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Evaluating Inclisiran and Other Lipid Lowering Treatments in Real-world Patients

A Non-interventional Implementation Study to Evaluate Treatment With Inclisiran (Leqvio®) and Other Lipid Lowering Treatments in a Real-world Setting (VICTORION-Implement)

Observational Novartis · NCT05362903

This study is testing how well Inclisiran and other cholesterol-lowering treatments work for people with high cholesterol in everyday settings.

Quick facts

Study typeObservational
Enrollment2030 (estimated)
Ages18 Years to 100 Years
SexAll
SponsorNovartis Industry-sponsored
Locations145 sites (Freudenstadt, Baden Wuerttemberg and 144 other locations)
Trial IDNCT05362903 on ClinicalTrials.gov

What this trial studies

This multicenter, non-randomized, non-interventional study aims to evaluate the effectiveness of Inclisiran and other lipid-lowering treatments in patients with hypercholesterolemia. The study consists of three cohorts: patients newly initiated on oral lipid-lowering treatments alongside statins, those starting Inclisiran, and those receiving Inclisiran in conjunction with lipid apheresis. Data will be collected prospectively as part of routine clinical care, allowing for real-world insights into treatment outcomes.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with hypercholesterolemia, particularly those with a history of atherosclerotic cardiovascular disease or those not achieving LDL-C goals.

Not a fit: Patients currently receiving PCSK9-targeted therapies or those with contraindications for Inclisiran may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable information on the effectiveness of Inclisiran and other lipid-lowering therapies in managing cholesterol levels and reducing cardiovascular risk.

How similar studies have performed: Other studies have shown success with similar lipid-lowering approaches, particularly in the context of managing cholesterol levels and cardiovascular risk.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Patients who provide written informed consent to participate in the study
2. Male or female patients ≥ 18 years of age
3. Oral LLT Cohort: Patients with documented ASCVD newly initiated on an oral lipid lowering treatment on top of a statin (e.g. ezetimibe, bempedoic acid, cholestyraimin)
4. Inclisiran Cohort: Patients newly initiated on Inclisiran fulfilling the restricted reimbursement criteria or individual access requirements who are not at LDL-C goal as per their CV risk as recommended in the 2019 EAS/ESC guidelines (Mach et al., 2020). At least 60% of the documented patients must be PCSK9-inhibitor naive
5. Apheresis plus Inclisiran Cohort: Patients with Inclisiran on top of regular weekly or bi-weekly lipoprotein apheresis (LDL-c or LP(a)).

Exclusion Criteria:

1. Oral LLT Cohort: Patients who receive a PCSK9-mAB or other PCSK9-targeted therapy
2. Inclisiran 1 Cohort: current or previous PCSK9-targeted treatment
3. Contraindication for Inclisiran according to the SmPC
4. Patients who have received Inclisiran previously
5. Patients with homozygous FH
6. Any underlying known disease, or surgical, physical, or medical condition that, in the opinion of the investigator (or delegate) might interfere with interpretation of the clinical study results.
7. Simultaneous or planned participation in an interventional research study

Where this trial is running

Freudenstadt, Baden Wuerttemberg and 144 other locations

+95 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions HypercholesterolemiaInclisiranAtherosclerotic Cardiovascular DiseaseASCVD
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.