MedTrace Logo

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

NCT05739383 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 14012

Last updated 2026-04-14

No results posted yet for this study

Summary

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.

Conditions

  • Primary Prevention of Atherosclerotic Cardiovascular Disease

Interventions

DRUG

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

Subcutaneous injection in pre-filled syringe.

DRUG

Placebo in 1.5ml

Matching placebo in 1.5ml solution for injection

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-09
Primary Completion
2029-04-16
Completion
2029-04-16
FDA Drug
Yes

Countries

  • 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

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05739383 on ClinicalTrials.gov