ACTIVE_NOT_RECRUITING

Phase 3 Study of Plozasiran in Adults With Hypertriglyceridemia

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Conditions

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 hypertriglyceridemia (HTG). 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.

Official Title

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

Quick Facts

Study Start:2024-05-21
Study Completion:2026-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06347133

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 CriteriaExclusion Criteria
  1. * Established diagnosis of hypertriglyceridemia (HTG) and prior documented evidence (medical history) of mean fasting TG level ≥150 mg/dL (≥1.69 mm/L) and ≤499 mg/dL (≤5.64 mmol/L)
  2. * Mean fasting TG level ≥150 mg/dL (≥1.69 mmol/L) and ≤499 mg/dL (≤5.64 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
  3. * Fasting low density lipoprotein-cholesterol (LDL-C) ≤ 130 mg/dL (≤3.37 mmol/L) at screening
  4. * Screening HbA1c ≤9%
  5. * Willing to follow diet counseling and maintain a stable low-fat diet
  6. * 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 a previous adverse reaction associated with, attributed to, or caused by specific drug) prior to collection of qualifying TG levels.
  1. * 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.
  2. * 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
  3. * Acute pancreatitis within 4 weeks prior to screening
  4. * Body mass index \>45 kg/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
Garden Grove, California, 92844
United States
National Institute of Clinical Research, Inc.
Huntington Beach, California, 92648
United States
Orange County Research Center, Inc.
Lake Forest, California, 92630
United States
Clinical Trials Research
Lincoln, California, 95648
United States
VA Long Beach Healthcare System
Long Beach, California, 90822
United States
Catalina Research Institute, LLC
Montclair, California, 91763
United States
Fomat Medical Research, Inc.
Oxnard, California, 93030
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
Innovative Research of West Florida, Inc.
Clearwater, Florida, 33756
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
Harmony Clinical Research, Inc.
North Miami, Florida, 33162
United States
Florida Institute for Clinical Research
Orlando, Florida, 32825
United States
Baptist Hospital Cardiology
Pensacola, Florida, 32503
United States
Cardiovascular Center of Sarasota Foundation for Research and Education
Sarasota, Florida, 34239
United States
TBC Research
Tamarac, Florida, 33321
United States
Georgia Clinical Research Center, Inc.
Lawrenceville, Georgia, 30044
United States
East Coast Institute For Research, LLC
Macon, Georgia, 31210
United States
Meridian Clinical Research, LLC
Savannah, Georgia, 31406
United States
RNA America Health Sciences
Sugar Hill, Georgia, 30518
United States
Advocate Lutheran General Hospital
Park Ridge, Illinois, 60068
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 & Vascular Specialists
Overland Park, Kansas, 66211
United States
Cotton-O'Neil Clinical Research Center, Stormont-Vail West
Topeka, Kansas, 66606
United States
University of Louisville Research Foundation
Louisville, Kentucky, 40202
United States
Southern Clinical Research
Metairie, Louisiana, 70001
United States
Annapolis Internal Medicine
Annapolis, Maryland, 21401
United States
Ascension Saint Agnes Heart Care
Baltimore, Maryland, 21229
United States
Elite Clinical Research Center
Flint, Michigan, 48532
United States
University of Minnesota Medical Center
Minneapolis, Minnesota, 55455
United States
Olive Branch Family Medical Center
Olive Branch, Mississippi, 38654
United States
Jefferson City Medical Group PC
Jefferson City, Missouri, 65109
United States
St. Louis Heart and Vascular
Saint Louis, Missouri, 63136
United States
Velocity Clinical Research
Norfolk, Nebraska, 68701
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
Overlook Medical Center
Summit, New Jersey, 07901
United States
CHEAR Center LLC
Bronx, New York, 10455
United States
Jack D Weike Hospital
Bronx, New York, 10461
United States
CTSI Investigational Pharmacy
New York, New York, 10016
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
University of Rochester - PARENT
Rochester, New York, 14642
United States
Velocity Clinical Research-Vestal New York
Vestal, New York, 13850
United States
Triad Internal Medicine
Asheboro, North Carolina, 27203
United States
Carteret Medical Group
Morehead City, North Carolina, 28557
United States
Wilmington Health
Wilmington, North Carolina, 28412
United States
Wake Forest University Health Sciences, Department of Cardiology
Winston-Salem, North Carolina, 27157
United States
Internal Medicine Care Inc
Beavercreek, Ohio, 45431
United States
University of Cincinnati College of Medicine
Cincinnati, Ohio, 45267
United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
United States
OhioHealth Research Institute
Columbus, Ohio, 43214
United States
Lynn Institute of Norman
Norman, Oklahoma, 73072
United States
Lynn Health Science Institute East
Oklahoma City, Oklahoma, 73111
United States
Lynn Health Sci. Inst.
Oklahoma City, Oklahoma, 73112
United States
Abington Medical Specialists, P.C.
Horsham, Pennsylvania, 19044
United States
Capital Area Research, LLC
Newport, Pennsylvania, 17074
United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, 18711
United States
Piedmont Research Partners
Fort Mill, South Carolina, 29707
United States
Tribe Clinical Research, LLC
Greenville, South Carolina, 29607
United States
University Diabetes and Endocrine Consultants
Chattanooga, Tennessee, 37411
United States
Cardiovascular Research Center of Knoxville
Powell, Tennessee, 37849
United States
David Turbay, MD, PLLC
El Paso, Texas, 79905
United States
Diabetes and Thyroid Center of Fort Worth
Fort Worth, Texas, 76132
United States
Gonzalez Research Institute
Houston, Texas, 77029
United States
Baylor College of Medicine
Houston, Texas, 77030
United States
Houston Methodist Hospital
Houston, Texas, 77030
United States
Juno Research LLC
Houston, Texas, 77040
United States
Clinical Trial Network LLC
Houston, Texas, 77074
United States
PlanIt Research, PLLC
Houston, Texas, 77079
United States
Synergy Groups Medical LLC
Houston, Texas, 77087
United States
Spring Clinical Research
Houston, Texas, 77090
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
Sugar Lakes Family Practice
Sugar Land, Texas, 77479
United States
Northwest Houston Heart Center
Tomball, Texas, 77375
United States
Crossroads Clinical Research
Victoria, Texas, 77901
United States
Cope Family Medicine
Bountiful, Utah, 84010
United States
Chrysalis Clinical Research, LLC
Saint George, Utah, 84790
United States
Manassas Clinical Research Center
Manassas, Virginia, 20110
United States
UW Medicine Diabetes Institute Clinical Research Unit
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 Date2024-05-21
Study Completion Date2026-10

Study Record Updates

Study Start Date2024-05-21
Study Completion Date2026-10

Terms related to this study

Additional Relevant MeSH Terms

  • Hypertriglyceridemia