ACTIVE_NOT_RECRUITING

Study of Plozasiran (ARO-APOC3) in Adults With Severe Hypertriglyceridemia

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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 Phase 3 study will evaluate the safety and efficacy of plozasiran injection (ARO-APOC3) in adult participants with severe hypertriglyceridemia (SHTG). After providing informed consent eligible participants will be randomized to receive 4 doses (once every 3 months) of plozasiran or placebo, and be evaluated for efficacy and safety. After month 12, eligible participants will be offered an opportunity to continue in an optional open-label extension under a separate protocol.

Official Title

Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Plozasiran in Adults With Severe Hypertriglyceridemia

Quick Facts

Study Start:2024-07-22

Study Completion:2026-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06347003

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, who are ≥18 years of age at screening * Established diagnosis of severe hypertriglyceridemia (SHTG) and prior documented evidence (medical history) of fasting TG levels of ≥ 500 mg/dL (≥5.65mmol/L) * Mean fasting TG level ≥500 mg/dL (≥5.65 mmol/L) collected at 2 separate and consecutive visits at least 7 days apart and no more than 17 days apart during the screening period * Fasting low density lipoprotein-cholesterol (LDL-C) ≤130 mg/dL (≤3.37 mmol/L) at screening * Screening 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 as determined by the Investigator, including an inability to safely administer or re-administer a specific drug because of fear, preference, genetic, clinical, or metabolic considerations, or due to a previous adverse reaction associated with, attributed to, or caused by specific drug)	* Use of any hepatocyte-targeted small interfering ribonucleic acid (siRNA) that targets lipids and/or triglycerides within 365 days before Day 1 (except inclisiran, which is permitted). Administration of investigational drug and inclisiran must be separated by at least 4 weeks * Use of any other hepatocyte-targeted siRNA or antisense oligonucleotide molecule within 60 days or within 5-half-lives before Day 1 based on plasma pharmacokinetics (PK), whichever is longer * Known diagnosis of familial chylomicronemia syndrome (FCS) (type 1 Hyperlipoproteinemia) by documentation of confirmed homozygote or double heterozygote for loss-of-function mutations in type 1-causing genes * Acute pancreatitis within 4 weeks prior to screening * Body mass index \>45kg/m\^2

Inclusion Criteria

Exclusion Criteria

* Males, or nonpregnant (who do not plan to become pregnant) nonlactating females, who are ≥18 years of age at screening
* Established diagnosis of severe hypertriglyceridemia (SHTG) and prior documented evidence (medical history) of fasting TG levels of ≥ 500 mg/dL (≥5.65mmol/L)
* Mean fasting TG level ≥500 mg/dL (≥5.65 mmol/L) collected at 2 separate and consecutive visits at least 7 days apart and no more than 17 days apart during the screening period
* Fasting low density lipoprotein-cholesterol (LDL-C) ≤130 mg/dL (≤3.37 mmol/L) at screening
* Screening 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 as determined by the Investigator, including an inability to safely administer or re-administer a specific drug because of fear, preference, genetic, clinical, or metabolic considerations, or due to a previous adverse reaction associated with, attributed to, or caused by specific drug)

* Use of any hepatocyte-targeted small interfering ribonucleic acid (siRNA) that targets lipids and/or triglycerides within 365 days before Day 1 (except inclisiran, which is permitted). Administration of investigational drug and inclisiran must be separated by at least 4 weeks
* Use of any other hepatocyte-targeted siRNA or antisense oligonucleotide molecule within 60 days or within 5-half-lives before Day 1 based on plasma pharmacokinetics (PK), whichever is longer
* Known diagnosis of familial chylomicronemia syndrome (FCS) (type 1 Hyperlipoproteinemia) by documentation of confirmed homozygote or double heterozygote for loss-of-function mutations in type 1-causing genes
* Acute pancreatitis within 4 weeks prior to screening
* Body mass index \>45kg/m\^2

Contacts and Locations

Study Locations (Sites)

National Institute of Clinical Research

Garden Grove, California, 92844

United States

Orange County Research Center

Lake Forest, California, 92630

United States

Catalina Research Institute

Montclair, California, 91763

United States

Velocity Clinical Research, Panorama City

Panorama City, California, 91402

United States

The Cardiovascular Center

Redding, California, 96001

United States

Legacy Clinical Trials

Colorado Springs, Colorado, 80909

United States

Neoclinical Research

Hialeah, Florida, 33016

United States

East Coast Institute for Research, LLC

Lake City, Florida, 32055

United States

Panax Clinical Research

Miami Lakes, Florida, 33014

United States

Adult Medicine of Lake County

Mount Dora, Florida, 32757

United States

Florida Institute for Clinical Research

Orlando, Florida, 32825

United States

Baptist Hospital Cardiology

Pensacola, Florida, 32503

United States

TBC Research

Tamarac, Florida, 33321

United States

R & B Medical Center

Tampa, Florida, 33614

United States

East Coast - Institute for Research

Macon, Georgia, 31210

United States

Meridian Clinical Research

Savannah, Georgia, 31401

United States

Advocate Lutheran General Hospital

Park Ridge, Illinois, 60068

United States

Horizon Research Group of Opelousas, LLC

Eunice, Louisiana, 70535

United States

Ascension Saint Agnes Heart care

Baltimore, Maryland, 21229

United States

Elite Clinical Research Center

Flint, Michigan, 48532

United States

University of Minnesota, Lillehei Clinical Research Unit

Minneapolis, Minnesota, 55455

United States

Olive Branch Family Medical Centre

Olive Branch, Mississippi, 38654

United States

Jefferson City Medical Group

Jefferson City, Missouri, 65109

United States

St. Louis Heart and Vascular

Saint Louis, Missouri, 63136

United States

Methodist Physicians Clinic Heart Consultants

Omaha, Nebraska, 68114

United States

Midwest Regional Health Services LLC

Omaha, Nebraska, 68144

United States

Santa Rosa Medical Centers of Nevada

Las Vegas, Nevada, 89119

United States

CHEAR Center LLC

Bronx, New York, 10455

United States

Endocrine Associates of West Village

Long Island City, New York, 11106

United States

NYU Langone Health

New York, New York, 10016

United States

University of Rochester

Rochester, New York, 14642

United States

Vestal Velocity Clinical Research

Vestal, New York, 13850

United States

Carteret Medical Group

Morehead City, North Carolina, 28557

United States

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157

United States

University of Cincinnati-COM

Cincinnati, Ohio, 45219

United States

The Ohio State University

Columbus, Ohio, 43210

United States

Lynn Institute of Norman

Norman, Oklahoma, 73072

United States

Lynn Health Science Institute

Oklahoma City, Oklahoma, 73111

United States

Cardiovascular Research Center of Knoxville

Powell, Tennessee, 37849

United States

Dr. David Turbay MD PLLC

El Paso, Texas, 79905

United States

Gonzalez Research Institute

Houston, Texas, 77029

United States

Baylor College of Medicine-Center for Cardiometabolic Disease Prevention

Houston, Texas, 77030

United States

Houston Methodist Hospital Department of Medicine Research

Houston, Texas, 77030

United States

Synergy Groups Medical LLC

Houston, Texas, 77061

United States

Clinical Trial Network LLC

Houston, Texas, 77074

United States

PlanIt Research PLLC

Houston, Texas, 77079

United States

Endocrine and Psychiatry Center

Houston, Texas, 77095

United States

Andres Garcia Zuniga MD PA

Laredo, Texas, 78041

United States

Synergy Groups Medical

Missouri City, Texas, 77459

United States

Stryde Research

Plano, Texas, 75093

United States

VIP Trials

San Antonio, Texas, 78230

United States

University of Washington

Seattle, Washington, 98109

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 Date2024-07-22

Study Completion Date2026-09

Study Record Updates

Study Start Date2024-07-22

Study Completion Date2026-09

Terms related to this study

Additional Relevant MeSH Terms

Severe Hypertriglyceridemia