Phase 3 Study of Plozasiran in Adults With Hypertriglyceridemia
- Registration Number
- NCT06347133
- Lead Sponsor
- Arrowhead Pharmaceuticals
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1328
- 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)
- 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
- Fasting low density lipoprotein-cholesterol (LDL-C) ≤ 130 mg/dL (≤3.37 mmol/L) at screening
- Screening HbA1c ≤8.5%
- Willing to follow diet counseling and maintain a stable low-fat diet
- Must be on standard of care lipid-lowering medications per local guidelines (unless documented as intolerant 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, 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
- Acute pancreatitis within 4 weeks prior to screening
- Body mass index >45 kg/m^2
Note: Additional Inclusion/Exclusion criteria may apply per protocol
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo calculated volume to match active treatment by sc injection Plozasiran Injection Plozasiran Injection 4 doses of plozasiran by subcutaneous (sc) injection
- Primary Outcome Measures
Name Time Method Percent Change in Fasting Serum Triglyceride (TG) Levels from Baseline to Month 12 Compared to Placebo Baseline, Month 12
- Secondary Outcome Measures
Name Time Method Percent Change in Fasting Serum TG Levels from Baseline to Month 10 Compared to Placebo Baseline, Month 10 Proportion of Participants who Achieve Fasting TG Levels of <150 mg/dL (<1.69 mmol/L) at Month 10 and Month 12 Compared to Placebo Month 10, Month 12 Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) Over Time through Month 12 as Compared to Placebo From first dose of study drug through Month 12 Incidence Rates of New-Onset Diabetes Mellitus (NODM) Throughout the Course of Treatment From first dose of study drug through Month 12 Incidence Rates of Worsening of Existing Diabetes Throughout the Course of Treatment From first dose of study drug through Month 12 Change from Baseline in Hemoglobin A1c (HbA1c) During the Treatment Period Compared to Placebo From first dose of study drug through Month 12 Change from Baseline in Fasting Blood Glucose During the Treatment Period Compared to Placebo From first dose of study drug through Month 12 Change from Baseline in C-peptide During the Treatment Period Compared to Placebo From first dose of study drug through Month 12 Change from Baseline in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) During the Treatment Period Compared to Placebo From first dose of study drug through Month 12 Change from Baseline in Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related Adverse Events (TRAEs) Associated with Worsening Glycemic Control During the Treatment Period Compared to Placebo From first dose of study drug through Month 12 Initiation of New Medication for Hyperglycemia Among Study Participants Not Known to Have Pre-existing Diabetes Mellitus During the Treatment Period Compared to Placebo From first dose of study drug through Month 12 Adjudicated Major Adverse Cardiovascular Events (MACE) Rates During the Treatment Period Compared to Placebo From first dose of study drug through Month 12 Incidence of Anti-drug Antibodies (ADA) to Plozasiran in Participants Receiving Plozasiran Over Time Through Month 12 From first dose of study drug through Month 12 Titers of Anti-drug Antibodies (ADA) to Plozasiran in Participants Receiving Plozasiran Over Time Through Month 12 From first dose of study drug through Month 12
Trial Locations
- Locations (231)
University of Louisville Research Foundation
🇺🇸Louisville, Kentucky, United States
University of Minnesota Medical Center
🇺🇸Minneapolis, Minnesota, United States
Geisinger Wyoming Valley Medical Center
🇺🇸Wilkes-Barre, Pennsylvania, United States
Expertia S.A- Mautalen Salud e Investigación
🇦🇷Caba, Buenos Aires, Argentina
Centro Privado de Medicina Familiar - Mind Out Research
🇦🇷Caba, Buenos Aires, Argentina
Glenny Corp. S.A.
🇦🇷Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Sanatorio Privado Duarte Quiroz De Clinica Colombo SA
🇦🇷Córdoba, Cordoba, Argentina
Centro Medico Luquez
🇦🇷Córdoba, Cordoba, Argentina
CIPADI
🇦🇷Godoy Cruz, Mendoza, Argentina
Instituto CAICI
🇦🇷Rosario, Santa Fe, Argentina
Instituto de Investigaciones Clinicas de Rosario
🇦🇷Rosario, Santa Fe, Argentina
Monash Medical Centre
🇦🇺Clayton, Victoria, Australia
Unilabs Diagnostics, k.s
🇨🇿Teplice, Czechia
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS
🇮🇹Bologna, Italy
Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda)
🇮🇹Milano, Italy
Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu
🇵🇱Toruń, Poland
CM Sedimed Wroclaw
🇵🇱Wrocław, Poland
Diabetes Care Centre
🇿🇦Pretoria, Gauteng, South Africa
Hospital Universitari Vall d'Hebron
🇪🇸Barcelona, Spain
Ascension St. Vincents Birmingham
🇺🇸Birmingham, Alabama, United States
IMC Diagnostic and Medical Clinic, LLC
🇺🇸Mobile, Alabama, United States
National Heart Institute
🇺🇸Beverly Hills, California, United States
Hope Clinical Research
🇺🇸Canoga Park, California, United States
National Institute of Clinical Research
🇺🇸Garden Grove, California, United States
National Institute of Clinical Research, Inc.
🇺🇸Huntington Beach, California, United States
Orange County Research Center, Inc.
🇺🇸Lake Forest, California, United States
Clinical Trials Research
🇺🇸Lincoln, California, United States
VA Long Beach Healthcare System
🇺🇸Long Beach, California, United States
Catalina Research Institute, LLC
🇺🇸Montclair, California, United States
Fomat Medical Research, Inc.
🇺🇸Oxnard, California, United States
Velocity Clinical Research, Panorama City
🇺🇸Panorama City, California, United States
The Cardiovascular Center
🇺🇸Redding, California, United States
Legacy Clinical Trials
🇺🇸Colorado Springs, Colorado, United States
Innovative Research of West Florida, Inc.
🇺🇸Clearwater, Florida, United States
Neoclinical Research
🇺🇸Hialeah, Florida, United States
East Coast Institute for Research, LLC
🇺🇸Lake City, Florida, United States
Panax Clinical Research
🇺🇸Miami Lakes, Florida, United States
Adult Medicine of Lake County
🇺🇸Mount Dora, Florida, United States
Harmony Clinical Research, Inc.
🇺🇸North Miami, Florida, United States
Florida Institute for Clinical Research
🇺🇸Orlando, Florida, United States
Baptist Hospital Cardiology
🇺🇸Pensacola, Florida, United States
Cardiovascular Center of Sarasota Foundation for Research and Education
🇺🇸Sarasota, Florida, United States
TBC Research
🇺🇸Tamarac, Florida, United States
Georgia Clinical Research Center, Inc.
🇺🇸Lawrenceville, Georgia, United States
East Coast Institute For Research, LLC
🇺🇸Macon, Georgia, United States
Meridian Clinical Research, LLC
🇺🇸Savannah, Georgia, United States
RNA America Health Sciences
🇺🇸Sugar Hill, Georgia, United States
Advocate Lutheran General Hospital
🇺🇸Park Ridge, Illinois, United States
Midwest Cardiovascular Research and Education Foundation
🇺🇸Elkhart, Indiana, United States
Ascension St. Vincent Heart Center
🇺🇸Indianapolis, Indiana, United States
The South Bend Clinic LLC
🇺🇸South Bend, Indiana, United States
Midwest Heart & Vascular Specialists
🇺🇸Overland Park, Kansas, United States
Cotton-O'Neil Clinical Research Center, Stormont-Vail West
🇺🇸Topeka, Kansas, United States
Southern Clinical Research
🇺🇸Metairie, Louisiana, United States
Annapolis Internal Medicine
🇺🇸Annapolis, Maryland, United States
Ascension Saint Agnes Heart Care
🇺🇸Baltimore, Maryland, United States
Elite Clinical Research Center
🇺🇸Flint, Michigan, United States
Olive Branch Family Medical Center
🇺🇸Olive Branch, Mississippi, United States
Jefferson City Medical Group PC
🇺🇸Jefferson City, Missouri, United States
St. Louis Heart and Vascular
🇺🇸Saint Louis, Missouri, United States
Velocity Clinical Research
🇺🇸Norfolk, Nebraska, United States
Methodist Physicians Clinic Heart Consultants
🇺🇸Omaha, Nebraska, United States
Midwest Regional Health Services LLC
🇺🇸Omaha, Nebraska, United States
Santa Rosa Medical Centers of Nevada
🇺🇸Las Vegas, Nevada, United States
Overlook Medical Center
🇺🇸Summit, New Jersey, United States
CHEAR Center LLC
🇺🇸Bronx, New York, United States
Jack D Weike Hospital
🇺🇸Bronx, New York, United States
CTSI Investigational Pharmacy
🇺🇸New York, New York, United States
Icahn School of Medicine at Mount Sinai
🇺🇸New York, New York, United States
Northwell Health Physician Partners at Peconic
🇺🇸Riverhead, New York, United States
University of Rochester - PARENT
🇺🇸Rochester, New York, United States
Velocity Clinical Research-Vestal New York
🇺🇸Vestal, New York, United States
Triad Internal Medicine
🇺🇸Asheboro, North Carolina, United States
Carteret Medical Group
🇺🇸Morehead City, North Carolina, United States
Wilmington Health
🇺🇸Wilmington, North Carolina, United States
Wake Forest University Health Sciences, Department of Cardiology
🇺🇸Winston-Salem, North Carolina, United States
Internal Medicine Care Inc
🇺🇸Beavercreek, Ohio, United States
University of Cincinnati College of Medicine
🇺🇸Cincinnati, Ohio, United States
The Ohio State University Wexner Medical Center
🇺🇸Columbus, Ohio, United States
OhioHealth Research Institute
🇺🇸Columbus, Ohio, United States
Lynn Institute of Norman
🇺🇸Norman, Oklahoma, United States
Lynn Health Science Institute East
🇺🇸Oklahoma City, Oklahoma, United States
Lynn Health Sci. Inst.
🇺🇸Oklahoma City, Oklahoma, United States
Abington Medical Specialists, P.C.
🇺🇸Horsham, Pennsylvania, United States
Capital Area Research, LLC
🇺🇸Newport, Pennsylvania, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Piedmont Research Partners
🇺🇸Fort Mill, South Carolina, United States
Tribe Clinical Research, LLC
🇺🇸Greenville, South Carolina, United States
University Diabetes and Endocrine Consultants
🇺🇸Chattanooga, Tennessee, United States
Cardiovascular Research Center of Knoxville
🇺🇸Powell, Tennessee, United States
David Turbay, MD, PLLC
🇺🇸El Paso, Texas, United States
Diabetes and Thyroid Center of Fort Worth
🇺🇸Fort Worth, Texas, United States
Gonzalez Research Institute
🇺🇸Houston, Texas, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Houston Methodist Hospital
🇺🇸Houston, Texas, United States
Juno Research LLC
🇺🇸Houston, Texas, United States
Clinical Trial Network LLC
🇺🇸Houston, Texas, United States
PlanIt Research, PLLC
🇺🇸Houston, Texas, United States
Synergy Groups Medical LLC
🇺🇸Houston, Texas, United States
Spring Clinical Research
🇺🇸Houston, Texas, United States
Endocrine and Psychiatry Center
🇺🇸Houston, Texas, United States
Andres Garcia Zuniga MD PA
🇺🇸Laredo, Texas, United States
Synergy Groups Medical
🇺🇸Missouri City, Texas, United States
Stryde Research
🇺🇸Plano, Texas, United States
VIP Trials
🇺🇸San Antonio, Texas, United States
Sugar Lakes Family Practice
🇺🇸Sugar Land, Texas, United States
Northwest Houston Heart Center
🇺🇸Tomball, Texas, United States
Crossroads Clinical Research
🇺🇸Victoria, Texas, United States
Cope Family Medicine
🇺🇸Bountiful, Utah, United States
Chrysalis Clinical Research, LLC
🇺🇸Saint George, Utah, United States
Manassas Clinical Research Center
🇺🇸Manassas, Virginia, United States
UW Medicine Diabetes Institute Clinical Research Unit
🇺🇸Seattle, Washington, United States
Paratus Clinical Research, Western Sydney
🇦🇺Blacktown, New South Wales, Australia
The Aim Centre
🇦🇺Merewether, New South Wales, Australia
Austin Health
🇦🇺Heidelberg, Victoria, Australia
MHAT Puls AD
🇧🇬Blagoevgrad, Bulgaria
Medical Center 4LIFE EOOD
🇧🇬Burgas, Bulgaria
MHAT Yuliya Vrevska - Byala, EOOD
🇧🇬Byala, Bulgaria
Medical Center Diamedical - 2013 OOD
🇧🇬Dimitrovgrad, Bulgaria
MHAT-Haskovo, AD
🇧🇬Haskovo, Bulgaria
Medical Center Hera - Kyustendil
🇧🇬Kyustendil, Bulgaria
Medical Center Medconsult Pleven OOD
🇧🇬Pleven, Bulgaria
MHAT Heart and Brain - Pleven
🇧🇬Pleven, Bulgaria
UMHAT Kaspela, EOOD
🇧🇬Plovdiv, Bulgaria
UMHAT Pulmed OOD
🇧🇬Plovdiv, Bulgaria
MHAT Sv. Karidad, EAD
🇧🇬Plovdiv, Bulgaria
MC Rusemed ltd.
🇧🇬Ruse, Bulgaria
Medical Center Unimed EOOD
🇧🇬Sevlievo, Bulgaria
Second Medical Center
🇧🇬Sofia, Bulgaria
MHAT Lyulin EAD
🇧🇬Sofia, Bulgaria
Medical Center 'Acad. I. Penchev', EOOD
🇧🇬Sofia, Bulgaria
UMHAT Alexandrovska EAD
🇧🇬Sofia, Bulgaria
UMHAT Sveta Ekaterina
🇧🇬Sofia, Bulgaria
Medical Center Hera EOOD
🇧🇬Sofia, Bulgaria
UMHAT Tsaritsa Ioanna ISUL Cardiology clinic
🇧🇬Sofia, Bulgaria
UMHAT Tsaritsa Yoanna - ISUL EAD
🇧🇬Sofia, Bulgaria
Medical Center Sv. Dimitar
🇧🇬Sofia, Bulgaria
MHAT Sv. Sofia, OOD
🇧🇬Sofia, Bulgaria
Diagnostic Consultation Center CONVEX EOOD
🇧🇬Sofia, Bulgaria
Medical Center Kalimat
🇧🇬Sofia, Bulgaria
UMHAT SofiaMed, OOD
🇧🇬Sofia, Bulgaria
Medical Center ZARA-MED EOOD
🇧🇬Stara Zagora, Bulgaria
Medical Arts Health Research Group
🇨🇦North Vancouver, British Columbia, Canada
Discovery Clinical Services Ltd.
🇨🇦Victoria, British Columbia, Canada
Centricity Research Brampton
🇨🇦Brampton, Ontario, Canada
Bluewater Clinical Research Group Inc.
🇨🇦Sarnia, Ontario, Canada
Clinical Research Solutions Inc.
🇨🇦Waterloo, Ontario, Canada
Ecogene-21
🇨🇦Chicoutimi, Quebec, Canada
Centre de Recherche Clinique de Laval
🇨🇦Laval, Quebec, Canada
Institut De Recherche Clinique De Montreal
🇨🇦Montréal, Quebec, Canada
Clinique des Maladies Lipidiques de Quebec
🇨🇦Québec, Quebec, Canada
Centre de Medicine Metabolique de Lanaudiere
🇨🇦Québec, Quebec, Canada
Nova Scotia Health Authority
🇨🇦Halifax, Canada
Recherche Clinique Sigma Inc
🇨🇦Quebec, Canada
Institut klinicke a experimentalni mediciny
🇨🇿Praha 4, Prague, Czechia
Fakultni nemocnice u svate Anny v Brne, I. Interni kardioangiologicka klinika
🇨🇿Brno, Czechia
CTC Hodonin s.r.o.
🇨🇿Hodonín, Czechia
Fakultni nemocnice Hradec Kralove
🇨🇿Hradec Králové, Czechia
EDUMED, s.r.o.
🇨🇿Náchod, Czechia
PreventaMed s.r.o.
🇨🇿Olomouc, Czechia
CCR Ostrava s.r.o.
🇨🇿Ostrava, Czechia
MUDr. Jan KVASNICKA CSc.
🇨🇿Praha 10, Czechia
Fakultni Thomayerova nemocnice
🇨🇿Praha 4-Krc, Czechia
Nemocnice Slany
🇨🇿Slaný, Czechia
Kardiologicka ambulance MUDr. Ferkl s.r.o.
🇨🇿Trutnov, Czechia
MEDICAL PLUS s.r.o.
🇨🇿Uherské Hradiště, Czechia
Krajska zdravotni a.s. - Masarykova nemocnice v Usti nad Labem o.z.
🇨🇿Ústí Nad Labem, Czechia
Assistance Publique Hopitaux de Marseille AP HM Hopital de La Conception
🇫🇷Marseille, Bouches Du Rhone, France
Groupe Hospitalier Sud Hôpital Haut-Lévêque
🇫🇷Pessac, Gironde, France
Centre Hospitalier Saint Joseph Saint Luc
🇫🇷Lyon, Rhone, France
APHP Hôpital Universitaire Pitié Salpêtrière
🇫🇷Paris, France
Gemeinschaftspraxis Dres. Jung
🇩🇪Deggingen, Baden Wuerttemberg, Germany
Gemeinschaftspraxis Dr. Josef Grosskopf und Dr. Wilma Grosskopf
🇩🇪Wallerfing, Bayern, Germany
SMO.MD GmbH
🇩🇪Magdeburg, Sachsen Anhalt, Germany
Clinexpert Kft.
🇭🇺Budapest, Hungary
Belvaros-Lipotvaros Egeszsegugyi Szolgalat
🇭🇺Budapest, Hungary
Privat Doktor Zrt.
🇭🇺Budapest, Hungary
UNO Medical Trials Kft.
🇭🇺Budapest, Hungary
Belgyogyaszati es Kardiologiai Maganrendelo
🇭🇺Békéscsaba, Hungary
Obudai Egeszsegugyi Centrum Kft.
🇭🇺Kaposvar, Hungary
IPR Hungary Kft.
🇭🇺Miskolc, Hungary
COROMed-SMO Kft.
🇭🇺Pécs, Hungary
Da Vinci Magánklinika
🇭🇺Pécs, Hungary
Szegedi Tudományegyetem Szent-Gyorgyi Albert Klinikai Kozpont
🇭🇺Szeged, Hungary
Minoseg Orvoscsoport Kft
🇭🇺Veszprém, Hungary
Belvarosi Egeszseghaz Kft.
🇭🇺Zalaegerszeg, Hungary
IRCCS Istituto Clinico Humanitas
🇮🇹Rozzano, Milano, Italy
Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
🇮🇹Palermo, Sicily, Italy
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia - Presidio Spedali Civili
🇮🇹Brescia, Italy
MICS Centrum Medyczne Bydgoszcz
🇵🇱Bydgoszcz, Poland
NZOZ Centrum Medyczne KERmed
🇵🇱Bydgoszcz, Poland
Centrum Kliniczno - Badawcze J. Brzezicki B. Gornikiewicz-Brzezicka Lekarze Społka Partnerska
🇵🇱Elbląg, Poland
Centrum Medyczne Pratia Gdynia
🇵🇱Gdynia, Poland
Clinical Medical Research Sp. z o.o.
🇵🇱Katowice, Poland
Pratia MCM Krakow
🇵🇱Kraków, Poland
Krakowskie Centrum Medyczne
🇵🇱Kraków, Poland
Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Sp z o.o.
🇵🇱Malbork, Poland
Twoja Przychodnia-Szczecinskie Centrum Medyczne
🇵🇱Szczecin, Poland
FutureMeds Warszawa Centrum
🇵🇱Warsaw, Poland
FutureMeds Targowek
🇵🇱Warsaw, Poland
NZOZ Zdrowie s.c. Agnieszka i Donald Drożdż
🇵🇱Wrocław, Poland
FutureMeds Wroclaw
🇵🇱Wrocław, Poland
Velocity Zamosc
🇵🇱Zamość, Poland
FutureMeds Lodz
🇵🇱Łódź, Poland
Indywidualna Specjalistyczna Praktyka Lekarska
🇵🇱Łódź, Poland
Centrum Medyczne Serafin med
🇵🇱Żarów, Poland
Kardiointerna s r o
🇸🇰Banská Bystrica, Slovakia
Alian s.r.o.
🇸🇰Bardejov, Slovakia
Kardiologická ambulancia Cliniq s.r.o.
🇸🇰Bratislava, Slovakia
Kardiovaskularne centrum, s.r.o.
🇸🇰Bratislava, Slovakia
Kardiologicka a interna ambulancia
🇸🇰Košice, Slovakia
Kardiologicka ambulancia MEDI MandM s.r.o.
🇸🇰Moldava Nad Bodvou, Slovakia
Kardiologicka ambulancia Cardioamb s.r.o.
🇸🇰Nové Zámky, Slovakia
Medispol s.r.o.
🇸🇰Prešov, Slovakia
Tatratrial s.r.o.
🇸🇰Roznava, Slovakia
Dr IO Ebrahim Inc
🇿🇦Centurion, Gauteng, South Africa
DJW Research
🇿🇦Krugersdorp, Gauteng, South Africa
Dr Jeevren Reddys Surgery
🇿🇦Durban, KwaZulu-Natal, South Africa
Corbod Research PTY Ltd
🇿🇦Cape Town, Western Cape, South Africa
Tiervlei Trial Centre
🇿🇦Cape Town, Western Cape, South Africa
Langeberg Clinical Trials
🇿🇦Cape Town, Western Cape, South Africa
Groote Schuur Hospital Lipid Laboratory
🇿🇦Cape Town, Western Cape, South Africa
Dr JM Engelbrecht Trial Site
🇿🇦Somerset West, Western Cape, South Africa
RYEXO Clinical Research
🇿🇦Pretoria, South Africa
Complejo Hospitalario Universitario A Coruña
🇪🇸A Coruña, La Coruña, Spain
Hospital Quironsalud Barcelona
🇪🇸Barcelona, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Hospital Clinico Universitario de Valencia
🇪🇸Valencia, Spain
Hospital Universitario Miguel Servet
🇪🇸Zaragoza, Spain
Knowle House Surgery
🇬🇧Plymouth, Devon, United Kingdom
Barts Health NHS Trust
🇬🇧London, United Kingdom