Actively Recruiting
Study of Plozasiran in Adults With Severe Hypertriglyceridemia at Risk of Acute Pancreatitis
Led by Arrowhead Pharmaceuticals · Updated on 2026-05-06
288
Participants Needed
83
Research Sites
214 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 6880 mg/dL (10 mmol/L) or higher
- At least one prior acute pancreatitis event not due to other causes within the last 60 months before screening
- Fasting LDL cholesterol 40 mg/dL (3.37 mmol/L) or lower at screening
- Hemoglobin A1c (HbA1c) of 9.5% or lower at screening
- Willing to follow diet counseling and maintain a stable low-fat diet
- 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 treatments for lipids or triglycerides within 365 days before day 1, except inclisiran
- Use of other hepatocyte-targeted siRNA or antisense oligonucleotides within 60 days or 5 half-lives before day 1, whichever is longer
- Acute pancreatitis within 4 weeks before randomization/day 1
- 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 before screening
- History of acute coronary syndrome within 24 weeks before screening
- Recent atherosclerotic cardiovascular disease event within 24 weeks before screening
- Recent unstable or symptomatic cardiac arrhythmia within 90 days before screening, except stable well-controlled atrial arrhythmia
- Pacemaker or automatic implantable cardioverter defibrillator implant within 30 days before screening
- New York Heart Association Class III-IV heart failure or ejection fraction below 30%
- Current nephrotic syndrome diagnosis
- 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 or C, or ALT or AST levels more than 2.5 times upper limit of normal at screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 83 locations
1
Research Site
Los Angeles, California, United States, 90027
Actively Recruiting
2
Clinical Research Site 4
Santa Clarita, California, United States, 91321
Actively Recruiting
3
Research Site
New Haven, Connecticut, United States, 06519
Actively Recruiting
4
Clinical Research Site 6
Springfield, Illinois, United States, 62702
Actively Recruiting
5
Research Site
Indianapolis, Indiana, United States, 46202
Actively Recruiting
6
Research Site
Kansas City, Kansas, United States, 66160
Actively Recruiting
7
Research Site
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
8
Research Site
St Louis, Missouri, United States, 63110
Actively Recruiting
9
Clinical Research Site 5
North Platte, Nebraska, United States, 69101
Actively Recruiting
10
Clinical Research Site 3
Greensboro, North Carolina, United States, 27401
Actively Recruiting
11
Research Site
Wilmington, North Carolina, United States, 28412
Actively Recruiting
12
Clinical Research Site 7
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
13
Research Site
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
14
Clinical Research Site 1
Mesquite, Texas, United States, 75149
Actively Recruiting
15
Clinical Research Site 2
San Antonio, Texas, United States, 78233
Actively Recruiting
16
Research Site
Seattle, Washington, United States, 98109
Actively Recruiting
17
Research Site
Ramos Mejía, Buenos Aires, Argentina, 1704
Actively Recruiting
18
Research Site
Córdoba, Córdoba Province, Argentina, 5000
Actively Recruiting
19
Research Site
Córdoba, Córdoba Province, Argentina, X5003DCE
Actively Recruiting
20
Research Site
Rosario, Santa Fe Province, Argentina, 2000
Actively Recruiting
21
Research Site
Ciudad Autonoma Buenos Aires, Argentina, C1430CKE
Actively Recruiting
22
Research Site
Graz, Austria, 8036
Actively Recruiting
23
Research Site
Fortaleza, Ceará, Brazil, 60430-370
Actively Recruiting
24
Research Site
Belo Horizonte, Minas Gerais, Brazil, 30150-274
Actively Recruiting
25
Research Site
Belo Horizonte, Minas Gerais, Brazil, 30150-320
Actively Recruiting
26
Research Site
Belo Horizonte, Minas Gerais, Brazil, 30220-140
Actively Recruiting
27
Research Site
Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
Actively Recruiting
28
Research Site
Pôrto Alegre, Rio Grande do Sul, Brazil, 90050-170
Actively Recruiting
29
Research Site
São Paulo, São Paulo, Brazil, 05403-900
Actively Recruiting
30
Research Site
Burgas, Bulgaria, 8000
Actively Recruiting
31
Research Site
Pleven, Bulgaria, 5800
Actively Recruiting
32
Research Center
Plovdiv, Bulgaria, 4002
Actively Recruiting
33
Research Site
Plovdiv, Bulgaria, 4003
Actively Recruiting
34
Research Site
Rousse, Bulgaria, 7013
Actively Recruiting
35
Research Site
Sofia, Bulgaria, 1404
Actively Recruiting
36
Research Site
Sofia, Bulgaria, 1431
Actively Recruiting
37
Research Site
Stara Zagora, Bulgaria, 6000
Actively Recruiting
38
Research Center
Beijing, Beijing Municipality, China, 100730
Actively Recruiting
39
Research Site
Guiyang, Guizhou, China, 550000
Actively Recruiting
40
Research Site
Harbin, Heilongjiang, China, 150040
Actively Recruiting
41
Research Center
Baotou, Inner Mongolia, China, 014010
Actively Recruiting
42
Research Site
Chifeng, Inner Mongolia, China, 024099
Actively Recruiting
43
Research Center
Nanchang, Jiangxi, China, 330006
Actively Recruiting
44
Research Center
Shanghai, Shanghai Municipality, China, 201620
Actively Recruiting
45
Research Site
Chengdu, Sichuan, China, 610041
Actively Recruiting
46
Research Center
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
47
Research Site
Hangzhou, Zhejiang, China, 310003
Actively Recruiting
48
Research Site
Beijing, China, 100053
Actively Recruiting
49
Research Site
Nanjing, China, 210002
Actively Recruiting
50
Research Site
Barranquilla, Colombia, 080020
Actively Recruiting
51
Research Site
Cali, Colombia, 760042
Actively Recruiting
52
Research Site
Puerto Colombia, Colombia, 081007
Actively Recruiting
53
Research Site
Budapest, Hungary, 1083
Actively Recruiting
54
Research Site
Budapest, Hungary, 1132
Actively Recruiting
55
Research Site
Szeged, Hungary, 6725
Actively Recruiting
56
Research Site
Amman, Jordan, 11190
Actively Recruiting
57
Research Center
Amman, Jordan, 11821
Actively Recruiting
58
Research Site
Amman, Jordan, 11942
Actively Recruiting
59
Research Center
Irbid, Jordan, 21166
Actively Recruiting
60
Research Center
Irbid, Jordan, 22110
Actively Recruiting
61
Research Site
Guadalajara, Jalisco, Mexico, 44670
Actively Recruiting
62
Research Site
Mexico City, Mexico City, Mexico, 06700
Actively Recruiting
63
Research Site
Muscat, Oman, 123
Actively Recruiting
64
Research Site
Riyadh, Saudi Arabia, 11211
Actively Recruiting
65
Research Site
Riyadh, Saudi Arabia, 11426
Actively Recruiting
66
Research Site
Riyadh, Saudi Arabia, 11472
Actively Recruiting
67
Research Center
Belgrade, Serbia, 11000
Actively Recruiting
68
Research Site
Belgrade, Serbia, 11000
Actively Recruiting
69
Research Site
Pančevo, Serbia, 26000
Actively Recruiting
70
Research Center
Zaječar, Serbia, 19000
Actively Recruiting
71
Research Site
Seongnam-si, Gyeonggi-do, South Korea, 13620
Actively Recruiting
72
Research Site
Jeonju, Jeollabuk-do, South Korea, 54907
Actively Recruiting
73
Research Site
Busan, South Korea, 49201
Actively Recruiting
74
Research Site
Sejong, South Korea, 30099
Actively Recruiting
75
Research Site
Seoul, South Korea, 02841
Actively Recruiting
76
Research Site
Seoul, South Korea, 05505
Actively Recruiting
77
Research Site
Seoul, South Korea, 06351
Actively Recruiting
78
Research Site
Seoul, South Korea, 06591
Actively Recruiting
79
Research Center
Gothenburg, Sweden, 41345
Actively Recruiting
80
Research Center
Stockholm, Sweden, 14186
Actively Recruiting
81
Research Site
Abu Dhabi, United Arab Emirates, 133500
Actively Recruiting
82
Research Site
Abu Dhabi, United Arab Emirates, 51900
Actively Recruiting
83
Research Site
Al Ain City, United Arab Emirates, 15258
Actively Recruiting
Research Team
M
Medical Monitor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here