A Study of Olezarsen (ISIS 678354) in Participants With Hypertriglyceridemia and Atherosclerotic Cardiovascular Disease, or With Severe Hypertriglyceridemia

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Ionis Pharmaceuticals, Inc.
Study ID
NCT05610280
Phase
PHASE3
Status
Completed

Conditions

  • Atherosclerosis
  • Cardiovascular Diseases
  • 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 effect of olezarsen on percent change in fasting triglyceride (TG) levels compared to placebo in participants with hypertriglyceridemia and atherosclerotic cardiovascular disease, or with severe hypertriglyceridemia.

Key Dates

Start date
Nov 21, 2022
Status verified
Feb 2026
Primary completion
Aug 8, 2024
Completion
Jun 9, 2025

Study Design

Enrollment
1,478 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Olezarsen
    Participants will be randomized to receive multiple doses of olezarsen, once every 4 weeks by subcutaneous (SC) injection up to Week 49.
  • Placebo Comparator: Placebo
    Participants will be randomized to receive olezarsen-matching placebo, once every 4 weeks by SC injection up to Week 49.

Primary Outcome Measure

Percent Change From Baseline to Week 25 in Fasting Triglycerides (TG) Compared to Placebo [ Time Frame: Baseline to Week 25 ]

Locations (68)

FacilityCityStateZIPSite coordinators
Alabama Clinical Therapeutics, LLC AlabasterBirminghamAlabama35235-
Heart Center Research PCHuntsvilleAlabama35801-
Cardiovascular Research Foundation of Southern CaliforniaBeverly HillsCalifornia90210-
Westside Medical Associates of Los AngelesBeverly HillsCalifornia90211-
Diabetes/Lipid Management & Research CenterHuntington BeachCalifornia92648-
University of California, San Diego (UCSD)La JollaCalifornia92037-
Clinical Trials ResearchLincolnCalifornia95648-
Amicis ResearchNorthridgeCalifornia91324-
Valley Clinical Trials, Inc.NorthridgeCalifornia91325-
Northern California ResearchSacramentoCalifornia95821-
Amicis Research CenterSanta ClaritaCalifornia91344-
Metabolic Institute of AmericaTarzanaCalifornia91356-
Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical CenterTorranceCalifornia90502-
Amicis Research CenterValenciaCalifornia91355-
Excel Clinical Medical TrialsBoca RatonFlorida33434-
Finlay Medical Research - West PalmGreenacres CityFlorida33467-
Global Research AssociatesHomesteadFlorida33030-
3Sync ResearchLake WorthFlorida33460-
Advanced Medical Research Institute (AMRI)MiamiFlorida33174-
De La Cruz Research Center, LLMiamiFlorida33184-
Finlay Medical ResearchMiamiFlorida33126-
Suncoast Clinical Research, Inc. - New Port RicheyNew Port RicheyFlorida34652-
Suncoast Clinical Research, Inc. - Palm HarborNew Port RicheyFlorida34652-
Proactive Clinical ResearchOakland ParkFlorida33309-
Ocala Cardiovascular ResearchOcalaFlorida34471-
Comprehensive Medical & Research CenterPlantationFlorida33317-
Progressive Medical ResearchPort OrangeFlorida32127-
St. Johns Center for Clinical ResearchSaint AugustineFlorida32086-
JSV Clinical Research Study, IncTampaFlorida33634-
Centricity ResearchColumbusGeorgia31904-
Atlanta Heart SpecialistsTuckerGeorgia30084-
Evanston Premier Healthcare Research LLCEvanstonIllinois60201-
Clinical Investigation Specialists, IncGurneeIllinois60031-
Affinity HealthPark RidgeIllinois60068-
Cardiovascular Research of Northwest Indiana, LLCMunsterIndiana46321-
Reid Hospital and Health Care ServicesRichmondIndiana47374-
West Broadway ClinicCouncil BluffsIowa51501-
Mercy One Iowa Heart CenterWest Des MoinesIowa50266-
University of Kansas Medical Center (KUMC)Kansas CityKansas66160-
Louisville Metabolic and Atherosclerosis Research CenterLouisvilleKentucky40213-
Norton Cardiovascular AssociatesLouisvilleKentucky40205-
Maryland Cardiovascular SpecialistsBaltimoreMaryland21229-
Aa Mrc, LlcFlintMichigan48504-
Clinical Research of South NevadaLas VegasNevada89104-
Palm Research Center, Inc.Las VegasNevada49148-
Palm Research Center, Inc.Las VegasNevada89148-
Medical University of South Carolina (MUSC)CharlestonNorth Carolina29425-
Moses H. Cone Memorial HospitalGreensboroNorth Carolina27401-
Aultman Hospital Cardiology Clinical TrialsCantonOhio44710-
McConnell Heart Health CenterColumbusOhio43214-
Summit Research Group, LLCStowOhio44224-
Central Oklahoma Early Detection CenterEdmondOklahoma73034-
Green and Seidner Family Practice AssociatesLansdalePennsylvania19446-
Main Street Physicians Care WaterwayLittle RiverSouth Carolina29566-
OnSite Clinical Solutions, LLCRock HillSouth Carolina29732-
Health ConceptsRapid CitySouth Dakota57702-
Monument Health Clinical ResearchRapid CitySouth Dakota57701-
The Jackson ClinicJacksonTennessee38301-
Affinity Health Corp.NashvilleTennessee37203-
Tennessee Center for Clinical TrialsTullahomaTennessee37388-
Baylor College of MedicineHoustonTexas77030-
Juno Research, LLCHoustonTexas77040-
Texas Institute of CardiologyMcKinneyTexas75071-
Southern Endocrinology AssociatesMesquiteTexas75149-
FMC ScienceRound RockTexas78681-
Carient Heart & VascularManassasVirginia20109-
Manassas Clinical Research CenterManassasVirginia20110-
Charleston Area Medical Center (CAMC) Clinical Trials CenterCharlestonWest Virginia25304-

Find similar trials in Birmingham, AL

By research site
Alabama Clinical Therapeutics, LLC Alabaster· Birmingham, ALHeart Center Research PC· Huntsville, ALCardiovascular Research Foundation of Southern California· Beverly Hills, CAWestside Medical Associates of Los Angeles· Beverly Hills, CADiabetes/Lipid Management & Research Center· Huntington Beach, CAUniversity of California, San Diego (UCSD)· La Jolla, CA

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