Study of ARO-APOC3 in Adults With Dyslipidemia

NCT05413135 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: AROAPOC3-2003
• Study Type: interventional
• Target: 418
• Locations: 7 countries
• Sites: 60

Brief 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.

Conditions

Dyslipidemias

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Treatment-Emergent Adverse Events (TEAEs)

  Through 24 months

Secondary Outcomes (12)

• Change from Baseline in Fasting Triglycerides (TG) Over Time

  Through 24 months

• Percent Change from Baseline in Fasting TG Over Time

  Through 24 months

• Change from Baseline in Apolipoprotein (Apo) C-III Over Time

  Through 24 months

• Percent Change from Baseline in ApoC-III Over Time

  Through 24 months

• Change from Baseline in Fasting Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) Over Time

  Through 24 months

Study Arms (1)

ARO-APOC3

EXPERIMENTAL

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

Drug: ARO-APOC3

Interventions

ARO-APOC3 DRUG

ARO-APOC3 Injection

ARO-APOC3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Arrowhead Pharmaceuticals: lead

Study Sites (60)

Clinical Research Site 1

Beverly Hills, California, 90211, United States

Location

Clinical Research Site 2

Northridge, California, 91325, United States

Location

Clinical Research Site 3

Palm Springs, California, 92292, United States

Location

Clincal Research Site 4

Boca Raton, Florida, 33434, United States

Location

Clinical Research Site 5

Fort Lauderdale, Florida, 33308, United States

Location

Clinical Research Site 8

Miami, Florida, 33155, United States

Location

Clinical Research Site 6

Miami, Florida, 33173, United States

Location

Clinical Research Site 9

Miami Springs, Florida, 33166, United States

Location

Clinical Research Site 10

Pembroke Pines, Florida, 33024, United States

Location

Clinical Research Site 11

Port Orange, Florida, 32127, United States

Location

Clinical Research Site 12

Dunwoody, Georgia, 30338, United States

Location

Clinical Research Site 13

Minneapolis, Minnesota, 55455, United States

Location

Clinical Research Site 14

Tupelo, Mississippi, 38801, United States

Location

Clinical Research Site 15

Omaha, Nebraska, 68114, United States

Location

Clinical Research Site 16

Las Vegas, Nevada, 89121, United States

Location

Clinical Research Site 17

Long Island City, New York, 11106, United States

Location

Clinical Research Site 18

New Windsor, New York, 12553, United States

Location

Clinical Research Site 19

New York, New York, 10029, United States

Location

Clinical Research Site 20

Morehead City, North Carolina, 28557, United States

Location

Clinical Research Site 21

Fargo, North Dakota, 58104, United States

Location

Clinical Research Site 22

Marion, Ohio, 43302, United States

Location

Clinical Research Site 23

Maumee, Ohio, 43537, United States

Location

Clinical Research Site 24

Oklahoma City, Oklahoma, 73135, United States

Location

Clinical Research Site 25

Greenville, South Carolina, 29607, United States

Location

Clinical Research Site 26

Chattanooga, Tennessee, 37421, United States

Location

Clinical Research Site 29

Houston, Texas, 77002, United States

Location

Clinical Research Site 27

Houston, Texas, 77030, United States

Location

Clinical Research Site 28

Houston, Texas, 77099, United States

Location

Clinical Research Site 30

San Antonio, Texas, 78249, United States

Location

Clinical Research Site 31

Manassas, Virginia, 20110, United States

Location

Clinical Research Site 32

Camperdown, New South Wales, 2050, Australia

Location

Clinical Research Site 33

Milton, Queensland, 4068, Australia

Location

Clinical Research Site 34

Sippy Downs, Queensland, 4556, Australia

Location

Clinical Research Site 35

Adelaide, South Australia, 5000, Australia

Location

Clinical Research Site 36

Clayton, Victoria, 3168, Australia

Location

Clinical Research Site 37

Joondalup, Washington, 6027, Australia

Location

Clinical Research Site 38

Nedlands, Washington, 6009, Australia

Location

Clinical Research Site 39

Concord, Ontario, L4K4M2, Canada

Location

Clinical Research Site 40

London, Ontario, N6A 5A5, Canada

Location

Clinical Research Site 41

Chicoutimi, Quebec, G7H 7K9, Canada

Location

Clinical Research Site 43

Montreal, Quebec, H2W 1R7, Canada

Location

Clinical Research Site 44

Québec, Quebec, G1G 3Z4, Canada

Location

Clinical Research Site 46

Balatonfüred, H-8230, Hungary

Location

Clinical Research Site 47

Békéscsaba, 5600, Hungary

Location

Clinical Research Site 48

Debrecen, 4032, Hungary

Location

Clinical Research Site 49

Gyöngyös, 3200, Hungary

Location

Clinical Research Site 50

Komárom, H-2900, Hungary

Location

Clinical Research Site 51

Nyíregyháza, 4400, Hungary

Location

Clinical Research Site 53

Amsterdam, 1105 AZ, Netherlands

Location

Clinical Research Site 54

Sneek, 8601 ZR, Netherlands

Location

Clinical Research Site 55

Zwijndrecht, 3331LZ, Netherlands

Location

Clinical Research Site 58

Papatoetoe, Aukland, 2025, New Zealand

Location

Clinical Research Site 56

Christchurch, 8011, New Zealand

Location

Clinical Research Site 57

Christchurch, 8013, New Zealand

Location

Clinical Research Site 59

Bydgoszcz, 85-605, Poland

Location

Clinical Research Site 64

Lodz, 93-338, Poland

Location

Clinical Research Site 63

Lodz, 94 046, Poland

Location

Clinical Research Site 60

Oświęcim, 32-600, Poland

Location

Clinical Research Site 61

Poznan, 61-655, Poland

Location

Clinical Research Site 62

Rzeszów, 35-055, Poland

Location

MeSH Terms

Conditions

Dyslipidemias

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2022
• First Posted: June 9, 2022
• Study Start: July 7, 2022
• Primary Completion: September 18, 2025
• Study Completion: September 18, 2025
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

AU (7); HU (6); NL (3); US (30); CA (5); NZ (3); PL (6)