Study of ARO-APOC3 in Adults With Dyslipidemia

May 8, 2026 updated by: Arrowhead Pharmaceuticals

A Phase 2 Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of ARO-APOC3 in Adults With Dyslipidemia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

418

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Clinical Research Site 32
    • Queensland
      • Milton, Queensland, Australia, 4068
        • Clinical Research Site 33
      • Sippy Downs, Queensland, Australia, 4556
        • Clinical Research Site 34
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Clinical Research Site 35
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Clinical Research Site 36
    • Washington
      • Joondalup, Washington, Australia, 6027
        • Clinical Research Site 37
      • Nedlands, Washington, Australia, 6009
        • Clinical Research Site 38
  • Canada
    • Ontario
      • Concord, Ontario, Canada, L4K4M2
        • Clinical Research Site 39
      • London, Ontario, Canada, N6A 5A5
        • Clinical Research Site 40
    • Quebec
      • Chicoutimi, Quebec, Canada, G7H 7K9
        • Clinical Research Site 41
      • Montreal, Quebec, Canada, H2W 1R7
        • Clinical Research Site 43
      • Québec, Quebec, Canada, G1G 3Z4
        • Clinical Research Site 44
  • Hungary
      • Balatonfüred, Hungary, H-8230
        • Clinical Research Site 46
      • Békéscsaba, Hungary, 5600
        • Clinical Research Site 47
      • Debrecen, Hungary, 4032
        • Clinical Research Site 48
      • Gyöngyös, Hungary, 3200
        • Clinical Research Site 49
      • Komárom, Hungary, H-2900
        • Clinical Research Site 50
      • Nyíregyháza, Hungary, 4400
        • Clinical Research Site 51
  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
        • Clinical Research Site 53
      • Sneek, Netherlands, 8601 ZR
        • Clinical Research Site 54
      • Zwijndrecht, Netherlands, 3331LZ
        • Clinical Research Site 55
  • New Zealand
      • Christchurch, New Zealand, 8011
        • Clinical Research Site 56
      • Christchurch, New Zealand, 8013
        • Clinical Research Site 57
    • Aukland
      • Papatoetoe, Aukland, New Zealand, 2025
        • Clinical Research Site 58
  • Poland
      • Bydgoszcz, Poland, 85-605
        • Clinical Research Site 59
      • Lodz, Poland, 93-338
        • Clinical Research Site 64
      • Lodz, Poland, 94 046
        • Clinical Research Site 63
      • Oświęcim, Poland, 32-600
        • Clinical Research Site 60
      • Poznan, Poland, 61-655
        • Clinical Research Site 61
      • Rzeszów, Poland, 35-055
        • Clinical Research Site 62
  • United States
    • California
      • Beverly Hills, California, United States, 90211
        • Clinical Research Site 1
      • Northridge, California, United States, 91325
        • Clinical Research Site 2
      • Palm Springs, California, United States, 92292
        • Clinical Research Site 3
    • Florida
      • Boca Raton, Florida, United States, 33434
        • Clincal Research Site 4
      • Fort Lauderdale, Florida, United States, 33308
        • Clinical Research Site 5
      • Miami, Florida, United States, 33155
        • Clinical Research Site 8
      • Miami, Florida, United States, 33173
        • Clinical Research Site 6
      • Miami Springs, Florida, United States, 33166
        • Clinical Research Site 9
      • Pembroke Pines, Florida, United States, 33024
        • Clinical Research Site 10
      • Port Orange, Florida, United States, 32127
        • Clinical Research Site 11
    • Georgia
      • Dunwoody, Georgia, United States, 30338
        • Clinical Research Site 12
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Clinical Research Site 13
    • Mississippi
      • Tupelo, Mississippi, United States, 38801
        • Clinical Research Site 14
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Clinical Research Site 15
    • Nevada
      • Las Vegas, Nevada, United States, 89121
        • Clinical Research Site 16
    • New York
      • Long Island City, New York, United States, 11106
        • Clinical Research Site 17
      • New Windsor, New York, United States, 12553
        • Clinical Research Site 18
      • New York, New York, United States, 10029
        • Clinical Research Site 19
    • North Carolina
      • Morehead City, North Carolina, United States, 28557
        • Clinical Research Site 20
    • North Dakota
      • Fargo, North Dakota, United States, 58104
        • Clinical Research Site 21
    • Ohio
      • Marion, Ohio, United States, 43302
        • Clinical Research Site 22
      • Maumee, Ohio, United States, 43537
        • Clinical Research Site 23
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73135
        • Clinical Research Site 24
    • South Carolina
      • Greenville, South Carolina, United States, 29607
        • Clinical Research Site 25
    • Tennessee
      • Chattanooga, Tennessee, United States, 37421
        • Clinical Research Site 26
    • Texas
      • Houston, Texas, United States, 77002
        • Clinical Research Site 29
      • Houston, Texas, United States, 77030
        • Clinical Research Site 27
      • Houston, Texas, United States, 77099
        • Clinical Research Site 28
      • San Antonio, Texas, United States, 78249
        • Clinical Research Site 30
    • Virginia
      • Manassas, Virginia, United States, 20110
        • Clinical Research Site 31

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults who are nonpregnant, nonlactating and do not plan to become pregnant during the study
  • Able and willing to provide written informed consent
  • Completed the 48-week study treatment period in the parent study

Exclusion Criteria:

  • Subject was permanently discontinued from ARO-APOC3 in the parent study due to elevated glycated hemoglobin (HbA1c), aspartate aminotransferase (AST) or alanine aminotransferase (ALT)
  • Any new condition or worsening of existing condition or any other situation that would make the subject unsuitable for enrollment, could interfere with the subject participating in or completing the study, would make it difficult to comply with protocol requirements or put the subject at additional safety risk
  • Unwilling to limit alcohol consumption to within moderate limits for the duration of the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ARO-APOC3
1 dose of ARO-APOC3 by subcutaneous (sc) injection every 3 months
Drug: ARO-APOC3
ARO-APOC3 Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
Time Frame: Through 24 months
Through 24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline in Fasting Triglycerides (TG) Over Time
Time Frame: Through 24 months
Through 24 months
Percent Change from Baseline in Fasting TG Over Time
Time Frame: Through 24 months
Through 24 months
Change from Baseline in Apolipoprotein (Apo) C-III Over Time
Time Frame: Through 24 months
Through 24 months
Percent Change from Baseline in ApoC-III Over Time
Time Frame: Through 24 months
Through 24 months
Change from Baseline in Fasting Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) Over Time
Time Frame: Through 24 months
Through 24 months
Percent Change from Baseline in Fasting Non-HDL-C Over Time
Time Frame: Through 24 months
Through 24 months
Change from Baseline in Fasting High-Density Lipoprotein-Cholesterol (HDL-C) Over Time
Time Frame: Through 24 months
Through 24 months
Percent Change from Baseline in Fasting HDL-C Over Time
Time Frame: Through 24 months
Through 24 months
Change from Baseline in Fasting Total Apolipoprotein B (ApoB) Over Time
Time Frame: Through 24 months
Through 24 months
Percent Change from Baseline in Fasting Total ApoB Over Time
Time Frame: Through 24 months
Through 24 months
Change from Baseline in Fasting Low-Density Lipoprotein-Cholesterol (LDL-C) Over Time Using Ultracentrifugation
Time Frame: Through 24 months
Through 24 months
Percent Change from Baseline in Fasting LDL-C Over Time Using Ultracentrifugation
Time Frame: Through 24 months
Through 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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 Major Dates

Study Start (Actual)

July 7, 2022

Primary Completion (Actual)

September 22, 2025

Study Completion (Actual)

September 22, 2025

Study Registration Dates

First Submitted

June 7, 2022

First Submitted That Met QC Criteria

June 7, 2022

First Posted (Actual)

June 9, 2022

Study Record Updates

Last Update Posted (Actual)

May 12, 2026

Last Update Submitted That Met QC Criteria

May 8, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AROAPOC3-2003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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