Leqvio rPMS (Regulatory Post-Marketing Surveillance in Korea)

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).

Study Overview

• Status: Recruiting
• Conditions: Primary Hypercholesterolemia or Mixed Dyslipidemia
• Intervention / Treatment: Other: Inclisiran

• Study Type: Observational
• Enrollment (Estimated): 1500

Contacts and Locations

• Study Contact: Name: Novartis Pharmaceuticals; Phone Number: +41613241111; Email: novartis.email@novartis.com
• Study Contact Backup: Name: Novartis Pharmaceuticals

Study Locations

• South Korea
  • Busan, South Korea, 49241
    • Recruiting
    • Novartis Investigative Site
  • Seoul, South Korea, 04763
    • Recruiting
    • Novartis Investigative Site
  • Taegu, South Korea, 41944
    • Recruiting
    • Novartis Investigative Site
  • Gyeongsangnam-do
    • Yangsan, Gyeongsangnam-do, South Korea, 50612
      • Recruiting
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Inclisiran; Patients who have been treated with inclisiran	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.; Other Names: Leqvio®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)]	up to 15 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	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.	up to 15 months

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): August 13, 2025
• Primary Completion (Estimated): January 2, 2031
• Study Completion (Estimated): January 2, 2031

Study Registration Dates

• First Submitted: January 7, 2025
• First Submitted That Met QC Criteria: January 7, 2025
• First Posted (Actual): January 13, 2025

Study Record Updates

• Last Update Posted (Actual): December 22, 2025
• Last Update Submitted That Met QC Criteria: December 15, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: inclisiran; mixed dyslipidemia; Leqvio; primary hypercholesterolemia,
• Additional Relevant MeSH Terms: Metabolic Diseases; Hyperlipidemias; Lipid Metabolism Disorders; Hypercholesterolemia; Dyslipidemias; ALN-PCS
• Other Study ID Numbers: CKJX839A1KR01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No