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

Completed · Phase 3 · Has a placebo group

Conditions studied: Hypertriglyceridemia, Cardiovascular Diseases, Atherosclerosis

In brief

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.

Key facts

Study ID

NCT05610280

Run by

Ionis Pharmaceuticals, Inc.

People needed

1478

Starts

2022-11-21

Expected to finish

2025-06-09

Last updated by the study team

2026-02-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify 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 m\^2
• NOTE: Other Inclusion/Exclusion criteria may apply.

Where it is running

• Alabama Clinical Therapeutics, LLC Alabaster — Birmingham, Alabama, United States
• Heart Center Research PC — Huntsville, Alabama, United States
• Cardiovascular Research Foundation of Southern California — Beverly Hills, California, United States
• Westside Medical Associates of Los Angeles — Beverly Hills, California, United States
• Diabetes/Lipid Management & Research Center — Huntington Beach, California, United States
• University of California, San Diego (UCSD) — La Jolla, California, United States
• Clinical Trials Research — Lincoln, California, United States
• Amicis Research — Northridge, California, United States
• Valley Clinical Trials, Inc. — Northridge, California, United States
• Northern California Research — Sacramento, California, United States
• Amicis Research Center — Santa Clarita, California, United States
• Metabolic Institute of America — Tarzana, California, United States
• Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center — Torrance, California, United States
• Amicis Research Center — Valencia, California, United States
• Excel Clinical Medical Trials — Boca Raton, Florida, United States
• Finlay Medical Research - West Palm — Greenacres City, Florida, United States
• Global Research Associates — Homestead, Florida, United States
• 3Sync Research — Lake Worth, Florida, United States
• Finlay Medical Research — Miami, Florida, United States
• Advanced Medical Research Institute (AMRI) — Miami, Florida, United States
• De La Cruz Research Center, LL — Miami, Florida, United States
• Suncoast Clinical Research, Inc. - New Port Richey — New Port Richey, Florida, United States
• Suncoast Clinical Research, Inc. - Palm Harbor — New Port Richey, Florida, United States
• Proactive Clinical Research — Oakland Park, Florida, United States
• AeskuLab k.s — Teplice, Czechia

Full record on ClinicalTrials.gov

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