Study of ARO-APOC3 in Adults With Dyslipidemia

Last updated: May 8, 2026
Sponsor: Arrowhead Pharmaceuticals
Overall Status: Completed

Phase

2

Condition

N/A

Treatment

ARO-APOC3

Clinical Study ID

NCT05413135
AROAPOC3-2003
  • Ages > 18
  • All Genders

Study Summary

This is an open-label extension of the parent studies AROAPOC3-2001 and AROAPOC3-2002. Adult participants with dyslipidemia who completed the blinded 12-month period from either parent study and continued to meet eligibility criteria had the option to be enrolled into this study. Eligible enrolled participants initially received open-label ARO-APOC3 every three or six months at the assigned dose level of the parent study until a final dose of 25 mg was selected, at which point all participants transitioned to the selected dosing regimen of 25 mg every 3 months.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adults who are nonpregnant, nonlactating and do not plan to become pregnant duringthe study

  • Able and willing to provide written informed consent

  • Completed the 48-week study treatment period in the parent study

Exclusion

Exclusion Criteria:

  • Subject was permanently discontinued from ARO-APOC3 in the parent study due toelevated glycated hemoglobin (HbA1c), aspartate aminotransferase (AST) or alanineaminotransferase (ALT)

  • Any new condition or worsening of existing condition or any other situation thatwould make the subject unsuitable for enrollment, could interfere with the subjectparticipating in or completing the study, would make it difficult to comply withprotocol requirements or put the subject at additional safety risk

  • Unwilling to limit alcohol consumption to within moderate limits for the duration ofthe study

Study Design

Total Participants: 418
Treatment Group(s): 1
Primary Treatment: ARO-APOC3
Phase: 2
Study Start date:
July 07, 2022
Estimated Completion Date:
September 22, 2025

Connect with a study center

  • Clinical Research Site 32

    Camperdown, New South Wales 2050
    Australia

    Site Not Available

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales 2050
    Australia

    Site Not Available

  • Clinical Research Site 32

    Camperdown 2172563, New South Wales 2155400 2050
    Australia

    Site Not Available

  • Clinical Research Site 33

    Milton, Queensland 4068
    Australia

    Site Not Available

  • Core Research Group Pty Ltd

    Milton, Queensland 4068
    Australia

    Site Not Available

  • Clinical Research Site 34

    Sippy Downs, Queensland 4556
    Australia

    Site Not Available

  • USC Clinical Trials - Sippy Downs

    Sippy Downs, Queensland 4556
    Australia

    Site Not Available

  • Clinical Research Site 33

    Milton 6943570, Queensland 2152274 4068
    Australia

    Site Not Available

  • Clinical Research Site 34

    Sippy Downs 8219830, Queensland 2152274 4556
    Australia

    Site Not Available

  • Clinical Research Site 35

    Adelaide, South Australia 5000
    Australia

    Site Not Available

  • Royal Adelaide Hospital

    Adelaide, South Australia 5000
    Australia

    Site Not Available

  • Clinical Research Site 35

    Adelaide 2078025, South Australia 2061327 5000
    Australia

    Site Not Available

  • Clinical Research Site 36

    Clayton, Victoria 3168
    Australia

    Site Not Available

  • Monash Health

    Clayton, Victoria 3168
    Australia

    Site Not Available

  • Clinical Research Site 36

    Clayton 2171400, Victoria 2145234 3168
    Australia

    Site Not Available

  • Clinical Research Site 37

    Joondalup, Washington 6027
    Australia

    Site Not Available

  • Clinical Research Site 37

    Joondalup 6695255, Washington 6027
    Australia

    Site Not Available

  • Clinical Research Site 38

    Nedlands, Washington 6009
    Australia

    Site Not Available

  • Clinical Research Site 38

    Nedlands 2064874, Washington 6009
    Australia

    Site Not Available

  • Genesis Care changing to Advara heartcare

    Joondalup, Western Australia 6027
    Australia

    Site Not Available

  • Linear Clinical Research

    Nedlands, Western Australia 6009
    Australia

    Site Not Available

  • Clinical Research Site 39

    Concord, Ontario L4K4M2
    Canada

    Site Not Available

  • LMC Clinical Research Inc

    Concord, Ontario L4K4M2
    Canada

    Site Not Available

  • Clinical Research Site 40

    London, Ontario N6A 5A5
    Canada

    Site Not Available

  • Lawson Health Research Institute

    London, Ontario N6A 5A5
    Canada

    Site Not Available

  • Clinical Research Site 39

    Concord 5926526, Ontario 6093943 L4K4M2
    Canada

    Site Not Available

  • Clinical Research Site 40

    London 6058560, Ontario 6093943 N6A 5A5
    Canada

    Site Not Available

  • Centre d'Etudes Cliniques ECOGENE-21

    Chicoutimi, Quebec G7H 7K9
    Canada

    Site Not Available

  • Clinical Research Site 41

    Chicoutimi, Quebec G7H 7K9
    Canada

    Site Not Available

  • ViaCar Recherches Cliniques Inc.

    Greenfield Park, Quebec J4V 2G8
    Canada

    Site Not Available

  • Clinical Research Site 43

    Montreal, Quebec H2W 1R7
    Canada

    Site Not Available

  • Institut de Recherches Cliniques de Montreal

    Montréal, Quebec H2W 1R7
    Canada

    Site Not Available

  • Clinical Research Site 44

    Québec, Quebec G1G 3Z4
    Canada

    Site Not Available

  • Recherche Clinique Sigma Inc

    Québec, Quebec G1G 3Z4
    Canada

    Site Not Available

  • Clinical Research Site 41

    Chicoutimi 5921225, Quebec 6115047 G7H 7K9
    Canada

    Site Not Available

  • Clinical Research Site 43

    Montreal 6077243, Quebec 6115047 H2W 1R7
    Canada

    Site Not Available

  • Clinical Research Site 44

    Québec 6325494, Quebec 6115047 G1G 3Z4
    Canada

    Site Not Available

  • Lausmed Kft

    Baja, 6500
    Hungary

    Site Not Available

  • Clinical Research Site 46

    Balatonfüred, H-8230
    Hungary

    Site Not Available

  • DRC Gyogyszervizsgalo Kozpont Balatonfured

    Balatonfüred, H-8230
    Hungary

    Site Not Available

  • Clinical Research Site 46

    Balatonfüred 3055566, H-8230
    Hungary

    Site Not Available

  • Belgyogyaszati Kardiologiai Maganrendelo

    Békéscsaba, 5600
    Hungary

    Site Not Available

  • Clinical Research Site 47

    Békéscsaba, 5600
    Hungary

    Site Not Available

  • Clinical Research Site 47

    Békéscsaba 722437, 5600
    Hungary

    Site Not Available

  • Clinical Research Site 48

    Debrecen, 4032
    Hungary

    Site Not Available

  • Debreceni Egyetem Klinikai K

    Debrecen, 4032
    Hungary

    Site Not Available

  • Clinical Research Site 48

    Debrecen 721472, 4032
    Hungary

    Site Not Available

  • Clinical Research Site 49

    Gyöngyös, 3200
    Hungary

    Site Not Available

  • Pharma4trial Ltd

    Gyöngyös, 3200
    Hungary

    Site Not Available

  • Clinical Research Site 49

    Gyöngyös 3052040, 3200
    Hungary

    Site Not Available

  • Clinical Research Site 50

    Komárom, H-2900
    Hungary

    Site Not Available

  • Selye Janos Korhaz

    Komárom, H-2900
    Hungary

    Site Not Available

  • Clinical Research Site 50

    Komárom 3049519, H-2900
    Hungary

    Site Not Available

  • Borbanya Praxis Kft

    Nyíregyháza, 4400
    Hungary

    Site Not Available

  • Clinical Research Site 51

    Nyíregyháza, 4400
    Hungary

    Site Not Available

  • Medifarma 98 Kft

    Nyíregyháza, 4400
    Hungary

    Site Not Available

  • Clinical Research Site 51

    Nyíregyháza 716935, 4400
    Hungary

    Site Not Available

  • AMC

    Amsterdam, 1105 AZ
    Netherlands

    Site Not Available

  • Clinical Research Site 53

    Amsterdam, 1105 AZ
    Netherlands

    Site Not Available

  • Clinical Research Site 53

    Amsterdam 2759794, 1105 AZ
    Netherlands

    Site Not Available

  • Clinical Research Site 54

    Sneek, 8601 ZR
    Netherlands

    Site Not Available

  • D and A Research

    Sneek, 8601 ZR
    Netherlands

    Site Not Available

  • Clinical Research Site 54

    Sneek 2747063, 8601 ZR
    Netherlands

    Site Not Available

  • Albert Schweitzer Ziekenhuis

    Zwijndrecht, 3331LZ
    Netherlands

    Site Not Available

  • Clinical Research Site 55

    Zwijndrecht, 3331LZ
    Netherlands

    Site Not Available

  • Clinical Research Site 55

    Zwijndrecht 2743493, 3331LZ
    Netherlands

    Site Not Available

  • Clinical Research Site 58

    Papatoetoe, Aukland 2025
    New Zealand

    Site Not Available

  • Middlemore Clinical Trials

    Papatoetoe, Aukland 2025
    New Zealand

    Site Not Available

  • Clinical Research Site 58

    Papatoetoe 6232008, Aukland 2025
    New Zealand

    Site Not Available

  • Clinical Research Site 56

    Christchurch, 8011
    New Zealand

    Site Not Available

  • Clinical Research Site 57

    Christchurch, 8013
    New Zealand

    Site Not Available

  • NZCR OpCo Ltd

    Christchurch, 8011
    New Zealand

    Site Not Available

  • Southern Clinical Trials Christchurch

    Christchurch, 8013
    New Zealand

    Site Not Available

  • Clinical Research Site 56

    Christchurch 2192362, 8011
    New Zealand

    Site Not Available

  • Clinical Research Site 57

    Christchurch 2192362, 8013
    New Zealand

    Site Not Available

  • Centrum Medyczne Intercor

    Bydgoszcz, 85-605
    Poland

    Site Not Available

  • Clinical Research Site 59

    Bydgoszcz, 85-605
    Poland

    Site Not Available

  • Clinical Research Site 59

    Bydgoszcz 3102014, 85-605
    Poland

    Site Not Available

  • Clinical Research Site 63

    Lodz, 94 046
    Poland

    Site Not Available

  • Clinical Research Site 64

    Lodz, 93-338
    Poland

    Site Not Available

  • Clinical Research Site 63

    Lodz 3093133, 94 046
    Poland

    Site Not Available

  • Clinical Research Site 64

    Lodz 3093133, 93-338
    Poland

    Site Not Available

  • Clinical Research Site 60

    Oświęcim, 32-600
    Poland

    Site Not Available

  • Medicome Sp. z o.o.

    Oświęcim, 32-600
    Poland

    Site Not Available

  • Clinical Research Site 60

    Oświęcim 3089658, 32-600
    Poland

    Site Not Available

  • Clinical Research Site 61

    Poznan, 61-655
    Poland

    Site Not Available

  • Clinical Research Site 61

    Poznan 3088171, 61-655
    Poland

    Site Not Available

  • Praktyka Lekarska Ewa Krzyzagorska

    Poznań, 61-655
    Poland

    Site Not Available

  • Centrum Medyczne Medyk

    Rzeszów, 35-055
    Poland

    Site Not Available

  • Clinical Research Site 62

    Rzeszów, 35-055
    Poland

    Site Not Available

  • Clinical Research Site 62

    Rzeszów 759734, 35-055
    Poland

    Site Not Available

  • All MED Centrum Medyczne

    Łódź, 94 046
    Poland

    Site Not Available

  • Instytut Centrum Zdrowia Matki Polki

    Łódź, 93-338
    Poland

    Site Not Available

  • Clinical Research Site 1

    Beverly Hills, California 90211
    United States

    Site Not Available

  • Westside Medical Associates of Los Angeles

    Beverly Hills, California 90211
    United States

    Site Not Available

  • Clinical Research Site 2

    Northridge, California 91325
    United States

    Site Not Available

  • Valley Clinical Trials; Inc.

    Northridge, California 91325
    United States

    Site Not Available

  • Clinical Research Site 3

    Palm Springs, California 92292
    United States

    Site Not Available

  • Desert Medical Group, Inc.

    Palm Springs, California 92292
    United States

    Site Not Available

  • Clinical Research Site 1

    Beverly Hills 5328041, California 5332921 90211
    United States

    Site Not Available

  • Clinical Research Site 2

    Northridge 5377985, California 5332921 91325
    United States

    Site Not Available

  • Clinical Research Site 3

    Palm Springs 5380668, California 5332921 92292
    United States

    Site Not Available

  • Clincal Research Site 4

    Boca Raton, Florida 33434
    United States

    Site Not Available

  • Preventive Cardiology Inc.

    Boca Raton, Florida 33434
    United States

    Site Not Available

  • Clinical Research Site 5

    Fort Lauderdale, Florida 33308
    United States

    Site Not Available

  • Invesclinic U,S, LLC

    Fort Lauderdale, Florida 33308
    United States

    Site Not Available

  • A Positive Research, Inc

    Miami, Florida 33173
    United States

    Site Not Available

  • AppleMed Res Group

    Miami, Florida 33155
    United States

    Site Not Available

  • Clinical Research Site 6

    Miami, Florida 33173
    United States

    Site Not Available

  • Clinical Research Site 8

    Miami, Florida 33155
    United States

    Site Not Available

  • Y and L Advance Health Care

    Miami, Florida 33144
    United States

    Site Not Available

  • Clinical Research Site 9

    Miami Springs, Florida 33166
    United States

    Site Not Available

  • Ocean Blue Medical Research Center Inc.

    Miami Springs, Florida 33166
    United States

    Site Not Available

  • A&R Research Group

    Pembroke Pines, Florida 33024
    United States

    Site Not Available

  • Clinical Research Site 10

    Pembroke Pines, Florida 33024
    United States

    Site Not Available

  • Clinical Research Site 11

    Port Orange, Florida 32127
    United States

    Site Not Available

  • Progressive Medical Research

    Port Orange, Florida 32127
    United States

    Site Not Available

  • Clincal Research Site 4

    Boca Raton 4148411, Florida 4155751 33434
    United States

    Site Not Available

  • Clinical Research Site 5

    Fort Lauderdale 4155966, Florida 4155751 33308
    United States

    Site Not Available

  • Clinical Research Site 6

    Miami 4164138, Florida 4155751 33173
    United States

    Site Not Available

  • Clinical Research Site 8

    Miami 4164138, Florida 4155751 33155
    United States

    Site Not Available

  • Clinical Research Site 9

    Miami Springs 4164223, Florida 4155751 33166
    United States

    Site Not Available

  • Clinical Research Site 10

    Pembroke Pines 4168139, Florida 4155751 33024
    United States

    Site Not Available

  • Clinical Research Site 11

    Port Orange 4169156, Florida 4155751 32127
    United States

    Site Not Available

  • Alta Pharmaceutical Research Center

    Dunwoody, Georgia 30338
    United States

    Site Not Available

  • Clinical Research Site 12

    Dunwoody, Georgia 30338
    United States

    Site Not Available

  • Clinical Research Site 12

    Dunwoody 4192375, Georgia 4197000 30338
    United States

    Site Not Available

  • Clinical Research Site 13

    Minneapolis, Minnesota 55455
    United States

    Site Not Available

  • University of Minnesota

    Minneapolis, Minnesota 55455
    United States

    Site Not Available

  • Clinical Research Site 13

    Minneapolis 5037649, Minnesota 5037779 55455
    United States

    Site Not Available

  • Cardiology Assoc Res LLC

    Tupelo, Mississippi 38801
    United States

    Site Not Available

  • Clinical Research Site 14

    Tupelo, Mississippi 38801
    United States

    Site Not Available

  • Clinical Research Site 14

    Tupelo 4448903, Mississippi 4436296 38801
    United States

    Site Not Available

  • Clinical Research Site 15

    Omaha, Nebraska 68114
    United States

    Site Not Available

  • Methodist Physicians Clinic Heart Consultants

    Omaha, Nebraska 68114
    United States

    Site Not Available

  • Clinical Research Site 15

    Omaha 5074472, Nebraska 5073708 68114
    United States

    Site Not Available

  • Clinical Res of South Nevada

    Las Vegas, Nevada 89121
    United States

    Site Not Available

  • Clinical Research Site 16

    Las Vegas, Nevada 89121
    United States

    Site Not Available

  • Clinical Research Site 16

    Las Vegas 5506956, Nevada 5509151 89121
    United States

    Site Not Available

  • Clinical Research Site 17

    Long Island City, New York 11106
    United States

    Site Not Available

  • NYC Research Inc.

    Long Island City, New York 11106
    United States

    Site Not Available

  • Clinical Research Site 18

    New Windsor, New York 12553
    United States

    Site Not Available

  • Mid Hudson Medical Research; PLLC

    New Windsor, New York 12553
    United States

    Site Not Available

  • Clinical Research Site 19

    New York, New York 10029
    United States

    Site Not Available

  • Icahn School of Medicine at Mount Sinai (ISMMS)

    New York, New York 10029
    United States

    Site Not Available

  • Clinical Research Site 17

    Long Island City 5125125, New York 5128638 11106
    United States

    Site Not Available

  • Clinical Research Site 18

    New Windsor 5128577, New York 5128638 12553
    United States

    Site Not Available

  • Clinical Research Site 19

    New York 5128581, New York 5128638 10029
    United States

    Site Not Available

  • Clinical Research Site 20

    Morehead City, North Carolina 28557
    United States

    Site Not Available

  • Lucas Research, Inc.

    Morehead City, North Carolina 28557
    United States

    Site Not Available

  • Clinical Research Site 20

    Morehead City 4480153, North Carolina 4482348 28557
    United States

    Site Not Available

  • Clinical Research Site 21

    Fargo, North Dakota 58104
    United States

    Site Not Available

  • Lillestol Research LLC

    Fargo, North Dakota 58104
    United States

    Site Not Available

  • Clinical Research Site 21

    Fargo 5059163, North Dakota 5690763 58104
    United States

    Site Not Available

  • Clinical Research Site 22

    Marion, Ohio 43302
    United States

    Site Not Available

  • Marion Area Health Center

    Marion, Ohio 43302
    United States

    Site Not Available

  • Advanced Medical Research

    Maumee, Ohio 43537
    United States

    Site Not Available

  • Clinical Research Site 23

    Maumee, Ohio 43537
    United States

    Site Not Available

  • Clinical Research Site 22

    Marion 5161902, Ohio 5165418 43302
    United States

    Site Not Available

  • Clinical Research Site 23

    Maumee 5162137, Ohio 5165418 43537
    United States

    Site Not Available

  • Clinical Research Site 24

    Oklahoma City, Oklahoma 73135
    United States

    Site Not Available

  • South Oklahoma Heart Res;LLC

    Oklahoma City, Oklahoma 73135
    United States

    Site Not Available

  • Clinical Research Site 24

    Oklahoma City 4544349, Oklahoma 4544379 73135
    United States

    Site Not Available

  • Clinical Research Site 25

    Greenville, South Carolina 29607
    United States

    Site Not Available

  • Tribe Clinical Research

    Greenville, South Carolina 29607
    United States

    Site Not Available

  • Clinical Research Site 25

    Greenville 4580543, South Carolina 4597040 29607
    United States

    Site Not Available

  • ClinSearch, LLC

    Chattanooga, Tennessee 37421
    United States

    Site Not Available

  • Clinical Research Site 26

    Chattanooga, Tennessee 37421
    United States

    Site Not Available

  • Clinical Research Site 26

    Chattanooga 4612862, Tennessee 4662168 37421
    United States

    Site Not Available

  • Baylor College of Medicine

    Houston, Texas 77030
    United States

    Site Not Available

  • Clinical Research Site 27

    Houston, Texas 77030
    United States

    Site Not Available

  • Clinical Research Site 28

    Houston, Texas 77099
    United States

    Site Not Available

  • Clinical Research Site 29

    Houston, Texas 77002
    United States

    Site Not Available

  • East Texas Cardiology PA

    Houston, Texas 77002
    United States

    Site Not Available

  • Pioneer Research Solutions, Inc.

    Houston, Texas 77099
    United States

    Site Not Available

  • BFHC Research

    San Antonio, Texas 78249
    United States

    Site Not Available

  • Clinical Research Site 30

    San Antonio, Texas 78249
    United States

    Site Not Available

  • Clinical Research Site 27

    Houston 4699066, Texas 4736286 77030
    United States

    Site Not Available

  • Clinical Research Site 28

    Houston 4699066, Texas 4736286 77099
    United States

    Site Not Available

  • Clinical Research Site 29

    Houston 4699066, Texas 4736286 77002
    United States

    Site Not Available

  • Clinical Research Site 30

    San Antonio 4726206, Texas 4736286 78249
    United States

    Site Not Available

  • Clinical Research Site 31

    Manassas, Virginia 20110
    United States

    Site Not Available

  • Manassas Clinical Research Center

    Manassas, Virginia 20110
    United States

    Site Not Available

  • Clinical Research Site 31

    Manassas 4771401, Virginia 6254928 20110
    United States

    Site Not Available

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