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New hope for rare cholesterol disease: can evinacumab shrink dangerous plaque?

NCT ID NCT07447648

Disease control Sponsor: Fondazione SISA (Societa Italiana per lo Studio della Arteriosclerosi) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Aug 21, 2026 · Updated 2 times

Summary

This study follows about 52 people with homozygous familial hypercholesterolemia (HoFH), a rare genetic condition causing extremely high cholesterol and early heart disease. Researchers will compare those who get evinacumab (a cholesterol-lowering antibody) added to their usual treatment against those on standard therapy alone. Using CT scans of the heart, they will measure changes in artery plaque over 18-24 months to see if evinacumab helps stabilize or reduce plaque buildup.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
evinacumab (a lab-made antibody that lowers cholesterol by blocking a protein called ANGPTL3)
What this could lead to
If successful, this study could show that adding evinacumab to standard treatment helps slow or shrink dangerous artery plaque in people with HoFH, pointing toward better long-term heart health.
What could go wrong
This is an observational study, not a controlled trial, so results may be less reliable. It is also small (52 people) and early-stage, so findings may not apply to everyone or lead to immediate changes in care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 52 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2026

Expected to finish

Feb 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Intensified treatment group: Male and Female HoFH patients aged ≥12 (exception for Italy and France ≥18 years) who initiated commercially available Evinacumab (at the approved dosage and administration) as add-on lipid-lowering treatment at stable dose for at least 30 days before Evinacumab initiation, in the routine clinical care. Conventional treatment group: Male and Female HoFH patients aged ≥12 (exception for Italy and France ≥18 years) on standard lipid-lowering therapy at stable dose for at least 30 days before the baseline CCTA from: 1. countries where Evinacumab will not be commercially available within the next 18 months; 2. participating countries who have the explicit wish not to receive treatment with Evinacumab.

Ages

12 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria (intensified treatment group - Evinacumab): 1. Willing and able to provide written informed consent form/assent form for the use of retrospective and prospective data. 2. Male or female patients aged ≥12 years old at time of enrolment (exception for Italy and France ≥18 years). 3. Clinical or genetic diagnosis of Homozygous Familial Hypercholesterolemia (HoFH) according to the consensus statement by Cuchel et al, 2023; EHJ (14). 4. Patients who initiated Evinacumab (at the approved dosage and administration) within 24 months before enrolment as add-on to lipid-lowering treatment (with statins, ezetimibe, PCSK9i and/or other agents or treatment) at stable dose for at least 30 days before Evinacumab initiation, as per routine clinical care and no change in dosing is anticipated. 5. Availability of a baseline CCTA performed at least 6 months prior or 1 month after Evinacumab initiation and a follow-up CCTA performed 18-24 months after Evinacumab initiation. 6. LDL-cholesterol ≥ 140 mg/dl (3.5 mmol/L) despite lipid-lowering treatment. Inclusion criteria (conventional treatment group - No Evinacumab) 1. Willing and able to provide written informed consent form/assent form for the use of retrospective and prospective data. 2. Male or female patients aged ≥12 years old at time of enrolment (exception for Italy and France ≥18 years). 3. Clinical or genetic diagnosis of Homozygous Familial Hypercholesterolemia (HoFH) according to the consensus statement by Cuchel et al, 2023; EHJ (14). 4. Patients with HoFH on standard lipid-lowering therapy (statins, ezetimibe, PCSK9i and/or other agents or treatment) at stable dose for at least 30 days before a baseline CCTA and with a follow-up CCTA after 18-24 months from the baseline one. * Required lipid lowering therapies: statin, ezetimibe and PCSK9 directed therapy (unless discontinuation due to \<15% LDL-cholesterol reduction). * Optional additional lipid-lowering therapies: * Lipoprotein apheresis, at stable intervals for at least 3 months. * Lomitapide, at stable dose for at least 3 months. 5. LDL-cholesterol ≥ 140 mg/dl (3.5 mmol/L) despite lipid-lowering treatment. Exclusion criteria (intensified treatment group - Evinacumab) 1. Patients participating in a clinical trial with an investigational drug within the last 6 months. 2. Patients treated outside of Evinacumab approved indication. 3. Inability to access adequate retrospective clinical data from medical records. 4. Inability or unwillingness to provide informed consent/assent or refusal to participate. 5. Previous multi-vessel coronary artery bypass grafting (CABG). Patients with single-vessel CABG are not excluded. 6. Pregnancy at the time of the LLT administration. 7. Moderate to severe renal impairment, or end-stage renal disease (ESRD) undergoing kidney transplantation or chronic renal replacement therapy. Exclusion criteria (conventional treatment group - No Evinacumab) 1. Participation in any interventional clinical trial involving investigational drugs within the last 6 months. 2. Inability to access adequate retrospective clinical data from medical records. 3. Inability or unwillingness to provide informed consent/assent or refusal to participate. 4. Previous multi-vessel coronary artery bypass grafting (CABG). Patients with single-vessel CABG are not excluded. 5. Moderate to severe renal impairment, or end-stage renal disease (ESRD) undergoing kidney transplantation or chronic renal replacement therapy. 6. Pregnancy at the time of the LLT administration.

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Conditions

The condition(s) this trial relates to.

atherosclerosis cardiovascular disorder homozygous familial hypercholesterolemia Lipid Metabolism Disorders

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Coronary computed tomography angiography Homozygous familial hypercholesterolemia (HOFH)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    13 sites in 4 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Amsterdam University Medical Center, Amsterdam UMC, locatie AMC

    RECRUITING

    Amsterdam, Netherlands

  • Centro per le Malattie Rare del Metabolismo dei Lipidi, Unità di Medicina Interna e Malattie Metaboliche, Dipartimento di Medicina Traslazionale e di Precisione Sapienza, Università di Roma

    RECRUITING

    Roma, Italy

  • DAI di Medicina Clinica, Centro di Riferimento Regionale di Lipidologia e Dislipidemie, AOU Federico II di Napoli

    RECRUITING

    Naples, Italy

  • Dipartimento Scienze-Cardiovascolari, AO "Sant'Anna e San Sebastiano" di Caserta

    RECRUITING

    Caserta, Italy

  • Ege University,Director of Lipid and Prevention Clinic, Department of Cardiology

    RECRUITING

    Bornova, Turkey (Türkiye)

  • Erasmus University Medical Center, Dr. Molewaterplein 40

    RECRUITING

    Rotterdam, Netherlands

  • Malattie Aterotrombotiche, Azienda Ospedaliero Universitaria Careggi

    RECRUITING

    Florence, Italy

  • Medicina Interna, Ospedale Molinette, AOU Città della Salute e della Scienza

    RECRUITING

    Torino, Italy

  • Nefrologia e Emodialisi, Centro Aterosclerosi e Dislipidemie, Ospedale Bassini, ASST Nord Milano

    RECRUITING

    Cinisello Balsamo, Italy

  • U.O. Astanteria/MCAU AOU, Policlinico "Paolo Giaccone" di Palermo

    RECRUITING

    Palermo, Italy

  • U.O.C. di Medicina Interna, P.O. Nesima, ARNAS Garibaldi

    RECRUITING

    Catania, Italy

  • UOC Clinica Medica I, AOU di Padova

    RECRUITING

    Padova, Italy

  • Unité de Lipidologie et Prévention Cardiovasculaire, Centre de Compétence Dyslipidémies Rares (CEDRA), Service de Nutrition, Hôpital Pitié-Salpétriêre

    RECRUITING

    Paris, France

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