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Antisense Oligonucleotide

Olezarsen for Chylomicronemia Syndrome

Phase 3
Waitlist Available
Research Sponsored by Ionis Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants with FCS (clinical or genetic diagnosis) currently on or previously treated with volanesorsen (ISIS 304801)
Be older than 18 years old
Must not have
Concomitant medication/procedure restrictions: Systemic corticosteroids or anabolic steroids within 6 weeks prior to Screening and during the study unless approved by the Sponsor Medical Monitor, Plasma apheresis within 4 weeks prior to Screening or planned during the study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial is testing olezarsen, a medication for people with FCS who have already tried another treatment. It aims to see if olezarsen is safe and effective by lowering a protein that affects blood fat levels.

Who is the study for?
This trial is for adults with Familial Chylomicronemia Syndrome (FCS) who have tried a drug called volanesorsen but stopped due to side effects. They can't be on systemic steroids or have had plasma apheresis recently, and should not switch their current medications like statins or omega-3s during the study.
What is being tested?
The trial tests Olezarsen's safety and how it affects the body in FCS patients previously treated with volanesorsen. It looks at how the body processes Olezarsen and its impact on lipid levels in participants.
What are the potential side effects?
While specific side effects of Olezarsen are not listed here, similar drugs may cause injection site reactions, flu-like symptoms, liver issues, potential kidney problems, and possible interactions with other medications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have FCS and have been treated with or am currently on volanesorsen.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I haven't taken steroids or had plasma apheresis in the last 6 weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: OlezarsenExperimental Treatment1 Intervention
Olezarsen will be administered once every 4 weeks by subcutaneous (SC) injection for up to 153 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Olezarsen
2022
Completed Phase 3
~1810

Find a Location

Who is running the clinical trial?

Ionis Pharmaceuticals, Inc.Lead Sponsor
149 Previous Clinical Trials
15,515 Total Patients Enrolled

Media Library

Olezarsen (Antisense Oligonucleotide) Clinical Trial Eligibility Overview. Trial Name: NCT05185843 — Phase 3
Chylomicronemia Syndrome Research Study Groups: Olezarsen
Chylomicronemia Syndrome Clinical Trial 2023: Olezarsen Highlights & Side Effects. Trial Name: NCT05185843 — Phase 3
Olezarsen (Antisense Oligonucleotide) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05185843 — Phase 3
~2 spots leftby Mar 2025
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