Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 4INTERVENTIONAL

Dual PCSK9 Inhibition With Inclisiran and Alirocumab in Secondary Prevention

Q: Who can participate in NCT07581808?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

Q: How do I contact the trial site for NCT07581808?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Q: Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Q: Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

PCSK9-DUO Trial: Dual PCSK9 Inhibition With Inclisiran and Alirocumab in Patients With High Cardiovascular Risk in Secondary Prevention

Dual PCSK9 Inhibition With Inclisiran and Alirocumab in Secondary Prevention (NCT07581808) is a Phase 4 interventional studying Hypercholesterolemia and Atherosclerotic Cardiovascular Disease (ASCVD), sponsored by University Medical Centre Ljubljana. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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.

What Stage of Research Is This?

Phase 4 studies happen after a treatment has been approved by the FDA. They monitor long-term safety, real-world effectiveness, and any rare side effects that only emerge in larger populations over longer periods. Phase 4 results sometimes lead to label changes, additional warnings, or — rarely — withdrawal of approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 60 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Hypercholesterolemia subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

DRUG

Inclisiran

Participants receive inclisiran 284 mg administered subcutaneously at baseline (Day 0) and at Month 3.

DRUG

Alirocumab

Participants receive alirocumab 300 mg administered subcutaneously every four weeks in a supervised clinical setting for 9 months.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

University Medical Centre Ljubljana

Ljubljana, Slovenia

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07581808), the sponsor (University Medical Centre Ljubljana), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07581808 clinical trial studying?

Who can participate in NCT07581808?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07581808?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Related Hypercholesterolemia Trials

Alirocumab in Patients on a Stable Dialysis Regimen

Phase 3 · Baylor Research Institute

A Study to See How Safe and Effective Alirocumab is When Given Weekly to Adult Participants Who Have Hypercholesterolemia

Phase 2 · Regeneron Pharmaceuticals

A Study Of SHR-1918 In Participants With Hypercholesterolemia With Inadequate Lipid Control on Statins Plus PCSK9 Inhibitors

Phase 2 / Phase 3 · Beijing Suncadia Pharmaceuticals Co., Ltd

Source: ClinicalTrials.gov API v2 record for NCT07581808. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07581808. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-26 · Data from ClinicalTrials.gov.