Inclisiran for Cardiovascular Disease

(VICTORION-2P Trial)

Recruiting at 1255 trial locations

Overseen By Garrett Sims

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Novartis Pharmaceuticals

Must be taking: High-intensity statins

Must not be taking: PCSK9 inhibitors

Disqualifiers: Heart failure, Active liver disease, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 72 months

17004 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing inclisiran, an injectable drug, on people with heart disease who are already on strong cholesterol-lowering medications. The goal is to see if inclisiran can further reduce the risk of heart attacks and strokes by lowering bad cholesterol levels. Participants will receive the injection periodically. Inclisiran works by significantly reducing bad cholesterol levels.

Research Team

Novartis Pharmaceuticals

Principal Investigator

Novartis Pharmaceuticals

Eligibility Criteria

This trial is for people with a history of heart issues like heart attacks, strokes, or peripheral arterial disease. They should be on a stable cholesterol-lowering regimen but not taking PCSK9 inhibitors. Those with severe non-heart diseases, pregnant women, and individuals who've had recent cardiovascular events or used inclisiran before are excluded.

Inclusion Criteria

I have had a heart attack, stroke, or peripheral arterial disease.

I am not using nor planning to use PCSK9 inhibitors like Repatha or Praluent.

I am currently taking medication to lower my cholesterol.

Exclusion Criteria

I had a stroke more than 4 weeks ago.

I haven't taken inclisiran or similar PCSK9 drugs in the last 2 years.

You are currently pregnant or breastfeeding.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive inclisiran sodium 300 mg subcutaneously on Day 1, Month 3, and every 6 months thereafter

72 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Inclisiran

Trial Overview The study tests if Inclisiran can prevent major heart problems in those already diagnosed with heart disease compared to a placebo. Participants will randomly receive either Inclisiran sodium 300 mg or a placebo to see which is more effective at reducing cardiovascular events.

Participant Groups

Group I: Inclisiran sodium Experimental Treatment 1 Intervention

Subcutaneous injection

Group II: Placebo Placebo Group 1 Intervention

Subcutaneous injection

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

Who Is Running the Clinical Trial?

Novartis Pharmaceuticals

Lead Sponsor

Trials

2,963

Recruited

4,275,000+

Founded

1996

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Gleevec, Cosentyx, Entresto, Kisqali

Dr. Vas Narasimhan

Novartis Pharmaceuticals

Chief Executive Officer since 2018

MD from Harvard Medical School

Dr. Shreeram Aradhye

Novartis Pharmaceuticals

Chief Medical Officer since 2021

MD