RECRUITING

Study of Plozasiran in Adults With Severe Hypertriglyceridemia at Risk of Acute Pancreatitis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study will evaluate the efficacy and safety of plozasiran in approximately 140 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.

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)

Quick Facts

Study Start:2025-04-24

Study Completion:2029-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06880770

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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 2 prior AP events not attributed to other etiologies with at least 1 occurring within the last 12 months prior to Screening. * Fasting low-density lipoprotein cholesterol (LDL-C) ≤ 130 mg/dL (≤ 3.37 mmol/L) at Screening * Screening hemoglobin A1c (HbA1c) ≤ 9.0% * 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)	* 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

Inclusion Criteria

Exclusion Criteria

* 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 2 prior AP events not attributed to other etiologies with at least 1 occurring within the last 12 months prior to Screening.
* Fasting low-density lipoprotein cholesterol (LDL-C) ≤ 130 mg/dL (≤ 3.37 mmol/L) at Screening
* Screening hemoglobin A1c (HbA1c) ≤ 9.0%
* 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)

* 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

Contacts and Locations

Study Contact

Medical Monitor

CONTACT

626-304-3400

plozasiran@arrowheadpharma.com

Study Locations (Sites)

Clinical Research Site 4

Santa Clarita, California, 91321

United States

Clinical Research Site 6

Springfield, Illinois, 62703

United States

Clinical Research Site 5

North Platte, Nebraska, 69101

United States

Clinical Research Site 3

Greensboro, North Carolina, 27401

United States

Clinical Research Site 7

Philadelphia, Pennsylvania, 19107

United States

Clinical Research Site 1

Mesquite, Texas, 75149

United States

Clinical Research Site 2

San Antonio, Texas, 78154

United States

Collaborators and Investigators

Sponsor: Arrowhead Pharmaceuticals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-24

Study Completion Date2029-06

Study Record Updates

Study Start Date2025-04-24

Study Completion Date2029-06

Terms related to this study

Additional Relevant MeSH Terms

Severe Hypertriglyceridemia