Inclisiran for Participants With Atherosclerotic Cardiovascular Disease and Elevated Low-density Lipoprotein Cholesterol (ORION-10)
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|ClinicalTrials.gov Identifier: NCT03399370|
Recruitment Status : Active, not recruiting
First Posted : January 16, 2018
Last Update Posted : April 17, 2019
|Condition or disease||Intervention/treatment||Phase|
|ASCVD Elevated Cholesterol||Drug: Inclisiran Sodium Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1561 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) and Elevated Low-Density Lipoprotein Cholesterol (LDL-C)|
|Actual Study Start Date :||December 21, 2017|
|Estimated Primary Completion Date :||October 2019|
|Estimated Study Completion Date :||December 2019|
Inclisiran sodium 300 milligrams (mg) will be administered as a SC injection on Day 1, Day 90, then every 6 months.
Drug: Inclisiran Sodium
Inclisiran is a small interfering ribonucleic acid (RNA) that inhibits PCSK9 synthesis.
Placebo Comparator: Saline Solution
Placebo will be administered as a SC injection of saline solution on Day 1, Day 90, 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 Percentage Change in LDL-C Levels from Baseline after Day 90 and up to Day 540 [ Time Frame: Baseline, Day 90, 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, 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): NCT03399370
Show 145 Study Locations
|Principal Investigator:||Scott Wright, MD||Mayo Clinic|