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Evaluating Plozasiran for Severe Hypertriglyceridemia

Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Plozasiran in Adults With Severe Hypertriglyceridemia

Phase 3 Interventional Arrowhead Pharmaceuticals · NCT06347003

This study is testing if a new injection called plozasiran can help adults with severe high triglyceride levels lower their triglycerides safely over a year.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment405 (estimated)
Ages18 Years and up
SexAll
SponsorArrowhead Pharmaceuticals Industry-sponsored
Locations196 sites (Garden Grove, California and 195 other locations)
Trial IDNCT06347003 on ClinicalTrials.gov

What this trial studies

This Phase 3 study assesses the safety and efficacy of plozasiran injection (ARO-APOC3) in adults diagnosed with severe hypertriglyceridemia. Participants will be randomly assigned to receive either plozasiran or a placebo, with four doses administered every three months. The study will monitor participants for efficacy and safety over a 12-month period, after which they may have the option to continue in an open-label extension. The goal is to determine if plozasiran can effectively lower triglyceride levels in this patient population.

Who should consider this trial

Good fit: Ideal candidates are adults with a documented diagnosis of severe hypertriglyceridemia and fasting triglyceride levels of 500 mg/dL or higher.

Not a fit: Patients who have used hepatocyte-targeted siRNA therapies targeting lipids within the past year may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce triglyceride levels in patients with severe hypertriglyceridemia, potentially lowering their risk of cardiovascular events.

How similar studies have performed: Other studies have shown promise with similar lipid-lowering approaches, but the specific use of plozasiran in this context is relatively novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Established diagnosis of severe hypertriglyceridemia (SHTG) and prior documented evidence (medical history) of fasting TG levels of ≥ 500 mg/dL (≥5.65mmol/L)
* Mean fasting TG level ≥500 mg/dL (≥5.65 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 ≤8.5%
* Willing to follow diet counseling and maintain a stable low-fat diet
* Must be on standard of care lipid-lowering medications per local guidelines (unless documented as intolerant as determined by the Investigator)

Exclusion Criteria:

* 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
* Known diagnosis of familial chylomicronemia syndrome (FCS) (type 1 Hyperlipoproteinemia) by documentation of confirmed homozygote or double heterozygote for loss-of-function mutations in type 1-causing genes
* Acute pancreatitis within 4 weeks prior to screening
* Body mass index \>45kg/m\^2

Note: Additional Inclusion/Exclusion criteria may apply per protocol

Where this trial is running

Garden Grove, California and 195 other locations

+146 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Severe Hypertriglyceridemia
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.