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New hope for rare fat disorder: safety trial of olezarsen underway

NCT ID NCT05185843

Disease control Sponsor: Ionis Pharmaceuticals, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests the safety of a new drug, olezarsen, in 24 adults with familial chylomicronemia syndrome (FCS), a rare condition causing extremely high blood fats. All participants have previously taken volanesorsen. The study monitors side effects like low platelet counts and kidney function, while also measuring how the drug affects blood fat levels.

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.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

24 people

The number who actually took part.

Started

Feb 2022

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

18 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.

Key Inclusion Criteria 1. Participants with FCS (clinical or genetic diagnosis) currently on or previously treated with volanesorsen (ISIS 304801) o Study participants in countries where Waylivra® is commercially approved and available for participants should not be deprived of the treatment option with Waylivra®. Participation in this study for such participants will only be allowed when Waylivra® was discontinued due to AEs 2. The following concomitant medications will be allowed if dosing regimen is expected to remain constant through the end of the study (occasional or intermittent use of over-the-counter (OTC) medications will be allowed at Investigator's discretion): * Statins, omega-3 fatty acids (prescription and OTC), fibrates, or other lipid-lowering medications. Participants taking OTC omega-3 fatty acids should make every effort to remain on the same brand through the end of the study * Antidiabetic medications * Oral anticoagulants (e.g., dabigatran, rivaroxaban, or apixaban, and warfarin with regular clinical monitoring) * Tamoxifen, estrogens or progestins Key Exclusion Criteria: 1. Treatment with another investigational drug (non-oligonucleotide), biological agent, or device within 4 weeks of Screening, or 5 half-lives of investigational agent, whichever is longer 2. Concomitant medication/procedure restrictions: 1. Systemic corticosteroids or anabolic steroids within 6 weeks prior to Screening and during the study unless approved by the Sponsor Medical Monitor 2. Plasma apheresis within 4 weeks prior to Screening or planned during the study

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Conditions

The condition(s) this trial relates to.

familial chylomicronemia syndrome Familial hyperchylomicronemia syndrome

As listed by the trial registrant

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

Familial chylomicronemia syndrome

Contacts and locations

Locations

  • ARC Biosystems, Clinical Assessment Unit (CAU)

    Vancouver, British Columbia, V6Z 2C7, Canada

  • Centre Hospitalier Universite de Sherbrooke (CHUS)

    Sherbrooke, Quebec, J1H 5N4, Canada

  • Centre for Heart Lung Innovation

    Vancouver, British Columbia, V6Z 1Y6, Canada

  • Clinique des Maladies Lipidiques de Quebec Inc.

    Québec, Quebec, G1V 4W2, Canada

  • Diabetes/Lipid Management & Research Center

    Huntington Beach, California, 92648, United States

  • Ecogene-21

    Chicoutimi, Quebec, G7H 7K9, Canada

  • Excel Medical Clinical Trials, LLC

    Boca Raton, Florida, 33434, United States

  • Karolinska University Hospital Huddinge

    Stockholm, 171 77, Sweden

  • St. Boniface General Hospital

    Winnipeg, Manitoba, R2H 2Ab, Canada

  • University of Michigan, Department of Internal Medicine, Division of Metabolism, Endocrinology and Diabetes (MEND)

    Ann Arbor, Michigan, 48109-2800, United States

  • University of Rochester School of Medicine

    Rochester, New York, 14642, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.