Actively Recruiting
Double-Blind, Placebo-Controlled Phase 3 Study Evaluating Plozasiran in Adults With Severe Hypertriglyceridemia and High Risk of Acute Pancreatitis
Led by Arrowhead Pharmaceuticals · Updated on 2026-05-06
288
Participants Needed
83
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the safety and effectiveness of plozasiran in adults with severe hypertriglyceridemia SHTG who have a history of at least two acute pancreatitis AP episodes, with one episode occurring within the last year before screening. The study is a phase 3, double-blind, placebo-controlled trial designed to better understand how plozasiran may help reduce the risk of AP events in this high-risk group. Participants will be randomly assigned to receive either plozasiran 25 mg or a matching placebo by subcutaneous injection every three months. During the double-blind treatment period, participants will continue a low-fat diet and maintain their standard lipid and triglyceride-lowering medications. If a participant experiences a confirmed AP event or completes the double-blind period, they will enter a 12-month open-label extension where all receive plozasiran injections every three months. Throughout the study, participants will undergo regular assessments including monitoring for acute pancreatitis events, changes in fasting triglyceride levels, and patient-reported health and productivity measures. Safety will be closely tracked through adverse event reporting and cardiovascular event monitoring. The primary outcome is the time to first confirmed AP event during the double-blind phase, with the entire study lasting up to approximately 62 months including follow-up.
CONDITIONS
Brief Title
Study of Plozasiran in Adults With Severe Hypertriglyceridemia at Risk of Acute Pancreatitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male, or nonpregnant, nonlactating female
- Established diagnosis of severe hypertriglyceridemia with fasting triglyceride levels ≥ 880 mg/dL (≥ 10 mmol/L)
- At least 1 prior acute pancreatitis event not due to other causes within the last 60 months
- Fasting LDL cholesterol ≤ 130 mg/dL (≤ 3.37 mmol/L) at screening
- Screening hemoglobin A1c ≤ 9.5%
- Willing to follow diet counseling and maintain a stable low-fat diet
- Must be on standard lipid and triglyceride-lowering medications unless intolerant or treatment failure as determined by the investigator
You will not qualify if you...
- Use of hepatocyte-targeted siRNA therapies affecting lipids or triglycerides within 365 days before Day 1, except inclisiran
- Use of other hepatocyte-targeted siRNA or antisense oligonucleotide treatments within 60 days or 5 half-lives before Day 1
- Acute pancreatitis within 4 weeks prior to randomization
- Body mass index over 45 kg/m²
- Planned bariatric surgery or similar weight-loss procedures during the study
- Planned coronary intervention during the study
- History of arterial revascularization within 16 weeks of screening
- History of acute coronary syndrome within 24 weeks of screening
- Recent atherosclerotic cardiovascular disease event within 24 weeks of screening
- Recent unstable or symptomatic cardiac arrhythmia within 90 days of screening; stable controlled atrial arrhythmia allowed
- Pacemaker or implantable cardioverter defibrillator implant within 30 days before screening
- New York Heart Association Class III-IV heart failure or ejection fraction below 30%
- Current diagnosis of nephrotic syndrome
- Chronic kidney disease with estimated glomerular filtration rate below 20 mL/min/1.73 m²
- Liver disease such as cirrhosis or Child-Pugh Class B/C, or ALT or AST over 2.5 times the upper normal limit at screening
- Other criteria may apply per protocol
Research Team
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Medical Monitor
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