Leqvio (inclisiran) post-marketing surveillance in Korea

Regulatory Post-Marketing Surveillance (rPMS) Study for Leqvio® Pre-filled Syringe(Inclisiran Sodium)

This will see if Leqvio (inclisiran) is safe and lowers LDL cholesterol for adults in Korea with primary hypercholesterolemia or mixed dyslipidemia who are prescribed it in routine care.

Quick facts

• Study type: Observational
• Enrollment: 1500 (estimated)
• Ages: 18 Years to 100 Years
• Sex: All
• Sponsor: Novartis (Industry-sponsored)
• Locations: 4 sites (Yangsan, Gyeongsangnam-do and 3 other locations)
• Trial ID: NCT06770543 on ClinicalTrials.gov

What this trial studies

This non-interventional regulatory post-marketing surveillance collects real-world safety and effectiveness data on Leqvio (inclisiran) when used according to its approved label in Korea. Adult patients prescribed the pre-filled syringe formulation who have primary hypercholesterolemia or mixed dyslipidemia—particularly those not reaching LDL-C targets on maximal tolerated statin or with statin intolerance—are enrolled after informed consent. The study records routine clinical outcomes, LDL-C levels, adverse events, and concomitant treatments at participating Novartis sites in Yangsan, Busan, and Seoul. Data are analyzed descriptively to characterize real-world use and safety in the Korean population.

Who should consider this trial

Good fit: Adult patients (≥18 years) in Korea with primary hypercholesterolemia or mixed dyslipidemia who are prescribed Leqvio per local label, are not reaching LDL-C targets on maximal tolerated statin or have statin intolerance, and provide informed consent.

Not a fit: Patients with contraindications per the product label, those currently enrolled in other investigational drug trials, or those who decline consent are not eligible and will not receive benefit from participation.

Why it matters

Potential benefit: If successful, the study could confirm the real-world LDL-C lowering effect and safety profile of Leqvio in Korean patients, supporting informed use by clinicians and regulators.

How similar studies have performed: Large randomized ORION trials have already shown inclisiran substantially lowers LDL-C with an acceptable safety profile, so this surveillance is confirming those results in Korean routine practice.

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

Where this trial is running

Yangsan, Gyeongsangnam-do and 3 other locations

• Novartis Investigative Site — Yangsan, Gyeongsangnam-do, South Korea (Recruiting)
• Novartis Investigative Site — Busan, South Korea (Recruiting)
• Novartis Investigative Site — Seoul, South Korea (Recruiting)
• Novartis Investigative Site — Taegu, South Korea (Recruiting)

Study contacts

• Study coordinator: Novartis Pharmaceuticals

Conditions Primary Hypercholesterolemia or Mixed Dyslipidemia; primary hypercholesterolemia,; mixed dyslipidemia; inclisiran; Leqvio