CORE-OLE: A Study of Olezarsen (ISIS 678354) Administered Subcutaneously to Participants With Severe Hypertriglyceridemia (SHTG)
Severe HypertriglyceridemiaThe purpose of this study is to evaluate the safety and tolerability of olezarsen in participants with SHTG.
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Participation Requirements
-
Sex:
ALL -
Eligible Ages:
18 and up
Participation Criteria
Key Inclusion Criteria:
* 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. 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.
Key Exclusion Criteria:
* 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.
NOTE: Other Inclusion/Exclusion criteria may apply.
Study Location
Clinique des Maladies Lipidiques de Quebec Inc.
Clinique des Maladies Lipidiques de Quebec Inc.Québec, Quebec
Canada
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Ecogene-21
Ecogene-21Chicoutimi, Quebec
Canada
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Bluewater Clinical Research Group, Inc.
Bluewater Clinical Research Group, Inc.Sarnia, Ontario
Canada
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Canadian Phase Onward Inc.
Canadian Phase Onward Inc.Toronto, Ontario
Canada
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- Study Sponsored By
- Ionis Pharmaceuticals, Inc.
- Participants Required
- More Information
- Study ID:
NCT05681351