Dyslipidemia, HypercholesterolemiaNCT07468500
Real World Adherence of PCSK9 Targeted Therapy
An observational study of Dyslipidemia, Hypercholesterolemia, run by Novartis Pharmaceuticals.
Trial summary
Retrospective observational cohort study to compare medication adherence at 12 months between patients in Japan with dyslipidemia and/or hypercholesterolemia (familial and non-familial hypercholesterolemia) who newly initiate inclisiran versus those who newly initiate evolocumab. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Dyslipidemia, Hypercholesterolemia
- How many people
- 3,600 participants
- Where
- No sites listed yet
- Study dates
- 30 Mar 2026to 30 Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with dyslipidemia and/or hypercholesterolemia who initiated treatment with inclisiran or evolocumab in the period after first approval of inclisiran in 22-Nov-2023
Who may be able to join
- The patients are included if they meet all the following criteria:
- At least one prescription of inclisiran or evolocumab (140 mg Pens) during the identification period.
- At least one diagnosis of dyslipidemia and/or hypercholesterolemia (familial and non-familial hypercholesterolemia) without suspicion flag during the look back period.
- At least 18 years on the index date.
- At least one claim record within the 210 days prior to the index date (excluding the index date).
Who cannot join
- Those with any of the following criteria will be excluded.
- Both prescription records of inclisiran and evolocumab 140 mg Pens on the index date.
- At least one claim data for inclisiran or evolocumab 140 mg Pens within the 210 days prior to the index date (excluding the index date).
- At least one claim data for evolocumab 420 mg Auto mini-dosers during the observation period.
- Incomplete data for the one year (365 days) follow-up period due to loss to follow-up (the end of the observation period) or death. (only for adherence cohort).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Novartis Pharmaceuticals contact
About this study
Official title: Real World Adherence of PCSK9 Targeted Therapy: A Retrospective Analysis of Japan Databases
Retrospective observational cohort study to compare medication adherence at 12 months between patients in Japan with dyslipidemia and/or hypercholesterolemia (familial and non-familial hypercholesterolemia) who newly initiate inclisiran versus those who newly initiate evolocumab.
- Conditions
- Dyslipidemia, Hypercholesterolemia
- Keywords
- retrospective, Japan, PCSK9i, adherence
- Medical subject headings
- Dyslipidemias, 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 |
|---|---|---|
| exposure group | patients who initiated inclisiran as their first treatment | |
| control group | patients who initiated evolocumab as their first treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication adherence at 12 months : proportion of days covered (PDC) within a period that the patient is persistent
Adherence is defined using proportion of days covered (PDC) within a period that the patient is persistent: calculated as the number of days covered by the target drug (inclisiran in the exposure group, evolocumab in the control group) during the 12 months follow-up period, divided by 365 days.
Measured: 12 months
Secondary outcomes (4)
Proportion of patients with good adherence
Proportion of patients with good adherence at 12 months follow-up period, defined as PDC ≥ 80%.
Measured: 12 months
Number of patients by demographic category
Measured: Baseline
Time to discontinuation
The date of discontinuation of first treatment drug will be considered as the date of outcome occurrence.
Measured: 12 months
Proportion of patients receiving LLTs
Proportion of patients receiving LLTs (statin only/ezetimibe only/statin and ezetimibe) during the baseline period and 12 months follow-up period
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start30 Mar 2026 (estimated)
- Primary completion30 Jul 2026 (estimated)
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dyslipidemia, 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
- 3,600 participants (estimated)
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
- NCT07468500
- Sponsor's protocol ID
- CKJX839A1JP08
- Status last verified
- Mar 2026
- First submitted
- 5 Mar 2026
- Last updated
- 20 Mar 2026
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real World Adherence of PCSK9 Targeted Therapy: A Retrospective Analysis of Japan Databases
- ClinicalTrials.gov ID
- NCT07468500
- Acronym / sponsor ID
- CKJX839A1JP08
- Conditions
- Dyslipidemia, Hypercholesterolemia
- Keywords
- retrospective, Japan, PCSK9i, adherence
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 3,600 participants (estimated)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 30 Mar 2026 (estimated)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 12 Mar 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.
Retrospective observational cohort study to compare medication adherence at 12 months between patients in Japan with dyslipidemia and/or hypercholesterolemia (familial and non-familial hypercholesterolemia) who newly initiate inclisiran versus those who newly initiate evolocumab.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| exposure group | – | –patients who initiated inclisiran as their first treatment |
| control group | – | –patients who initiated evolocumab as their first treatment |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with dyslipidemia and/or hypercholesterolemia who initiated treatment with inclisiran or evolocumab in the period after first approval of inclisiran in 22-Nov-2023
Key inclusion criteria (5 listed)
- At least one prescription of inclisiran or evolocumab (140 mg Pens) during the identification period.
- At least one diagnosis of dyslipidemia and/or hypercholesterolemia (familial and non-familial hypercholesterolemia) without suspicion flag during the look back period.
- At least 18 years on the index date.
- At least one claim record within the 210 days prior to the index date (excluding the index date).
Key exclusion criteria (5 listed)
- Those with any of the following criteria will be excluded.
- Both prescription records of inclisiran and evolocumab 140 mg Pens on the index date.
- At least one claim data for inclisiran or evolocumab 140 mg Pens within the 210 days prior to the index date (excluding the index date).
- At least one claim data for evolocumab 420 mg Auto mini-dosers during the observation period.
- Incomplete data for the one year (365 days) follow-up period due to loss to follow-up (the end of the observation period) or death. (only for adherence cohort).
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
Medication adherence at 12 months : proportion of days covered (PDC) within a period that the patient is persistent
Time frame: 12 months
Adherence is defined using proportion of days covered (PDC) within a period that the patient is persistent: calculated as the number of days covered by the target drug (inclisiran in the exposure group, evolocumab in the control group) during the 12 months follow-up period, divided by 365 days.
4 secondary outcomes
Proportion of patients with good adherence
Time frame: 12 months
Number of patients by demographic category
Time frame: Baseline
Time to discontinuation
Time frame: 12 months
Proportion of patients receiving LLTs
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Novartis Pharmaceuticals contact
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
Questions about this trial
What is this clinical trial studying?
An observational study of Dyslipidemia, Hypercholesterolemia, run by Novartis Pharmaceuticals.
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 5 inclusion and 5 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: opening soon, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Novartis Pharmaceuticals (+41613241111, novartis.email@novartis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication adherence at 12 months : proportion of days covered (PDC) within a period that the patient is persistent (time frame: 12 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 20 Mar 2026.