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

ClinicalTrials.gov ID: NCT06822790

Public ClinicalTrials.gov record NCT06822790. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 7, 2026, 8:53 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT06822790
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 3
Lead sponsor: Arrowhead Pharmaceuticals; Industry
Enrollment: 869 participants

Conditions and interventions

Conditions

Hypertriglyceridemia

Interventions

Plozasiran Injection Drug

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Apr 8, 2025
Primary completion: Jun 30, 2028
Completion: Jun 30, 2028
Last update posted: Aug 11, 2026

2025 – 2028

United States locations

U.S. sites: 71
U.S. states: 24
U.S. cities: 65

Facility	City	State	ZIP	Site status
Research Site 21	Bakersfield	California	93311	Active, not recruiting
Research Site 9	Beverly Hills	California	90211	Active, not recruiting
Research Site 11	Canoga Park	California	91303	Active, not recruiting
Research Site 40	Garden Grove	California	92844	Active, not recruiting
Research Site 235	Huntington Beach	California	92648	Active, not recruiting
Research Site 236	Lake Forest	California	92630	Active, not recruiting
Research Site 39	Lincoln	California	95648	Active, not recruiting
Research Site 34	Oxnard	California	93030	Active, not recruiting
Research Site 229	Palm Springs	California	92262	Active, not recruiting
Research Site 275	Redding	California	96001	Recruiting
Research Site 155	Fort Lauderdale	Florida	33308	Withdrawn
Research Site 14	Hialeah	Florida	33016	Active, not recruiting
Research Site 154	Miami	Florida	33144	Active, not recruiting
Research Site 1	Miami Lakes	Florida	33014	Active, not recruiting
Research Site 42	Mt. Dora	Florida	32757	Active, not recruiting
Research Site 38	North Miami	Florida	33162	Withdrawn
Research Site 41	Orlando	Florida	32825	Active, not recruiting
Research Site 16	Tamarac	Florida	33321	Active, not recruiting
Research Site 18	Tampa	Florida	33614	Active, not recruiting
Research Site 237	Lawrenceville	Georgia	30044	Recruiting
Research Site 17	Park Ridge	Illinois	60068	Active, not recruiting
Research Site 43	Elkhart	Indiana	46514	Active, not recruiting
Research Site 157	Indianapolis	Indiana	46290	Active, not recruiting
Research Site 28	Overland Park	Kansas	66211	Active, not recruiting
Research Site 23	Topeka	Kansas	66606	Active, not recruiting
Research Site 12	Annapolis	Maryland	21401	Active, not recruiting
Research Site 44	Baltimore	Maryland	21229	Active, not recruiting
Research Site 30	Flint	Michigan	48532	Active, not recruiting
Research Site 290	Minneapolis	Minnesota	55455	Recruiting
Research Site 33	Jackson	Mississippi	39202	Active, not recruiting
Research Site 32	Olive Branch	Mississippi	38654	Active, not recruiting
Research Site 2	Jefferson City	Missouri	65109	Active, not recruiting
Research Site 232	St Louis	Missouri	63136	Active, not recruiting
Research Site 29	Fremont	Nebraska	68025	Active, not recruiting
Research Site 3	Omaha	Nebraska	68144	Active, not recruiting
Research Site 77	Summit	New Jersey	07901	Active, not recruiting
Research Site 72	Long Island City	New York	11106	Recruiting
Research Site 233	New York	New York	10016	Active, not recruiting
Research Site 228	New York	New York	10029	Active, not recruiting
Research Site 273	Riverhead	New York	12401	Active, not recruiting
Research Site 37	Asheboro	North Carolina	27203	Active, not recruiting
Research Site 36	Morehead City	North Carolina	28557	Active, not recruiting
Research Site 169	Wilmington	North Carolina	28401	Recruiting
Research Site 22	Beavercreek	Ohio	45431	Active, not recruiting
Research Site 234	Columbus	Ohio	43214	Recruiting
Research Site 294	Vandalia	Ohio	45377	Recruiting
Research Site 76	Norman	Oklahoma	73072	Active, not recruiting
Research Site 31	Oklahoma City	Oklahoma	73112	Active, not recruiting
Research Site 26	Horsham	Pennsylvania	19044	Active, not recruiting
Research Site 8	Newport	Pennsylvania	17074	Active, not recruiting
Research Site 231	Philadelphia	Pennsylvania	19104	Active, not recruiting
Research Site 238	Fort Mill	South Carolina	29707	Active, not recruiting
Research Site 293	Chattanooga	Tennessee	37411	Recruiting
Research Site 27	El Paso	Texas	79905	Active, not recruiting
Research Site 160	Fort Worth	Texas	76132	Active, not recruiting
Research Site 272	Houston	Texas	77030	Active, not recruiting
Research Site 292	Houston	Texas	77030	Active, not recruiting
Research Site 73	Houston	Texas	77061	Active, not recruiting
Research Site 291	Houston	Texas	77074	Active, not recruiting
Research Site 75	Houston	Texas	77090	Active, not recruiting
Research Site 24	Houston	Texas	77095	Active, not recruiting
Research Site 230	Missouri City	Texas	77459	Active, not recruiting
Research Site 74	Plano	Texas	75093	Active, not recruiting
Research Site 168	San Antonio	Texas	78230	Withdrawn
Research Site 13	Sugar Land	Texas	77479	Active, not recruiting
Research Site 170	Tomball	Texas	77375	Active, not recruiting
Research Site 25	Victoria	Texas	77901	Active, not recruiting
Research Site 15	Bountiful	Utah	84010	Active, not recruiting
Research Site 35	St. George	Utah	84790	Active, not recruiting
Research Site 10	Manassas	Virginia	20110	Active, not recruiting
Research Site 274	Seattle	Washington	98109	Active, not recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 184 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT06822790, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Aug 11, 2026 · Synced Sep 7, 2026

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The complete protocol, eligibility criteria, and contact information for NCT06822790 live on ClinicalTrials.gov.

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