The purpose of this study is to evaluate the safety and tolerability of olezarsen in participants with SHTG.
This is a multi-center, open-label extension (OLE) study of approximately 800 participants with SHTG who would be rolled over from studies ISIS 678354-CS5 (NCT05079919) or ISIS 678354-CS6 (NCT05552326). Day 1 of this study may be same as the Week 53 visit of either ISIS 678354-CS5 or ISIS 678354-CS6, as applicable. Participants will receive olezarsen during the 157-week treatment period. The study will include a 31-day qualification Period, a 157-week treatment period, and a 13-week post-treatment period.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
885
Administered as SC injection.
Proportion of Participants With Change in Clinical Laboratory Values From Baseline to Week 53, From Baseline to Week 105, and From Baseline to Week 157
Time frame: Baseline up to Week 157
Proportion of Participants Who Experience Adverse Events (AEs)
Time frame: Baseline up to Week 157
Proportion of Participants Who Use Concomitant Medications
Time frame: Baseline up to Week 157
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Miami, Florida, United States
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