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NCT05739383

A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

14082 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-09

Study Completion Date

2029-04-16

Brief Summary

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CKJX839D12302 is a pivotal Phase III study designed to test the hypothesis that treatment with inclisiran sodium 300 milligram (mg) subcutaneous (s.c.) administered on Day 1, Day 90, and every 6 months thereafter in patients at high cardiovascular (CV) risk without a prior major atherosclerotic cardiovascular disease (ASCVD) event will significantly reduce the risk of 4-Point-Major Adverse Cardiovascular Events (4P-MACE) defined as a composite of CV death, non-fatal myocardial infarction (MI), non-fatal ischemic stroke, and urgent coronary revascularization, compared to placebo.

Detailed Description

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The purpose of this study is to evaluate inclisiran sodium 300 mg s.c. (equivalent to 284 mg inclisiran) compared to placebo on reducing the risk of 4P-MACE in adult patients at high risk for their first major adverse cardiovascular event.

Randomized participants will receive study medication (inclisiran or placebo), administered s.c. on Day 1, Day 90, then every 6 months thereafter. This is an event-driven study. Therefore, the study will continue until the required number of clinical events have occurred across both treatment arms, and all participants have a minimum of 3 years of follow-up during the double-blind treatment period.

Conditions

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Primary Prevention of Atherosclerotic Cardiovascular Disease

Keywords

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Inclisiran PCSK9 primary prevention cardiovascular disease MACE myocardial infarction stroke LDL-C hyperlipidemia hypercholesterolemia dyslipidemia cholesterol Coronary Artery Disease (CAD) Non-Obstructive Coronary Artery Disease (NOCAD) Coronary Artery Calcium Coronary artery stenosis Coronary angiogram

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Inclisiran sodium 300mg

Inclisiran sodium 300 mg in 1.5 mL solution for injection (subcutaneous) in pre-filled syringe.

Randomized in a 1:1 ratio with matching placebo

Group Type EXPERIMENTAL

Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) in 1.5 mL

Intervention Type DRUG

Subcutaneous injection in pre-filled syringe.

Placebo

Matching placebo in 1.5ml pre-filled syringe. Randomized in a 1:1 ratio with Inclisiran.

Group Type PLACEBO_COMPARATOR

Placebo in 1.5ml

Intervention Type DRUG

Matching placebo in 1.5ml solution for injection

Interventions

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Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) in 1.5 mL

Subcutaneous injection in pre-filled syringe.

Intervention Type DRUG

Placebo in 1.5ml

Matching placebo in 1.5ml solution for injection

Intervention Type DRUG

Other Intervention Names

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KJX839

Eligibility Criteria

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Inclusion Criteria

* At an increased risk for a first MACE (i.e., no prior major ASCVD event), defined as any one of the following:

1. Evidence of atherosclerotic coronary artery disease (CAD) on computer tomography (CT) or invasive coronary angiogram defined as a coronary artery stenosis ≥20% but \<50% in the left main coronary artery or stenosis ≥20% but \<70% in any other major epicardial coronary artery, or
2. Coronary artery calcium (CAC) score obtained by CT-scan ≥100 Agatston units, or
3. High 10-year ASCVD risk ≥20%, or
4. Intermediate 10-year ASCVD risk 7.5% - \<20% with at least 2 risk-enhancing factors.
* LDL-C ≥70 mg/dL (≥1.81 mmol/L) but \<190 mg/dL (\<4.91 mmol/L) at the screening visit. If on a background lipid lowering therapy, the dose should be stable for at least 4 weeks prior to the screening visit and the participant should be willing to remain on this background therapy for the entire duration of the study.

Exclusion Criteria

* History of major ASCVD event.
* History of, or planned, ischemia-driven revascularization in a coronary or extracoronary arterial bed prior to randomization
* Absence of coronary atherosclerosis on a CT angiogram or an invasive coronary angiogram in the 2 years prior to randomization
* Coronary artery calcium (CAC) score of 0 obtained in the 2 years prior to randomization
* Active liver disease or hepatic dysfunction
* Previous, current, or planned treatment with a monoclonal antibody (mAb) directed toward proprotein convertase subtilisin/kexin type 9 (PCSK9) (e.g., evolocumab, alirocumab)
* Pregnant or nursing (lactating) women
* Women of childbearing potential unless they are using effective methods of contraception while taking study treatment which includes for 6 months after last study drug administration

Minimum Eligible Age

40 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

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United States Argentina Australia Austria Belgium Brazil Bulgaria Canada China Colombia Croatia Czechia Denmark Estonia France Greece Hong Kong Hungary India Israel Italy Latvia Lithuania Malaysia Mexico Netherlands Philippines Poland Portugal Puerto Rico Romania Singapore Slovakia South Africa Spain Sweden Switzerland Taiwan Thailand Turkey (Türkiye) United Kingdom Vietnam

Other Identifiers

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CKJX839D12302

Identifier Type: -

Identifier Source: org_study_id

A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

Inclisiran sodium 300mg

Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) in 1.5 mL

Placebo

Placebo in 1.5ml

Interventions

Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) in 1.5 mL

Placebo in 1.5ml

Other Intervention Names

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Novartis Pharmaceuticals

Responsible Party

Principal Investigators

Novartis Pharmaceuticals

Locations

Central Alabama Research

UAB St Vincents

Eastern Shore Research Institute

G and L Research LLC

Longwood Research

CB Flock Corporation

Mobile Heart Specialists

The Center for Clinical Trials

Alaska Heart and Vascular

Synexus

Lenzmeier Family Practice

Avacare Center for Dermatology

Clinical Research Inst of Arizona

Clinical Research Advantage Fiel Family and Sports Med, PC

Synexus Clinical Research US Inc

Cardiovascular Res Found

National Heart Institute

Alliance Clinical

Inland Psychiatric Medical Group

Valley Clinical Trials Inc

Keck Medical Center USC

Charles R Drew University of Medicine and Science

C for Endo Diabetes and MD

California Medical Research Associates Inc

Valley Clinical Trials

Stanford University Medical Center

Clinical Trials Research Sacramento

Cordova Clinical Research

University of California San Diego

Kaiser Permanente San Diego

Acclaim Clinical Research

San Diego Cardiac Center

Encompass Clinical Research

Harbor UCLA Medical Center

Cardiology Associates Medical Group

Blue Coast Research Center LLC

Interv Cardiology Med Grp

South Denver Cardiology Associates PC

Cardiology Ass of Fairfield County

Chase Medical Research LLC

Excel Medical Clinical Trials LLC

Nova Clinical Research LLC

Bay Care Medical Group

Clearwater Cardiovascular and Interventional Consultants

Tampa Bay Medical Research

Cardiology Research Associates

Hillcrest Medical Research

Personal Physicians Care

Fleming Island Ctr Clinical Res.

Proactive Clinical Research

Qway Research

Indago Research and Health Ctr Inc

Sister Life Research Inc

Center for Diabetes and Endocrine Care