A Phase 3 interventional study of Plozasiran Injection and Placebo in Severe Hypertriglyceridemia, sponsored by Arrowhead Pharmaceuticals. Completed at 196 sites in 17 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-08.
Sponsored by Arrowhead Pharmaceuticals · Phase 3, Interventional, and Treatment
This Phase 3 study will evaluate the safety and efficacy of plozasiran injection (ARO-APOC3) in adult participants with severe hypertriglyceridemia (SHTG). 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. After month 12, eligible participants will be offered an opportunity to continue in an optional open-label extension under a separate protocol.
324 studies on the registry are indexed under Hypertriglyceridemia; 38 are open to participants now.
This study's enrollment of 446 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.
Exclusion Criteria:
Note: Additional 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.
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.
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.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
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.
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.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
4 doses of plozasiran (ARO-APOC3) by subcutaneous (sc) injection
Drug: Plozasiran Injection
calculated volume to match active treatment by sc injection
Drug: Placebo
ARO-APOC3 Injection
Also known as: ARO-APOC3
sterile normal saline (0.9% NaCl)
Percent Change in Fasting Serum Triglyceride (TG) Levels from Baseline to Month 12 Compared to Placebo
Time frame: Baseline, Month 12
Percent Change in Fasting Serum TG Levels from Baseline to Month 10 Compared to Placebo
Time frame: Baseline, Month 10
Proportion of Participants Who Achieve Fasting TG Levels of <500 mg/dL (<5.65 mmol/L) at Month 12 Compared to Placebo
Time frame: Baseline, Month 12
Proportion of Participants Who Achieve Fasting TG Levels of <150 mg/dL (<1.69 mmol/L) at Month 12 Compared to Placebo
Time frame: Baseline, Month 12
Percent change in remnant cholesterol (VLDL-C) from baseline to Month 12 compared to placebo
Time frame: Baseline, Month 12
Percent change in non-HDL-C from baseline to Month 12 compared to placebo
Time frame: Baseline, Month 12
Adjudicated AP Event Rate During the Treatment Period Compared to Placebo From Day 1 to Month 12
Time frame: Month 12
Number of participants with adverse events (AEs) and serious adverse events (SAEs) over time through Month 12 as compared to placebo
Time frame: From first dose of study drug through Month 12
Incidence Rates of New-Onset Diabetes Mellitus (NODM) Throughout the Course of Treatment
Time frame: From first dose of study drug through Month 12
Incidence rates of impaired glucose tolerance throughout the course of treatment
Time frame: From first dose of study drug through Month 12
Incidence rates of worsening of existing diabetes throughout the course of treatment
Time frame: From first dose of study drug through Month 12
Change from baseline in HbA1c during the treatment period compared to placebo.
Time frame: From first dose of study drug through Month 12
Change from Baseline in Fasting Blood Glucose During the Treatment Period Compared to Placebo
Time frame: From first dose of study drug through Month 12
Change from Baseline in C-peptide During the Treatment Period Compared to Placebo
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From first dose of study drug through Month 12
Adjudicated Major Adverse Cardiovascular Events (MACE) Rates During the Treatment Period Compared to Placebo
Time frame: 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
Time frame: 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
Time frame: From first dose of study drug through Month 12
Change and/or percent change from baseline to Month 12 in liver fat content using MRI-PDFF, only in a subset of subjects
Time frame: Baseline, Month 12
Showing the first 100 of 196 sites across 17 countries. Choose a country and city above to see the rest.
Plan to share: No
No publications or documents are linked to this record.
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 completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Plozasiran