NCT07581808RecruitingPhase 4
Dual PCSK9 Inhibition With Inclisiran and Alirocumab in Secondary Prevention
PCSK9-DUO Trial: Dual PCSK9 Inhibition With Inclisiran and Alirocumab in Patients With High Cardiovascular Risk in Secondary Prevention
Source: ClinicalTrials.gov · Last updated 2 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 5 May 2026
- Start date
- 18 May 2026
- Primary completion date
- May 2027
- Lead sponsor
- University Medical Centre Ljubljana
- Diseases
- Familial hypercholesterolaemia
- NCT number
- NCT07581808
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 60
- From 18 May 2026 to the primary completion date, May 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Participation in another interventional clinical trial within 30 days prior to enrollment
Other illness
- Active malignancy or life expectancy \<1 year
- Known hypersensitivity to inclisiran, alirocumab, or any of their excipients
- Any condition that, in the opinion of the investigator, would interfere with study participation or interpretation of results
Lab values
- 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)
Other
- Known homozygous familial hypercholesterolemia
- Pregnancy, breastfeeding, or women of childbearing potential not using effective contraception
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Medical Centre Ljubljana Coordinator of this site? Confirm its status | Ljubljana | Slovenia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.