Last Update: Dec 22, 2025
Regulatory Post-Marketing Surveillance (rPMS) Study for Leqvio® Pre-filled Syringe(Inclisiran Sodium)
ClinicalTrials.gov Identifier:
NCT06770543
Novartis Reference Number:CKJX839A1KR01
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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

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).

Primary Hypercholesterolemia or Mixed Dyslipidemia
Recruiting
1500
Aug 13, 2025
Jan 02, 2031
All
18 Years - 100 Years (Adult, Older Adult)

Interventions

Other

Inclisiran

There is no treatment allocation. Patients administered Leqvio by prescription that have started before inclusion of the patient into the study will be enrolled.

Eligibility Criteria

Inclusion Criteria:

If a subject meets all of the following criteria, he/she can participate in this study:

1. 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
2. Patients who are unable to reach LDL-C target with maximum tolerated dose of statin, or patients with statin intolerance
3. Patients who provided consent to participate in the study(informed consent form)

Exclusion Criteria:

A subjects who meets any of the following criteria cannot participate in this study:

1. Contraindications in accordance with domestic prescribing information
2. Patients participating in clinical trials of other investigational drugs
3. Patients who do not provide consent to participate in the study

Novartis Investigative Site

Recruiting

Yangsan,Gyeongsangnam-do,50612,South Korea

Novartis Investigative Site

Recruiting

Busan,49241,South Korea

Novartis Investigative Site

Recruiting

Seoul,04763,South Korea

Novartis Investigative Site

Recruiting

Taegu,41944,South Korea

Worldwide Contacts

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Novartis Pharmaceuticals

+41613241111