Primary Hypercholesterolemia or Mixed DyslipidemiaNCT06770543
Leqvio rPMS (Regulatory Post-Marketing Surveillance in Korea)
An observational study of Primary Hypercholesterolemia or Mixed Dyslipidemia, run by Novartis Pharmaceuticals at 4 sites in South Korea.
Trial summary
This non-interventional study is a mandatory regular Post Marketing Surveillance(rPMS) granted by the Korean health authorities, and is conducted to assess the effectiveness and safety of Leqvio® Pre-filled Syringe(inclisiran sodium) in routine clinical practice for the approved indications (primary… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Primary Hypercholesterolemia or Mixed Dyslipidemia
- What is being tested?
- Inclisiran
- How many people
- 1,500 participants
- Where
- 4 sitesSouth Korea
- Study dates
- 13 Aug 2025to 2 Jan 2031
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will involve patients who received at least one dose of Leqvio for the treatment of primary hypercholesterolemia or mixed dyslipidemia according to the current label information in Korea.
Who may be able to join
- If a subject meets all of the following criteria, he/she can participate in this study:
- Adult patients(18 years or older) who have hypercholesterolemia or mixed dyslipidemia and are prescribed Leqvio® Pre-filled Syringe(inclisiran sodium) according to domestically approved product information in real clinical practice
- Patients who are unable to reach LDL-C target with maximum tolerated dose of statin, or patients with statin intolerance
- Patients who provided consent to participate in the study(informed consent form)
Who cannot join
- A subjects who meets any of the following criteria cannot participate in this study:
- Contraindications in accordance with domestic prescribing information
- Patients participating in clinical trials of other investigational drugs
- Patients who do not provide consent to participate in the study
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Novartis Pharmaceuticals contact
South Korea4 sites, 4 recruiting
- Recruiting
Novartis Investigative Site
Busan, 49241
- Recruiting
Novartis Investigative Site
Seoul, 04763
- Recruiting
Novartis Investigative Site
Taegu, 41944
- Recruiting
Novartis Investigative Site
Yangsan, Gyeongsangnam-do, 50612
About this study
Official title: Regulatory Post-Marketing Surveillance (rPMS) Study for Leqvio® Pre-filled Syringe(Inclisiran Sodium)
This non-interventional study is a mandatory regular Post Marketing Surveillance(rPMS) granted by the Korean health authorities, and is conducted to assess the effectiveness and safety of Leqvio® Pre-filled Syringe(inclisiran sodium) in routine clinical practice for the approved indications (primary hypercholesterolemia or mixed dyslipidemia).
- Being tested
- Inclisiran
- Keywords
- primary hypercholesterolemia,, mixed dyslipidemia, inclisiran, Leqvio
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InclisiranOther
Also called Leqvio®
There is no treatment allocation. Patients administered Leqvio by prescription that have started before inclusion of the patient into the study will be enrolled.
| Study group | Role | What they receive |
|---|---|---|
| Inclisiran | Patients who have been treated with inclisiran Receives: Other: Inclisiran |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidences of adverse events/adverse drug reactions (AEs/ADRs)
Cumulative incidences of AEs, ADRs, SAEs, Serious ADR(SADRs), Unexpected AEs, and Unexpected ADRs due to Leqvio® Pre-filled Syringe(inclisiran sodium) during the observation period ["The term "unexpected" means that it is not listed in the domestic labeling(according to health authority regulations)]
Measured: up to 15 months
Secondary outcomes (3)
Change from baseline in low-density lipoprotein-cholesterol (LDL-C) and lipid profiles
Effectiveness of Leqvio® Pre-filled Syringe (inclisiran sodium) through changes in LDL-C and lipid profiles (total cholesterol, Apolipoprotein B (ApoB), non high-density lipoprotein cholesterol (non-HDL-C), Apolipoprotein A-1 (ApoA1), High Density Lipoprotein Cholesterol (HDL-C), Lipoprotein(a) (Lp(a)) and triglyceride).
Measured: Baseline, Months 3, 9 and 15
Impact of subjects' baseline characteristics and medication usage on cumulative incidence of AEs and SAEs
Impact of subjects' baseline characteristics(age, gender, pregnancy, BMI, lipid profile, cardiovascular risk factors and comorbidities) and medication \& non-medication(reason for using the drug, usage period, amount of use, concomitant medications) on cumulative incidence of AEs and SAEs during the observation period.
Measured: up to 15months
Impact of subjects' baseline characteristics and medication usage on changes from baseline in LDL-C and lipid profiles
Impact of subjects' baseline characteristics(age, gender, pregnancy, BMI, lipid profile, cardiovascular risk factors and comorbidities) and medication \& non-medication(reason for using the drug, usage period, amount of use, concomitant medications) on the changes in LDL-C and lipid profiles after treatment compared to baseline.
Measured: up to 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study start13 Aug 2025
- Primary completion2 Jan 2031 (estimated)
- Study completion2 Jan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Hypercholesterolemia or Mixed DyslipidemiaStudies 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
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06770543
- Sponsor's protocol ID
- CKJX839A1KR01
- Status last verified
- Dec 2025
- First submitted
- 7 Jan 2025
- Last updated
- 22 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regulatory Post-Marketing Surveillance (rPMS) Study for Leqvio® Pre-filled Syringe(Inclisiran Sodium)
- ClinicalTrials.gov ID
- NCT06770543
- Acronym / sponsor ID
- CKJX839A1KR01
- Keywords
- primary hypercholesterolemia,, mixed dyslipidemia, inclisiran, Leqvio
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 13 Aug 2025 (actual)
- Primary completion
- 2 Jan 2031 (estimated)
- Study completion
- 2 Jan 2031 (estimated)
- First posted
- 13 Jan 2025 (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.
This non-interventional study is a mandatory regular Post Marketing Surveillance(rPMS) granted by the Korean health authorities, and is conducted to assess the effectiveness and safety of Leqvio® Pre-filled Syringe(inclisiran sodium) in routine clinical practice for the approved indications (primary hypercholesterolemia or mixed dyslipidemia).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inclisiran | – | Other: InclisiranPatients who have been treated with inclisiran |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will involve patients who received at least one dose of Leqvio for the treatment of primary hypercholesterolemia or mixed dyslipidemia according to the current label information in Korea.
Key inclusion criteria (4 listed)
- Adult patients(18 years or older) who have hypercholesterolemia or mixed dyslipidemia and are prescribed Leqvio® Pre-filled Syringe(inclisiran sodium) according to domestically approved product information in real clinical practice
- Patients who are unable to reach LDL-C target with maximum tolerated dose of statin, or patients with statin intolerance
- Patients who provided consent to participate in the study(informed consent form)
Key exclusion criteria (4 listed)
- Contraindications in accordance with domestic prescribing information
- Patients participating in clinical trials of other investigational drugs
- Patients who do not provide consent to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InclisiranAlso: Leqvio®There is no treatment allocation. Patients administered Leqvio by prescription that have started before inclusion of the patient into the study will be enrolled. | Other | Inclisiran |
Primary outcome
Incidences of adverse events/adverse drug reactions (AEs/ADRs)
Time frame: up to 15 months
Cumulative incidences of AEs, ADRs, SAEs, Serious ADR(SADRs), Unexpected AEs, and Unexpected ADRs due to Leqvio® Pre-filled Syringe(inclisiran sodium) during the observation period ["The term "unexpected" means that it is not listed in the domestic labeling(according to health authority regulations)]
3 secondary outcomes
Change from baseline in low-density lipoprotein-cholesterol (LDL-C) and lipid profiles
Time frame: Baseline, Months 3, 9 and 15
Impact of subjects' baseline characteristics and medication usage on cumulative incidence of AEs and SAEs
Time frame: up to 15months
Impact of subjects' baseline characteristics and medication usage on changes from baseline in LDL-C and lipid profiles
Time frame: up to 15 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 22 Dec 2025.
- 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
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Hypercholesterolemia or Mixed Dyslipidemia, run by Novartis Pharmaceuticals at 4 sites in South Korea.
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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in South Korea. 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?
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?
Incidences of adverse events/adverse drug reactions (AEs/ADRs) (time frame: up to 15 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 22 Dec 2025.