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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Ionis Pharmaceuticals, Inc.
Study ID
NCT05681351
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Severe Hypertriglyceridemia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Olezarsen — DRUG
    Administered as SC injection.

Study Details

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

Key Dates

Start date
Dec 13, 2022
Status verified
Nov 2025
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
885 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Olezarsen
    Participants who completed either ISIS 678354-CS5 (NCT05079919) or ISIS 678354-CS6 (NCT05552326) study would be enrolled to receive olezarsen, subcutaneous (SC) injection, once every 4 weeks from Week 1 through Week 153.

Primary Outcome Measure

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 [ Time Frame: Baseline up to Week 157 ]

Locations (65)

FacilityCityStateZIPSite coordinators
LA Universal Research Center, Inc.Los AngelesCalifornia90057-
University of California, San Diego (UCSD)San DiegoCalifornia92161-
Metabolic Institute of AmericaTarzanaCalifornia91356-
Excel Medical Clinical TrialsBoca RatonFlorida33434-
Finlay Medical ResearchGreenacres CityFlorida33467-
Columbus Clinical Services, LLCMiamiFlorida33125-
Finlay Medical ResearchMiamiFlorida33126-
Innovia Research Center, Inc.MiramarFlorida33027-
Harmony Clinical Research, Inc.North Miami BeachFlorida33162-
JSV Clinical Research Study, Inc.TampaFlorida33634-
R & B Medical Center LLCTampaFlorida33614-
VICIS Clinical ResearchTampaFlorida33615-
Bayside Clinical ResearchTrinityFlorida34655-
Centricity ResearchColumbusGeorgia31904-
IACT HealthColumbusGeorgia31904-
Affinity HealthOak BrookIllinois60523-
St. Vincent Medical Group, Inc.CarmelIndiana46290-
University of Kansas Medical Center (KUMC)Kansas CityKansas66160-
The Research Group of Lexington, LLCLexingtonKentucky40503-
Louisville Metabolic and Atherosclerosis Research Center (L-MARC)LouisvilleKentucky40213-
Grace Research, LLCBossier CityLouisiana71111-
University of Maryland School of MedicineBaltimoreMaryland21201-
IRC ClinicsTowsonMaryland21204-
Massachusetts General Hospital Heart CenterBostonMassachusetts02114-
University of Michigan- Endocrinology & MetabolismAnn ArborMichigan48109-
Aa Mrc, LlcFlintMichigan48504-
Washington School of MedicineSt LouisMissouri63110-
Bryan Medical CenterLincolnNebraska68506-
Palm Research Center, Inc.Las VegasNevada89128-
Hudson County Clinical Trials Research CenterUnion CityNew Jersey07087-
Modern MedicalBrooklynNew York33709-
NYU Langone HealthMineolaNew York11501-
Langone Medical CenterNew YorkNew York10016-
Vagelos College of Physicians and Surgeons of Columbia UniversityNew YorkNew York10032-
Orchard Park Family PracticeOrchard ParkNew York14127-
The Presbyterian Hospital DBA Novant Health Heart and Vascular InstituteCharlotteNorth Carolina28204-
Kenneth HiltyGreensboroNorth Carolina27401-
Clinical Trials of America, LLCLenoirNorth Carolina28645-
LexingtonWinston-SalemNorth Carolina27103-
The Ohio State UniversityColumbusOhio43203-
Central Oklahoma Early Detection CenterEdmondOklahoma73034-
Oklahoma Heart InstituteTulsaOklahoma74104-
University of PennsylvaniaPhiladelphiaPennsylvania19014-
Medical University of South CarolinaCharlestonSouth Carolina29425-
Walker Family CareLittle RiverSouth Carolina29566-
Health ConceptsRapid CitySouth Dakota57702-
Monument Health Clinical ResearchRapid CitySouth Dakota57701-
Chattanooga Research & Medicine, PLLCChattanoogaTennessee37404-
The Jackson ClinicJacksonTennessee38301-
University of Texas SouthwesternDallasTexas75390-
Baylor College of MedicineHoustonTexas77030-
Juno ResearchHoustonTexas77040-
Pioneer Research SolutionsHoustonTexas77099-
Sante Clinical Research LLCKerrvilleTexas78028-
FMC ScienceLampasasTexas76550-
DCT- McAllen Primary Care, LLCMcAllenTexas78503-
Texas Institute of CardiologyMcKinneyTexas75071-
SMS Clinical Research, LLCMesquiteTexas75149-
Southern Endocrinology AssociatesMesquiteTexas75149-
Permian Research FoundationOdessaTexas79761-
Diabetes & Glandular Disease Clinic, P.A.San AntonioTexas78229-
Tranquil Clinical and Research Consulting ServicesWebsterTexas77598-
Manassas Clinical ResearchManassasVirginia20110-
York Clinical ResearchNorfolkVirginia23510-
WVU Heart and Vascular InstituteMorgantownWest Virginia26506-

Find similar trials in Los Angeles, CA

By research site
LA Universal Research Center, Inc.· Los Angeles, CAUniversity of California, San Diego (UCSD)· San Diego, CAMetabolic Institute of America· Tarzana, CAExcel Medical Clinical Trials· Boca Raton, FLFinlay Medical Research· Greenacres City, FLColumbus Clinical Services, LLC· Miami, FL

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