ACTIVE_NOT_RECRUITING

Study of Plozasiran 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 Plozsiran in Adults With Severe Hypertriglyceridemia

Quick Facts

Study Start:2024-07-23

Study Completion:2026-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06347016

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
* Established diagnosis of severe hypertriglyceridemia (SHTG) and prior documented evidence (medical history) of fasting TG levels of ≥500 mg/dL (≥5.65 mmol/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% * Must be on standard of care lipid-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 (except inclisiran, which is permitted) * 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 * Body mass index \>45kg/m\^2

Inclusion Criteria

Exclusion Criteria

* Established diagnosis of severe hypertriglyceridemia (SHTG) and prior documented evidence (medical history) of fasting TG levels of ≥500 mg/dL (≥5.65 mmol/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%
* Must be on standard of care lipid-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 (except inclisiran, which is permitted)
* 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
* Body mass index \>45kg/m\^2

Contacts and Locations

Study Locations (Sites)

Ascension St. Vincents Birmingham

Birmingham, Alabama, 35205

United States

IMC-Diagnostic and Medical Clinic LLC

Mobile, Alabama, 36604

United States

National Heart Institute

Beverly Hills, California, 90211

United States

Hope Clinical Research

Canoga Park, California, 91303

United States

National Institute of Clinical Research, Inc.

Huntington Beach, California, 92648

United States

Clinical Trials Research

Lincoln, California, 95648

United States

VA Long Beach Healthcare System

Long Beach, California, 90822

United States

FOMAT Medical Research

Oxnard, California, 93030

United States

Innovative Research of West Florida, Inc.

Clearwater, Florida, 33756

United States

Harmony Clinical Research

North Miami, Florida, 33162

United States

Cardiovascular Center of Sarasota Foundation for Research and Education

Sarasota, Florida, 34239

United States

Georgia Clinical Research, LLC

Lawrenceville, Georgia, 30044

United States

RNA America Health Sciences

Sugar Hill, Georgia, 30518

United States

Midwest Cardiovascular Research and Education Foundation

Elkhart, Indiana, 46514

United States

Ascension St. Vincent Heart Center

Indianapolis, Indiana, 46290

United States

The South Bend Clinic LLC

South Bend, Indiana, 46617

United States

Midwest Heart and Vascular Specialists

Overland Park, Kansas, 66211

United States

Cotton-O'Neil Clinical Research Center, Stormont-Vail West

Topeka, Kansas, 66606

United States

Southern Clinical Research Associates

Metairie, Louisiana, 70001

United States

Annapolis Internal Medicine

Annapolis, Maryland, 21401

United States

Elite Clinical Research

Jackson, Mississippi, 39202

United States

Methodist Physicians Clinic

Fremont, Nebraska, 68025

United States

Velocity Clinical Research

Norfolk, Nebraska, 68701

United States

Overlook Medical Center

Morristown, New Jersey, 07960

United States

Jack D. Weiler Hospital

Bronx, New York, 10461

United States

Icahn School of Medicine at Mount Sinai

New York, New York, 10029

United States

Northwell Health Physician Partners at Peconic

Riverhead, New York, 11901

United States

Triad Internal Medicine

Asheboro, North Carolina, 27203

United States

Wilmington Health

Wilmington, North Carolina, 28412

United States

Internal Medicine Care Beavercreek

Beaver Creek, Ohio, 45431

United States

OhioHealth Riverside Methodist Hospital

Columbus, Ohio, 43214

United States

Lynn Health Science Institute

Oklahoma City, Oklahoma, 73112

United States

AMS Cardiology

Horsham, Pennsylvania, 19044

United States

Capital Area Research, LLC

Newport, Pennsylvania, 17074

United States

University of Pennsylvania

Philadelphia, Pennsylvania, 19104

United States

Piedmont Research Partners

Fort Mill, South Carolina, 29707

United States

Tribe Clinical Research

Greenville, South Carolina, 29607

United States

University Diabetes & Endocrine Consultants

Chattanooga, Tennessee, 37411

United States

Diabetes and Thyroid Center of Fort Worth

Fort Worth, Texas, 76132

United States

Juno Research LLC

Houston, Texas, 77040

United States

Care and Cure Clinic

Houston, Texas, 77090

United States

Spring Clinical Research

Houston, Texas, 77090

United States

Sugar Lakes Family Practice

Sugar Land, Texas, 77479

United States

Northwest Houston Clinical Research, PLLC

Tomball, Texas, 77375

United States

Crossroads Clinical Research

Victoria, Texas, 77901

United States

Cope Family Medicine

Bountiful, Utah, 84010

United States

Chrysalis Clinical Research

Saint George, Utah, 84790

United States

Manassas Clinical Research Center

Manassas, Virginia, 20110

United States

Roanoke Heart Institute

Roanoke, Virginia, 24014

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 Date2024-07-23

Study Completion Date2026-09

Study Record Updates

Study Start Date2024-07-23

Study Completion Date2026-09

Terms related to this study

Additional Relevant MeSH Terms

Severe Hypertriglyceridemia