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

Description

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

Conditions

Severe Hypertriglyceridemia

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Study Overview

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Study Details

Study overview

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

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

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

Condition
Severe Hypertriglyceridemia
Intervention / Treatment

-

Contacts and Locations

San Diego

University of California, San Diego (UCSD), San Diego, California, United States, 92161

Tarzana

Metabolic Institute of America, Tarzana, California, United States, 91356

Boca Raton

Excel Medical Clinical Trials, Boca Raton, Florida, United States, 33434

Greenacres City

Finlay Medical Research, Greenacres City, Florida, United States, 33467

Miami

Columbus Clinical Services, LLC, Miami, Florida, United States, 33125

Miami

Finlay Medical Research, Miami, Florida, United States, 33126

Miramar

Innovia Research Center, Inc., Miramar, Florida, United States, 33027

North Miami Beach

Harmony Clinical Research, Inc., North Miami Beach, Florida, United States, 33162

Tampa

R & B Medical Center LLC, Tampa, Florida, United States, 33614

Tampa

VICIS Clinical Research, Tampa, Florida, United States, 33615

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Satisfactory completion of either ISIS 678354-CS5 or ISIS 678354-CS6 (last dose as scheduled at Week 49) 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Ionis Pharmaceuticals, Inc.,

Study Record Dates

2026-09