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DyslipidemiasPhase 2NCT05413135

Study of ARO-APOC3 in Adults With Dyslipidemia

A Phase 2 study testing ARO-APOC3 in people with Dyslipidemias, run by Arrowhead Pharmaceuticals at 60 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Dyslipidemias
What is being tested?
ARO-APOC3
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
418 participants
Where
60 sitesin 7 countries
Study dates
7 Jul 2022to 22 Sep 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

60 sites in 7 countries.

60 sites in 7 countries

United States30 sites

  • Clinical Research Site 1

    Beverly Hills, California, 90211

  • Clincal Research Site 4

    Boca Raton, Florida, 33434

  • Clinical Research Site 26

    Chattanooga, Tennessee, 37421

  • Clinical Research Site 12

    Dunwoody, Georgia, 30338

  • Clinical Research Site 21

    Fargo, North Dakota, 58104

  • Clinical Research Site 5

    Fort Lauderdale, Florida, 33308

  • Clinical Research Site 25

    Greenville, South Carolina, 29607

  • Clinical Research Site 29

    Houston, Texas, 77002

  • Clinical Research Site 27

    Houston, Texas, 77030

  • Clinical Research Site 28

    Houston, Texas, 77099

  • Clinical Research Site 16

    Las Vegas, Nevada, 89121

  • Clinical Research Site 17

    Long Island City, New York, 11106

  • Clinical Research Site 31

    Manassas, Virginia, 20110

  • Clinical Research Site 22

    Marion, Ohio, 43302

  • Clinical Research Site 23

    Maumee, Ohio, 43537

  • Clinical Research Site 8

    Miami, Florida, 33155

  • Clinical Research Site 6

    Miami, Florida, 33173

  • Clinical Research Site 9

    Miami Springs, Florida, 33166

  • Clinical Research Site 13

    Minneapolis, Minnesota, 55455

  • Clinical Research Site 20

    Morehead City, North Carolina, 28557

  • Clinical Research Site 18

    New Windsor, New York, 12553

  • Clinical Research Site 19

    New York, New York, 10029

  • Clinical Research Site 2

    Northridge, California, 91325

  • Clinical Research Site 24

    Oklahoma City, Oklahoma, 73135

  • Clinical Research Site 15

    Omaha, Nebraska, 68114

  • Clinical Research Site 3

    Palm Springs, California, 92292

  • Clinical Research Site 10

    Pembroke Pines, Florida, 33024

  • Clinical Research Site 11

    Port Orange, Florida, 32127

  • Clinical Research Site 30

    San Antonio, Texas, 78249

  • Clinical Research Site 14

    Tupelo, Mississippi, 38801

Other trials in United States

Australia7 sites

  • Clinical Research Site 35

    Adelaide, South Australia, 5000

  • Clinical Research Site 32

    Camperdown, New South Wales, 2050

  • Clinical Research Site 36

    Clayton, Victoria, 3168

  • Clinical Research Site 37

    Joondalup, Washington, 6027

  • Clinical Research Site 33

    Milton, Queensland, 4068

  • Clinical Research Site 38

    Nedlands, Washington, 6009

  • Clinical Research Site 34

    Sippy Downs, Queensland, 4556

Other trials in Australia

Hungary6 sites

  • Clinical Research Site 46

    Balatonfüred, H-8230

  • Clinical Research Site 47

    Békéscsaba, 5600

  • Clinical Research Site 48

    Debrecen, 4032

  • Clinical Research Site 49

    Gyöngyös, 3200

  • Clinical Research Site 50

    Komárom, H-2900

  • Clinical Research Site 51

    Nyíregyháza, 4400

Other trials in Hungary

Poland6 sites

  • Clinical Research Site 59

    Bydgoszcz, 85-605

  • Clinical Research Site 64

    Lodz, 93-338

  • Clinical Research Site 63

    Lodz, 94 046

  • Clinical Research Site 60

    Oświęcim, 32-600

  • Clinical Research Site 61

    Poznan, 61-655

  • Clinical Research Site 62

    Rzeszów, 35-055

Other trials in Poland

Canada5 sites

  • Clinical Research Site 41

    Chicoutimi, Quebec, G7H 7K9

  • Clinical Research Site 39

    Concord, Ontario, L4K4M2

  • Clinical Research Site 40

    London, Ontario, N6A 5A5

  • Clinical Research Site 43

    Montreal, Quebec, H2W 1R7

  • Clinical Research Site 44

    Québec, Quebec, G1G 3Z4

Other trials in Canada

Netherlands3 sites

  • Clinical Research Site 53

    Amsterdam, 1105 AZ

  • Clinical Research Site 54

    Sneek, 8601 ZR

  • Clinical Research Site 55

    Zwijndrecht, 3331LZ

Other trials in Netherlands

New Zealand3 sites

  • Clinical Research Site 56

    Christchurch, 8011

  • Clinical Research Site 57

    Christchurch, 8013

  • Clinical Research Site 58

    Papatoetoe, Aukland, 2025

Other trials in New Zealand

About this study

Official title: 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.

Conditions
Dyslipidemias
Being tested
ARO-APOC3
Medical subject headings
Dyslipidemias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ARO-APOC3Drug

    ARO-APOC3 Injection

Study groups in NCT05413135
Study groupRoleWhat they receive
ARO-APOC3Experimental1 dose of ARO-APOC3 by subcutaneous (sc) injection every 3 months
Receives: Drug: ARO-APOC3

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Through 24 months

Secondary outcomes (12)

  1. Change from Baseline in Fasting Triglycerides (TG) Over Time

    Measured: Through 24 months

  2. Percent Change from Baseline in Fasting TG Over Time

    Measured: Through 24 months

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

    Measured: Through 24 months

  4. Percent Change from Baseline in ApoC-III Over Time

    Measured: Through 24 months

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

    Measured: Through 24 months

  6. Percent Change from Baseline in Fasting Non-HDL-C Over Time

    Measured: Through 24 months

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

    Measured: Through 24 months

  8. Percent Change from Baseline in Fasting HDL-C Over Time

    Measured: Through 24 months

  9. Change from Baseline in Fasting Total Apolipoprotein B (ApoB) Over Time

    Measured: Through 24 months

  10. Percent Change from Baseline in Fasting Total ApoB Over Time

    Measured: Through 24 months

  11. Change from Baseline in Fasting Low-Density Lipoprotein-Cholesterol (LDL-C) Over Time Using Ultracentrifugation

    Measured: Through 24 months

  12. Percent Change from Baseline in Fasting LDL-C Over Time Using Ultracentrifugation

    Measured: Through 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jun 2022
  2. Study start7 Jul 2022
  3. Primary completion22 Sep 2025
  4. Study completion22 Sep 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
418 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05413135
Sponsor's protocol ID
AROAPOC3-2003
Status last verified
May 2026
First submitted
7 Jun 2022
Last updated
12 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ballantyne CM, Baass A, Rosenson RS, Hegele RA, Nicholls SJ, Vasas S, Clifton P, Lucas KJ, Pall D, Zhou R, Leeper NJ, Hellawell J, Aiyer L, Watts GF, Gaudet D. Use of plozasiran across a spectrum of hypertriglyceridemia: Long-term efficacy and safety data from the open-label extension period of SHASTA-2 and MUIR Trials. Am J Prev Cardiol. 2026 Mar 24;27:101523. doi: 10.1016/j.ajpc.2026.101523. eCollection 2026 Jun.

    PubMed 42291067

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ARO-APOC3 in people with Dyslipidemias, run by Arrowhead Pharmaceuticals at 60 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 60 sites in United States, Australia, Hungary, Poland, Canada and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with Treatment-Emergent Adverse Events (TEAEs) (time frame: Through 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05413135, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.

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