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

NCT07409636 | Completed

• 1 other identifier: CKJX839A1CN07
• Study Type: observational
• Target: 11,991
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypercholesterolemia; Mixed Dyslipidemia

Keywords

Inclisiran; PCSK9 mAb; Low density lipoprotein cholesterol; Adherence; Real-world; Meta-analysis

Outcome Measures

Primary Outcomes (1)

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

  From Baseline to 6 months

Secondary Outcomes (11)

• Percentage Change in LDL-C From Baseline

  From Baseline to 3, 9, and 12 months

• Absolute Change in LDL-C From Baseline

  From Baseline to 3, 6, 9, and 12 months

• Proportion of Days Covered (PDC)

  12 months

• Proportion of Patients who Remained (Persistence) on Medication

  12 months

• Number of Inclisiran Injections

  12 months

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis

East Hanover, New Jersey, 07936, United States

Location

Related Links

• Link to study results

MeSH Terms

Conditions

Hypercholesterolemia

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2025
• First Posted: February 13, 2026
• Study Start: January 23, 2025
• Primary Completion: December 22, 2025
• Study Completion: December 22, 2025
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)