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Clinical Trials in the UK / NCT05681351
Active, not recruiting Phase 3

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

NCT05681351 · tracked via the Priya Life Science UK tracker
Sponsor
Ionis Pharmaceuticals, Inc.
Phase
Phase 3
Started
2022-12-13
Last updated
2025-12-01

Condition(s) studied

Severe Hypertriglyceridemia

Investigational drug(s) / intervention(s)

Olezarsen

Olezarsen: Administered as SC injection.

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Key Inclusion Criteria: * Satisfactory completion of either ISIS 678354-CS5 or ISIS 678354-CS6 with an acceptable safety profile, per Investigator judgment. Satisfactory completion requires that the patient did not terminate early from treatment. * Participants must be on a stable regimen of lipid-lowering therapy that should adhere to standard of care (SOC) per local guidelines. A patient may be eligible if their regimen of lipid-lowering therapy has been changed recently, provided that lipid lowering medications are optimized and stabilized for at least 4 weeks prior to the end of the Qualification Period of this OLE study; ideally, such changes are initiated after Week 53 of the index study (ISIS 678354-CS5 or CS6). * A patient may re-enroll in the study after having completed the study when the Treatment Period was 53 weeks, if the patient satisfactorily completed the study with an acceptable safety profile, per Investigator judgment. In the case of re-enrollment, there is no limit on the time gap between completion of treatment under the previous protocol and dosing upon re-enrollment (i.e., may exceed 17 weeks between doses). Key Exclusion Criteria: • Have any new condition or worsening of existing condition which in the opinion of the Investigator would make the participant unsuitable for enrollment, or could interfere with the participant participating in or completing the study, including need for treatment with disallowed medications, or need to change the required stable regimen as per either ISIS 678354-CS5 or ISIS 678354-CS6 study entry criteria. It is acceptable to adjust a regimen of lipid-lowering therapy as described in the second Key Inclusion Criterion above, and it is acceptable to adjust or stop lipid-lowering therapy at or after Week 13 per Investigator judgment. NOTE: Other Inclusion/Exclusion criteria may apply.

Primary outcome measure(s)

Trial sites (262)

FacilityCityRegionStatus
LA Universal Research Center, Inc. Los Angeles California
University of California, San Diego (UCSD) San Diego California
Metabolic Institute of America Tarzana California
Excel Medical Clinical Trials Boca Raton Florida
Finlay Medical Research Greenacres City Florida
Columbus Clinical Services, LLC Miami Florida
Finlay Medical Research Miami Florida
Innovia Research Center, Inc. Miramar Florida
Harmony Clinical Research, Inc. North Miami Beach Florida
R & B Medical Center LLC Tampa Florida
VICIS Clinical Research Tampa Florida
JSV Clinical Research Study, Inc. Tampa Florida
Bayside Clinical Research Trinity Florida
Centricity Research Columbus Georgia
IACT Health Columbus Georgia
Affinity Health Oak Brook Illinois
St. Vincent Medical Group, Inc. Carmel Indiana
University of Kansas Medical Center (KUMC) Kansas City Kansas
The Research Group of Lexington, LLC Lexington Kentucky
Louisville Metabolic and Atherosclerosis Research Center (L-MARC) Louisville Kentucky
Grace Research, LLC Bossier City Louisiana
University of Maryland School of Medicine Baltimore Maryland
IRC Clinics Towson Maryland
Massachusetts General Hospital Heart Center Boston Massachusetts
University of Michigan- Endocrinology & Metabolism Ann Arbor Michigan
Aa Mrc, Llc Flint Michigan
Washington School of Medicine St Louis Missouri
Bryan Medical Center Lincoln Nebraska
Palm Research Center, Inc. Las Vegas Nevada
Hudson County Clinical Trials Research Center Union City New Jersey
Modern Medical Brooklyn New York
NYU Langone Health Mineola New York
Langone Medical Center New York New York
Vagelos College of Physicians and Surgeons of Columbia University New York New York
Orchard Park Family Practice Orchard Park New York
The Presbyterian Hospital DBA Novant Health Heart and Vascular Institute Charlotte North Carolina
Kenneth Hilty Greensboro North Carolina
Clinical Trials of America, LLC Lenoir North Carolina
Lexington Winston-Salem North Carolina
The Ohio State University Columbus Ohio

+ 222 more sites — see the full list on the official registry below.

More Ionis Pharmaceuticals, Inc. trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05681351 on ClinicalTrials.gov ↗ ← All trials in the UK