Leqvio rPMS (Regulatory Post-Marketing Surveillance in Korea)

NCT06770543 | Recruiting

• 1 other identifier: CKJX839A1KR01
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 4

Brief 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 hypercholesterolemia or mixed dyslipidemia).

Conditions

Primary Hypercholesterolemia or Mixed Dyslipidemia

Keywords

primary hypercholesterolemia,; mixed dyslipidemia; inclisiran; Leqvio

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change from baseline in low-density lipoprotein-cholesterol (LDL-C) and lipid profiles

  Baseline, Months 3, 9 and 15

• Impact of subjects' baseline characteristics and medication usage on cumulative incidence of AEs and SAEs

  up to 15months

• Impact of subjects' baseline characteristics and medication usage on changes from baseline in LDL-C and lipid profiles

  up to 15 months

Study Arms (1)

Inclisiran

Patients who have been treated with inclisiran

Other: Inclisiran

Interventions

Inclisiran OTHER

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

Also known as: Leqvio®

Inclisiran

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (4)

Novartis Investigative Site

Yangsan, Gyeongsangnam-do, 50612, South Korea

RECRUITING

Novartis Investigative Site

Busan, 49241, South Korea

RECRUITING

Novartis Investigative Site

Seoul, 04763, South Korea

RECRUITING

Novartis Investigative Site

Taegu, 41944, South Korea

RECRUITING

MeSH Terms

Interventions

ALN-PCS

Central Study Contacts

Novartis Pharmaceuticals

CONTACT

+41613241111; novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2025
• First Posted: January 13, 2025
• Study Start: August 13, 2025
• Primary Completion (Estimated): January 2, 2031
• Study Completion (Estimated): January 2, 2031
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (4)