A Study of Olezarsen (ISIS 678354) Administered to Participants With Severe Hypertriglyceridemia

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Ionis Pharmaceuticals, Inc.
Study ID
NCT05079919
Phase
PHASE3
Status
Completed

Conditions

  • Severe Hypertriglyceridemia

Eligibility Criteria

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

Interventions

  • Olezarsen — DRUG
    Olezarsen will be administered by SC injection.
  • Placebo — DRUG
    Olezarsen-matching placebo will be administered by SC injection.

Study Details

The purpose of the study is to evaluate the efficacy of olezarsen as compared to placebo on the percent change in fasting triglycerides (TG) from baseline.

Key Dates

Start date
Oct 25, 2021
Status verified
Feb 2026
Primary completion
Oct 22, 2024
Completion
Jul 8, 2025

Study Design

Enrollment
617 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Olezarsen
    Olezarsen will be administered once every 4 weeks by subcutaneous (SC) injection from Week 1 through Week 49.
  • Placebo Comparator: Placebo
    Olezarsen-matching placebo will be administered once every 4 weeks by SC injection from Week 1 through Week 49.

Primary Outcome Measure

Percent Change from Baseline in Fasting TG Compared to Placebo [ Time Frame: Baseline and Month 6 ]

Locations (56)

FacilityCityStateZIPSite coordinators
Accel Research Sites NetworkBirminghamAlabama35216-
Mayo ClinicScottsdaleArizona85259-
Velocity Clinical ResearchChula VistaCalifornia91911-
Diabetes/Lipid Management & Research CenterHuntington BeachCalifornia92648-
University of California, San Diego (UCSD)La JollaCalifornia92037-
LA Universal Research Center, Inc.Los AngelesCalifornia90057-
America Clinical TrialsTarzanaCalifornia91356-
Excel Medical Clinical Trials, LLCBoca RatonFlorida33434-
Southeast Clinical Research LLCChieflandFlorida32626-
Westside Center for Clinical ResearchJacksonvilleFlorida32205-
Finlay Medical ResearchMiamiFlorida33126-
Innovia Research Center, INCMiramarFlorida33027-
Ocala Cardiovascular ResearchOcalaFlorida34471-
IMA Clinical ResearchSt. PetersburgFlorida33709-
VICIS Clinical ResearchTampaFlorida33614-
Bayside Clinical ResearchTrinityFlorida34655-
IACT HealthColumbusGeorgia31904-
IMA Clinical Research ChicagoChicagoIllinois60602-
Affinity HealthOak BrookIllinois60523-
West Broadway ClinicCouncil BluffsIowa51501-
Kansas University Medical CenterKansas CityKansas66160-
Clinical Trials of America, LLCMonroeLouisiana71201-
Continental Clinical SolutionsTowsonMaryland21204-
University of Michigan Hospital and Health Systems/ Dept. of Pharmacy-Research PharmacyAnn ArborMichigan48109-
Aa Mrc, LlcFlintMichigan48504-
IMA Clinical ResearchSt LouisMissouri63117-
Washington University School of MedicineSt LouisMissouri63110-
Bryan Medical Center Clinical ResearchLincolnNebraska68506-
Palm Research Center, INC.Las VegasNevada89148-
Hudson County Clinical Trials Research CenterUnion CityNew Jersey07087-
Modern MedicineBrooklynNew York11235-
Northwell HealthGreat NeckNew York11021-
Circuit Clinical (Crystal Run Healthcare)MiddletownNew York10941-
Columbia UniversityNew YorkNew York10032-
NYU LangoneNew YorkNew York10016-
Circuit ClinicalNiagara FallsNew York14304-
Modern MedicalSyossetNew York11791-
Novant Health Cancer Institute Elizabeth Investigational Drug ServicesCharlotteNorth Carolina28204-
Cone Medical CenterGreensboroNorth Carolina27401-
Clinical Trials of America, LLCMount AiryNorth Carolina27030-
Wake Forest University Health SciencesSalemNorth Carolina27157-
Aventiv ResearchColumbusOhio43213-
Summit Research Group, LLCMunroe FallsOhio44262-
Hightower Clinical Trial ServicesOklahoma CityOklahoma73102-
Velocity Clinical ResearchMedfordOregon97504-
The Miriam HospitalProvidenceRhode Island02906-
Health ConceptsRapid CitySouth Dakota57702-
Chattanooga Research & Medicine, PLLCChattanoogaTennessee37404-
Velocity Clinical ResearchCedar ParkTexas78613-
University of Texas SouthwesternDallasTexas75390-
Baylor College of MedicineHoustonTexas77030-
Medicus Alliance Clinical ResearchSugar LandTexas77478-
Velocity ClinicalWest JordanUtah84088-
Manassas Clinical Research CenterManassasVirginia20110-
York Clinical Research LLCNorfolkVirginia23510-
West Virginia University Heart and Vascular InstituteMorgantownWest Virginia26506-

Find similar trials in Birmingham, AL

By research site
Accel Research Sites Network· Birmingham, ALMayo Clinic· Scottsdale, AZVelocity Clinical Research· Chula Vista, CADiabetes/Lipid Management & Research Center· Huntington Beach, CAUniversity of California, San Diego (UCSD)· La Jolla, CALA Universal Research Center, Inc.· Los Angeles, CA

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