Condition: Hypertriglyceridemia · Cardiovascular Diseases · Atherosclerosis · Sponsor: Ionis Pharmaceuticals, Inc.
Sponsor, CRO or site team? See where this study is running → — listed sites, countries and recruiting context. Everything below is written for patients and caregivers.
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.
This description comes directly from the study's public registry record.
No contact information is available for this study as per the public registry record.
Always discuss trial participation with your own doctor first.
Inclusion Criteria: * 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. 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.
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| 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 | — |
+ 156 more locations — full list on the registry record.
This study lists sites in the areas below. Each link shows other recruiting studies near that city, from the public registry record.
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