Long-Term Study of Plozasiran for High Triglycerides
This study is looking at the long-term safety and effectiveness of an injection called Plozasiran (ARO-APOC3) for adults with high triglycerides (hypertriglyceridemia) and very high triglycerides (severe hypertriglyceridemia). The study is open-label, meaning both you and the study team will know you are receiving Plozasiran. To join, you must have already completed all required visits in a previous study (like AROAPOC3-2003, AROAPOC3-3001, AROAPOC3-3003, AROAPOC3-3004, or AROAPOC3-3009). The main goal is to track any side effects you might experience over 24 months. This study plans to enroll 869 participants, but its current recruitment status is unclear.
- Study design
- This is an open-label study, meaning everyone knows they are receiving the study drug. It plans to include 869 adult participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your safety will be monitored for 24 months after your first dose of the study drug.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06822790
Long-Term Safety and Efficacy of Plozasiran in Adults With Hypertriglyceridemia
Recruiting
PHASE3Ages 18+InterventionalTreatmentArrowhead Pharmaceuticals
~869 participants
Updated 2026-08-12 on ClinicalTrials.gov
What's tested:Plozasiran Injection
At a glance
Recruiting sites
17 of 255 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
Measured over From first dose of study drug through Month 24
Conditions
Where it's being run
255 sites across 84 statesBulgaria18
Poland18
Texas14
Czechia12
California10
Florida9
Argentina9
Hungary9
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Adult males, or nonpregnant (who do not plan to become pregnant), nonlactating adult females, who are able and willing to provide written informed consent prior to the performance of any study-specific procedures
Completed all required study visits per protocol in the parent study
Female subjects of childbearing potential must agree to use a highly effective method of contraception during the study and for at least 90 days after the End of Study (EOS) or the last dose of plozasiran, whichever is later. Male subjects must agree to use a condom during the study and for at least 90 days after the EOS or last dose of plozasiran whichever is later. Subjects must not donate sperm or eggs during the study and for at least 90 days after the EOS or last dose of plozasiran, whichever is later. Female subjects of childbearing potential on hormonal contraceptives must be stable on medication for \>1 menstrual cycle prior to Day 1.
Subjects 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 to a previous adverse reaction associated with, attributed to, or caused by specific drug)
If the subject has a medical history of clinical atherosclerotic cardiovascular disease (ASCVD) or elevated 10-year ASCVD risk (eg, ≥7.5% per American Heart Association/American College of Cardiology \[AHA/ACC\] risk calculator for subjects ≥40 years of age or Framingham risk score calculator for subjects under the age of 40), the subject must be on appropriate lipid-lowering therapy as per local standard of care (ie, including moderate-to-high intensity statin, as indicated).
HbA1c ≤10% within 30 days prior to Day 1
Completed AROAPOC3-2001 prior to entry into AROAPOC3-2003 AND either (c) or (d) below:
Baseline fasting TG level of ≥500 mg/dL and prior history of acute pancreatitis at the time of enrollment into AROAPOC3-2001
Baseline fasting TG level of ≥1000 mg/dL at the time of enrollment into AROAPOC3-2001
Exclusion
Subject was permanently discontinued from receiving plozasiran in the parent study due to elevated aspartate aminotransferase (AST) or alanine aminotransferase (ALT) or due to HbA1c elevation that did not respond to antidiabetic regimen
Subject withdrew consent for continued study treatment in the parent study
Known hypersensitivity to the active substance or to any of the excipients of plozasiran
Known hypersensitivity to the active substance or to any of the excipients of plozasiran
Any new condition or worsening of existing condition or any other situation that in the Investigator's judgment, would make the subject unsuitable for enrollment, could interfere with the subject participating in or completing the study, would make it difficult to comply with protocol requirements, or put the subject at an additional safety risk
Unwilling to limit alcohol consumption to within moderate limits for the duration of the study.
Poorly controlled glycemia (ie, HbA1c \>10%) based upon the most recent HbA1c level reported in the parent trial prior to Day 1
Acute pancreatitis within 4 weeks prior to Day 1
Use of any hepatocyte-targeted siRNA that targets lipids and/or triglycerides within 365 days before Day 1 (except plozasiran or inclisiran, which are permitted). Administration of inclisiran must be separated from administration of plozasiran by at least 4 weeks throughout the treatment period
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 PK, whichever is longer.
Use of an investigational agent (other than plozasiran) or device within 30 days or within 5 half-lives, based on plasma PK, whichever is longer, prior to Day 1 (V1) or current participation in an interventional investigational study.
Recent unstable or symptomatic cardiac arrhythmia (including any associated medication changes) within 90 days prior to Day 1. Individuals with stable well-controlled atrial arrhythmias will be allowed to participate in the study.
Uncontrolled hypertension (ie, seated systolic blood pressure \>160 mmHg and/or diastolic blood pressure \>100 mmHg) at Day 1; subject may be re-evaluated when hypertension is controlled.
What this trial measures
- Number of Participants with Treatment-Emergent Adverse Events (TEAEs)From first dose of study drug through Month 24