NCT06880770 Study of Plozasiran in Adults With Severe Hypertriglyceridemia at Risk of Acute Pancreatitis
| NCT ID | NCT06880770 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Arrowhead Pharmaceuticals |
| Condition | Severe Hypertriglyceridemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 288 participants |
| Start Date | 2025-04-24 |
| Primary Completion | 2029-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 288 participants in total. It began in 2025-04-24 with a primary completion date of 2029-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study will evaluate the efficacy and safety of plozasiran in approximately 288 adult participants with severe hypertriglyceridemia (SHTG) and history of at least two prior acute pancreatitis (AP) events not attributed to other etiologies, with at least one occurring within the last 12 months prior to screening. Eligible participants will be randomly assigned in a double-blind manner to either receive plozasiran 25 mg by subcutaneous (SC) injection every three months (Q3M) or matching placebo. Enrolled participants will be counseled to remain on the specified low-fat diet and background medications throughout the study. Following completion of the double-blind treatment period, or if the participant has a positively adjudicated AP event (whichever occurs first), participants will transition to the 12-month Open-Label Extension (OLE) treatment period receiving plozasiran 25 mg by SC injection Q3M.
Eligibility Criteria
Inclusion Criteria: * 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 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. * 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 Note: Additional Inclusion/Exclusion Criteria may apply per protocol
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06880770 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Severe Hypertriglyceridemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06880770 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 288 participants.
Is NCT06880770 currently recruiting?
Yes, NCT06880770 is actively recruiting participants. Contact the research team at plozasiran@arrowheadpharma.com for enrollment information.
Where is the NCT06880770 trial being conducted?
This trial is being conducted at Los Angeles, United States, Santa Clarita, United States, New Haven, United States, Springfield, United States and 11 additional locations.
Who is sponsoring the NCT06880770 clinical trial?
NCT06880770 is sponsored by Arrowhead Pharmaceuticals. The trial plans to enroll 288 participants.