Inclisiran for Subjects With ASCVD or ASCVD-Risk Equivalents and Elevated Low-density Lipoprotein Cholesterol (ORION-11)
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|ClinicalTrials.gov Identifier: NCT03400800|
Recruitment Status : Completed
First Posted : January 17, 2018
Results First Posted : August 21, 2020
Last Update Posted : August 21, 2020
|Condition or disease||Intervention/treatment||Phase|
|ASCVD Risk Factor, Cardiovascular Elevated Cholesterol||Drug: Inclisiran Sodium Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1617 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||A Placebo-Controlled, Double-Blind, Randomized Trial to Evaluate the Effect of 300 mg of Inclisiran Sodium Given as Subcutaneous Injections in Subjects With Atherosclerotic Cardiovascular Disease (ASCVD) or ACSVD Risk-Equivalents and Elevated Low-Density Lipoprotein Cholesterol (LDL-C)|
|Actual Study Start Date :||November 1, 2017|
|Actual Primary Completion Date :||July 31, 2019|
|Actual Study Completion Date :||August 27, 2019|
Inclisiran sodium 300 milligrams (mg) (equivalent to 284 mg inclisiran) in 1.5 milliliters (mL) will be administered as a SC injection on Day 1, Day 90, and then every 6 months.
Drug: Inclisiran Sodium
Inclisiran is a small interfering ribonucleic acid (RNA) that inhibits PCSK9 synthesis.
Placebo Comparator: Saline Solution
Placebo (1.5 mL) will be administered as a SC injection of saline solution on Day 1, Day 90, and then every 6 months.
Placebo will be supplied as sterile normal saline (0.9% sodium chloride in water for injection).
Other Name: Saline Solution
- Percentage Change in LDL-C From Baseline to Day 510 [ Time Frame: Baseline, Day 510 ]
- Time-adjusted Percent Change in LDL-C Levels From Baseline After Day 90 and up to Day 540 [ Time Frame: Baseline, Day 90 to Day 540 ]
- Absolute Change In LDL-C From Baseline To Day 510 [ Time Frame: Baseline, Day 510 ]
- Time-adjusted Absolute Change in LDL-C From Baseline After Day 90 and up to Day 540 [ Time Frame: Baseline, Day 90 to Day 540 ]
- Percentage Change in Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) From Baseline to Day 510 [ Time Frame: Baseline, Day 510 ]
- Percentage Change in Total Cholesterol From Baseline to Day 510 [ Time Frame: Baseline, Day 510 ]
- Percentage Change in Apolipoprotein B (ApoB) From Baseline to Day 510 [ Time Frame: Baseline, Day 510 ]
- Percentage Change in Non-HDL-C From Baseline to Day 510 [ Time Frame: Baseline, Day 510 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03400800
|Principal Investigator:||Ray Kausik, MD||Imperial College of London|