protocolSection identificationModule nctId: NCT06347133, orgStudyIdInfo id: AROAPOC3-3009, secondaryIdInfos id: 2023-509302-30, type: EUDRACT_NUMBER, briefTitle: Phase 3 Study of Plozasiran in Adults With Hypertriglyceridemia, acronym: MUIR-3, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2026-07, completionDateStruct date: 2026-10, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Arrowhead Pharmaceuticals, class: INDUSTRY, descriptionModule briefSummary: 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., conditionsModule conditions: Hypertriglyceridemia, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 1328, type: ESTIMATED, armsInterventionsModule interventions name: Plozasiran Injection, interventions name: Placebo, outcomesModule primaryOutcomes measure: Percent Change in Fasting Serum Triglyceride (TG) Levels from Baseline to Month 12 Compared to Placebo, secondaryOutcomes measure: Percent Change in Fasting Serum TG Levels from Baseline to Month 10 Compared to Placebo, secondaryOutcomes measure: Proportion of Participants who Achieve Fasting TG Levels of <150 mg/dL (<1.69 mmol/L) at Month 10 and Month 12 Compared to Placebo, secondaryOutcomes measure: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) Over Time through Month 12 as Compared to Placebo, secondaryOutcomes measure: Incidence Rates of New-Onset Diabetes Mellitus (NODM) Throughout the Course of Treatment, secondaryOutcomes measure: Incidence Rates of Worsening of Existing Diabetes Throughout the Course of Treatment, secondaryOutcomes measure: Change from Baseline in Hemoglobin A1c (HbA1c) During the Treatment Period Compared to Placebo, secondaryOutcomes measure: Change from Baseline in Fasting Blood Glucose During the Treatment Period Compared to Placebo, secondaryOutcomes measure: Change from Baseline in C-peptide During the Treatment Period Compared to Placebo, secondaryOutcomes measure: Change from Baseline in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) During the Treatment Period Compared to Placebo, secondaryOutcomes measure: Change from Baseline in Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related Adverse Events (TRAEs) Associated with Worsening Glycemic Control During the Treatment Period Compared to Placebo, secondaryOutcomes measure: Initiation of New Medication for Hyperglycemia Among Study Participants Not Known to Have Pre-existing Diabetes Mellitus During the Treatment Period Compared to Placebo, secondaryOutcomes measure: Adjudicated Major Adverse Cardiovascular Events (MACE) Rates During the Treatment Period Compared to Placebo, secondaryOutcomes measure: Incidence of Anti-drug Antibodies (ADA) to Plozasiran in Participants Receiving Plozasiran Over Time Through Month 12, secondaryOutcomes measure: Titers of Anti-drug Antibodies (ADA) to Plozasiran in Participants Receiving Plozasiran Over Time Through Month 12, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False