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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Severe Hypertriglyceridemia

In brief

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.

Key facts

Study ID: NCT06880770
Run by: Arrowhead Pharmaceuticals
People needed: 288
Starts: 2025-04-24
Expected to finish: 2029-06-01
Last updated by the study team: 2026-07-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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)

You may not qualify if…

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

Where it is running

Clinical Research Site 4 — Santa Clarita, California, United States (enrolling)
Research Site — New Haven, Connecticut, United States (enrolling)
Clinical Research Site 6 — Springfield, Illinois, United States (enrolling)
Research Site — Indianapolis, Indiana, United States (enrolling)
Research Site — Kansas City, Kansas, United States (enrolling)
Research Site — Ann Arbor, Michigan, United States (enrolling)
Research Site — St Louis, Missouri, United States (enrolling)
Clinical Research Site 5 — North Platte, Nebraska, United States (enrolling)
Clinical Research Site 3 — Greensboro, North Carolina, United States (enrolling)
Research Site — Wilmington, North Carolina, United States (enrolling)
Clinical Research Site 7 — Philadelphia, Pennsylvania, United States (enrolling)
Research Site — Pittsburgh, Pennsylvania, United States (enrolling)
Clinical Research Site 1 — Mesquite, Texas, United States (enrolling)
Clinical Research Site 2 — San Antonio, Texas, United States (enrolling)
Research Site — Seattle, Washington, United States (enrolling)
Research Site — Ramos Mejía, Buenos Aires, Argentina (enrolling)
Research Site — Córdoba, Córdoba Province, Argentina (enrolling)
Research Site — Córdoba, Córdoba Province, Argentina (enrolling)
Research Site — Rosario, Santa Fe Province, Argentina (enrolling)
Research Site — Ciudad Autonoma Buenos Aires, Argentina (enrolling)
Research Site — Graz, Austria (enrolling)
Research Site — Linz, Austria (enrolling)
Research Site — Vienna, Austria (enrolling)
Research Site — Fortaleza, Ceará, Brazil (enrolling)
Research Site — Los Angeles, California, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.