Phase 3 Study of Plozasiran in Adults With Hypertriglyceridemia
- 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.
- Acronym
- MUIR-3
- Short title
- Phase 3 Study of Plozasiran in Adults With Hypertriglyceridemia
- Official title
- Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Plozasiran in Adults With Hypertriglyceridemia
- Control arm
- Placebo
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Active, not recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Completion date
- 2026-09-01
- First posted
- 2024-04-04
- Registry last updated
- 2026-06-26
- Primary completion date
- 2026-06-01
- Start date
- 2024-05-21
- Actual participants
- 1,456
- Participants
- 1,456
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Arrowhead Pharmaceuticals
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT06347133
- ClinicalTrials.gov ID
- NCT06347133
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- Quadruple masking
- Masked roles
- Participants, Care providers, Investigators, Outcome assessors
Percent Change in Fasting Serum Triglyceride (TG) Levels from Baseline to Month 12 Compared to Placebo
Timeframe: Baseline, Month 12
Percent Change in Fasting Serum TG Levels from Baseline to Month 10 Compared to Placebo
Timeframe: Baseline, Month 10
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
Percent change in remnant cholesterol (VLDL-C) from baseline to Month 12 compared to placebo.
Timeframe: Baseline, Month 12
Percent change in non-HDL-C from baseline to Month 12 compared to placebo
Timeframe: Baseline, Month 12
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
Incidence Rates of New-Onset Diabetes Mellitus (NODM) Throughout the Course of Treatment
Timeframe: From first dose of study drug through Month 12
Incidence Rates of Impaired Glucose Tolerance Throughout the Course of Treatment
Timeframe: From first dose of study drug through Month 12
Incidence Rates of Worsening of Existing Diabetes Throughout the Course of Treatment
Timeframe: From first dose of study drug through Month 12
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
Change from Baseline in Fasting Blood Glucose During the Treatment Period Compared to Placebo
Timeframe: From first dose of study drug through Month 12
Change from Baseline in C-peptide During the Treatment Period Compared to Placebo
Timeframe: From first dose of study drug through Month 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
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
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
Adjudicated Major Adverse Cardiovascular Events (MACE) Rates During the Treatment Period Compared to Placebo
Timeframe: From first dose of study drug through Month 12
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
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
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Healthy volunteers
- No
- 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.
- 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
- 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.
- 2023
- 2023-509302-30
Related records
Drugs (1)
Lead sponsors (1)
Conditions (1)
- Hypertriglyceridemia Primary condition