Phase 3 Study of Plozasiran Injection Every Three Months in Adults with Severe Hypertriglyceridemia at High Risk of Acute Pancreatitis

What this Trial Is About

Researchers are evaluating plozasiran in adults with severe hypertriglyceridemia SHTG who have experienced at least two prior acute pancreatitis AP events, with one event occurring within the last 12 months before screening. The study aims to assess the efficacy and safety of plozasiran compared to a placebo in reducing AP events and managing triglyceride levels. About 288 adult participants will be involved in this randomized, double-blind, phase 3 clinical trial. Participants will be randomly assigned to receive either plozasiran 25 mg or a matching placebo by subcutaneous injection every three months Q3M. They will be counseled to maintain a low-fat diet and continue their prescribed lipid and triglyceride-lowering medications throughout the study. After the double-blind treatment period or upon experiencing a confirmed AP event, participants will enter a 12-month open-label extension, receiving plozasiran 25 mg by subcutaneous injection every three months. During the study, participants will be regularly monitored for the time to first AP event, changes in fasting serum triglyceride levels, cardiovascular events, patient-reported productivity, and health status. Safety assessments will include tracking treatment-emergent adverse events. The study will last approximately up to 62 months, including the double-blind and open-label phases, with ongoing evaluations and follow-up visits to assess treatment effects and participant health.

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