Phase 3 Study of Plozasiran in Adults With Hypertriglyceridemia

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Arrowhead Pharmaceuticals
Study ID
NCT06347133
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Hypertriglyceridemia

Eligibility Criteria

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

Interventions

Study Details

This Phase 3 study will evaluate the safety and efficacy of plozasiran injection (ARO-APOC3) in adult participants with hypertriglyceridemia (HTG). After providing informed consent eligible participants will be randomized to receive 4 doses (once every 3 months) of plozasiran or placebo and be evaluated for efficacy and safety.

Key Dates

Start date
May 21, 2024
Status verified
Oct 2025
Primary completion
May 31, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
1,456 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Plozasiran Injection
    4 doses of plozasiran by subcutaneous (sc) injection
  • Placebo Comparator: Placebo
    calculated volume to match active treatment by sc injection

Primary Outcome Measure

Percent Change in Fasting Serum Triglyceride (TG) Levels from Baseline to Month 12 Compared to Placebo [ Time Frame: Baseline, Month 12 ]

Locations (97)

FacilityCityStateZIPSite coordinators
Research Site 1BirminghamAlabama35205-
Research Site 2MobileAlabama36604-
Research Site 3Beverly HillsCalifornia90211-
Research Site 4Canoga ParkCalifornia91303-
Research Site 5Garden GroveCalifornia92844-
Research Site 6Huntington BeachCalifornia92648-
Research Site 7Lake ForestCalifornia92630-
Research Site 8LincolnCalifornia95648-
Research Site 9Long BeachCalifornia90822-
Research Site 10MontclairCalifornia91763-
Research Site 11OxnardCalifornia93030-
Research Site 12ReddingCalifornia96001-
Research Site 13Van NuysCalifornia91402-
Research Site 14Colorado SpringsColorado80909-
Research Site 15ClearwaterFlorida33756-
Research Site 16HialeahFlorida33016-
Research Site 17Lake CityFlorida32055-
Research Site 18Miami LakesFlorida33014-
Research Site 19Mt. DoraFlorida32757-
Research Site 20North Miami BeachFlorida33162-
Research Site 21OrlandoFlorida32825-
Research Site 22PensacolaFlorida32503-
Research Site 23SarasotaFlorida34239-
Research Site 24TamaracFlorida33321-
Research Site 25LawrencevilleGeorgia30044-
Research Site 26MaconGeorgia31210-
Research Site 27SavannahGeorgia31406-
Research Site 28Sugar HillGeorgia30518-
Research Site 29Park RidgeIllinois60068-
Research Site 30ElkhartIndiana46514-
Research Site 31IndianapolisIndiana46290-
Research Site 32South BendIndiana46617-
Research Site 33Overland ParkKansas66211-
Research Site 34TopekaKansas66606-
Research Site 35LouisvilleKentucky40202-
Research Site 36ZacharyLouisiana70791-
Research Site 37AnnapolisMaryland21401-
Research Site 38BaltimoreMaryland21229-
Research Site 39FlintMichigan48532-
Research Site 40MinneapolisMinnesota55455-
Research Site 41Olive BranchMississippi38654-
Research Site 42Jefferson CityMissouri65109-
Research Site 43St LouisMissouri63136-
Research Site 44NorfolkNebraska68701-
Research Site 45OmahaNebraska68144-
Research Site 46OmahaNebraska68114-
Research Site 47Las VegasNevada89119-
Research Site 48SummitNew Jersey07901-
Research Site 51New YorkNew York10029-
Research Site 52New YorkNew York10016-
Research Site 53RiverheadNew York11901-
Research Site 54RochesterNew York14642-
Research Site 49The BronxNew York10455-
Research Site 50The BronxNew York10461-
Research Site 55VestalNew York13850-
Research Site 56AsheboroNorth Carolina27203-
Research Site 57Morehead CityNorth Carolina28557-
Research Site 58WilmingtonNorth Carolina28412-
Research Site 59Winston-SalemNorth Carolina27157-
Research Site 60BeavercreekOhio45431-
Research Site 61CincinnatiOhio45267-
Research Site 62ColumbusOhio43214-
Research Site 63ColumbusOhio43210-
Research Site 64NormanOklahoma73072-
Research Site 65Oklahoma CityOklahoma73112-
Research Site 66Oklahoma CityOklahoma73111-
Research Site 67HorshamPennsylvania19044-
Research Site 68NewportPennsylvania17074-
Research Site 69NewportPennsylvania17074-
Research Site 70PhiladelphiaPennsylvania19104-
Research Site 71Wilkes-BarrePennsylvania18711-
Research Site 72Fort MillSouth Carolina29707-
Research Site 73GreenvilleSouth Carolina29607-
Research Site 74ChattanoogaTennessee37411-
Research Site 75PowellTennessee37849-
Research Site 76El PasoTexas79905-
Research Site 77Fort WorthTexas76132-
Research Site 78HoustonTexas77040-
Research Site 79HoustonTexas77090-
Research Site 80HoustonTexas77061-
Research Site 81HoustonTexas77095-
Research Site 82HoustonTexas77079-
Research Site 83HoustonTexas77074-
Research Site 84HoustonTexas77030-
Research Site 85HoustonTexas77030-
Research Site 86HoustonTexas77029-
Research Site 87LaredoTexas78041-
Research Site 88Missouri CityTexas77459-
Research Site 89PlanoTexas75093-
Research Site 90San AntonioTexas78230-
Research Site 91Sugar LandTexas77479-
Research Site 92TomballTexas77375-
Research Site 93VictoriaTexas77901-
Research Site 94BountifulUtah84010-
Research Site 95St. GeorgeUtah84790-
Research Site 96ManassasVirginia20110-
Research Site 97SeattleWashington98109-

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