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A Study of Olezarsen (ISIS 678354) Administered Subcutaneously to Participants with Severe Hypertriglyceridemia (SHTG)
EU CTIS ID: 2022-501999-26-00
What this study is testing
To evaluate the safety and tolerability of olezarsen
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Satisfactory completion of either ISIS 678354-CS5 or ISIS 678354-CS6 with an acceptable safety profile, per Investigator judgment. Satisfactory completion requires that the patient did not terminate early from treatment.
- Participants must be on a stable regimen of lipid-lowering therapy that should adhere to standard of care (SOC) per local guidelines. A patient may be eligible if their regimen of lipid-lowering therapy has been changed recently, provided that lipid lowering medications are optimized and stabilized for at least 4 weeks prior to the end of the Qualification Period of this OLE study; ideally, such changes are initiated after Week 53 of the index study (ISIS 678354-CS5 or -CS6).
- A patient may re-enroll in the study after having completed the study when the Treatment Period was 53 weeks, if the patient satisfactorily completed the study with an acceptable safety profile, per Investigator judgment. For a given patient to re-enroll, there is no maximum time between their last dose of olezarsen when initially enrolled and their first dose of olezarsen when re-enrolled (i.e., not exceeding 17 weeks between doses does not apply when re-enrolling).
You likely can't join if
- Have any new condition or worsening of existing condition which in the opinion of the Investigator would make the participant unsuitable for enrollment, or could interfere with the participant participating in or completing the study, including need for treatment with disallowed medications, or need to change the required stable regimen as per either ISIS 678354-CS5 or ISIS 678354-CS6 study entry criteria. Although, it is acceptable to adjust a regimen of lipid-lowering therapy as described in Inclusion Criterion 3, and it is acceptable to adjust or stop lipid-lowering therapy at or after Week 13 per Investigator judgment.
The study team makes the final eligibility decision.
Where it's taking place
- Mexico
- United States
- Malaysia
- Canada
- Israel
- South Africa
- New Zealand
- Brazil
- Turkey
- Argentina
- Taiwan
- United Kingdom
- Australia
- India
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Mexico; United States; Malaysia; Canada; Israel; South Africa and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.