A Study to Assess the Real-World Effectiveness of Inclisiran and PCSK9 mAbs in Chinese Hypercholesterolemia Adult Patients

February 13, 2026 updated by: Novartis Pharmaceuticals

A Retrospective, Observational Database Study to Assess the Real-World Effectiveness of Inclisiran and PCSK9 mAbs in Chinese Hypercholesterolemia Adult Patients

The purpose of this study was to describe the effectiveness of inclisiran and proprotein convertase subtilisin/kexin type 9 (PCSK9) monoclonal antibodies (mAbs) in the real-world setting in China.

Data for this study was obtained from three regional electronic health record (rEHR) databases and included patients who met the enrollment requirements during the study identification period (October 1, 2023 to June 30, 2024) who had used either inclisiran or PCSK9 mAb for the first time. The retrospective data up to the date of ethics committee (EC) approval was extracted from multiple rEHR databases to generate study-specific datasets supporting this study on respective secure data analysis platforms. Due to the requirements of data security policies, the patient-level data from rEHR databases could not be transferred out of the secure platform. Thus, independent analysis based on data from each of the three databases was performed separately and meta-analysis was conducted to integrate one result of all independent data analyses.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

11991

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

  • United States
    • New Jersey
      • East Hanover, New Jersey, United States, 07936
        • Novartis

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Chinese adults with hypercholesterolemia or mixed dyslipidemia who used either inclisiran or PCSK9 mAb for the first time between October 1, 2023 and June 30, 2024, and whose EHRs were in one of three regional EHR databases.

Description

Inclusion criteria:

• First received inclisiran or any PCSK9 mAbs during the indexing period.

Exclusion criteria:

  • Participated in any interventional or observational study of inclisiran or PCSK9 mAbs anytime during the study period.
  • In the inclisiran cohort, the first inclisiran injection was during the index period, and patients were treated with PCSK9 mAbs within 3 months prior to first inclisiran.

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

Cohorts and Interventions

Group / Cohort
Inclisiran Cohort
Adult patients who first received inclisiran between 01 October 2023 and 30 June 2024.
PCSK9 mAbs Cohort
Adult patients who first received PCSK9 mAbs between 01 October 2023 and 30 June 2024.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage Change in Low Density Lipoprotein Cholesterol (LDL-C) From Baseline
Time Frame: From Baseline to 6 months
From Baseline to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage Change in LDL-C From Baseline
Time Frame: From Baseline to 3, 9, and 12 months
From Baseline to 3, 9, and 12 months
Absolute Change in LDL-C From Baseline
Time Frame: From Baseline to 3, 6, 9, and 12 months
From Baseline to 3, 6, 9, and 12 months
Proportion of Days Covered (PDC)
Time Frame: 12 months
PDC: (number of days covered by medication over 12 months/365 days) x 100%
12 months
Proportion of Patients who Remained (Persistence) on Medication
Time Frame: 12 months
12 months
Number of Inclisiran Injections
Time Frame: 12 months
12 months
Percentage Change in Other Lipids and Lipoproteins From Baseline
Time Frame: From Baseline to 3, 6, 9, and 12 months
Other lipids and lipoproteins include total cholesterol (TC), high density lipoprotein cholesterol (HDL-C), lipoprotein (a) (Lp [a]), serum apolipoproteins A1 (Apo A1), apolipoproteins B (Apo B), non-HDL-C, and triglyceride (TG).
From Baseline to 3, 6, 9, and 12 months
Absolute Change in Other Lipids and Lipoproteins From Baseline
Time Frame: From Baseline to 3, 6, 9, and 12 months
Other lipids and lipoproteins include total cholesterol (TC), high density lipoprotein cholesterol (HDL-C), lipoprotein (a) (Lp [a]), serum apolipoproteins A1 (Apo A1), apolipoproteins B (Apo B), non-HDL-C, and triglyceride (TG).
From Baseline to 3, 6, 9, and 12 months
Number of Patients by Demographic Category
Time Frame: Baseline
Demographics include smoking history and alcohol history.
Baseline
Number of Patients by Clinical Characteristic
Time Frame: Baseline
Clinical characteristics include previous lipid-lowering drugs, type of diagnosis, family history of familial hypercholesterolemia, comorbidities, and statin intolerance.
Baseline
LDL-C Measures of Variability - Standard Deviation
Time Frame: Baseline, Month 6, Month 9, Month 12
LDL-C variability from Baseline to 6 months, 9 months, and 12 months was assessed using two measures of variability: standard deviation and coefficients of variation.
Baseline, Month 6, Month 9, Month 12
LDL-C Measures of Variability - Correlation of Variation
Time Frame: Baseline, Month 6, Month 9, Month 12
LDL-C variability from Baseline to 6 months, 9 months, and 12 months was assessed using two measures of variability: standard deviation and coefficients of variation.
Baseline, Month 6, Month 9, Month 12

Collaborators and Investigators

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

Sponsor

Novartis Pharmaceuticals

Investigators

  • Study Director: Novartis Pharmaceuticals, 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.

Helpful Links

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)

January 23, 2025

Primary Completion (Actual)

December 22, 2025

Study Completion (Actual)

December 22, 2025

Study Registration Dates

First Submitted

May 12, 2025

First Submitted That Met QC Criteria

February 12, 2026

First Posted (Actual)

February 13, 2026

Study Record Updates

Last Update Posted (Actual)

February 17, 2026

Last Update Submitted That Met QC Criteria

February 13, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CKJX839A1CN07

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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