NCT06880770

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

Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Plozasiran in Adults With Severe Hypertriglyceridemia at High Risk of Acute Pancreatitis (SHASTA-5 Study)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 288 (estimated)
• Sponsor: Arrowhead Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Severe Hypertriglyceridemia

Interventions

Type	Name	Description
DRUG	Plozasiran	ARO-APOC3 injection
DRUG	Placebo	sterile normal saline (0.9% NaCl)

Timeline

• Start date: 2025-04-24
• Primary completion: 2029-03-01
• Completion: 2029-06-01
• First posted: 2025-03-18
• Last updated: 2026-02-06

Locations

61 sites across 12 countries: United States, Austria, Brazil, Bulgaria, China, Hungary, Jordan, Oman, Serbia, South Korea, Sweden, United Arab Emirates

Regulatory

• FDA-regulated drug study