NCT05355402Phase 2Completed

A Study of Olezarsen (Formerly Known as AKCEA-APOCIII-LRx) in Adults With Hypertriglyceridemia and Atherosclerotic Cardiovascular Disease (Established or at Increased Risk for), and/or With Severe Hypertriglyceridemia

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 completion2023-03-22Actual

Enrollment · participants154Actual

Source updated2026-04-23Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Posted 2026-04-23 · 1 field changed

Primary completion date changed

− Before

~~17 Jan 2023~~

+ After

22 Mar 2023

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Posted 2026-03-20 · 2 fields changed

Main study measure wording changed

Text changed; whether the study measures changed has not been verified. Saved text may be shortened.

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− Before

Measure: Percent Change From Baseline at Month 6 ~~(average of Weeks 25 and 27) in Fasting Triglycerides (TG)~~

+ After

Measure: Percent Change From Baseline in Fasting TG at Month 6

Primary completion date changed

− Before

~~22 Mar 2023~~

+ After

17 Jan 2023

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Study details

Conditions studied

Hypertriglyceridemia; Atherosclerotic Cardiovascular Disease; Severe Hypertriglyceridemia

Treatments or interventions studied

OlezarsenDrugAlso known as ISIS 678354, AKCEA-APOCIII-LRx
PlaceboDrug

Primary outcomes · main study measures

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measure: Percent Change From Baseline in Fasting TG at Month 6; description: Baseline was defined as the average of the pre-dose measurement on Day 1 and all non-missing measurements from the qualification period. If the Day 1 pre-dose and qualification period measurements were all missing, then the last non-missing measurement from the screening period was used as baseline. Month 6 was defined as the average of Weeks 25 and 27. If 1 of the 2 assessments was missing, then the non-missing assessment was used. Missing data after the last observed value for participants in the olezarsen arms were imputed using the jump to reference (J2R) approach.; timeFrame: Baseline, Month 6

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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