Long-Term Safety and Efficacy of Plozasiran in Adults With Hypertriglyceridemia

Conditions

• Hypertriglyceridemia

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Plozasiran Injection — DRUG
  ARO-APOC3 injection

Study Details

This is an open-label study to be conducted in adults with hypertriglyceridemia (HTG) and severe hypertriglyceridemia (SHTG). Each participant must have completed all required visits per protocol in the parent study AROAPOC3-2003 (USA and Canada participants only; NCT# 05413135), AROAPOC3-3001(Canada and Japan participants only; NCT05089084), AROAPOC3-3003 (NCT06347003), AROAPOC3-3004 (NCT06347016) or AROAPOC3-3009 (Argentina, Italy, South Africa, and Spain; NCT06347133). Subjects who previously met all eligibility requirements for AROAPOC3-3003 or AROAPOC3-3004 and were not permitted to proceed to randomization per the Sponsor's direction in order to prevent excessive over-enrollment may also be enrolled in this trial. The subjects must meet all other applicable eligibility criteria prior to enrollment and have an HbA1c results of \<=10% within 30 days prior to Day 1. Subjects entering this OLE from AROAPOC3-2003 must meet the following additional criteria to be considered for enrollment in addition to applicable eligibility criteria: 1. HbA1c ≤10% within 30 days prior to Day 1 2. Completed AROAPOC3-2001 prior to entry into AROAPOC3-2003 AND fulfill either (c) or (d) 3. Baseline fasting TG level of ≥500 mg/dL and prior history of acute pancreatitis at the time of enrollment into AROAPOC3-2001 4. Baseline fasting TG level of ≥1000 mg/dL at the time of enrollment into AROAPOC3-2001 All eligible participants will receive plozasiran administered subcutaneously (SC) approximately every 3 months for 24 months. Participants will be counseled to remain on the specified low-fat diet throughout the study in accordance with local standard of care.

Key Dates

Start date

Apr 9, 2025

Status verified

May 2026

Primary completion

Jul 31, 2028

Completion

Jul 31, 2028

Study Design

Enrollment

869 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Plozasiran Injection
  8 doses of plozasiran (ARO-APOC3) administered by subcutaneous (SC) injection

Primary Outcome Measure

Number of Participants with Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: From first dose of study drug through Month 24 ]

Central Contacts

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

Locations (76)

Find similar trials in Bakersfield, CA

Related Studies

• A Mechanistic Study of MAR001 in Adults With Elevated Triglycerides and Remnant Cholesterol
  PHASE2 · Recruiting · Marea Therapeutics · Chula Vista, California
• A Safety and Tolerability Trial Evaluating CTX310 in Participants With Refractory Dyslipidemias
  PHASE1 · Recruiting · CRISPR Therapeutics AG · Jacksonville, Florida
• A Study to Assess the Safety, Tolerability and Efficacy of ION775
  PHASE2 · Recruiting · Ionis Pharmaceuticals, Inc. · Lincoln, California
• Differential Thrombogenesis by EPA and DHA Mediated by HDL
  EARLY_PHASE1 · Recruiting · The Miriam Hospital · Providence, Rhode Island