Last Update: Dec 22, 2025 Regulatory Post-Marketing Surveillance (rPMS) Study for Leqvio® Pre-filled Syringe(Inclisiran Sodium) ClinicalTrials.gov Identifier: [NCT06770543](https://clinicaltrials.gov/ct2/show/NCT06770543) Novartis Reference Number:CKJX839A1KR01 [See if you Pre-qualify](#trial-eligibility "See if you Pre-qualify") 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). Condition Primary Hypercholesterolemia or Mixed Dyslipidemia Overall Status Recruiting Number of Participants1500 Start Date Aug 13, 2025 Completion Date Jan 02, 2031 Gender All Age(s) 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 South Korea #### 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 If the location of your choosing does not feature any contact detail, please reach out using the information below. #### Novartis Pharmaceuticals Phone: [ +41613241111](tel:+41613241111) Email: