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Antisense Oligonucleotide
Olezarsen for High Triglycerides
Phase 3
Recruiting
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 must be on a stable regimen of lipid-lowering therapy that should adhere to standard of care (SOC) per local guidelines.
Satisfactory completion of either ISIS 678354-CS5 or ISIS 678354-CS6 (last dose as scheduled at Week 49) with an acceptable safety profile, per Investigator judgment.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 66 weeks
Awards & highlights
Study Summary
This trial is testing a new drug to see if it's safe and tolerable for people with sight-threatening eye disease.
Who is the study for?
This trial is for people with severe hypertriglyceridemia who are already on a stable regimen of lipid-lowering therapy. Participants should have completed previous olezarsen studies (ISIS 678354-CS5 or CS6) without serious issues. Those with new or worsening conditions that could affect study participation, or who need disallowed medications, can't join.Check my eligibility
What is being tested?
The trial is testing the safety and tolerability of a drug called Olezarsen when given by injection to patients with very high triglyceride levels in their blood. The goal is to see how well participants handle the medication over time.See study design
What are the potential side effects?
While specific side effects aren't listed here, generally speaking, drugs like Olezarsen may cause reactions at the injection site, liver problems, changes in fat levels in blood other than triglycerides, and possible interactions with other medications.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am on a stable cholesterol treatment plan as per local health guidelines.
Select...
I completed a specific treatment course without major side effects.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 66 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 66 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 Who Experience Adverse Events (AEs)
Proportion of Participants Who Use Concomitant Medications
Proportion of Participants With Change in Clinical Laboratory Values From Baseline to Week 53
Trial Design
1Treatment groups
Experimental Treatment
Group I: OlezarsenExperimental Treatment1 Intervention
Participants who completed either ISIS 678354-CS5 (NCT05079919) or ISIS 678354-CS6 (NCT05552326) study would be enrolled to receive olezarsen, subcutaneous (SC) injection, once every 4 weeks from Week 1 through Week 49.
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
145 Previous Clinical Trials
14,564 Total Patients Enrolled
10 Trials studying Hypertriglyceridemia
2,922 Patients Enrolled for Hypertriglyceridemia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am on a stable cholesterol treatment plan as per local health guidelines.I completed a specific treatment course without major side effects.
Research Study Groups:
This trial has the following groups:- Group 1: Olezarsen
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
What can be said about the security of Olezarsen for individuals?
"Data from efficacy and safety trials warrant a score of 3 for Olezarsen's perceived risk level."
Answered by AI
How many individuals have volunteered to participate in this research project?
"Affirmative. Clinicaltrials.gov has information that this study, which was first published on December 13th 2022, is currently recruiting patients. To complete the trial, 700 volunteers must be found across 2 medical centres."
Answered by AI
Are there any openings for enrolment in this study right now?
"According to clinicaltrials.gov, the medical study posted on December 13th 2022 is still recruiting participants. The most recent update was made on Christmas day of that same year."
Answered by AI
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