A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of ISIS 678354 Administered Subcutaneously to Patients With Severe Hypertriglyceridemia

  • STATUS
    Recruiting
  • End date
    Feb 22, 2025
  • participants needed
    540
  • sponsor
    Ionis Pharmaceuticals, Inc.
Updated on 22 October 2022
Investigator
Ionis Pharmaceuticals
Primary Contact
Canadian Phase Onward Inc (2.9 mi away) Contact
+63 other location

Summary

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

Description

This is a multi-center, randomized, double-blind, placebo-controlled study in up to approximately 540 participants. Participants will be randomized to receive olezarsen or placebo in a 53-week treatment period. The length of participation in the study will be approximately 74 weeks, which includes an up to 8-week screening period, a 53-week treatment period, and a 13-week post-treatment evaluation period or transition to open-label extension (OLE) study with up to 1-year treatment.

Details
Condition Severe Hypertriglyceridemia
Treatment Placebo, ISIS 678354, Olezarsen
Clinical Study IdentifierNCT05079919
SponsorIonis Pharmaceuticals, Inc.
Last Modified on22 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Fasting TG ≥ 500 mg/dL (5.65 mmol/L) at Screening and Qualification
Patients 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

Exclusion Criteria

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