NCT05185843Phase 3Active not recruiting

A Study of Olezarsen (Formerly Known as AKCEA-APOCIII-LRX) Administered to Adults With Familial Chylomicronemia Syndrome (FCS) Previously Treated With Volanesorsen

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 completion2027-06Estimated

Enrollment · participants24Actual

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

Version history

Changes to this trial

Last 12 months

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No recorded changes are available for this view and time period. Our history may be incomplete; this does not establish that the trial stayed unchanged.

Study details

Conditions studied

Familial Chylomicronemia Syndrome

Treatments or interventions studied

OlezarsenDrugAlso known as ISIS 678354, AKCEA-APOCIII-LRx

Primary outcomes · main study measures

Read the study measures

measure: Proportion of Participants With Decrease in Platelet Count by >30% or >50%, or With Platelet Count Value <50,000/cubic millimeter (mm^3); timeFrame: Baseline to Week 209; measure: Proportion of Participants With Clinical Bleeding Events; timeFrame: Baseline to Week 209; measure: Proportion of Participants With Decrease in Estimated Glomerular Filtration Rate (eGFR) by ≥30% or ≥50%; timeFrame: Baseline to Week 209; measure: Proportion of Participants With Urine Protein/Creatinine Ratio (UPCR) ≥1000 milligram (mg)/gram (g) or with Urine/Albumin Creatinine Ratio (UACR) ≥500 mg/g; timeFrame: Baseline to Week 209; measure: Proportion of Participants With Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) ≥5 x Upper Limit of Normal (ULN); timeFrame: Baseline to Week 209; measure: Proportion of Participants With ALT or AST ≥3 x ULN and Total Bilirubin > 2 x ULN; timeFrame: Baseline to Week 209; measure: Proportion of Participants With Total Bilirubin ≥2 mg/deciliter (dL); timeFrame: Baseline to Week 209

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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