At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Plozasiran Injection (drug)
- How long the study runs
- Study runs about 39 months (dates as stated)
- About the drug or intervention
- Plozasiran Injection — drug: ARO-APOC3 injection
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 710
- Started
- 2025-04-09
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for hypertriglyceridemia
- • Phase3 - 710 participants
- • This is an open-label study to be conducted in adults with hypertriglyceridemia (HTG) and severe hypertriglyceridemia (SHTG)
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with hypertriglyceridemia
Where?
- • Plymouth - Research Site 71
- • Torquay - Research Site 153
- • London - Research Site 227
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
How this trial compares with your answers
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What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ study visits per protocol in the parent study
What the study is looking for
- ✓Completed all required study visits per protocol in the parent study
- ✓If the subject has diabetes:
- ✓Subject must be on optimized antidiabetic regimen as defined by the local standards, Investigator, and institutional...
- ✓HbA1c ≤10% within 30 days prior to Day 1
- ✓Completed AROAPOC3-2001 prior to entry into AROAPOC3-2003 AND either (c) or (d) below:
Who cannot take part
- ✗Subject withdrew consent for continued study treatment in the parent study
- ✗Known hypersensitivity to the active substance or to any of the excipients of plozasiran
- ✗Unwilling to limit alcohol consumption to within moderate limits for the duration of the study.
- ✗Poorly controlled glycemia (ie, HbA1c \>10%) based upon the most recent HbA1c level reported in the parent trial...
- ✗Acute pancreatitis within 4 weeks prior to Day 1
See the full criteria
Where Is This Study? (3 UK sites)
Research Site 71
Plymouth PL5 3JB, United Kingdom
Research Site 153
Torquay TQ2 7AA, United Kingdom
Research Site 227
London EC1M 6BQ, United Kingdom
