Leqvio (inclisiran) post-marketing surveillance in Korea
Official title: Regulatory Post-Marketing Surveillance (rPMS) Study for Leqvio® Pre-filled Syringe(Inclisiran Sodium)
Run by Novartis · NCT06770543 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years to 100 Years |
| Sex | All |
| Enrollment | 1500 (estimated) |
| Sponsor | Novartis Industry-sponsored |
| Locations | 4 sites (Yangsan, Gyeongsangnam-do and 3 other locations) |
| Status | Recruiting |
| Started | August 13, 2025 |
| Main results expected | January 2, 2031 |
| Study ends | January 2, 2031 |
| Registry record updated | December 22, 2025 |
| Trial ID | NCT06770543 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
-
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
- Email: novartis.email@novartis.com
- Phone: +41613241111
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.