CompletedPhase 3

A Study of Olezarsen Administered Subcutaneously to Participants With Severe Hypertriglyceridemia

United States446 participantsStarted 2022-08-31

Plain-language summary

The purpose of this study is to evaluate the efficacy of olezarsen as compared to placebo on the percent change in fasting triglycerides (TG) from baseline.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Fasting TG ≥ 500 mg/dL (5.65 mmol/L) at Screening and Qualification
✓. Participants must be on lipid-lowering therapy that should adhere to standard of care (SOC) per local guidelines. Lipid-lowering medications should be optimized and stabilized for at least 4 weeks prior to screening to minimize changes in these medications during the study.
✓. Participants must be willing to comply with diet and lifestyle recommendations as able.

Exclusion criteria

✕. Hemoglobin A1c (HbA1c) ≥ 9.5% at Screening
✕. Alanine aminotransferase or aspartate aminotransferase \> 3.0 × upper limit of normal
✕. Total bilirubin \> 1.5 ULN unless due to Gilbert's syndrome
✕. Estimated GFR \< 30 mL/min/1.73 m\^2

What they're measuring

Percent Change from Baseline in Fasting TG Compared to Placebo

Timeframe: Baseline and Month 6

Trial details

NCT IDNCT05552326

SponsorIonis Pharmaceuticals, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-12-17

View on ClinicalTrials.gov More Severe Hypertriglyceridemia trials