Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA UCSD
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

  • University of California, San Diego (UCSD) accepting new patients
    La Jolla California 92037 United States
  • Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center accepting new patients
    Torrance California 90502 United States
  • Cardiovascular Research Foundation of Southern California accepting new patients
    Beverly Hills California 90210 United States
  • Westside Medical Associates of Los Angeles accepting new patients
    Beverly Hills California 90211 United States
  • Metabolic Institute of America accepting new patients
    Tarzana California 91356 United States
  • Diabetes/Lipid Management & Research Center accepting new patients
    Huntington Beach California 92648 United States
  • Amicis Research accepting new patients
    Northridge California 91324 United States
  • Valley Clinical Trials, Inc. accepting new patients
    Northridge California 91325 United States
  • Amicis Research Center accepting new patients
    Santa Clarita California 91344 United States
  • Northern California Research accepting new patients
    Sacramento California 95821 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Ionis Pharmaceuticals, Inc.
ID
NCT05610280
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 1312 study participants
Last Updated