Study of Plozasiran in Adults With Severe Hypertriglyceridemia at Risk of Acute Pancreatitis
Public ClinicalTrials.gov record NCT06880770. 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.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Plozasiran in Adults With Severe Hypertriglyceridemia at High Risk of Acute Pancreatitis (SHASTA-5 Study)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study will evaluate the efficacy and safety of plozasiran in approximately 288 adult participants with severe hypertriglyceridemia (SHTG) and history of at least two prior acute pancreatitis (AP) events not attributed to other etiologies, with at least one occurring within the last 12 months prior to screening. Eligible participants will be randomly assigned in a double-blind manner to either receive plozasiran 25 mg by subcutaneous (SC) injection every three months (Q3M) or matching placebo. Enrolled participants will be counseled to remain on the specified low-fat diet and background medications throughout the study. Following completion of the double-blind treatment period, or if the participant has a positively adjudicated AP event (whichever occurs first), participants will transition to the 12-month Open-Label Extension (OLE) treatment period receiving plozasiran 25 mg by SC injection Q3M.
Study identification
- NCT ID
- NCT06880770
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 288 participants
Conditions and interventions
Conditions
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 23, 2025
- Primary completion
- Feb 28, 2029
- Completion
- May 31, 2029
- Last update posted
- Sep 1, 2026
2025 – 2029
United States locations
- U.S. sites
- 17
- U.S. states
- 13
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Research Site | Los Angeles | California | 90027 | Recruiting |
| Clinical Research Site 4 | Santa Clarita | California | 91321 | Recruiting |
| Research Site | New Haven | Connecticut | 06519 | Recruiting |
| Clinical Research Site 6 | Springfield | Illinois | 62702 | Recruiting |
| Research Site | Indianapolis | Indiana | 46202 | Recruiting |
| Research Site | Kansas City | Kansas | 66160 | Recruiting |
| Research Site | Ann Arbor | Michigan | 48109 | Recruiting |
| Research Site | St Louis | Missouri | 63110 | Recruiting |
| Clinical Research Site 5 | North Platte | Nebraska | 69101 | Recruiting |
| Research Site | New York | New York | 10029 | Recruiting |
| Clinical Research Site 3 | Greensboro | North Carolina | 27401 | Recruiting |
| Research Site | Wilmington | North Carolina | 28412 | Recruiting |
| Clinical Research Site 7 | Philadelphia | Pennsylvania | 19107 | Recruiting |
| Research Site | Pittsburgh | Pennsylvania | 15213 | Recruiting |
| Clinical Research Site 1 | Mesquite | Texas | 75149 | Recruiting |
| Clinical Research Site 2 | San Antonio | Texas | 78233 | Recruiting |
| Research Site | Seattle | Washington | 98109 | 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 104 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06880770, 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 Sep 1, 2026 · Synced Sep 9, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06880770 live on ClinicalTrials.gov.