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

Launched by ARROWHEAD PHARMACEUTICALS · Mar 12, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a medication called plozasiran, which is being tested in adults who have a condition known as severe hypertriglyceridemia (SHTG) and have experienced at least two episodes of acute pancreatitis (a serious inflammation of the pancreas) in the past, with one occurring within the last year. The trial aims to find out if plozasiran is effective and safe for these patients. About 140 adults will take part in the study, and they will either receive the medication or a placebo (which looks like the medication but has no active ingredients) through a shot every three months. Participants will also need to stick to a low-fat diet and continue any other prescribed medications during the study.

To be eligible for this trial, participants must be adults who do not plan to become pregnant, have a confirmed diagnosis of SHTG, and have experienced the required number of pancreatitis events. They should also have specific cholesterol and blood sugar levels and be willing to follow the dietary guidelines. Throughout the study, participants will be monitored closely, and after the initial treatment period, they will receive plozasiran for an additional 12 months if they have any serious health events. This study is not yet recruiting participants, but it represents an important step in potentially helping those at risk for severe complications from high triglyceride levels.

Gender

ALL

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 2 prior AP events not attributed to other etiologies with at least 1 occurring within the last 12 months prior to Screening.
• • Fasting low-density lipoprotein cholesterol (LDL-C) ≤ 130 mg/dL (≤ 3.37 mmol/L) at Screening
• • Screening hemoglobin A1c (HbA1c) ≤ 9.0%
• • 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:
• • 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