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Study identifier: NCT07581808 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Dual PCSK9 Inhibition With Inclisiran and Alirocumab in Secondary Prevention

Condition: Hypercholesterolemia · Atherosclerotic Cardiovascular Disease (ASCVD)  ·  Sponsor: University Medical Centre Ljubljana

PhasePhase 4
Planned participants60
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

This study will evaluate the effectiveness and safety of combining two different types of PCSK9 inhibitors, inclisiran and alirocumab, in patients with high cardiovascular risk who are unable to tolerate statins. Lowering low-density lipoprotein cholesterol (LDL-C) is essential to reduce the risk of cardiovascular events. While PCSK9 inhibitors are effective, many patients treated with a single agent do not reach recommended LDL-C targets, especially those who cannot take statins. Inclisiran and alirocumab reduce LDL-C through different mechanisms. Inclisiran decreases the production of PCSK9 in the liver, while alirocumab binds circulating PCSK9 in the blood. Combining these therapies may lead to a greater reduction in LDL-C levels. In this randomized, open-label clinical trial, approximately 60 patients in secondary prevention will be assigned to one of three groups: inclisiran alone, alirocumab alone, or a combination of both treatments. Patients will be followed for 9 months with regular clinical and laboratory assessments. The main goal of the study is to determine whether combination therapy leads to greater LDL-C reduction compared to each treatment alone. Secondary objectives include assessing the proportion of patients achieving target LDL-C levels and evaluating treatment safety and tolerability.

This description comes directly from the study's public registry record.

Talk to the study team

Zlatko Fras, MD, PhD  ·  +386 1 522 25 62  ·  zlatko.fras@kclj.si

Jan Kafol, MD  ·  jan.kafol@kclj.si

Always discuss trial participation with your own doctor first.

Locations (1)

University Medical Centre LjubljanaLjubljana, SloveniaRecruiting

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Source record: clinicaltrials.gov/study/NCT07581808