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Completed

NCT Number: NCT07409636

A 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.

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Key information

Conditions

Hypercholesterolemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Mixed Dyslipidemia Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis

East Hanover, New Jersey, 07936, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Percentage Change in Low Density Lipoprotein Cholesterol (LDL-C) From Baseline

    Time frame: From Baseline to 6 months

Secondary outcomes

  1. Percentage Change in LDL-C From Baseline

    Time frame: From Baseline to 3, 9, and 12 months

  2. Absolute Change in LDL-C From Baseline

    Time frame: From Baseline to 3, 6, 9, and 12 months

  3. Proportion of Days Covered (PDC)

    Time frame: 12 months

    PDC: (number of days covered by medication over 12 months/365 days) x 100%

  4. Proportion of Patients who Remained (Persistence) on Medication

    Time frame: 12 months

  5. Number of Inclisiran Injections

    Time frame: 12 months

  6. 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).

  7. 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).

  8. Number of Patients by Demographic Category

    Time frame: Baseline

    Demographics include smoking history and alcohol history.

  9. 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.

  10. 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.

  11. 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.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 13, 2026
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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