This study is in progress, not accepting new patients

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

a study on Hypertriglyceridemia Cardiovascular Disease Atherosclerosis Peripheral Artery Disease

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Torrance, California and other locations
Dates
study started
completion around

Description

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.

Official Title

A Randomized, Double-blind, Placebo-Controlled, Phase 3 Study of Olezarsen (ISIS 678354) in Patients With Hypertriglyceridemia and Atherosclerotic Cardiovascular Disease (Established or at Increased Risk for), or With Severe Hypertriglyceridemia

Details

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.

Keywords

Hypertriglyceridemia, Cardiovascular Diseases, Atherosclerosis, ISIS 678354, Olezarsen

Eligibility

You can join if…

Open to people ages 18 years and up

  • Participants must fall into 1 of the following groups (a or b):
    1. 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
    1. 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.

You CAN'T join if...

  • 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 m2

    NOTE: Other Inclusion/Exclusion criteria may apply.

Locations

  • Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center
    Torrance California 90502 United States
  • Cardiovascular Research Foundation of Southern California
    Beverly Hills California 90210 United States
  • Westside Medical Associates of Los Angeles
    Beverly Hills California 90211 United States
  • Metabolic Institute of America
    Tarzana California 91356 United States
  • Amicis Research
    Northridge California 91324 United States
  • Valley Clinical Trials, Inc.
    Northridge California 91325 United States
  • Amicis Research Center
    Santa Clarita California 91344 United States
  • Amicis Research Center
    Valencia California 91355 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Ionis Pharmaceuticals, Inc.
ID
NCT05610280
Phase
Phase 3 research study
Study Type
Interventional
Participants
About 1478 people participating
Last Updated