Study of ARO-APOC3 in Adults With Dyslipidemia

NCT ID: NCT05413135

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

418 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-07

Study Completion Date

2025-09-18

Brief Summary

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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.

Detailed Description

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Conditions

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Dyslipidemias

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ARO-APOC3

1 dose of ARO-APOC3 by subcutaneous (sc) injection every 3 months

Group Type EXPERIMENTAL

ARO-APOC3

Intervention Type DRUG

ARO-APOC3 Injection

Interventions

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ARO-APOC3

ARO-APOC3 Injection

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Arrowhead Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Clinical Research Site 1

Beverly Hills, California, United States

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Clinical Research Site 2

Northridge, California, United States

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Clinical Research Site 3

Palm Springs, California, United States

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Clincal Research Site 4

Boca Raton, Florida, United States

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Clinical Research Site 5

Fort Lauderdale, Florida, United States

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Clinical Research Site 8

Miami, Florida, United States

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Clinical Research Site 6

Miami, Florida, United States

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Clinical Research Site 9

Miami Springs, Florida, United States

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Clinical Research Site 10

Pembroke Pines, Florida, United States

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Clinical Research Site 11

Port Orange, Florida, United States

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Clinical Research Site 12

Dunwoody, Georgia, United States

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Clinical Research Site 13

Minneapolis, Minnesota, United States

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Clinical Research Site 14

Tupelo, Mississippi, United States

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Clinical Research Site 15

Omaha, Nebraska, United States

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Clinical Research Site 16

Las Vegas, Nevada, United States

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Clinical Research Site 17

Long Island City, New York, United States

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Clinical Research Site 18

New Windsor, New York, United States

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Clinical Research Site 19

New York, New York, United States

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Clinical Research Site 20

Morehead City, North Carolina, United States

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Clinical Research Site 21

Fargo, North Dakota, United States

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Clinical Research Site 22

Marion, Ohio, United States

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Clinical Research Site 23

Maumee, Ohio, United States

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Clinical Research Site 24

Oklahoma City, Oklahoma, United States

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Clinical Research Site 25

Greenville, South Carolina, United States

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Clinical Research Site 26

Chattanooga, Tennessee, United States

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Clinical Research Site 29

Houston, Texas, United States

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Clinical Research Site 27

Houston, Texas, United States

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Clinical Research Site 28

Houston, Texas, United States

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Clinical Research Site 30

San Antonio, Texas, United States

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Clinical Research Site 31

Manassas, Virginia, United States

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Clinical Research Site 32

Camperdown, New South Wales, Australia

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Clinical Research Site 33

Milton, Queensland, Australia

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Clinical Research Site 34

Sippy Downs, Queensland, Australia

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Clinical Research Site 35

Adelaide, South Australia, Australia

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Clinical Research Site 36

Clayton, Victoria, Australia

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Clinical Research Site 37

Joondalup, Washington, Australia

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Clinical Research Site 38

Nedlands, Washington, Australia

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Clinical Research Site 39

Concord, Ontario, Canada

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Clinical Research Site 40

London, Ontario, Canada

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Clinical Research Site 41

Chicoutimi, Quebec, Canada

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Clinical Research Site 43

Montreal, Quebec, Canada

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Clinical Research Site 44

Québec, Quebec, Canada

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Clinical Research Site 46

Balatonfüred, , Hungary

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Clinical Research Site 47

Békéscsaba, , Hungary

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Clinical Research Site 48

Debrecen, , Hungary

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Clinical Research Site 49

Gyöngyös, , Hungary

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Clinical Research Site 50

Komárom, , Hungary

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Clinical Research Site 51

Nyíregyháza, , Hungary

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Clinical Research Site 53

Amsterdam, , Netherlands

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Clinical Research Site 54

Sneek, , Netherlands

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Clinical Research Site 55

Zwijndrecht, , Netherlands

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Clinical Research Site 58

Papatoetoe, Aukland, New Zealand

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Clinical Research Site 56

Christchurch, , New Zealand

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Clinical Research Site 57

Christchurch, , New Zealand

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Clinical Research Site 59

Bydgoszcz, , Poland

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Clinical Research Site 64

Lodz, , Poland

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Clinical Research Site 63

Lodz, , Poland

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Clinical Research Site 60

Oświęcim, , Poland

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Clinical Research Site 61

Poznan, , Poland

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Clinical Research Site 62

Rzeszów, , Poland

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Countries

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United States Australia Canada Hungary Netherlands New Zealand Poland

Other Identifiers

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AROAPOC3-2003

Identifier Type: -

Identifier Source: org_study_id