ClinicalTrials.gov record
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 May 20, 2026, 1:30 AM 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)
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
Conditions
Interventions
- Olezarsen Drug
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 12, 2022
- Primary completion
- Feb 28, 2027
- Completion
- Feb 28, 2027
- Last update posted
- Nov 30, 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 Nov 30, 2025 · Synced May 20, 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 protocol, eligibility criteria, and contact information for NCT05681351 live on ClinicalTrials.gov.