Trial to Assess the Effect of Long Term Dosing of Inclisiran in Subjects With High CV Risk and Elevated LDL-C (ORION-8)
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|ClinicalTrials.gov Identifier: NCT03814187|
Recruitment Status : Recruiting
First Posted : January 23, 2019
Last Update Posted : August 9, 2019
|Condition or disease||Intervention/treatment||Phase|
|ASCVD Elevated Cholesterol Heterozygous Familial Hypercholesterolemia Homozygous Familial Hypercholesterolemia||Drug: Inclisiran Sodium||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||3700 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label Extension Trial of the Phase III Lipid-lowering Trials to Assess the Effect of Long Term Dosing of Inclisiran Given as Subcutaneous Injections in Subjects With High Cardiovascular Risk and Elevated LDL-C|
|Actual Study Start Date :||April 16, 2019|
|Estimated Primary Completion Date :||August 2023|
|Estimated Study Completion Date :||December 2023|
Inclisiran sodium 300 milligrams (mg) will be administered as a single SC injection on Day 1*, 90, then every 180 days to Day 990.
*Subjects who received blinded placebo in the feeder study will receive blinded inclisiran and subjects who received blinded inclisiran in the feeder study will receive blinded placebo on Day 1 in ORION-8. Subjects from the open label ORION-5 study will not receive any injection of study drug/placebo on Day 1.
Drug: Inclisiran Sodium
Inclisiran is a small interfering ribonucleic acid (RNA) that inhibits PCSK9 synthesis.
- Proportion of subjects reaching on treatment LDL-C targets of <70 mg/dL [ Time Frame: Day 1080 ]Proportion of subjects who attain global lipid targets (entry criterion from respective previous study) for their level of ASCVD risk at EOS.
- Proportion of subjects reaching on treatment LDL-C targets of <100 mg/dL [ Time Frame: Day 1080 ]Proportion of subjects who attain global lipid targets (entry criterion from respective previous study) for their level of ASCVD risk at EOS.
- Evaluate the effect of inclisiran on LDL-C levels [ Time Frame: Baseline, Day 1080 ]
- Evaluate the effect of inclisiran on total cholesterol (TC), triglycerides, LDL-C, and high density lipoprotein cholesterol (HDL-C) [ Time Frame: Baseline, Day 1080 ]
- Safety assessments including adverse events, serious adverse events, ECGs, concomitant medications, and safety laboratory parameters will be performed. The formation and further characterization of anti-drug antibodies will also be evaluated. [ Time Frame: Baseline, Day 1080 ]
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): NCT03814187
|Contact: The Medicines Company Global Health Science Centerfirstname.lastname@example.org|
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|Principal Investigator:||Scott Wright, MD||Mayo Clinic|