A Phase 3 interventional study of Olezarsen in Severe Hypertriglyceridemia, sponsored by Ionis Pharmaceuticals, Inc.. Active, not recruiting at 262 sites in 33 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-01.
Sponsored by Ionis Pharmaceuticals, Inc. · Phase 3, Interventional, and Treatment
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.
296 studies on the registry are indexed under Hypertriglyceridemia; 39 are open to participants now.
This study's enrollment of 885 is above the median of 66 across 259 interventional studies indexed under Hypertriglyceridemia.
Browse Hypertriglyceridemia studies →Ionis Pharmaceuticals, Inc. is the lead sponsor of 116 studies on the registry; 10 are open to participants now.
Of its 48 completed or terminated interventional studies of FDA-regulated products, 21 (44%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other Inclusion/Exclusion criteria may apply.
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 153.
Drug: Olezarsen
Administered as SC injection.
Also known as: AKCEA-APOCIII-LRx, ISIS 678354
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
Showing the first 100 of 262 sites across 33 countries.
Plan to share: Yes — Ionis may share anonymized individual participant data, aggregated clinical data, and other types of data that support the results in this study. Data requests from qualified researchers will be considered once all three of the following criteria are met: (1) 12 months from marketing approval of the study drug in both the United States and European Union; (2) 18 months from conclusion of the study; and (3) 6 months from publication of study article. Access would be via a secure environment and is contingent upon approval of a research proposal and entry into an appropriate data use agreement. Requests to access data can be submitted via the website https://vivli.org/ourmember/ionis/.
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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Ionis Pharmaceuticals, Inc.