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Completed Phase 3 Interventional

A Study of Olezarsen Administered Subcutaneously to Participants With Severe Hypertriglyceridemia

ClinicalTrials.gov ID: NCT05552326

Public ClinicalTrials.gov record NCT05552326. 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, 11:15 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 Olezarsen (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 this 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
NCT05552326
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Ionis Pharmaceuticals, Inc.
Industry
Enrollment
446 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
Aug 31, 2022 (Actual)
Primary completion
Dec 17, 2024 (Actual)
Completion
Sep 12, 2025 (Actual)
Last update posted
Oct 22, 2025

2022 – 2025

United States locations

U.S. sites
63
U.S. states
24
U.S. cities
54
Facility City State ZIP Site status
Central Research Associates, Inc. Birmingham Alabama 35205 —
Alabama Clinical Therapeutics, LLC Alabaster Birmingham Alabama 35235 —
Onyx Clinical Research Peoria Arizona 85381 —
NRC Research Institute Los Angeles California 90015 —
Accel Research Sites DeLand Florida 32720 —
Finlay Medical Research Greenacres City Florida 33467 —
University of Florida Jacksonville Jacksonville Florida 32209 —
Meridien Research Maitland Florida 32751 —
Columbus Clinical Services Miami Florida 33125 —
Harmony Clinical Research, Inc North Miami Beach Florida 33162 —
Combined Research Orlando Phase I-IV Orlando Florida 32807 —
3Sync Research Sunrise Florida 33325 —
R & B Medical Center LLC Tampa Florida 33614 —
JSV Clinical Research Study, Inc. Tampa Florida 33634 —
Metabolic Research Institute West Palm Beach Florida 33401 —
Emory University Atlanta Georgia 30322 —
Accel Clinical Research Eatonton Georgia 31024 —
Northeast Georgia Medical Center Gainesville Georgia 30501 —
Randomize Now Newnan Georgia 30265 —
St. Vincent Medical Group Carmel Indiana 46290 —
University of Kansas Medical Center (KUMC) Kansas City Kansas 66160 —
The Research Group of Lexington, LLC Lexington Kentucky 40503 —
University of Louisville Louisville Kentucky 40202 —
Louisville Metabolic and Atherosclerosis Research Center (L-MARC) Louisville Kentucky 40213 —
Grace Research, LLC Bossier City Louisiana 71111 —
Clinical Trials of America LA, LLC Monroe Louisiana 71201 —
University of Maryland School of Medicine Baltimore Maryland 21201 —
Maryland Cardiovascular Specialists Baltimore Maryland 21229 —
Massachusetts General Hospital Boston Massachusetts 02114 —
Onyx Clinical Research Flint Michigan 48532 —
Onyx Clinical Research Rochester Hills Michigan 48307 —
Stern Cardiovascular Southaven Mississippi 38671 —
NYU Langone Hospital - Long Island Mineola New York 11501 —
Orchard Park Family Practice Orchard Park New York 14127 —
Clinical Trials of America, LLC Lenoir North Carolina 28645 —
Diabetes and Endocrinology Consultants, P.C. Morehead City North Carolina 28557 —
OnSite Clinical Solutions, LLC Salisbury North Carolina 28144 —
The Ohio State University (OSU) Columbus Ohio 43203 —
SV Research LLC Marion Ohio 43302 —
Oklahoma Heart Institute Tulsa Oklahoma 74133 —
University of Pennsylvania Philadelphia Pennsylvania 19104 —
Medical University of South Carolina (MUSC) Charleston South Carolina 29425 —
Main Street Physicians Care Waterway Little River South Carolina 29566 —
Monument Health Clinical Research Rapid City South Dakota 57701 —
The Jackson Clinic Jackson Tennessee 38305 —
Texas Health Family Care Fort Worth Texas 76107 —
Vilo Research Group Houston Texas 77017 —
Juno Research Houston Texas 77040 —
Juno Research Houston Texas 77054 —
Clinical Trial Network Houston Texas 77074 —
Pioneer Research Solutions, Inc Houston Texas 77099 —
Sante Clinical Research, LLC Kerrville Texas 78028 —
FMC Science Lampasas Texas 76550 —
DCT - McAllen Primary Care, LLC McAllen Texas 78503 —
Texas Institute of Cardiology McKinney Texas 75071 —
SMS Clinical Research, LLC Mesquite Texas 75149 —
Southern Endocrinology Associates Mesquite Texas 75149 —
Permian Research Foundation Odessa Texas 79761 —
Diabetes & Glandular Disease Clinic, P.A. San Antonio Texas 78229 —
Tranquil Research Webster Texas 77598 —
Aspen Clinical Research Orem Utah 84058 —
Ogden Clinic Grandview Roy Utah 84401 —
Clinical Investigation Specialists Inc. Kenosha Wisconsin 53144 —

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 142 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05552326, 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 Oct 22, 2025 · Synced Oct 19, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT05552326 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →