Study of Plozasiran in Adults With Severe Hypertriglyceridemia

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Arrowhead Pharmaceuticals
Study ID
NCT06347016
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Severe 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 severe hypertriglyceridemia (SHTG). 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. After Month 12, eligible participants will be offered an opportunity to continue in an optional open-label extension under a separate protocol.

Key Dates

Start date
Jul 23, 2024
Status verified
Oct 2025
Primary completion
Jun 30, 2026
Completion
Sep 30, 2026

Study Design

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

Arms

  • Experimental: Plozasiran Injection
    4 doses of plozasiran (ARO-APOC3) by subcutaneous (sc) injection
  • Placebo Comparator: Placebo
    calculated volume to match active treatment by sc injection

Primary Outcome Measure

Percent change in fasting serum TG levels from baseline to Month 12 compared to placebo [ Time Frame: Baseline, Month 12 ]

Locations (50)

FacilityCityStateZIPSite coordinators
Research Site 1BirminghamAlabama35205-
Research Site 2MobileAlabama36604-
Research Site 3Beverly HillsCalifornia90211-
Research Site 4Canoga ParkCalifornia91303-
Research Site 5Huntington BeachCalifornia92648-
Research Site 6LincolnCalifornia95648-
Research Site 7Long BeachCalifornia90822-
Research Site 8OxnardCalifornia93030-
Research Site 9ClearwaterFlorida33756-
Research Site 10North MiamiFlorida33162-
Research Site 11SarasotaFlorida34239-
Research Site 12LawrencevilleGeorgia30044-
Research Site 13Sugar HillGeorgia30518-
Research Site 14ElkhartIndiana46514-
Research Site 15IndianapolisIndiana46290-
Research Site 16South BendIndiana46617-
Research Site 17Overland ParkKansas66211-
Research Site 18TopekaKansas66606-
Research Site 19MetairieLouisiana70001-
Research Site 20AnnapolisMaryland21401-
Research Site 21JacksonMississippi39202-
Research Site 22FremontNebraska68025-
Research Site 23NorfolkNebraska68701-
Research Site 24MorristownNew Jersey07960-
Research Site 26New YorkNew York10029-
Research Site 27RiverheadNew York11901-
Research Site 25The BronxNew York10461-
Research Site 28AsheboroNorth Carolina27203-
Research Site 29WilmingtonNorth Carolina28412-
Research Site 30BeavercreekOhio45431-
Research Site 31ColumbusOhio43214-
Research Site 32Oklahoma CityOklahoma73112-
Research Site 33HorshamPennsylvania19044-
Research Site 34NewportPennsylvania17074-
Research Site 35PhiladelphiaPennsylvania19104-
Research Site 36PhiladelphiaPennsylvania19104-
Research Site 37Fort MillSouth Carolina29707-
Research Site 38GreenvilleSouth Carolina29607-
Research Site 39ChattanoogaTennessee37411-
Research Site 40Fort WorthTexas76132-
Research Site 41HoustonTexas77040-
Research Site 42HoustonTexas77090-
Research Site 43HoustonTexas77090-
Research Site 44Sugar LandTexas77479-
Research Site 45TomballTexas77375-
Research Site 46VictoriaTexas77901-
Research Site 47BountifulUtah84010-
Research Site 48St. GeorgeUtah84790-
Research Site 49ManassasVirginia20110-
Research Site 50RoanokeVirginia24014-

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