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Evaluating plozasiran for treating high triglyceride levels in adults

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

Phase 3 Interventional Arrowhead Pharmaceuticals · NCT06347133

This study is testing if a new injection called plozasiran can help adults with high triglyceride levels lower them safely while they continue their usual diet and medications.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment1328 (estimated)
Ages18 Years and up
SexAll
SponsorArrowhead Pharmaceuticals Industry-sponsored
Locations231 sites (Birmingham, Alabama and 230 other locations)
Trial IDNCT06347133 on ClinicalTrials.gov

What this trial studies

This Phase 3 study assesses the safety and effectiveness of plozasiran injection in adults diagnosed with hypertriglyceridemia. Participants will be randomly assigned to receive either plozasiran or a placebo, with four doses administered every three months. The study aims to evaluate the impact of this treatment on triglyceride levels and overall safety through regular monitoring and assessments. Eligible participants must have specific triglyceride levels and follow a low-fat diet while on standard lipid-lowering medications.

Who should consider this trial

Good fit: Ideal candidates are adults with established hypertriglyceridemia and specific triglyceride levels who are willing to adhere to dietary counseling.

Not a fit: Patients who have used certain lipid-targeting therapies recently or have uncontrolled diabetes may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly lower triglyceride levels in patients with hypertriglyceridemia, reducing their risk of cardiovascular diseases.

How similar studies have performed: Other studies have shown promise with similar lipid-targeting approaches, suggesting potential for success in this trial.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Established diagnosis of hypertriglyceridemia (HTG) and prior documented evidence (medical history) of mean fasting TG level ≥150 mg/dL (≥1.69 mm/L) and ≤499 mg/dL (≤5.64 mmol/L)
* Mean fasting TG level ≥150 mg/dL (≥1.69 mmol/L) and ≤499 mg/dL (≤5.64 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
* Acute pancreatitis within 4 weeks prior to screening
* Body mass index \>45 kg/m\^2

Note: Additional Inclusion/Exclusion criteria may apply per protocol

Where this trial is running

Birmingham, Alabama and 230 other locations

+181 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 Hypertriglyceridemia
Last reviewed 2026-06-13 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.