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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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 6 months
Awards & highlights

Study Summary

This trial will study how well olezarsen works in lowering triglyceride levels in adults.

Who is the study for?
This trial is for people who have Familial Chylomicronemia Syndrome (FCS) and have already been treated with Olezarsen in a previous study without any safety concerns. Participants should not have new or worsening conditions that could affect their ability to complete the study.Check my eligibility
What is being tested?
The trial is testing the effectiveness of a drug called Olezarsen on lowering fasting triglycerides, which are fats found in blood, from where they started at the beginning of treatment.See study design
What are the potential side effects?
While specific side effects for Olezarsen aren't listed here, common ones may include reactions at injection sites, liver enzyme changes, and potential interactions with other medications.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percent Change From Baseline in Fasting TG at 6 Months (Average of Weeks 23, 25, and 27) Compared to Baseline
Secondary outcome measures
Adjudicated Acute Pancreatitis Event Rate During the Treatment Period
Adjudicated Acute Pancreatitis Event Rate During the Treatment Period in Participants With ≥ 2 Events of Adjudicated Acute Pancreatitis in 5 Years Prior to Treatment With Study Drug in the Index Study
Adjudicated Acute Pancreatitis Event Rate During the Treatment Period in Patients with a Prior History of Pancreatitis within 10 Years Prior to Screening in the Index Study
+15 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: OlezarsenExperimental Treatment1 Intervention
Olezarsen will be administered once every 4 weeks by subcutaneous (SC) injection from Week 1 through Week 153.
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
15,222 Total Patients Enrolled

Media Library

Olezarsen (Antisense Oligonucleotide) Clinical Trial Eligibility Overview. Trial Name: NCT05130450 — Phase 3
Chylomicronemia Syndrome Research Study Groups: Olezarsen
Chylomicronemia Syndrome Clinical Trial 2023: Olezarsen Highlights & Side Effects. Trial Name: NCT05130450 — Phase 3
Olezarsen (Antisense Oligonucleotide) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05130450 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Olezarsen undergone drug trials by the Federal Drug Administration?

"There is some efficacy data from Olezarsen's Phase 3 clinical trial, as well as additional safety data from multiple rounds of testing. This gives Olezarsen a Power score of 3."

Answered by AI

Are patients being enrolled in this study at this time?

"This study, as indicated by clinicaltrials.gov, is still looking for patients to enroll. The trial was first posted on 18 November 2021 and was last updated on 3 November 2022."

Answered by AI

How many hospitals are testing this new treatment?

"7 sites are currently enrolling patients for this trial, which are located in Chicoutimi, Montreal, Québec, and other cities. You will be minimally required to travel if you enroll at the location nearest to you."

Answered by AI

How many people are recruited for this clinical trial at most?

"The trial is currently seeking participants, with the most recent update occurring on November 3, 2022. Sixty people are needed in total, with seven different sites hosting the trial."

Answered by AI

Who else is applying?

What state do they live in?
Quebec
Florida
How old are they?
18 - 65
What site did they apply to?
Excel Medical Clinical Trials, LLC
Institute de Recherches Cliniques de Montreal
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Study of Olezarsen (Formerly Known as AKCEA-APOCIII-LRx) in Participants With Familial Chylomicronemia Syndrome (FCS)
2021. "A Study of Olezarsen (Formerly Known as AKCEA-APOCIII-LRx) in Participants With Familial Chylomicronemia Syndrome (FCS)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05130450.
~13 spots leftby Jan 2025
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