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

Conditions

• Severe Hypertriglyceridemia

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Plozasiran — DRUG
  ARO-APOC3 injection
• Placebo — DRUG
  sterile normal saline (0.9% NaCl)

Study Details

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 Dates

Start date

Apr 24, 2025

Status verified

Jun 2026

Primary completion

Mar 31, 2029

Completion

Jun 30, 2029

Study Design

Enrollment

288 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Plozasiran Injection
  Plozasiran by SC injection every 3 months (Q3M) through completion of the randomized period Plozasiran by SC injection Q3M through completion of the OLE period
• Experimental: Placebo
  calculated volume to match active treatment by SC injection (randomized period)

Primary Outcome Measure

Time to First Occurrence of Positively Adjudicated AP Event (Event Occurring More Than 10 Days After First Dose of Study Drug) [ Time Frame: Randomization up to end of Double Blind Treatment Period compared to placebo (Approximate Maximum 50 Months)] ]

Central Contacts

• Medical Monitor
  626-304-3400
  [email protected]

Locations (16)

Find similar trials in Los Angeles, CA

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