Phase 3 Study of Plozasiran in Adults With Hypertriglyceridemia

Last updated: March 22, 2025
Sponsor: Arrowhead Pharmaceuticals
Overall Status: Active - Recruiting

Phase

3

Condition

Hypertriglyceridemia

Treatment

Placebo

Plozasiran Injection

Clinical Study ID

NCT06347133
AROAPOC3-3009
2023-509302-30
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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 morethan 17 days apart during the screening period

  • Fasting low density lipoprotein-cholesterol (LDL-C) ≤ 130 mg/dL (≤3.37 mmol/L) atscreening

  • 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 (unlessdocumented as intolerant as determined by the Investigator)

Exclusion

Exclusion Criteria:

  • Use of any hepatocyte-targeted small interfering ribonucleic acid (siRNA) thattargets lipids and/or triglycerides within 365 days before Day 1 (except inclisiran,which is permitted). Administration of investigational drug and inclisiran must beseparated by at least 4 weeks.

  • Use of any other hepatocyte targeted siRNA or antisense Oligonucleotide moleculewithin 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

Total Participants: 1328
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
May 21, 2024
Estimated Completion Date:
October 31, 2026

Connect with a study center

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  • Glenny Corp. S.A.

    Ciudad Autonoma de Buenos Aires, Buenos Aires C1430CKE
    Argentina

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  • Centro Medico Luquez

    Córdoba, Cordoba 5006
    Argentina

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  • Sanatorio Privado Duarte Quiroz De Clinica Colombo SA

    Córdoba, Cordoba 5000
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  • CIPADI

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  • Instituto CAICI

    Rosario, Santa Fe 2000
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  • Instituto de Investigaciones Clinicas de Rosario

    Rosario, Santa Fe 2000
    Argentina

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  • Paratus Clinical Research, Western Sydney

    Blacktown, New South Wales 2148
    Australia

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  • The Aim Centre

    Merewether, New South Wales 2291
    Australia

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  • Monash Medical Centre

    Clayton, Victoria 3168
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  • Austin Health

    Heidelberg, Victoria 3084
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    Burgas, 8000
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    Hungary

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    Hungary

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    Hungary

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    Italy

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  • Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone

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    Italy

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  • Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS

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    Italy

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  • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia - Presidio Spedali Civili

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    Italy

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    Poland

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  • NZOZ Centrum Medyczne KERmed

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    Gdynia, 81-338
    Poland

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  • Clinical Medical Research Sp. z o.o.

    Katowice, 40-156
    Poland

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  • Krakowskie Centrum Medyczne

    Kraków, 31-501
    Poland

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  • Pratia MCM Krakow

    Kraków, 30-727
    Poland

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  • Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Sp z o.o.

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    Poland

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  • Twoja Przychodnia-Szczecinskie Centrum Medyczne

    Szczecin, 71-500
    Poland

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  • Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu

    Toruń, 87-100
    Poland

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  • FutureMeds Targowek

    Warsaw, 03-291
    Poland

    Active - Recruiting

  • FutureMeds Warszawa Centrum

    Warsaw, 00-215
    Poland

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  • CM Sedimed Wroclaw

    Wrocław, 53-030
    Poland

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  • FutureMeds Wroclaw

    Wrocław, 53-673
    Poland

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  • NZOZ Zdrowie s.c. Agnieszka i Donald Drożdż

    Wrocław, 51-314
    Poland

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  • Velocity Zamosc

    Zamość, 22-400
    Poland

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  • FutureMeds Lodz

    Łódź, 91-363
    Poland

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  • Indywidualna Specjalistyczna Praktyka Lekarska

    Łódź, 94-255
    Poland

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  • Centrum Medyczne Serafin med

    Żarów, 58-130
    Poland

    Active - Recruiting

  • Kardiointerna s r o

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    Slovakia

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  • Kardiologická ambulancia Cliniq s.r.o.

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    Slovakia

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  • Kardiovaskularne centrum, s.r.o.

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    Slovakia

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    Slovakia

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    Slovakia

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    Slovakia

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  • Tatratrial s.r.o.

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    Slovakia

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  • Dr IO Ebrahim Inc

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    South Africa

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    South Africa

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    South Africa

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    South Africa

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  • RYEXO Clinical Research

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    South Africa

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  • Complejo Hospitalario Universitario A Coruña

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    Spain

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  • Hospital Quironsalud Barcelona

    Barcelona, 08023
    Spain

    Active - Recruiting

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Hospital Universitario 12 de Octubre

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    Spain

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  • Hospital Clinico Universitario de Valencia

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    Spain

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  • Hospital Universitario Miguel Servet

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    Spain

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  • Knowle House Surgery

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    United Kingdom

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  • Barts Health NHS Trust

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    United Kingdom

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    United States

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    United States

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    United States

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    United States

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    United States

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    United States

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    United States

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    United States

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    United States

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    United States

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    Overland Park, Kansas 66211
    United States

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    Topeka, Kansas 66606
    United States

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    Louisville, Kentucky 40202
    United States

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    Metairie, Louisiana 70001
    United States

    Active - Recruiting

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    Annapolis, Maryland 21401
    United States

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  • Ascension Saint Agnes Heart Care

    Baltimore, Maryland 21229
    United States

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    United States

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  • University of Minnesota Medical Center

    Minneapolis, Minnesota 55455
    United States

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    Olive Branch, Mississippi 38654
    United States

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    Jefferson City, Missouri 65109
    United States

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    Saint Louis, Missouri 63136
    United States

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    Norfolk, Nebraska 68701
    United States

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    Omaha, Nebraska 68114
    United States

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    Omaha, Nebraska 68144
    United States

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    Las Vegas, Nevada 89119
    United States

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    Summit, New Jersey 07901
    United States

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    Bronx, New York 10455
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    Bronx, New York 10461
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    New York, New York 10016
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    New York, New York 10029
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    Active - Recruiting

  • Northwell Health Physician Partners at Peconic

    Riverhead, New York 11901
    United States

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  • University of Rochester - PARENT

    Rochester, New York 14642
    United States

    Active - Recruiting

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    Vestal, New York 13850
    United States

    Active - Recruiting

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    Asheboro, North Carolina 27203
    United States

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    Morehead City, North Carolina 28557
    United States

    Active - Recruiting

  • Wilmington Health

    Wilmington, North Carolina 28412
    United States

    Active - Recruiting

  • Wake Forest University Health Sciences, Department of Cardiology

    Winston-Salem, North Carolina 27157
    United States

    Active - Recruiting

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    Beavercreek, Ohio 45431
    United States

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  • University of Cincinnati College of Medicine

    Cincinnati, Ohio 45267
    United States

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    Columbus, Ohio 43214
    United States

    Active - Recruiting

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio 43210
    United States

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    Norman, Oklahoma 73072
    United States

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  • Lynn Health Sci. Inst.

    Oklahoma City, Oklahoma 73112
    United States

    Active - Recruiting

  • Lynn Health Science Institute East

    Oklahoma City, Oklahoma 73111
    United States

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    Horsham, Pennsylvania 19044
    United States

    Active - Recruiting

  • Capital Area Research, LLC

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    United States

    Active - Recruiting

  • University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • Geisinger Wyoming Valley Medical Center

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    United States

    Active - Recruiting

  • Piedmont Research Partners

    Fort Mill, South Carolina 29707
    United States

    Active - Recruiting

  • Tribe Clinical Research, LLC

    Greenville, South Carolina 29607
    United States

    Active - Recruiting

  • University Diabetes and Endocrine Consultants

    Chattanooga, Tennessee 37411
    United States

    Active - Recruiting

  • Cardiovascular Research Center of Knoxville

    Powell, Tennessee 37849
    United States

    Active - Recruiting

  • David Turbay, MD, PLLC

    El Paso, Texas 79905
    United States

    Active - Recruiting

  • Diabetes and Thyroid Center of Fort Worth

    Fort Worth, Texas 76132
    United States

    Active - Recruiting

  • Baylor College of Medicine

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Clinical Trial Network LLC

    Houston, Texas 77074
    United States

    Active - Recruiting

  • Endocrine and Psychiatry Center

    Houston, Texas 77095
    United States

    Active - Recruiting

  • Gonzalez Research Institute

    Houston, Texas 77029
    United States

    Active - Recruiting

  • Houston Methodist Hospital

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Juno Research LLC

    Houston, Texas 77040
    United States

    Active - Recruiting

  • PlanIt Research, PLLC

    Houston, Texas 77079
    United States

    Active - Recruiting

  • Spring Clinical Research

    Houston, Texas 77090
    United States

    Active - Recruiting

  • Synergy Groups Medical LLC

    Houston, Texas 77087
    United States

    Active - Recruiting

  • Andres Garcia Zuniga MD PA

    Laredo, Texas 78041
    United States

    Active - Recruiting

  • Synergy Groups Medical

    Missouri City, Texas 77459
    United States

    Active - Recruiting

  • Stryde Research

    Plano, Texas 75093
    United States

    Active - Recruiting

  • VIP Trials

    San Antonio, Texas 78230
    United States

    Active - Recruiting

  • Sugar Lakes Family Practice

    Sugar Land, Texas 77479
    United States

    Active - Recruiting

  • Northwest Houston Heart Center

    Tomball, Texas 77375
    United States

    Active - Recruiting

  • Crossroads Clinical Research

    Victoria, Texas 77901
    United States

    Active - Recruiting

  • Cope Family Medicine

    Bountiful, Utah 84010
    United States

    Active - Recruiting

  • Chrysalis Clinical Research, LLC

    Saint George, Utah 84790
    United States

    Active - Recruiting

  • Manassas Clinical Research Center

    Manassas, Virginia 20110
    United States

    Active - Recruiting

  • UW Medicine Diabetes Institute Clinical Research Unit

    Seattle, Washington 98109
    United States

    Active - Recruiting

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