Actively Recruiting
Double-Blind, Placebo-Controlled Phase 3 Study Evaluating Plozasiran in Adults With Severe Hypertriglyceridemia and High Risk of Acute Pancreatitis
Led by Arrowhead Pharmaceuticals · Updated on 2026-05-06
288
Participants Needed
83
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the safety and effectiveness of plozasiran in adults with severe hypertriglyceridemia (SHTG) who have a history of at least two acute pancreatitis (AP) episodes, with one episode occurring within the last year before screening. The study is a phase 3, double-blind, placebo-controlled trial designed to better understand how plozasiran may help reduce the risk of AP events in this high-risk group. Participants will be randomly assigned to receive either plozasiran 25 mg or a matching placebo by subcutaneous injection every three months. During the double-blind treatment period, participants will continue a low-fat diet and maintain their standard lipid and triglyceride-lowering medications. If a participant experiences a confirmed AP event or completes the double-blind period, they will enter a 12-month open-label extension where all receive plozasiran injections every three months. Throughout the study, participants will undergo regular assessments including monitoring for acute pancreatitis events, changes in fasting triglyceride levels, and patient-reported health and productivity measures. Safety will be closely tracked through adverse event reporting and cardiovascular event monitoring. The primary outcome is the time to first confirmed AP event during the double-blind phase, with the entire study lasting up to approximately 62 months including follow-up.
CONDITIONS
Brief Title
Study of Plozasiran in Adults With Severe Hypertriglyceridemia at Risk of Acute Pancreatitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male, or nonpregnant, nonlactating female
- Established diagnosis of severe hypertriglyceridemia with fasting triglyceride levels ≥ 880 mg/dL (≥ 10 mmol/L)
- At least 1 prior acute pancreatitis event not due to other causes within the last 60 months
- Fasting LDL cholesterol ≤ 130 mg/dL (≤ 3.37 mmol/L) at screening
- Screening hemoglobin A1c ≤ 9.5%
- Willing to follow diet counseling and maintain a stable low-fat diet
- Must be on standard lipid and triglyceride-lowering medications unless intolerant or treatment failure as determined by the investigator
You will not qualify if you...
- Use of hepatocyte-targeted siRNA therapies affecting lipids or triglycerides within 365 days before Day 1, except inclisiran
- Use of other hepatocyte-targeted siRNA or antisense oligonucleotide treatments within 60 days or 5 half-lives before Day 1
- Acute pancreatitis within 4 weeks prior to randomization
- Body mass index over 45 kg/m²
- Planned bariatric surgery or similar weight-loss procedures during the study
- Planned coronary intervention during the study
- History of arterial revascularization within 16 weeks of screening
- History of acute coronary syndrome within 24 weeks of screening
- Recent atherosclerotic cardiovascular disease event within 24 weeks of screening
- Recent unstable or symptomatic cardiac arrhythmia within 90 days of screening; stable controlled atrial arrhythmia allowed
- Pacemaker or implantable cardioverter defibrillator implant within 30 days before screening
- New York Heart Association Class III-IV heart failure or ejection fraction below 30%
- Current diagnosis of nephrotic syndrome
- Chronic kidney disease with estimated glomerular filtration rate below 20 mL/min/1.73 m²
- Liver disease such as cirrhosis or Child-Pugh Class B/C, or ALT or AST over 2.5 times the upper normal limit at screening
- Other criteria may apply per protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 50 months
Participants receive Plozasiran or placebo by subcutaneous injection every 3 months during the randomized double-blind treatment period.
Injections every 3 months with additional assessment visits during treatment period
Duration - Up to approximately 12 months after treatment period
Participants are monitored for safety and long-term outcomes following the treatment period.
Periodic visits for safety and outcome assessments
Trial Site Locations
Total: 83 locations
1
Research Site
Los Angeles, California, United States, 90027
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2
Clinical Research Site 4
Santa Clarita, California, United States, 91321
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3
Research Site
New Haven, Connecticut, United States, 06519
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4
Clinical Research Site 6
Springfield, Illinois, United States, 62702
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5
Research Site
Indianapolis, Indiana, United States, 46202
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6
Research Site
Kansas City, Kansas, United States, 66160
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7
Research Site
Ann Arbor, Michigan, United States, 48109
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8
Research Site
St Louis, Missouri, United States, 63110
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9
Clinical Research Site 5
North Platte, Nebraska, United States, 69101
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10
Clinical Research Site 3
Greensboro, North Carolina, United States, 27401
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11
Research Site
Wilmington, North Carolina, United States, 28412
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12
Clinical Research Site 7
Philadelphia, Pennsylvania, United States, 19107
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13
Research Site
Pittsburgh, Pennsylvania, United States, 15213
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14
Clinical Research Site 1
Mesquite, Texas, United States, 75149
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15
Clinical Research Site 2
San Antonio, Texas, United States, 78233
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16
Research Site
Seattle, Washington, United States, 98109
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17
Research Site
Ramos Mejía, Buenos Aires, Argentina, 1704
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18
Research Site
Córdoba, Córdoba Province, Argentina, 5000
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19
Research Site
Córdoba, Córdoba Province, Argentina, X5003DCE
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20
Research Site
Rosario, Santa Fe Province, Argentina, 2000
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21
Research Site
Ciudad Autonoma Buenos Aires, Argentina, C1430CKE
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22
Research Site
Graz, Austria, 8036
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23
Research Site
Fortaleza, Ceará, Brazil, 60430-370
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24
Research Site
Belo Horizonte, Minas Gerais, Brazil, 30150-274
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25
Research Site
Belo Horizonte, Minas Gerais, Brazil, 30150-320
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26
Research Site
Belo Horizonte, Minas Gerais, Brazil, 30220-140
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27
Research Site
Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
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28
Research Site
Pôrto Alegre, Rio Grande do Sul, Brazil, 90050-170
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29
Research Site
São Paulo, São Paulo, Brazil, 05403-900
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30
Research Site
Burgas, Bulgaria, 8000
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31
Research Site
Pleven, Bulgaria, 5800
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32
Research Center
Plovdiv, Bulgaria, 4002
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33
Research Site
Plovdiv, Bulgaria, 4003
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34
Research Site
Rousse, Bulgaria, 7013
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35
Research Site
Sofia, Bulgaria, 1404
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36
Research Site
Sofia, Bulgaria, 1431
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37
Research Site
Stara Zagora, Bulgaria, 6000
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38
Research Center
Beijing, Beijing Municipality, China, 100730
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39
Research Site
Guiyang, Guizhou, China, 550000
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40
Research Site
Harbin, Heilongjiang, China, 150040
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41
Research Center
Baotou, Inner Mongolia, China, 014010
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42
Research Site
Chifeng, Inner Mongolia, China, 024099
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43
Research Center
Nanchang, Jiangxi, China, 330006
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44
Research Center
Shanghai, Shanghai Municipality, China, 201620
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45
Research Site
Chengdu, Sichuan, China, 610041
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46
Research Center
Hangzhou, Zhejiang, China, 310000
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47
Research Site
Hangzhou, Zhejiang, China, 310003
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48
Research Site
Beijing, China, 100053
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49
Research Site
Nanjing, China, 210002
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50
Research Site
Barranquilla, Colombia, 080020
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51
Research Site
Cali, Colombia, 760042
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52
Research Site
Puerto Colombia, Colombia, 081007
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53
Research Site
Budapest, Hungary, 1083
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54
Research Site
Budapest, Hungary, 1132
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55
Research Site
Szeged, Hungary, 6725
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56
Research Site
Amman, Jordan, 11190
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57
Research Center
Amman, Jordan, 11821
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58
Research Site
Amman, Jordan, 11942
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59
Research Center
Irbid, Jordan, 21166
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60
Research Center
Irbid, Jordan, 22110
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61
Research Site
Guadalajara, Jalisco, Mexico, 44670
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62
Research Site
Mexico City, Mexico City, Mexico, 06700
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63
Research Site
Muscat, Oman, 123
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64
Research Site
Riyadh, Saudi Arabia, 11211
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65
Research Site
Riyadh, Saudi Arabia, 11426
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66
Research Site
Riyadh, Saudi Arabia, 11472
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67
Research Center
Belgrade, Serbia, 11000
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68
Research Site
Belgrade, Serbia, 11000
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69
Research Site
Pančevo, Serbia, 26000
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70
Research Center
Zaječar, Serbia, 19000
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71
Research Site
Seongnam-si, Gyeonggi-do, South Korea, 13620
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72
Research Site
Jeonju, Jeollabuk-do, South Korea, 54907
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73
Research Site
Busan, South Korea, 49201
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74
Research Site
Sejong, South Korea, 30099
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75
Research Site
Seoul, South Korea, 02841
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76
Research Site
Seoul, South Korea, 05505
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77
Research Site
Seoul, South Korea, 06351
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78
Research Site
Seoul, South Korea, 06591
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79
Research Center
Gothenburg, Sweden, 41345
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80
Research Center
Stockholm, Sweden, 14186
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81
Research Site
Abu Dhabi, United Arab Emirates, 133500
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82
Research Site
Abu Dhabi, United Arab Emirates, 51900
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83
Research Site
Al Ain City, United Arab Emirates, 15258
Actively Recruiting
Research Team
M
Medical Monitor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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