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Study of Plozasiran for Severe Hypertriglyceridemia and Risk of Pancreatitis

This study is looking at a drug called plozasiran (ARO-APOC3 injection) for adults who have very high triglyceride levels (severe hypertriglyceridemia, SHTG) and have had acute pancreatitis (AP) before. Participants will receive either plozasiran or a placebo (a substance with no active drug, like sterile saline) by injection every three months. The main goal is to see if plozasiran can reduce the chance of having another acute pancreatitis event. To join, you must be an adult with SHTG, have had at least one AP event in the last 60 months, and have fasting triglyceride levels of 880 mg/dL or higher. The study plans to enroll about 288 people, but its current status is unclear.

Study design
This is an interventional study that will randomly assign about 288 adult participants to receive either plozasiran or a placebo in a double-blind manner.
What's involved
You would receive injections every three months and be advised to follow a low-fat diet and continue your background medications throughout the study. The study could last up to approximately 50 months.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint measures events up to the end of the double-blind treatment period, which could be approximately 50 months after randomization.

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NCT06880770

Study of Plozasiran in Adults With Severe Hypertriglyceridemia at Risk of Acute Pancreatitis

Recruiting
PHASE3Ages 18+InterventionalTreatment
Arrowhead Pharmaceuticals
~288 participants
Updated 2026-07-23 on ClinicalTrials.gov
What's tested:PlozasiranPlacebo

At a glance

Recruiting sites
101 of 102 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Time to First Occurrence of Positively Adjudicated AP Event (Event Occurring More Than 10 Days After First Dose of Study Drug)
Measured over Randomization up to end of Double Blind Treatment Period compared to placebo (Approximate Maximum 50 Months)]

Conditions

Severe Hypertriglyceridemia

Explore related trials

Hypertriglyceridemia

Where it's being run

102 sites across 50 states
Bulgaria8
Colombia6
South Korea6
China5
Jordan5
Hungary4
Serbia4
Austria3

Who to contact

Medical Monitor
[email protected]
626-304-3400
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Males, or nonpregnant (who do not plan to become pregnant) nonlactating females
Established diagnosis of SHTG and prior documented evidence of fasting TG levels of ≥ 880 mg/dL (≥ 10 mmol/L)
Documented evidence of at least 1 prior AP event not attributed to other etiologies occurring within the last 60 months prior to Screening.
Fasting low-density lipoprotein cholesterol (LDL-C) ≤ 130 mg/dL (≤ 3.37 mmol/L) at Screening
Screening hemoglobin A1c (HbA1c) ≤ 9.5%
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, or a treatment failure as determined by the Investigator)

Exclusion

Use of any hepatocyte-targeted small interfering ribonucleic acid (siRNA) that targets lipids and/or triglycerides within 365 days before Day 1, except inclisiran.
Use of any other hepatocyte targeted siRNA or antisense oligonucleotide molecule within 60 days or within 5 half-lives lives before day 1. Whichever is longer.
AP ≤ 4 weeks prior to Randomization/Day 1
Body mass index (BMI) \> 45 kg/m\^2
Any planned bariatric surgery or similar procedures to induce weight lost starting at consent through End of Study (EOS)
Planned coronary intervention (e.g. stent placement or heart bypass) during the study
History of arterial revascularization within 16 weeks of Screening
History of acute coronary syndrome event within 24 weeks of Screening
Recent atherosclerotic cardiovascular disease (ASCVD) event within 24 weeks of Screening
Recent unstable or symptomatic cardiac arrhythmia (including any associated medication changes) within 90 days of Screening. Individuals with stable well-controlled atrial arrhythmia will be allowed to participate in the study
History of pacemaker or automatic implantable cardioverter defibrillators implant within 30 days before Screening
New York Heart Association Class III-IV heart failure or last known ejection fraction of \< 30%
Current diagnosis of nephrotic syndrome
Chronic kidney disease, defined by an estimated glomerular filtration rate (eGFR) \< 20 mL/min/1.73 m\^2
Liver disease defined as cirrhosis or Child-Pugh Class B and C, or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2.5× Upper Limit of Normal (ULN) at Screening

What this trial measures

  • Time to First Occurrence of Positively Adjudicated AP Event (Event Occurring More Than 10 Days After First Dose of Study Drug)Randomization up to end of Double Blind Treatment Period compared to placebo (Approximate Maximum 50 Months)]