HypercholesterolemiaNCT07409636
A Study to Assess the Real-World Effectiveness of Inclisiran and PCSK9 mAbs in Chinese Hypercholesterolemia Adult Patients
An observational study of Hypercholesterolemia and Mixed Dyslipidemia, run by Novartis Pharmaceuticals at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypercholesterolemia, Mixed Dyslipidemia
- How many people
- 11,991 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jan 2025to 22 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- First received inclisiran or any PCSK9 mAbs during the indexing period.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Hypercholesterolemia, Mixed Dyslipidemia
- Keywords
- Inclisiran, PCSK9 mAb, Low density lipoprotein cholesterol, Adherence, Real-world, Meta-analysis
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Percentage Change in Low Density Lipoprotein Cholesterol (LDL-C) From Baseline
Measured: From Baseline to 6 months
Secondary outcomes (11)
Percentage Change in LDL-C From Baseline
Measured: From Baseline to 3, 9, and 12 months
Absolute Change in LDL-C From Baseline
Measured: From Baseline to 3, 6, 9, and 12 months
Proportion of Days Covered (PDC)
PDC: (number of days covered by medication over 12 months/365 days) x 100%
Measured: 12 months
Proportion of Patients who Remained (Persistence) on Medication
Measured: 12 months
Number of Inclisiran Injections
Measured: 12 months
Percentage Change in Other Lipids and Lipoproteins From Baseline
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).
Measured: From Baseline to 3, 6, 9, and 12 months
Absolute Change in Other Lipids and Lipoproteins From Baseline
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).
Measured: From Baseline to 3, 6, 9, and 12 months
Number of Patients by Demographic Category
Demographics include smoking history and alcohol history.
Measured: Baseline
Number of Patients by Clinical Characteristic
Clinical characteristics include previous lipid-lowering drugs, type of diagnosis, family history of familial hypercholesterolemia, comorbidities, and statin intolerance.
Measured: Baseline
LDL-C Measures of Variability - Standard Deviation
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.
Measured: Baseline, Month 6, Month 9, Month 12
LDL-C Measures of Variability - Correlation of Variation
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.
Measured: Baseline, Month 6, Month 9, Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start23 Jan 2025
- Primary completion22 Dec 2025
- Study completion22 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 11,991 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07409636
- Sponsor's protocol ID
- CKJX839A1CN07
- Status last verified
- Feb 2026
- First submitted
- 12 May 2025
- Last updated
- 17 Feb 2026
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective, Observational Database Study to Assess the Real-World Effectiveness of Inclisiran and PCSK9 mAbs in Chinese Hypercholesterolemia Adult Patients
- ClinicalTrials.gov ID
- NCT07409636
- Acronym / sponsor ID
- CKJX839A1CN07
- Conditions
- Hypercholesterolemia, Mixed Dyslipidemia
- Keywords
- Inclisiran, PCSK9 mAb, Low density lipoprotein cholesterol, Adherence, Real-world, Meta-analysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11,991 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 23 Jan 2025 (actual)
- Primary completion
- 22 Dec 2025 (actual)
- Study completion
- 22 Dec 2025 (actual)
- First posted
- 13 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- First received inclisiran or any PCSK9 mAbs during the indexing period.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage Change in Low Density Lipoprotein Cholesterol (LDL-C) From Baseline
Time frame: From Baseline to 6 months
11 secondary outcomes
Percentage Change in LDL-C From Baseline
Time frame: 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
Proportion of Days Covered (PDC)
Time frame: 12 months
Proportion of Patients who Remained (Persistence) on Medication
Time frame: 12 months
Number of Inclisiran Injections
Time frame: 12 months
Percentage Change in Other Lipids and Lipoproteins From Baseline
Time frame: 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
Number of Patients by Demographic Category
Time frame: Baseline
Number of Patients by Clinical Characteristic
Time frame: Baseline
LDL-C Measures of Variability - Standard Deviation
Time frame: Baseline, Month 6, Month 9, Month 12
LDL-C Measures of Variability - Correlation of Variation
Time frame: Baseline, Month 6, Month 9, Month 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Link to study resultsLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Hypercholesterolemia
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A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypercholesterolemia and Mixed Dyslipidemia, run by Novartis Pharmaceuticals at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage Change in Low Density Lipoprotein Cholesterol (LDL-C) From Baseline (time frame: From Baseline to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.