Leqvio under the microscope: real-world safety study launched for cholesterol drug
NCT ID NCT06770543
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tracks 1,500 adults with high cholesterol who are prescribed Leqvio (inclisiran) in routine care. The goal is to monitor side effects and measure how well the drug lowers LDL cholesterol. It is a mandatory safety review required by Korean health authorities, not a test of a new treatment.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 1,500 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2025
- Expected to finish
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Jan 2031
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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.
- Ages
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18 to 100 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
4 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Novartis Investigative Site
RECRUITINGYangsan, Gyeongsangnam-do, 50612, South Korea
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Novartis Investigative Site
RECRUITINGBusan, 49241, South Korea
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Novartis Investigative Site
RECRUITINGSeoul, 04763, South Korea
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Novartis Investigative Site
RECRUITINGTaegu, 41944, South Korea
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