Status:
RECRUITING
Study of Plozasiran in Adults With Severe Hypertriglyceridemia at Risk of Acute Pancreatitis
Lead Sponsor:
Arrowhead Pharmaceuticals
Conditions:
Severe Hypertriglyceridemia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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)...
Eligibility Criteria
Inclusion
- Males, or nonpregnant (who do not plan to become pregnant) nonlactating females
- Established diagnosis of SHTG and prior documented evidence of fasting TG levels of ≥ 880 mg/dL (≥ 10 mmol/L)
- Documented evidence of at least 1 prior AP event not attributed to other etiologies occurring within the last 60 months prior to Screening.
- Fasting low-density lipoprotein cholesterol (LDL-C) ≤ 130 mg/dL (≤ 3.37 mmol/L) at Screening
- Screening hemoglobin A1c (HbA1c) ≤ 9.5%
- Willing to follow diet counseling and maintain a stable low-fat diet
- Must be on standard of care lipid and TG-lowering medications per local guidelines (unless documented as intolerant, or a treatment failure as determined by the Investigator)
Exclusion
- Use of any hepatocyte-targeted small interfering ribonucleic acid (siRNA) that targets lipids and/or triglycerides within 365 days before Day 1, except inclisiran.
- Use of any other hepatocyte targeted siRNA or antisense oligonucleotide molecule within 60 days or within 5 half-lives lives before day 1. Whichever is longer.
- AP ≤ 4 weeks prior to Randomization/Day 1
- Body mass index (BMI) \> 45 kg/m\^2
- Any planned bariatric surgery or similar procedures to induce weight lost starting at consent through End of Study (EOS)
- Planned coronary intervention (e.g. stent placement or heart bypass) during the study
- History of arterial revascularization within 16 weeks of Screening
- History of acute coronary syndrome event within 24 weeks of Screening
- Recent atherosclerotic cardiovascular disease (ASCVD) event within 24 weeks of Screening
- Recent unstable or symptomatic cardiac arrhythmia (including any associated medication changes) within 90 days of Screening. Individuals with stable well-controlled atrial arrhythmia will be allowed to participate in the study
- History of pacemaker or automatic implantable cardioverter defibrillators implant within 30 days before Screening
- New York Heart Association Class III-IV heart failure or last known ejection fraction of \< 30%
- Current diagnosis of nephrotic syndrome
- Chronic kidney disease, defined by an estimated glomerular filtration rate (eGFR) \< 20 mL/min/1.73 m\^2
- Liver disease defined as cirrhosis or Child-Pugh Class B and C, or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2.5× Upper Limit of Normal (ULN) at Screening
- Note: Additional Inclusion/Exclusion Criteria may apply per protocol
Key Trial Info
Start Date :
April 24 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2029
Estimated Enrollment :
288 Patients enrolled
Trial Details
Trial ID
NCT06880770
Start Date
April 24 2025
End Date
June 1 2029
Last Update
December 15 2025
Active Locations (33)
Enter a location and click search to find clinical trials sorted by distance.
1
Clinical Research Site 4
Santa Clarita, California, United States, 91321
2
Clinical Research Site 6
Springfield, Illinois, United States, 62703
3
Research Site
Kansas City, Kansas, United States, 66160
4
Research Site
St Louis, Missouri, United States, 63110