurements at Day 1080/EOS were included in the analysis. | Percentage of participants | NUMBER |
| PRIMARY | Incidence of Treatment-emergent Adverse Events (TEAEs) | From ORION-8 Day 1 to the end of study (up to 1080 days) | Safety Population: All ORION-3 rollover subjects who signed the informed consent to Study Orion-8, and all ORION-9/ORION-10/ORION-11 rollover subjects with at least one study drug administration in Study | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Absolute Change in LDL-C From the Initial Feeder Study Baseline | Feeder study baseline, ORION-8 baseline, Day 1080/EOS (ORION-8) (up to a maximum of 2340 days) | Safety Population: All ORION-3 rollover subjects who signed the informed consent to Study Orion-8, and all ORION-9/ORION-10/ORION-11 rollover subjects with at least one study drug administration in Study | mg/dL | MEAN |
| SECONDARY | Percentage Change in LDL-C From the Initial Feeder Study Baseline | Feeder study baseline, ORION-8 baseline, Day 1080/EOS (ORION-8) (up to a maximum of 2340 days) | Safety Population: All ORION-3 rollover subjects who signed the informed consent to Study Orion-8, and all ORION-9/ORION-10/ORION-11 rollover subjects with at least one study drug administration in Study | Percentage change in LDL-C | MEAN |
| SECONDARY | Absolute Change From the Initial Feeder Study Baseline in Total Cholesterol, Triglycerides and HDL-C | Feeder study baseline, ORION-8 baseline, Day 1080/EOS (ORION-8) (up to a maximum of 2340 days) | Safety Population: All ORION-3 rollover subjects who signed the informed consent to Study Orion-8, and all ORION-9/ORION-10/ORION-11 rollover subjects with at least one study drug administration in Study | mg/dL | MEAN |
| SECONDARY | Percentage Change From the Initial Feeder Study Baseline in Total Cholesterol, Triglycerides and HDL-C | Feeder study baseline, ORION-8 baseline, Day 1080/EOS (ORION-8) (up to a maximum of 2340 days) | Safety Population: All ORION-3 rollover subjects who signed the informed consent to Study Orion-8, and all ORION-9/ORION-10/ORION-11 rollover subjects with at least one study drug administration in Study | Percentage change | MEAN |
Source ClinicalTrials.gov
Results by group84
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Proportion of Subjects Achieving Global Lipid Targets for Their Level of ASCVD Risk | Phase III Inclisiran-Inclisiran | % of subjects Who Attain Global Lipid Targets at Day 1080 / EOS | 78.18 | 95% Confidence Interval 75.8 to 80.4 | Percentage of participants |
| Proportion of Subjects Achieving Global Lipid Targets for Their Level of ASCVD Risk | Phase III Placebo-Inclisiran | % of subjects Who Attain Global Lipid Targets at Day 1080 / EOS | 79.07 | 95% Confidence Interval 76.7 to 81.3 | Percentage of participants |
| Proportion of Subjects Achieving Global Lipid Targets for Their Level of ASCVD Risk | ORION-3 Rollover | % of subjects Who Attain Global Lipid Targets at Day 1080 / EOS | 76.81 | 95% Confidence Interval 71.4 to 81.6 | Percentage of participants |
| Proportion of Subjects Achieving Global Lipid Targets for Their Level of ASCVD Risk | Total | % of subjects Who Attain Global Lipid Targets at Day 1080 / EOS | 78.43 | 95% Confidence Interval 76.8 to 80.0 | Percentage of participants |
| Proportion of Subjects Achieving Global Lipid Targets for Their Level of ASCVD Risk | Phase III Inclisiran-Inclisiran | % of ASCVD subjects Who Attain Global Lipid Targets of <70 mg/dL at Day 1080 / EOS | 79.34 | 95% Confidence Interval 76.8 to 81.7 | Percentage of participants |
| Proportion of Subjects Achieving Global Lipid Targets for Their Level of ASCVD Risk | Phase III Placebo-Inclisiran | % of ASCVD subjects Who Attain Global Lipid Targets of <70 mg/dL at Day 1080 / EOS | 79.96 | 95% Confidence Interval 77.4 to 82.4 | Percentage of participants |
| Proportion of Subjects Achieving Global Lipid Targets for Their Level of ASCVD Risk | ORION-3 Rollover | % of ASCVD subjects Who Attain Global Lipid Targets of <70 mg/dL at Day 1080 / EOS | 76.70 | 95% Confidence Interval 70.0 to 82.5 | Percentage of participants |
| Proportion of Subjects Achieving Global Lipid Targets for Their Level of ASCVD Risk | Total | % of ASCVD subjects Who Attain Global Lipid Targets of <70 mg/dL at Day 1080 / EOS | 79.41 | 95% Confidence Interval 77.7 to 81.1 | Percentage of participants |
| Proportion of Subjects Achieving Global Lipid Targets for Their Level of ASCVD Risk | Phase III Inclisiran-Inclisiran | % of ASCVD Risk Equivalent subjects Who Attain Global Lipid Targets of <100 mg/dL at Day 1080 / EOS | 72.56 | 95% Confidence Interval 66.1 to 78.3 | Percentage of participants |
| Proportion of Subjects Achieving Global Lipid Targets for Their Level of ASCVD Risk | Phase III Placebo-Inclisiran | % of ASCVD Risk Equivalent subjects Who Attain Global Lipid Targets of <100 mg/dL at Day 1080 / EOS | 74.88 | 95% Confidence Interval 68.6 to 80.5 | Percentage of participants |
1 to 10 of 84Source ClinicalTrials.gov
See all 84 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Phase III Inclisiran-Inclisiran | 1,513 | |
| Overall Study | STARTED | Phase III Placebo-Inclisiran | 1,478 | |
| Overall Study | STARTED | ORION-3 Rollover | 284 | |
| Overall Study | Safety Population | Phase III Inclisiran-Inclisiran | 1,512 | |
| Overall Study | Safety Population | Phase III Placebo-Inclisiran | 1,478 | |
| Overall Study | Safety Population | ORION-3 Rollover | 284 | |
| Overall Study | COMPLETED | Phase III Inclisiran-Inclisiran | 1,246 | |
| Overall Study | COMPLETED | Phase III Placebo-Inclisiran | 1,200 | |
| Overall Study | COMPLETED | ORION-3 Rollover | 0 | |
| Overall Study | NOT COMPLETED | Phase III Inclisiran-Inclisiran | 267 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events7,876
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 | Anaemia | Blood and lymphatic system disorders | Phase III Inclisiran-Inclisiran | 45 | 1,512 | |
| other | Anaemia | Blood and lymphatic system disorders | Phase III Placebo-Inclisiran | 33 | 1,478 | |
| other | Anaemia | Blood and lymphatic system disorders | ORION-3 Rollover | 2 | 284 | |
| other | Anaemia | Blood and lymphatic system disorders | Total | 80 | 3,274 | |
| other | Anaemia macrocytic | Blood and lymphatic system disorders | Phase III Inclisiran-Inclisiran | 1 | 1,512 | |
| other | Anaemia macrocytic | Blood and lymphatic system disorders | Phase III Placebo-Inclisiran | 3 | 1,478 | |
| other | Anaemia macrocytic | Blood and lymphatic system disorders | ORION-3 Rollover | 0 | 284 | |
| other | Anaemia macrocytic | Blood and lymphatic system disorders | Total | 4 | 3,274 | |
| other | Anaemia megaloblastic | Blood and lymphatic system disorders | Phase III Inclisiran-Inclisiran | 0 | 1,512 | |
| other | Anaemia megaloblastic | Blood and lymphatic system disorders | Phase III Placebo-Inclisiran | 1 | 1,478 |
1 to 10 of 7,876Source ClinicalTrials.gov
See all 7,876 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase III Inclisiran-Inclisiran | 80 | 1,512 |
| Total, all-cause mortality | Phase III Placebo-Inclisiran | 81 | 1,478 |
| Total, all-cause mortality | ORION-3 Rollover | 4 | 284 |
| Total, all-cause mortality | Total | 165 | 3,274 |
| Total, other adverse events | Phase III Inclisiran-Inclisiran | 1,110 | 1,512 |
| Total, other adverse events | Phase III Placebo-Inclisiran | 1,073 | 1,478 |
| Total, other adverse events | ORION-3 Rollover | 169 | 284 |
| Total, other adverse events | Total | 2,352 | 3,274 |
| Total, serious adverse events | Phase III Inclisiran-Inclisiran | 464 | 1,512 |
| Total, serious adverse events | Phase III Placebo-Inclisiran | 482 | 1,478 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers2
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
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