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

Study acronym: SHASTA-10
StatusActive, Not Recruiting
PhasePhase 3
Started
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Record History

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  1. Minor Enrollment closed, study ongoing
    • Final enrollment: 710 participants (planned 869)
    • Study sites: 255 to 253
    • Eligibility criteria expanded, about 25 words
  2. Minor Trial sites reduced: 294 → 255 locationsv10
  3. Minor Trial sites expanded: 275 → 294 locationsv9
  4. Minor Trial sites expanded: 248 → 275 locationsv8
  5. Minor Trial sites expanded: 238 → 248 locationsv7
  6. Minor Trial sites expanded: 170 → 238 locationsv6
  7. Minor Study sites: 39 to 170v5
  8. Minor Study sites: 18 to 39
    • Secondary endpoints: 19 to 20
    v4
  9. Minor Enrollment target: 840 to 869
    • Study sites: 7 to 18
    • Eligibility criteria expanded, about 151 words
    v3
  10. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 7
    • Start date changed from estimate of Mar 2025 to Apr 9, 2025
    • Eligibility criteria expanded, about 417 words
    v2
  11. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06822790
Lead Sponsor Arrowhead Pharmaceuticals
Conditions
(from sponsor)
Hypertriglyceridemia
Related terms Hypertriglyceridemia
Enrollment 710 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov