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Active, not recruiting Phase 3 Interventional

CORE-OLE: A Study of Olezarsen (ISIS 678354) Administered Subcutaneously to Participants With Severe Hypertriglyceridemia (SHTG)

ClinicalTrials.gov ID: NCT05681351

Public ClinicalTrials.gov record NCT05681351. 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 30, 2026, 9:26 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

An Open-Label Extension Study of Olezarsen (ISIS 678354) Administered Subcutaneously to Patients With Severe Hypertriglyceridemia (SHTG)

Brief summary

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

The purpose of this study is to evaluate the safety and tolerability of olezarsen in participants with SHTG.

Study identification

NCT ID
NCT05681351
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Ionis Pharmaceuticals, Inc.
Industry
Enrollment
885 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
Dec 13, 2022 (Actual)
Primary completion
Mar 2027 (Estimated)
Completion
Mar 2027 (Estimated)
Last update posted
Dec 1, 2025

2022 – 2027

United States locations

U.S. sites
65
U.S. states
26
U.S. cities
56
Facility City State ZIP Site status
LA Universal Research Center, Inc. Los Angeles California 90057 —
University of California, San Diego (UCSD) San Diego California 92161 —
Metabolic Institute of America Tarzana California 91356 —
Excel Medical Clinical Trials Boca Raton Florida 33434 —
Finlay Medical Research Greenacres City Florida 33467 —
Columbus Clinical Services, LLC Miami Florida 33125 —
Finlay Medical Research Miami Florida 33126 —
Innovia Research Center, Inc. Miramar Florida 33027 —
Harmony Clinical Research, Inc. North Miami Beach Florida 33162 —
R & B Medical Center LLC Tampa Florida 33614 —
VICIS Clinical Research Tampa Florida 33615 —
JSV Clinical Research Study, Inc. Tampa Florida 33634 —
Bayside Clinical Research Trinity Florida 34655 —
Centricity Research Columbus Georgia 31904 —
IACT Health Columbus Georgia 31904 —
Affinity Health Oak Brook Illinois 60523 —
St. Vincent Medical Group, Inc. Carmel Indiana 46290 —
University of Kansas Medical Center (KUMC) Kansas City Kansas 66160 —
The Research Group of Lexington, LLC Lexington Kentucky 40503 —
Louisville Metabolic and Atherosclerosis Research Center (L-MARC) Louisville Kentucky 40213 —
Grace Research, LLC Bossier City Louisiana 71111 —
University of Maryland School of Medicine Baltimore Maryland 21201 —
IRC Clinics Towson Maryland 21204 —
Massachusetts General Hospital Heart Center Boston Massachusetts 02114 —
University of Michigan- Endocrinology & Metabolism Ann Arbor Michigan 48109 —
Aa Mrc, Llc Flint Michigan 48504 —
Washington School of Medicine St Louis Missouri 63110 —
Bryan Medical Center Lincoln Nebraska 68506 —
Palm Research Center, Inc. Las Vegas Nevada 89128 —
Hudson County Clinical Trials Research Center Union City New Jersey 07087 —
Modern Medical Brooklyn New York 33709 —
NYU Langone Health Mineola New York 11501 —
Langone Medical Center New York New York 10016 —
Vagelos College of Physicians and Surgeons of Columbia University New York New York 10032 —
Orchard Park Family Practice Orchard Park New York 14127 —
The Presbyterian Hospital DBA Novant Health Heart and Vascular Institute Charlotte North Carolina 28204 —
Kenneth Hilty Greensboro North Carolina 27401 —
Clinical Trials of America, LLC Lenoir North Carolina 28645 —
Lexington Winston-Salem North Carolina 27103 —
The Ohio State University Columbus Ohio 43203 —
Central Oklahoma Early Detection Center Edmond Oklahoma 73034 —
Oklahoma Heart Institute Tulsa Oklahoma 74104 —
University of Pennsylvania Philadelphia Pennsylvania 19014 —
Medical University of South Carolina Charleston South Carolina 29425 —
Walker Family Care Little River South Carolina 29566 —
Monument Health Clinical Research Rapid City South Dakota 57701 —
Health Concepts Rapid City South Dakota 57702 —
Chattanooga Research & Medicine, PLLC Chattanooga Tennessee 37404 —
The Jackson Clinic Jackson Tennessee 38301 —
University of Texas Southwestern Dallas Texas 75390 —
Baylor College of Medicine Houston Texas 77030 —
Juno Research Houston Texas 77040 —
Pioneer Research Solutions 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 Clinical and Research Consulting Services Webster Texas 77598 —
Manassas Clinical Research Manassas Virginia 20110 —
York Clinical Research Norfolk Virginia 23510 —
WVU 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 197 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05681351, 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 Dec 1, 2025 · Synced Oct 30, 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 NCT05681351 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →