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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 170 weeks
Awards & highlights
Study Summary
This trial will test the safety and effectiveness of a new drug, olezarsen, in people with a rare genetic condition called familial chylomicronemia syndrome (FCS) who have already been treated with another drug called volanesorsen.
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.Check my eligibility
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.See study design
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 belowSelect...
I have FCS and have been treated with or am currently on volanesorsen.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 170 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 170 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of Participants With ALT or AST >3 x ULN and Total Bilirubin > 2 x ULN
Proportion of Participants With Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) >5 x Upper Limit of Normal (ULN)
Proportion of Participants With Decrease in Estimated Glomerular Filtration Rate (eGFR) by >30% or >50%
+4 moreSecondary outcome measures
Change and Percent Change From Baseline in Fasting Apolipoprotein C-III (APOC-III)
Change and Percent Change From Baseline in Fasting Apoprotein A-1 (ApoA-1)
Change and Percent Change From Baseline in Fasting Apoprotein B (apoB)
+11 moreTrial 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
~330
Find a Location
Who is running the clinical trial?
Ionis Pharmaceuticals, Inc.Lead Sponsor
146 Previous Clinical Trials
15,258 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I stopped taking Waylivra® due to side effects and it's approved in my country.I have FCS and have been treated with or am currently on volanesorsen.I haven't taken any experimental drugs or used new medical devices in the last month.I am taking medications like statins, omega-3s, diabetes, blood thinners, or hormone therapy and can keep my doses constant.I haven't taken steroids or had plasma apheresis in the last 6 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Olezarsen
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
When will Olezarsen likely receive FDA approval?
"Our team has given Olezarsen a safety score of 3. This is based off of the fact that it is a phase 3 trial, so there is already some evidence of efficacy, as well as multiple rounds of data affirming its safety."
Answered by AI
How many medical facilities are managing this trial today?
"This study is enrolling patients at the moment. The 10 sites are situated in Ann Arbor, Vancouver, Rochester and other places nearby. To limit travel, patients should enroll at the closest site to them."
Answered by AI
Are there any participants needed for this experiment who have not yet signed up?
"The trial is, as of this writing, looking for patients to enroll. According to the listing on clinicaltrials.gov, the first posting was on February 25th, 2022 and the most recent update was on August 4th, 2022."
Answered by AI
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