Study of Efficacy and Safety of Inclisiran in Asian Participants With Atherosclerotic Cardiovascular Disease (ASCVD) or ASCVD High Risk and Elevated Low Density Lipoprotein Cholesterol (LDL-C)

December 22, 2025 updated by: Novartis Pharmaceuticals

A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Inclisiran in Asian Patients With ASCVD or ASCVD High Risk and Elevated Low-density Lipoprotein Cholesterol as an Adjunct to Diet and Maximally Tolerated Statins With or Without Additional Lipid-lowering Therapy (ORION-18)

A multicenter study to evaluate safety and efficacy of inclisiran in Asian patients with ASCVD or ASCVD high risk and elevated LDL-C

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The purpose of the study is to demonstrate the efficacy and safety of inclisiran sodium 300mg to support the indication for LDL-C reduction of inclisiran in Asian patients with atherosclerotic cardiovascular disease (ASCVD) or ASCVD-high risk patients with elevated LDL-C as an adjunct to diet and maximally tolerated dose statins with or without additional lipid-lowering therapy.

A core part (2-week screening period and a 12-month double-blinded treatment period), and an extension part (until reasonable access to the IMP post product launch provided for the participants)

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
345

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100034
        • Novartis Investigative Site
      • Beijing, China, 100050
        • Novartis Investigative Site
      • Beijing, China, 100191
        • Novartis Investigative Site
      • Beijing, China, 100039
        • Novartis Investigative Site
      • Shanghai, China, 200080
        • Novartis Investigative Site
      • Shanghai, China, 200032
        • Novartis Investigative Site
      • Shanghai, China, 200040
        • Novartis Investigative Site
      • Shanghai, China, 200120
        • Novartis Investigative Site
      • Tianjin, China, 300052
        • Novartis Investigative Site
      • Tianjin, China, 300140
        • Novartis Investigative Site
      • Xiamen, China, 361004
        • Novartis Investigative Site
    • Gansu
      • Lanzhou, Gansu, China, 730030
        • Novartis Investigative Site
    • Guangdong
      • Foshan, Guangdong, China, 528000
        • Novartis Investigative Site
      • Guangzhou, Guangdong, China, 510080
        • Novartis Investigative Site
    • Hebei
      • Shijiazhuang, Hebei, China, 050000
        • Novartis Investigative Site
    • Inner Mongolia
      • Baotou, Inner Mongolia, China, 014040
        • Novartis Investigative Site
      • Hohhot, Inner Mongolia, China, 010017
        • Novartis Investigative Site
    • Jiangsu
      • Nanjing, Jiangsu, China, 210008
        • Novartis Investigative Site
      • Nanjing, Jiangsu, China, 211166
        • Novartis Investigative Site
      • Nantong, Jiangsu, China, 226000
        • Novartis Investigative Site
      • Suzhou, Jiangsu, China, 215004
        • Novartis Investigative Site
      • Xuzhou, Jiangsu, China, 221003
        • Novartis Investigative Site
    • Jilin
      • Changchun, Jilin, China, 130021
        • Novartis Investigative Site
      • Changchun, Jilin, China, 130000
        • Novartis Investigative Site
    • Shandong
      • Jinan, Shandong, China, 250013
        • Novartis Investigative Site
    • Shanghai Municipality
      • Zhujing, Shanghai Municipality, China, 201508
        • Novartis Investigative Site
    • Shanxi
      • Taiyuan, Shanxi, China, 030002
        • Novartis Investigative Site
      • Xian, Shanxi, China, 710061
        • Novartis Investigative Site
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300121
        • Novartis Investigative Site
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310014
        • Novartis Investigative Site
  • Singapore
      • Singapore, Singapore, 119074
        • Novartis Investigative Site
      • Singapore, Singapore, 169609
        • Novartis Investigative Site
  • South Korea
      • Gwangju, South Korea, 61469
        • Novartis Investigative Site
      • Seoul, South Korea, 05505
        • Novartis Investigative Site
      • Seoul, South Korea, 03722
        • Novartis Investigative Site
    • Gangwon-do
      • Wŏnju, Gangwon-do, South Korea, 26427
        • Novartis Investigative Site
    • Korea
      • Incheon, Korea, South Korea, 405 760
        • Novartis Investigative Site
      • Seoul, Korea, South Korea, 02841
        • Novartis Investigative Site
      • Seoul, Korea, South Korea, 03080
        • Novartis Investigative Site
    • Seoul
      • Seoul, Seoul, South Korea, 06351
        • Novartis Investigative Site
    • South Korea
      • Seoul, South Korea, South Korea, 110-746
        • Novartis Investigative Site
  • Taiwan
      • Kaohsiung City, Taiwan, 80756
        • Novartis Investigative Site
      • Taipei, Taiwan, 10002
        • Novartis Investigative Site
      • Taipei, Taiwan, 11217
        • Novartis Investigative Site
      • Taipei, Taiwan, 11220
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

-At screening participants with: ASCVD (including acute coronary syndrome (ACS), stable coronary heart disease, post revascularization, ischemic cardiomyopathy, ischemic stroke, transient ischemic attack (TIA), and peripheral atherosclerosis) and Serum LDL-C ≥1.8 mmol/L (≥70 mg/dL) OR ASCVD high risk (LDL-C ≥4.9 mmol/L, diabetes, high 10-year ASCVD risk assessed by Chinese ASCVD Risk Assessment Flow Chart , or high risk per local guidelines with a target LDL-C of <100 mg/dL) and Serum LDL-C ≥2.6 mmol/L (≥100 mg/dL)

  • Fasting triglyceride < 400 mg/dL (< 4.52 mmol/L) at screening.
  • Participants on statins should be receiving a maximally tolerated dose . Maximum tolerated dose is defined as the maximum dose of statin that can be taken on a regular basis without intolerable AE. Intolerance to any dose of statin must be documented as historical AEs attributed to the statin in question on the source documentation and on the Medical history page of the eCRF
  • Participants not receiving statin must have a documented evidence of intolerance to all doses of at least 2 different statins(or the corresponding local definition of complete intolerance to statins)
  • Participants following lifestyle modification should be on the therapy of LDL-C lowering (such as statin monotherapy, or statin incombination with ezetimibe) with a stable dose for ≥30 days before screening and have no planned medication or dose change during study participation.
  • Participants are willing and able to give informed consent before initiation of any study related procedures and willing to comply with all required study procedures.

Exclusion Criteria:

  • New York Heart Association (NYHA) class IV heart failure or last known left ventricular ejection fraction <25%.
  • Cardiac arrhythmia with clinical significance within 3 months prior to randomization that is not controlled by medication or via ablation.
  • Major adverse cardiovascular event within 3 months prior to randomization.
  • Uncontrolled severe hypertension: systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg prior to randomization despite antihypertensive therapy.
  • Calculated glomerular filtration rate ≤30 mL/min by estimated glomerular filtration rate (eGFR) using standardized clinical methodology.
  • Severe concomitant non-cardiovascular disease that carries the risk of reducing life expectancy to less than 2 years.
  • History of malignancy that required surgery (excluding local and wide-local excision), radiation therapy and/or systemic therapy during the three years prior to randomization.
  • Barrier method: Condom or Occlusive cap (e.g. diaphragm or cervical/vault caps).
  • Other protocol-defined inclusion/exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Subcutaneous injection
Drug: Placebo
Subcutaneously injected on Day 1, 90, and 270.
Experimental: inclisiran sodium 300 mg
Subcutaneous injection
Drug: inclisiran sodium
Subcutaneously injected on Day 1, 90 and 270 (Core Part). Subcutaneously injected on Day 360 and every 6 months thereafter until EOS visit (Extension Part)
Other Names:
  • KJX839

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Core: Percentage change in low- density lipoprotein cholesterol (LDL-C)
Time Frame: Baseline, Day 330
Superiority of inclisiran compared to placebo in reducing LDL-C from baseline to Day 330
Baseline, Day 330
Extension: Number of participants with Adverse Events
Time Frame: Day 360 until study completion, an average of 3 years
Evaluation of the safety and tolerability of inclisiran, treatment emergent Adverse events and Serious Adverse Events
Day 360 until study completion, an average of 3 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Core: Time adjusted percentage change in LDL-C
Time Frame: From baseline after Day 90 and up to Day 360
The superiority of inclisiran compared to placebo in reducing LDL-C from baseline to Day 330 and over time
From baseline after Day 90 and up to Day 360
Core: Absolute change in LDL-C
Time Frame: From baseline to Day 330
The superiority of inclisiran compared to placebo in reducing LDL-C from baseline to Day 330 and over time
From baseline to Day 330
Core: Time adjusted absolute change in LDL-C
Time Frame: From baseline after Day 90 and up to Day 360
The superiority of inclisiran compared to placebo in reducing LDL-C from baseline to Day 330 and over time
From baseline after Day 90 and up to Day 360
Core: Percentage change in PCSK9
Time Frame: From baseline to Day 330
The superiority of inclisiran compared to placebo in reducing PCSK9 from baseline to Day 330
From baseline to Day 330
Core: Absolute change in PCSK9
Time Frame: From baseline to Day 330
The superiority of inclisiran compared to placebo in reducing PCSK9 from baseline to Day 330
From baseline to Day 330
Core: Proportion of participants reaching LDL-C levels of <25 mg/dL, <50 mg/dL, <70 mg/dL, and <100 mg/dL
Time Frame: Day 330
The superiority of inclisiran compared to placebo in individual response rate for lipid controlling
Day 330
Core: Proportion of participants in each group with ≥ 50% LDL-C reduction
Time Frame: From baseline to Day 330
The superiority of inclisiran compared to placebo in individual response rate for lipid controlling
From baseline to Day 330
Core: Proportion of participants in each group who attain global lipid targets for their level of ASCVD risk (55mg/dl for ASCVD patients, 70mg/dl for ASCVD high risk patients)
Time Frame: Day 330
The superiority of inclisiran compared to placebo in individual response rate for lipid controlling
Day 330
Core: Percentage change in total cholesterol, ApoB, non-HDL-C, ApoA1, HDL-C, Lp(a) and triglycerides
Time Frame: From baseline to Day 330
The superiority of inclisiran compared to placebo in reducing other lipids, lipoproteins and apolipoproteins
From baseline to Day 330
Core: Absolute change in total cholesterol, ApoB, non-HDL-C, ApoA1, HDL-C, Lp(a) and triglycerides
Time Frame: From baseline to Day 330
The superiority of inclisiran compared to placebo in reducing other lipids, lipoproteins and apolipoproteins
From baseline to Day 330

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 9, 2022

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 28, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 5, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 19, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 21, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 30, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 22, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CKJX839A12307

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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