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Last Updated: May 19, 2024

CLINICAL TRIALS PROFILE FOR INCLISIRAN SODIUM


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All Clinical Trials for Inclisiran Sodium

Trial ID Title Status Sponsor Phase Start Date Summary
NCT03397121 ↗ Trial to Evaluate the Effect of Inclisiran Treatment on Low Density Lipoprotein Cholesterol (LDL-C) in Subjects With Heterozygous Familial Hypercholesterolemia (HeFH) Completed The Medicines Company Phase 3 2017-11-28 This is a Phase III, placebo-controlled, double-blind, randomized study in participants with HeFH and elevated LDL-C to evaluate the efficacy, safety, and tolerability of subcutaneous (SC) injection(s) of inclisiran. The study will be multicenter and international.
NCT03399370 ↗ Inclisiran for Participants With Atherosclerotic Cardiovascular Disease and Elevated Low-density Lipoprotein Cholesterol Completed The Medicines Company Phase 3 2017-12-21 This is a Phase III, placebo-controlled, double-blind, randomized study in participants with ASCVD and elevated LDL-C despite maximum tolerated dose of LDL-C lowering therapies to evaluate the efficacy, safety, and tolerability of subcutaneous (SC) inclisiran injection(s). The study will be a multicenter study in the United States.
NCT03400800 ↗ Inclisiran for Subjects With ASCVD or ASCVD-Risk Equivalents and Elevated Low-density Lipoprotein Cholesterol Completed The Medicines Company Phase 3 2017-11-01 This is a Phase III, placebo-controlled, double-blind, randomized study in participants with ASCVD or ASCVD-Risk equivalents and elevated LDL-C despite maximum tolerated dose of LDL-C lowering therapies to evaluate the efficacy, safety, and tolerability of subcutaneous (SC) inclisiran injection(s). The study will be an international multicenter study (non-United States).
NCT03705234 ↗ A Randomized Trial Assessing the Effects of Inclisiran on Clinical Outcomes Among People With Cardiovascular Disease Recruiting Novartis Pharmaceuticals Phase 3 2018-10-30 ORION-4 is a research study coordinated by the University of Oxford and co-sponsored by The University of Oxford and Novartis (Protocol: CTSU_MDCO-PCS-17-01 (CKJX839B12301)). The study aims to find out if a new cholesterol-lowering injection (inclisiran) safely lowers the risk of heart attacks and strokes in people who have already had one of these conditions, or who have had an operation or procedure to treat blocked arteries.
NCT03705234 ↗ A Randomized Trial Assessing the Effects of Inclisiran on Clinical Outcomes Among People With Cardiovascular Disease Recruiting The Medicines Company Phase 3 2018-10-30 ORION-4 is a research study coordinated by the University of Oxford and co-sponsored by The University of Oxford and Novartis (Protocol: CTSU_MDCO-PCS-17-01 (CKJX839B12301)). The study aims to find out if a new cholesterol-lowering injection (inclisiran) safely lowers the risk of heart attacks and strokes in people who have already had one of these conditions, or who have had an operation or procedure to treat blocked arteries.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Inclisiran Sodium

Condition Name

Condition Name for Inclisiran Sodium
Intervention Trials
Elevated Cholesterol 4
Hypercholesterolemia 4
ASCVD 3
Atherosclerotic Cardiovascular Disease 3
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Condition MeSH

Condition MeSH for Inclisiran Sodium
Intervention Trials
Hypercholesterolemia 9
Atherosclerosis 6
Cardiovascular Diseases 5
Hyperlipoproteinemia Type II 3
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Clinical Trial Locations for Inclisiran Sodium

Trials by Country

Trials by Country for Inclisiran Sodium
Location Trials
United States 69
Japan 15
United Kingdom 12
China 11
South Africa 10
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Trials by US State

Trials by US State for Inclisiran Sodium
Location Trials
Ohio 3
Nevada 3
Minnesota 3
Georgia 3
Florida 3
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Clinical Trial Progress for Inclisiran Sodium

Clinical Trial Phase

Clinical Trial Phase for Inclisiran Sodium
Clinical Trial Phase Trials
Phase 4 1
Phase 3 11
Phase 2 1
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Clinical Trial Status

Clinical Trial Status for Inclisiran Sodium
Clinical Trial Phase Trials
Not yet recruiting 5
Recruiting 3
Completed 3
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Clinical Trial Sponsors for Inclisiran Sodium

Sponsor Name

Sponsor Name for Inclisiran Sodium
Sponsor Trials
Novartis Pharmaceuticals 10
The Medicines Company 5
The TIMI Study Group 1
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Sponsor Type

Sponsor Type for Inclisiran Sodium
Sponsor Trials
Industry 15
Other 2
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