Trial to Assess the Effect of Long Term Dosing of Inclisiran in Subjects With High CV Risk and Elevated LDL-C
(ORION-8 Trial)

Recruiting in Palo Alto (17 mi)

+237 other locations

Overseen byScott Wright, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Novartis

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial tested the use of Inclisiran, an injectable medication, in patients with high cholesterol that doesn't respond to other treatments. Inclisiran works by lowering a protein that increases cholesterol levels. The study aimed to see if it is safe and effective over a longer period. Inclisiran has shown about a 50% reduction in cholesterol levels with occasional use.

Research Team

Scott Wright, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

Inclusion Criteria

Completion on a previously qualifying inclisiran Phase II trial MDCO-PCS-16-01 (ORION-3), or Phase III lipid lowering ORION feeder study [MDCO-PCS-17-03 (ORION-9), MDCO-PCS-17-4 (ORION-10), or MDCO-PCS-17-08 (ORION-11)] meaning the subject received the last dose of study drug and completed the final study visit per applicable protocol.

On current lipid-lowering therapies (such as a statin and/or ezetimibe) from previous study with no planned medication or dose change during study participation.

Willing and able to give informed consent before initiation of any study-related procedures and willing to comply with all required study procedures.

Treatment Details

Interventions

Inclisiran Sodium (siRNA)

Participant Groups

1Treatment groups

Experimental Treatment

Group I: InclisiranExperimental Treatment1 Intervention

Inclisiran sodium 300 milligrams (mg) was 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 received blinded inclisiran and subjects who received blinded inclisiran in the feeder study received blinded placebo on Day 1 in ORION-8. Subjects from the open label ORION-3 study did not receive any injection of study drug on Day 1. Their first dose of study medication was at day 90

Find a Clinic Near You

Who Is Running the Clinical Trial?

Novartis

Lead Sponsor

Trials

1,646

Recruited

2,778,000+

Vasant Narasimhan

Novartis

Chief Executive Officer since 2018

MD from Harvard Medical School, Bachelor's in Biological Sciences from University of Chicago, Master's in Public Policy from John F. Kennedy School of Government