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Study identifier: NCT05610280 Synced from ClinicalTrials.gov · August 08, 2026
● Study status: Completed

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

Condition: Hypertriglyceridemia · Cardiovascular Diseases · Atherosclerosis  ·  Sponsor: Ionis Pharmaceuticals, Inc.

PhasePhase 3
Planned participants1478
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNoCheck eligibility criteria ↓
Where168 locations · 14 countries

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.

About this study

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.

Talk to the study team

No contact information is available for this study as per the public registry record.

Always discuss trial participation with your own doctor first.

Full eligibility criteria (exactly as the study team wrote them)

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.

Locations (168)

Alabama Clinical Therapeutics, LLC AlabasterBirmingham, Alabama, United States
Heart Center Research PCHuntsville, Alabama, United States
Cardiovascular Research Foundation of Southern CaliforniaBeverly Hills, California, United States
Westside Medical Associates of Los AngelesBeverly Hills, California, United States
Diabetes/Lipid Management & Research CenterHuntington Beach, California, United States
University of California, San Diego (UCSD)La Jolla, California, United States
Clinical Trials ResearchLincoln, California, United States
Amicis ResearchNorthridge, California, United States
Valley Clinical Trials, Inc.Northridge, California, United States
Northern California ResearchSacramento, California, United States
Amicis Research CenterSanta Clarita, California, United States
Metabolic Institute of AmericaTarzana, California, United States

+ 156 more locations — full list on the registry record.

More studies in these areas

This study lists sites in the areas below. Each link shows other recruiting studies near that city, from the public registry record.

BirminghamHuntsvilleBeverly HillsHuntington Beach

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