Inclisiran for Cardiovascular Disease

(ORION-4 Trial)

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen by Martin Landray

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: University of Oxford

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial tests inclisiran, a new injection to lower cholesterol, in people who have had heart attacks, strokes, or surgeries for blocked arteries. It works by blocking a protein that produces bad cholesterol.

Research Team

Marion Mafham

Principal Investigator

University of Oxford

David Preiss

Principal Investigator

University of Oxford

Louise Bowman

Principal Investigator

University of Oxford

Martin Landray

Principal Investigator

University of Oxford

Eligibility Criteria

This trial is for men over 40 and women over 55 with a history of heart attack, stroke, or procedures for blocked arteries. It's not open to those planning heart surgery soon, with chronic liver disease, on dialysis/transplantation, pregnant/breastfeeding women, or anyone with severe illnesses that could interfere with the study.

Inclusion Criteria

You have been diagnosed with Hypercholesterolemia

Have you at least 4 weeks of been taking statins

Exclusion Criteria

You have been diagnosed with Stroke

I have previously used inclisiran or been in a study for it.

I am scheduled for a heart artery procedure in the next 6 months.

Treatment Details

Interventions

• Inclisiran (RNA-based Therapeutic)
• Placebo (Drug)

Trial Overview ORION-4 is testing whether inclisiran injections can reduce the risk of heart attacks and strokes in people who've already had cardiovascular events. Participants will be randomly assigned to receive either inclisiran or a placebo.

Participant Groups

Group I: Inclisiran Experimental Treatment 1 Intervention

Inclisiran sodium 300 milligrams (mg) will be administered as a SC injection at randomization, 3 months and then every 6 months.

Group II: Placebo Placebo Group 1 Intervention

Placebo will be administered as SC injections of saline solution at randomization, 3 months and then every 6 months.

Inclisiran is already approved in European Union, United States, China for the following indications:

🇪🇺 Approved in European Union as Leqvio for:

• Primary hypercholesterolemia (heterozygous familial and non-familial)
• Mixed dyslipidemia

🇺🇸 Approved in United States as Leqvio for:

• Heterozygous familial hypercholesterolemia (HeFH)
• Clinical atherosclerotic cardiovascular disease (ASCVD)
• Primary hypercholesterolemia

🇨🇳 Approved in China as Leqvio for:

• Primary hypercholesterolemia (heterozygous familial and non-familial)
• Mixed dyslipidemia

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

RegeneratePrimary medical Research Miami, FL

TIMI Study Group Boston, MA

Who Is Running the Clinical Trial?

University of Oxford

Lead Sponsor

Trials

1113

Patients Recruited

21,220,000+

The TIMI Study Group

Collaborator

Trials

22

Patients Recruited

129,000+

Novartis Pharmaceuticals

Industry Sponsor

Trials

2963

Patients Recruited

4,275,000+

Founded

1996

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Gleevec, Cosentyx, Entresto, Kisqali

References