NCT05681351Phase 3Active not recruiting

CORE-OLE: A Study of Olezarsen (ISIS 678354) Administered Subcutaneously to Participants With Severe Hypertriglyceridemia (SHTG)

Study sponsor: Ionis Pharmaceuticals, Inc. · IONS

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2027-03Estimated

Enrollment · participants885Actual

Source updated2025-12-01Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Posted 2025-12-01 · 3 fields changed

Participant count type changed

− Before

~~Estimated~~

+ After

Actual

Enrollment · participant count changed

− Before

~~800 participants (planned)~~

+ After

885 participants (actual)

Recruitment status changed

− Before

~~Recruiting~~

+ After

Active not recruiting

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Study details

Conditions studied

Severe Hypertriglyceridemia

Treatments or interventions studied

OlezarsenDrugAlso known as AKCEA-APOCIII-LRx, ISIS 678354

Primary outcomes · main study measures

Read the study measures

measure: 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; timeFrame: Baseline up to Week 157; measure: Proportion of Participants Who Experience Adverse Events (AEs); timeFrame: Baseline up to Week 157; measure: Proportion of Participants Who Use Concomitant Medications; timeFrame: Baseline up to Week 157

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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