Study of Plozasiran (ARO-APOC3) in Adults With Severe Hypertriglyceridemia

Part of paid clinical trials in Garden Grove, California.

Sponsor
Arrowhead Pharmaceuticals
Study ID
NCT06347003
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 22, 2024
Status verified
Oct 2025
Primary completion
Jun 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
446 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 Triglyceride (TG) Levels from Baseline to Month 12 Compared to Placebo [ Time Frame: Baseline, Month 12 ]

Locations (52)

FacilityCityStateZIPSite coordinators
Research Center 1Garden GroveCalifornia92844-
Research Center 2Lake ForestCalifornia92630-
Research Center 3MontclairCalifornia91763-
Research Center 4Panorama CityCalifornia91402-
Research Center 5ReddingCalifornia96001-
Research Center 6Colorado SpringsColorado80909-
Research Center 7HialeahFlorida33016-
Research Center 8Lake CityFlorida32055-
Research Center 9Miami LakesFlorida33014-
Research Center 10Mt. DoraFlorida32757-
Research Center 11OrlandoFlorida32825-
Research Center 12PensacolaFlorida32503-
Research Center 13TamaracFlorida33321-
Research Center 14TampaFlorida33614-
Research Center 15MaconGeorgia31210-
Research Center 16SavannahGeorgia31401-
Research Center 17Park RidgeIllinois60068-
Research Center 18EuniceLouisiana70535-
Research Center 19BaltimoreMaryland21229-
Research Center 20FlintMichigan48532-
Research Center 21MinneapolisMinnesota55455-
Research Center 22Olive BranchMississippi38654-
Research Center 23Jefferson CityMissouri65109-
Research Center 24St LouisMissouri63136-
Research Center 25OmahaNebraska68144-
Research Center 26OmahaNebraska68114-
Research Center 27Las VegasNevada89119-
Research Center 29Long Island CityNew York11106-
Research Center 30New YorkNew York10016-
Research Center 31RochesterNew York14642-
Research Center 28The BronxNew York10455-
Research Center 32VestalNew York13850-
Research Center 33Morehead CityNorth Carolina28557-
Research Center 34Winston-SalemNorth Carolina27157-
Research Center 35CincinnatiOhio45219-
Research Center 36ColumbusOhio43210-
Research Center 37NormanOklahoma73072-
Research Center 38Oklahoma CityOklahoma73111-
Research Center 39PowellTennessee37849-
Research Center 40El PasoTexas79905-
Research Center 41HoustonTexas77095-
Research Center 42HoustonTexas77061-
Research Center 43HoustonTexas77079-
Research Center 44HoustonTexas77074-
Research Center 45HoustonTexas77030-
Research Center 46HoustonTexas77030-
Research Center 47HoustonTexas77029-
Research Center 48LaredoTexas78041-
Research Center 49Missouri CityTexas77459-
Research Center 50PlanoTexas75093-
Research Center 51San AntonioTexas78230-
Research Center 52SeattleWashington98109-

Find similar trials in Garden Grove, CA

By research site
Research Center 1· Garden Grove, CAResearch Center 2· Lake Forest, CAResearch Center 3· Montclair, CAResearch Center 4· Panorama City, CAResearch Center 5· Redding, CAResearch Center 6· Colorado Springs, CO

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