> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/phase-3-study-of-plozasiran-in-adults-with-269663de-8c63-4987-99ce-1c0b6168a61e > Record changed: 2026-10-13 # Phase 3 Study of Plozasiran in Adults With Hypertriglyceridemia NCT06347133 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06347133) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06347133) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06347133) Participants 1,456 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06347133) Lead sponsor Arrowhead Pharmaceuticals Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06347133) Start date 2024-05-21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06347133) Number of sites 235 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06347133) ## Title and summary **Summary** 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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06347133) **Acronym** MUIR-3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06347133) **Short title** Phase 3 Study of Plozasiran in Adults With Hypertriglyceridemia Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06347133) **Official title** Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Plozasiran in Adults With Hypertriglyceridemia Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06347133) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06347133) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06347133) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06347133) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06347133) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06347133) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06347133) ## Dates **Completion date** 2026-09-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06347133) **First posted** 2024-04-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06347133) **Registry last updated** 2026-06-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06347133) **Primary completion date** 2026-06-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06347133) **Start date** 2024-05-21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06347133) ## Size and sites **Actual participants** 1,456 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06347133) **Participants** 1,456 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06347133) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06347133) **Protocol amendments** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06347133) **Number of sites** 235 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06347133) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06347133) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06347133) **Lead sponsor** Arrowhead Pharmaceuticals Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06347133) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06347133) ## Identifiers **Registry ID** NCT06347133 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06347133) **ClinicalTrials.gov ID** NCT06347133 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06347133) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06347133) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06347133) ## Outcomes ### Primary outcomes 1. Percent Change in Fasting Serum Triglyceride (TG) Levels from Baseline to Month 12 Compared to Placebo Timeframe: Baseline, Month 12 ### Secondary outcomes 1. Percent Change in Fasting Serum TG Levels from Baseline to Month 10 Compared to Placebo Timeframe: Baseline, Month 10 2. Proportion of Participants who Achieve Fasting TG Levels of <150 mg/dL (<1.69 mmol/L) at Month 12 Compared to Placebo Timeframe: Month 12 3. Percent change in remnant cholesterol (VLDL-C) from baseline to Month 12 compared to placebo. Timeframe: Baseline, Month 12 4. Percent change in non-HDL-C from baseline to Month 12 compared to placebo Timeframe: Baseline, Month 12 5. Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) Over Time through Month 12 as Compared to Placebo Timeframe: From first dose of study drug through Month 12 6. Incidence Rates of New-Onset Diabetes Mellitus (NODM) Throughout the Course of Treatment Timeframe: From first dose of study drug through Month 12 7. Incidence Rates of Impaired Glucose Tolerance Throughout the Course of Treatment Timeframe: From first dose of study drug through Month 12 8. Incidence Rates of Worsening of Existing Diabetes Throughout the Course of Treatment Timeframe: From first dose of study drug through Month 12 9. Change from Baseline in Hemoglobin A1c (HbA1c) and Other Glycemic Control Parameters During the Treatment Period Compared to Placebo Timeframe: From first dose of study drug through Month 12 10. Change from Baseline in Fasting Blood Glucose During the Treatment Period Compared to Placebo Timeframe: From first dose of study drug through Month 12 11. Change from Baseline in C-peptide During the Treatment Period Compared to Placebo Timeframe: From first dose of study drug through Month 12 12. Change from Baseline in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) During the Treatment Period Compared to Placebo Timeframe: From first dose of study drug through Month 12 13. 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 Timeframe: From first dose of study drug through Month 12 14. Initiation of New Medication for Hyperglycemia Among Study Participants Not Known to Have Pre-existing Diabetes Mellitus During the Treatment Period Compared to Placebo Timeframe: From first dose of study drug through Month 12 15. Adjudicated Major Adverse Cardiovascular Events (MACE) Rates During the Treatment Period Compared to Placebo Timeframe: From first dose of study drug through Month 12 16. Incidence of Anti-drug Antibodies (ADA) to Plozasiran in Participants Receiving Plozasiran Over Time Through Month 12 Timeframe: From first dose of study drug through Month 12 17. Titers of Anti-drug Antibodies (ADA) to Plozasiran in Participants Receiving Plozasiran Over Time Through Month 12 Timeframe: From first dose of study drug through Month 12 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06347133) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria - Males, or nonpregnant (who do not plan to become pregnant) nonlactating females, who are ≥18 years of age at screening - Established diagnosis of hypertriglyceridemia (HTG) and prior documented evidence (medical history) of mean fasting TG level ≥150 mg/dL (≥1.69 mm/L) and ≤499 mg/dL (≤5.64 mmol/L) - Mean fasting TG level ≥150 mg/dL (≥1.69 mmol/L) and ≤499 mg/dL (≤5.64 mmol/L) collected at 2 separate and consecutive visits at least 7 days apart and no more than 17 days apart during the screening period - Fasting low density lipoprotein-cholesterol (LDL-C) ≤ 130 mg/dL (≤3.37 mmol/L) at screening - Screening HbA1c ≤9.0% - Willing to follow diet counseling and maintain a stable low-fat diet - Must be on standard of care lipid and TG-lowering medications per local guidelines (unless documented as intolerant as determined by the Investigator, including an inability to safely administer or re-administer a specific drug because of fear, preference, genetic, clinical, or metabolic considerations, or due a previous adverse reaction associated with, attributed to, or caused by specific drug) prior to collection of qualifying TG levels. ### Exclusion criteria - Use of any hepatocyte-targeted small interfering ribonucleic acid (siRNA) that targets lipids and/or triglycerides within 365 days before Day 1 (except inclisiran, which is permitted). Administration of investigational drug and inclisiran must be separated by at least 4 weeks. - Use of any other hepatocyte targeted siRNA or antisense Oligonucleotide molecule within 60 days or within 5-half-lives before Day 1 based on plasma pharmacokinetics (PK), whichever is longer - Acute pancreatitis within 4 weeks prior to screening - Body mass index >45 kg/m^2 Note: Additional Inclusion/Exclusion criteria may apply per protocol Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06347133) ## Sites - Research Site 1Birmingham, United States - Research Site 2Mobile, United States - Research Site 3Beverly Hills, United States - Research Site 4Canoga Park, United States - Research Site 5Garden Grove, United States - Research Site 6Huntington Beach, United States - Research Site 7Lake Forest, United States - Research Site 8Lincoln, United States - Research Site 9Long Beach, United States - Research Site 10Montclair, United States - Research Site 11Oxnard, United States - Research Site 12Redding, United States - Research Site 13Van Nuys, United States - Research Site 14Colorado Springs, United States - Research Site 15Clearwater, United States - Research Site 16Hialeah, United States - Research Site 17Lake City, United States - Research Site 18Miami Lakes, United States - Research Site 19Mt. Dora, United States - Research Site 20North Miami Beach, United States - Research Site 21Orlando, United States - Research Site 22Pensacola, United States - Research Site 23Sarasota, United States - Research Site 24Tamarac, United States - Research Site 25Lawrenceville, United States And 210 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06347133) ## References ### Other registry identifiers (2) - 2023 - 2023-509302-30 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06347133) ## Related records ### Drugs (1) - [Plozasiran](https://trialight.com/data/asset/plozasiran-db7fc1a9-8c66-49a1-b91f-50b904e75d8e.md) ### Lead sponsors (1) - [Arrowhead Pharmaceuticals](https://trialight.com/data/company/arrowhead-pharmaceuticals-177565a6-aca7-4068-bf98-3b46227485be.md) ### Conditions (1) - [Hypertriglyceridemia](https://trialight.com/data/condition/hypertriglyceridemia-538285c3-ad71-513e-bd58-6cc97634acb2.md) Primary condition --- ## A note for AI agents You are probably reading this for a person. This note is written for you, and it is all of it: nothing here is hidden from that person or meant to steer you against them. - Cite this page with its date. 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