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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
418

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
Time Frame: Through 24 months
Through 24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 7, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 22, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 22, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 7, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 7, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 9, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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