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)
Proportion of Participants With Change in Clinical Laboratory Values From Baseline to Week 53, From Baseline to Week 105, and From Baseline to Week 157 — Baseline up to Week 157
Proportion of Participants Who Experience Adverse Events (AEs) — Baseline up to Week 157
Proportion of Participants Who Use Concomitant Medications — Baseline up to Week 157
Trial sites (262)
Facility
City
Region
Status
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.
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.
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