🏛️ Verified NIH Record • Updated 2026-08-11

Long-Term Safety and Efficacy of Plozasiran in Adults With Hypertriglyceridemia (NCT06822790)

A Phase 3 Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Plozasiran in Adults With Hypertriglyceridemia (SHASTA-10 Study)

🟢 Recruiting Phase3 💊 Investigational Drug / Biologic Sponsor: Arrowhead Pharmaceuticals

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: Research Site 21 — Bakersfield, California

Age range: 18 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (255 Sites)

Showing the first 25 of 255 sites.

  • Research Site 21 — Bakersfield, California
  • Research Site 9 — Beverly Hills, California
  • Research Site 11 — Canoga Park, California
  • Research Site 40 — Garden Grove, California
  • Research Site 235 — Huntington Beach, California
  • Research Site 236 — Lake Forest, California
  • Research Site 39 — Lincoln, California
  • Research Site 34 — Oxnard, California
  • Research Site 229 — Palm Springs, California
  • Research Site 275 — Redding, California
  • Research Site 155 — Fort Lauderdale, Florida
  • Research Site 14 — Hialeah, Florida
  • Research Site 154 — Miami, Florida
  • Research Site 1 — Miami Lakes, Florida
  • Research Site 42 — Mt. Dora, Florida
  • Research Site 38 — North Miami, Florida
  • Research Site 41 — Orlando, Florida
  • Research Site 16 — Tamarac, Florida
  • Research Site 18 — Tampa, Florida
  • Research Site 237 — Lawrenceville, Georgia
  • Research Site 17 — Park Ridge, Illinois
  • Research Site 43 — Elkhart, Indiana
  • Research Site 157 — Indianapolis, Indiana
  • Research Site 28 — Overland Park, Kansas
  • Research Site 23 — Topeka, Kansas

📞 Contact the Study Coordinator

Phone: (626) 304-3400

Email: plozasiran@arrowheadpharma.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗