A Study of Olezarsen (ISIS 678354) in Participants With Hypertriglyceridemia and Atherosclerotic Cardiovascular Disease, or With Severe Hypertriglyceridemia

  • STATUS
    Recruiting
  • End date
    Jun 16, 2025
  • participants needed
    1312
  • sponsor
    Ionis Pharmaceuticals, Inc.
Updated on 16 September 2023

Summary

The purpose of the study is to evaluate the effect of olezarsen on percent change in fasting triglyceride (TG) levels compared to placebo in participants with hypertriglyceridemia and atherosclerotic cardiovascular disease, or with severe hypertriglyceridemia.

Description

This is a Phase 3, multi-center, placebo-controlled study of up to 1312 participants with hypertriglyceridemia and atherosclerotic cardiovascular disease. The study consists of 3 periods: 1) Screening Period: Week -12 to Week -1 (up to 12 weeks); 2) Treatment Period up to Week 53; and 3) Post-Treatment Follow-up Period: Week 54 to Week 66 (13 weeks). Participants enrolled will receive olezarsen or placebo once every 4 weeks during the 53-week Treatment Period.

The Screening Period was extended with no impact to overall study timelines. Endpoints added to provide assessment on the pancreatitis rate after olezarsen reaches steady state levels.

A coronary computed tomographic angiography (CTA) sub study will be performed to assess whether triglyceride lowering through inhibition of apoC-III protein synthesis may reduce coronary plaque progression.

Details
Condition Hypertriglyceridemia, Cardiovascular Diseases, Atherosclerosis
Treatment Placebo, Olezarsen
Clinical Study IdentifierNCT05610280
SponsorIonis Pharmaceuticals, Inc.
Last Modified on16 September 2023

Eligibility

Yes No Not Sure

Inclusion Criteria

Participants must fall into 1 of the following groups (a or b)
Hypertriglyceridemia with fasting TG ≥200 mg/dL (2.26 millimoles per liter [mmol/L]) and <500 mg/dL (5.65 mmol/L) with either
Clinical diagnosis of atherosclerotic cardiovascular disease (ASCVD) or
At increased risk for ASCVD b. Severe hypertriglyceridemia with fasting TG ≥500 mg/dL (5.65 mmol/L)
Participants should be on standard of care (SOC) lipid-lowering medications 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 > 1.5 upper limit of normal unless due to Gilbert's syndrome
Estimated GFR < 30 mL/min/1.73 m^2
NOTE: Other Inclusion/Exclusion criteria may apply
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