A Study of Olezarsen Administered Subcutaneously to Participants With Severe Hypertriglyceridemia

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Ionis Pharmaceuticals, Inc.
Study ID
NCT05552326
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 this 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
Aug 31, 2022
Status verified
Oct 2025
Primary completion
Dec 17, 2024
Completion
Sep 12, 2025

Study Design

Enrollment
446 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 subcutaneous (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 (63)

FacilityCityStateZIPSite coordinators
Alabama Clinical Therapeutics, LLC AlabasterBirminghamAlabama35235-
Central Research Associates, Inc.BirminghamAlabama35205-
Onyx Clinical ResearchPeoriaArizona85381-
NRC Research InstituteLos AngelesCalifornia90015-
Accel Research SitesDeLandFlorida32720-
Finlay Medical ResearchGreenacres CityFlorida33467-
University of Florida JacksonvilleJacksonvilleFlorida32209-
Meridien ResearchMaitlandFlorida32751-
Columbus Clinical ServicesMiamiFlorida33125-
Harmony Clinical Research, IncNorth Miami BeachFlorida33162-
Combined Research Orlando Phase I-IVOrlandoFlorida32807-
3Sync ResearchSunriseFlorida33325-
JSV Clinical Research Study, Inc.TampaFlorida33634-
R & B Medical Center LLCTampaFlorida33614-
Metabolic Research InstituteWest Palm BeachFlorida33401-
Emory UniversityAtlantaGeorgia30322-
Accel Clinical ResearchEatontonGeorgia31024-
Northeast Georgia Medical CenterGainesvilleGeorgia30501-
Randomize NowNewnanGeorgia30265-
St. Vincent Medical GroupCarmelIndiana46290-
University of Kansas Medical Center (KUMC)Kansas CityKansas66160-
The Research Group of Lexington, LLCLexingtonKentucky40503-
Louisville Metabolic and Atherosclerosis Research Center (L-MARC)LouisvilleKentucky40213-
University of LouisvilleLouisvilleKentucky40202-
Grace Research, LLCBossier CityLouisiana71111-
Clinical Trials of America LA, LLCMonroeLouisiana71201-
Maryland Cardiovascular SpecialistsBaltimoreMaryland21229-
University of Maryland School of MedicineBaltimoreMaryland21201-
Massachusetts General HospitalBostonMassachusetts02114-
Onyx Clinical ResearchFlintMichigan48532-
Onyx Clinical ResearchRochester HillsMichigan48307-
Stern CardiovascularSouthavenMississippi38671-
NYU Langone Hospital - Long IslandMineolaNew York11501-
Orchard Park Family PracticeOrchard ParkNew York14127-
Clinical Trials of America, LLCLenoirNorth Carolina28645-
Diabetes and Endocrinology Consultants, P.C.Morehead CityNorth Carolina28557-
OnSite Clinical Solutions, LLCSalisburyNorth Carolina28144-
The Ohio State University (OSU)ColumbusOhio43203-
SV Research LLCMarionOhio43302-
Oklahoma Heart InstituteTulsaOklahoma74133-
University of PennsylvaniaPhiladelphiaPennsylvania19104-
Medical University of South Carolina (MUSC)CharlestonSouth Carolina29425-
Main Street Physicians Care WaterwayLittle RiverSouth Carolina29566-
Monument Health Clinical ResearchRapid CitySouth Dakota57701-
The Jackson ClinicJacksonTennessee38305-
Texas Health Family CareFort WorthTexas76107-
Clinical Trial NetworkHoustonTexas77074-
Juno ResearchHoustonTexas77040-
Juno ResearchHoustonTexas77054-
Pioneer Research Solutions, IncHoustonTexas77099-
Vilo Research GroupHoustonTexas77017-
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 ResearchWebsterTexas77598-
Aspen Clinical ResearchOremUtah84058-
Ogden Clinic GrandviewRoyUtah84401-
Clinical Investigation Specialists Inc.KenoshaWisconsin53144-

Find similar trials in Birmingham, AL

By research site
Alabama Clinical Therapeutics, LLC Alabaster· Birmingham, ALCentral Research Associates, Inc.· Birmingham, ALOnyx Clinical Research· Peoria, AZNRC Research Institute· Los Angeles, CAAccel Research Sites· DeLand, FLFinlay Medical Research· Greenacres City, FL

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