Dual PCSK9 Inhibition in secondary prevention for high LDL-C with statin intolerance

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, open-label, single-center Phase 4 trial enrolling about 60 adults with established ASCVD and statin intolerance. Participants are assigned to inclisiran alone, alirocumab alone, or both therapies, and are followed for 9 months to assess LDL-C reduction and safety. Inclisiran reduces hepatic PCSK9 production while alirocumab neutralizes circulating PCSK9; the combination aims for greater LDL-C lowering. Eligible patients have LDL-C between 2.5 and 5.0 mmol/L despite background lipid-lowering therapy. The study is conducted at University Medical Centre Ljubljana, with strict criteria to ensure appropriate patient selection.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Adults aged ≥18 years
* Established atherosclerotic cardiovascular disease (secondary prevention), defined as prior cardiovascular events or imaging-confirmed atherosclerosis (e.g., coronary artery disease on angiography or CT, carotid plaque on ultrasound, or peripheral arterial disease).
* Eligible for PCSK9 inhibitor therapy according to national clinical criteria
* Fasting LDL cholesterol ≥2.5 mmol/L and ≤5.0 mmol/L at screening
* Documented statin intolerance or contraindication to statin therapy
* On stable background lipid-lowering therapy (including ezetimibe if applicable) for at least 4 weeks prior to enrollment
* Able and willing to provide written informed consent

Exclusion Criteria:

* Eligibility for PCSK9 inhibitor therapy solely based on elevated lipoprotein(a) \>1000 mg/L with LDL-C below inclusion threshold
* Prior use of any PCSK9 inhibitor (alirocumab, evolocumab or inclisiran) before enrollment
* Planned initiation or modification of lipid-lowering therapy during the study period
* Known homozygous familial hypercholesterolemia
* Active liver disease or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>3× upper limit of normal
* Severe renal impairment (eGFR \<30 mL/min/1.73 m²)
* Active malignancy or life expectancy \<1 year
* Pregnancy, breastfeeding, or women of childbearing potential not using effective contraception
* Known hypersensitivity to inclisiran, alirocumab, or any of their excipients
* Participation in another interventional clinical trial within 30 days prior to enrollment
* Any condition that, in the opinion of the investigator, would interfere with study participation or interpretation of results

Where it's running

• University Medical Centre Ljubljana
  Ljubljana, Slovenia Recruiting

Study contacts

• Principal investigator: Jan Kafol, MD — University Medical Centre Ljubljana
• Study coordinator: Zlatko Fras, MD, PhD
• Email: zlatko.fras@kclj.si
• Phone: +386 1 522 25 62

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Alirocumab for people on stable dialysis

  This study tests whether alirocumab can safely lower cholesterol in adults on stable hemodialysis or peritoneal dialysis over 12 weeks.

  Recruiting Phase 3 Baylor Research Institute · Dallas, Texas · NCT03480568

• VERVE-102 for adults with or at high risk for heart disease

  This study tests whether VERVE-102 can lower bad cholesterol (LDL-C) compared with a placebo in adults with plaque buildup or high risk for it.

  Recruiting Phase 2 Verve Therapeutics, Inc. · DeSoto, Texas · NCT07839936

• Understanding why some people see bigger LDL drops after starting ezetimibe

  This study tests what factors predict how much a person’s LDL cholesterol drops after starting ezetimibe, to help tailor cholesterol treatment.

  Recruiting Phase 4 Universidade do Porto · Porto · NCT07839741

• Enlicitide (MK-0616) for adults with high cholesterol in India

  This study tests whether enlicitide helps lower bad cholesterol (LDL-C) compared with placebo in adults with hyperlipidemia/hypercholesterolemia.

  Recruiting at 2 sites Phase 3 Merck Sharp & Dohme LLC · Belagavi, Karnataka and 1 other locations · NCT07821944

• Health for Hungary: Long-term blood and health data collection to study aging and disease onset

  This study tests whether routine blood tests plus advanced molecular analyses can help detect the early stages of non-communicable diseases in adults over 40.

  Recruiting at 21 sites Center for Molecular Fingerprinting Research Nonprofit LLC · Balatonfüred and 32 other locations · NCT07743021

• Pemafibrate in people with high cholesterol not fully controlled by statins

  This study tests whether taking Pemafibrate at 0.2 mg or 0.4 mg daily for 12 weeks helps people with high cholesterol who still don’t respond well to statins, compared with a placebo.

  Recruiting at 10 sites Phase 4 Kowa Company, Ltd. · Hokkaido and 9 other locations · NCT07634484

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.