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Completed Phase 3 Interventional

A Study of Olezarsen (ISIS 678354) Administered to Participants With Severe Hypertriglyceridemia

ClinicalTrials.gov ID: NCT05079919

Public ClinicalTrials.gov record NCT05079919. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 19, 2026, 11:29 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of ISIS 678354 Administered Subcutaneously to Patients With Severe Hypertriglyceridemia

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The purpose of the study is to evaluate the efficacy of olezarsen as compared to placebo on the percent change in fasting triglycerides (TG) from baseline.

Study identification

NCT ID
NCT05079919
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Ionis Pharmaceuticals, Inc.
Industry
Enrollment
617 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 25, 2021 (Actual)
Primary completion
Oct 22, 2024 (Actual)
Completion
Jul 8, 2025 (Actual)
Last update posted
Feb 10, 2026

2021 – 2025

United States locations

U.S. sites
56
U.S. states
27
U.S. cities
54
Facility City State ZIP Site status
Accel Research Sites Network Birmingham Alabama 35216 —
Mayo Clinic Scottsdale Arizona 85259 —
Velocity Clinical Research Chula Vista California 91911 —
Diabetes/Lipid Management & Research Center Huntington Beach California 92648 —
University of California, San Diego (UCSD) La Jolla California 92037 —
LA Universal Research Center, Inc. Los Angeles California 90057 —
America Clinical Trials Tarzana California 91356 —
Excel Medical Clinical Trials, LLC Boca Raton Florida 33434 —
Southeast Clinical Research LLC Chiefland Florida 32626 —
Westside Center for Clinical Research Jacksonville Florida 32205 —
Finlay Medical Research Miami Florida 33126 —
Innovia Research Center, INC Miramar Florida 33027 —
Ocala Cardiovascular Research Ocala Florida 34471 —
IMA Clinical Research St. Petersburg Florida 33709 —
VICIS Clinical Research Tampa Florida 33614 —
Bayside Clinical Research Trinity Florida 34655 —
IACT Health Columbus Georgia 31904 —
IMA Clinical Research Chicago Chicago Illinois 60602 —
Affinity Health Oak Brook Illinois 60523 —
West Broadway Clinic Council Bluffs Iowa 51501 —
Kansas University Medical Center Kansas City Kansas 66160 —
Clinical Trials of America, LLC Monroe Louisiana 71201 —
Continental Clinical Solutions Towson Maryland 21204 —
University of Michigan Hospital and Health Systems/ Dept. of Pharmacy-Research Pharmacy Ann Arbor Michigan 48109 —
Aa Mrc, Llc Flint Michigan 48504 —
Washington University School of Medicine St Louis Missouri 63110 —
IMA Clinical Research St Louis Missouri 63117 —
Bryan Medical Center Clinical Research Lincoln Nebraska 68506 —
Palm Research Center, INC. Las Vegas Nevada 89148 —
Hudson County Clinical Trials Research Center Union City New Jersey 07087 —
Modern Medicine Brooklyn New York 11235 —
Northwell Health Great Neck New York 11021 —
Circuit Clinical (Crystal Run Healthcare) Middletown New York 10941 —
NYU Langone New York New York 10016 —
Columbia University New York New York 10032 —
Circuit Clinical Niagara Falls New York 14304 —
Modern Medical Syosset New York 11791 —
Novant Health Cancer Institute Elizabeth Investigational Drug Services Charlotte North Carolina 28204 —
Cone Medical Center Greensboro North Carolina 27401 —
Clinical Trials of America, LLC Mount Airy North Carolina 27030 —
Wake Forest University Health Sciences Salem North Carolina 27157 —
Aventiv Research Columbus Ohio 43213 —
Summit Research Group, LLC Munroe Falls Ohio 44262 —
Hightower Clinical Trial Services Oklahoma City Oklahoma 73102 —
Velocity Clinical Research Medford Oregon 97504 —
The Miriam Hospital Providence Rhode Island 02906 —
Health Concepts Rapid City South Dakota 57702 —
Chattanooga Research & Medicine, PLLC Chattanooga Tennessee 37404 —
Velocity Clinical Research Cedar Park Texas 78613 —
University of Texas Southwestern Dallas Texas 75390 —
Baylor College of Medicine Houston Texas 77030 —
Medicus Alliance Clinical Research Sugar Land Texas 77478 —
Velocity Clinical West Jordan Utah 84088 —
Manassas Clinical Research Center Manassas Virginia 20110 —
York Clinical Research LLC Norfolk Virginia 23510 —
West Virginia University Heart and Vascular Institute Morgantown West Virginia 26506 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 153 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05079919, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Feb 10, 2026 · Synced Oct 19, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT05079919 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →