A Phase 3 interventional study of Plozasiran Injection in Hypertriglyceridemia, sponsored by Arrowhead Pharmaceuticals. Active, not recruiting at 253 sites in 24 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-01.
Sponsored by Arrowhead Pharmaceuticals · Phase 3, Interventional, and Treatment
This is an open-label study to be conducted in adults with hypertriglyceridemia (HTG) and severe hypertriglyceridemia (SHTG). Each participant must have completed all required visits per protocol in the parent study AROAPOC3-2003 (USA and Canada participants only; NCT# 05413135), AROAPOC3-3001(Canada and Japan participants only; NCT05089084), AROAPOC3-3003 (NCT06347003), AROAPOC3-3004 (NCT06347016) or AROAPOC3-3009 (Argentina, Italy, South Africa, and Spain; NCT06347133).
Subjects who previously met all eligibility requirements for AROAPOC3-3003 or AROAPOC3-3004 and were not permitted to proceed to randomization per the Sponsor's direction in order to prevent excessive over-enrollment may also be enrolled in this trial. The subjects must meet all other applicable eligibility criteria prior to enrollment and have an HbA1c results of \<=10% within 30 days prior to Day 1.
Subjects entering this OLE from AROAPOC3-2003 must meet the following additional criteria to be considered for enrollment in addition to applicable eligibility criteria:
All eligible participants will receive plozasiran administered subcutaneously (SC) approximately every 3 months for 24 months. Participants will be counseled to remain on the specified low-fat diet throughout the study in accordance with local standard of care.
324 studies on the registry are indexed under Hypertriglyceridemia; 38 are open to participants now.
This study's enrollment of 710 is above the median of 66 across 288 interventional studies indexed under Hypertriglyceridemia.
Browse Hypertriglyceridemia studies →Arrowhead Pharmaceuticals is the lead sponsor of 50 studies on the registry; 9 are open to participants now.
Of its 24 completed or terminated interventional studies of FDA-regulated products, 12 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
If the subject has diabetes:
Subjects in the USA and Canada who completed protocol AROAPOC3-2003 meeting all eligibility criteria (with the exception of inclusion criteria #9 which is not applicable to these subjects) who also meet the following additional criteria may enroll in this trial:
Baseline fasting TG level of ≥1000 mg/dL at the time of enrollment into AROAPOC3-2001
Exclusion Criteria:
Note: Other inclusion/exclusion criteria may apply per protocol
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
8 doses of plozasiran (ARO-APOC3) administered by subcutaneous (SC) injection
Drug: Plozasiran Injection
ARO-APOC3 injection
Also known as: ARO-APOC3
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
Time frame: From first dose of study drug through Month 24
Change from Baseline Over Time in Fasting Serum Triglyceride (TG) Levels
Time frame: From first dose of study drug through Month 24
Percent Change from Baseline Over Time in Fasting Serum TG Levels
Time frame: From first dose of study drug through Month 24
Change from Baseline Over Time in Apolipoprotein CIII (APOC3)
Time frame: From first dose of study drug through Month 24
Percent Change from Baseline Over Time in APOC3
Time frame: From first dose of study drug through Month 24
Change from Baseline Over Time in Remnant Cholesterol
Time frame: From first dose of study drug through Month 24
Percent Change from Baseline Over Time in Remnant Cholesterol
Time frame: From first dose of study drug through Month 24
Change from Baseline Over Time in Fasting Non-High-Density Lipoprotein Cholesterol (non-HDL-C)
Time frame: From first dose of study drug through Month 24
Percent Change from Baseline Over Time in Fasting non-HDL-C
Time frame: From first dose of study drug through Month 24
Change from Baseline Over Time in Fasting High-Density Lipoprotein Cholesterol (HDL-C)
Time frame: From first dose of study drug through Month 24
Percent Change from Baseline Over Time in Fasting HDL-C
Time frame: From first dose of study drug through Month 24
Change from Baseline Over Time in Fasting Total Apolipoprotein B (Apo B)
Time frame: From first dose of study drug through Month 24
Percent Change from Baseline Over Time in Fasting Total Apo B
Time frame: From first dose of study drug through Month 24
Change from Baseline Over Time in Fasting Low-Density Lipoprotein Cholesterol (LDL-C) using Ultracentrifugation
Time frame: From first dose of study drug through Month 24
Percent Change from Baseline Over Time in Fasting LDL-C using Ultracentrifugation
Time frame: From first dose of study drug through Month 24
Change from Baseline Over Time in Hemoglobin A1c (HbA1c)
Time frame: From first dose of study drug through Month 24
Number of Participants With Emergent Apheresis
Time frame: From first dose of study drug through Month 24
Adjudicated Major Adverse Cardiovascular Event Rates During the Treatment Period
Time frame: From first dose of study drug through Month 24
Incidence of Anti-Drug Antibodies (ADA) to Plozasiran Over Time
Time frame: From first dose of study drug through Month 24
Titers of ADA to Plozasiran Over Time
Time frame: From first dose of study drug through Month 24
Adjudicated Acute Pancreatitis (AP) Event Rate During the Treatment Period
Time frame: From first dose of study drug through Month 24
Showing the first 100 of 253 sites across 24 countries. Choose a country and city above to see the rest.
Plan to share: No
No publications or documents are linked to this record.
Started Apr 2025 (actual). Primary completion is estimated for Jul 2028, 39 months after the start.
Of 28 industry-sponsored phase 3 interventional studies under Hypertriglyceridemia, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 31. This study's planned 39 months is above that.
Counting every sponsor, half of 29 studies reached it within 24 months; a quarter within 18 and three quarters within 31.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Plozasiran