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Study of ARO-APOC3 in Adults With Dyslipidemia

Primary Purpose

Dyslipidemias

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ARO-APOC3
Sponsored by
Arrowhead Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyslipidemias

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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

Sites / Locations

  • Westside Medical Associates of Los Angeles
  • Valley Clinical Trials; Inc.
  • Desert Medical Group, Inc.
  • Preventive Cardiology Inc.
  • Invesclinic U,S, LLC
  • Ocean Blue Medical Research Center Inc.
  • Y and L Advance Health Care
  • AppleMed Res Group
  • A Positive Research, Inc
  • A&R Research Group
  • Progressive Medical Research
  • Alta Pharmaceutical Research Center
  • University of Minnesota
  • Cardiology Assoc Res LLC
  • Methodist Physicians Clinic Heart Consultants
  • Clinical Res of South Nevada
  • NYC Research Inc.
  • Mid Hudson Medical Research; PLLC
  • Icahn School of Medicine at Mount Sinai (ISMMS)
  • Lucas Research, Inc.
  • Lillestol Research LLC
  • Marion Area Health Center
  • Advanced Medical Research
  • South Oklahoma Heart Res;LLC
  • Tribe Clinical Research
  • ClinSearch, LLC
  • East Texas Cardiology PA
  • Baylor College of Medicine
  • Pioneer Research Solutions, Inc.
  • BFHC Research
  • Manassas Clinical Research Center
  • Royal Prince Alfred Hospital
  • Core Research Group Pty Ltd
  • USC Clinical Trials - Sippy Downs
  • Royal Adelaide Hospital
  • Monash Health
  • Genesis Care changing to Advara heartcare
  • Linear Clinical Research
  • LMC Clinical Research Inc
  • Lawson Health Research Institute
  • Centre d'Etudes Cliniques ECOGENE-21
  • ViaCar Recherches Cliniques Inc.
  • Institut de Recherches Cliniques de Montreal
  • Recherche Clinique Sigma Inc
  • Lausmed Kft
  • DRC Gyogyszervizsgalo Kozpont Balatonfured
  • Belgyogyaszati Kardiologiai Maganrendelo
  • Debreceni Egyetem Klinikai K
  • Pharma4trial Ltd
  • Selye Janos Korhaz
  • Borbanya Praxis Kft
  • AMC
  • D and A Research
  • Albert Schweitzer Ziekenhuis
  • Middlemore Clinical Trials
  • NZCR OpCo Ltd
  • Southern Clinical Trials Christchurch
  • Centrum Medyczne Intercor
  • Medicome Sp. z o.o.
  • Praktyka Lekarska Ewa Krzyzagorska
  • Centrum Medyczne Medyk
  • Instytut Centrum Zdrowia Matki Polki
  • All MED Centrum Medyczne

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ARO-APOC3

Arm Description

1 dose of ARO-APOC3 by subcutaneous (sc) injection every 3 or 6 months

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
June 7, 2022
Last Updated
October 23, 2023
Sponsor
Arrowhead Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT05413135
Brief Title
Study of ARO-APOC3 in Adults With Dyslipidemia
Official Title
A Phase 2 Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of ARO-APOC3 in Adults With Dyslipidemia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 7, 2022 (Actual)
Primary Completion Date
October 2025 (Anticipated)
Study Completion Date
October 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Arrowhead Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 continue to meet eligibility criteria have the option to be enrolled into this study. Eligible enrolled participants will initially receive open-label ARO-APOC3 at the assigned dose level until a final dose is selected, at which point all participants will be transitioned to the selected dosing regimen.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidemias

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
418 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ARO-APOC3
Arm Type
Experimental
Arm Description
1 dose of ARO-APOC3 by subcutaneous (sc) injection every 3 or 6 months
Intervention Type
Drug
Intervention Name(s)
ARO-APOC3
Intervention Description
ARO-APOC3 Injection
Primary Outcome Measure Information:
Title
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
Time Frame
Through 24 months
Secondary Outcome Measure Information:
Title
Change from Baseline in Fasting Triglycerides (TG) Over Time
Time Frame
Through 24 months
Title
Percent Change from Baseline in Fasting TG Over Time
Time Frame
Through 24 months
Title
Change from Baseline in Apolipoprotein (Apo) C-III Over Time
Time Frame
Through 24 months
Title
Percent Change from Baseline in ApoC-III Over Time
Time Frame
Through 24 months
Title
Change from Baseline in Fasting Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) Over Time
Time Frame
Through 24 months
Title
Percent Change from Baseline in Fasting Non-HDL-C Over Time
Time Frame
Through 24 months
Title
Change from Baseline in Fasting High-Density Lipoprotein-Cholesterol (HDL-C) Over Time
Time Frame
Through 24 months
Title
Percent Change from Baseline in Fasting HDL-C Over Time
Time Frame
Through 24 months
Title
Change from Baseline in Fasting Total Apolipoprotein B (ApoB) Over Time
Time Frame
Through 24 months
Title
Percent Change from Baseline in Fasting Total ApoB Over Time
Time Frame
Through 24 months
Title
Change from Baseline in Fasting Low-Density Lipoprotein-Cholesterol (LDL-C) Over Time Using Ultracentrifugation
Time Frame
Through 24 months
Title
Percent Change from Baseline in Fasting LDL-C Over Time Using Ultracentrifugation
Time Frame
Through 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Westside Medical Associates of Los Angeles
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Valley Clinical Trials; Inc.
City
Northridge
State/Province
California
ZIP/Postal Code
91325
Country
United States
Facility Name
Desert Medical Group, Inc.
City
Palm Springs
State/Province
California
ZIP/Postal Code
92292
Country
United States
Facility Name
Preventive Cardiology Inc.
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33434
Country
United States
Facility Name
Invesclinic U,S, LLC
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
Ocean Blue Medical Research Center Inc.
City
Miami Springs
State/Province
Florida
ZIP/Postal Code
33166
Country
United States
Facility Name
Y and L Advance Health Care
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
AppleMed Res Group
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
A Positive Research, Inc
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
A&R Research Group
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
Progressive Medical Research
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32127
Country
United States
Facility Name
Alta Pharmaceutical Research Center
City
Dunwoody
State/Province
Georgia
ZIP/Postal Code
30338
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Cardiology Assoc Res LLC
City
Tupelo
State/Province
Mississippi
ZIP/Postal Code
38801
Country
United States
Facility Name
Methodist Physicians Clinic Heart Consultants
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Clinical Res of South Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89121
Country
United States
Facility Name
NYC Research Inc.
City
Long Island City
State/Province
New York
ZIP/Postal Code
11106
Country
United States
Facility Name
Mid Hudson Medical Research; PLLC
City
New Windsor
State/Province
New York
ZIP/Postal Code
12553
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai (ISMMS)
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Lucas Research, Inc.
City
Morehead City
State/Province
North Carolina
ZIP/Postal Code
28557
Country
United States
Facility Name
Lillestol Research LLC
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58104
Country
United States
Facility Name
Marion Area Health Center
City
Marion
State/Province
Ohio
ZIP/Postal Code
43302
Country
United States
Facility Name
Advanced Medical Research
City
Maumee
State/Province
Ohio
ZIP/Postal Code
43537
Country
United States
Facility Name
South Oklahoma Heart Res;LLC
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73135
Country
United States
Facility Name
Tribe Clinical Research
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607
Country
United States
Facility Name
ClinSearch, LLC
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
Facility Name
East Texas Cardiology PA
City
Houston
State/Province
Texas
ZIP/Postal Code
77002
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Pioneer Research Solutions, Inc.
City
Houston
State/Province
Texas
ZIP/Postal Code
77099
Country
United States
Facility Name
BFHC Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78249
Country
United States
Facility Name
Manassas Clinical Research Center
City
Manassas
State/Province
Virginia
ZIP/Postal Code
20110
Country
United States
Facility Name
Royal Prince Alfred Hospital
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Core Research Group Pty Ltd
City
Milton
State/Province
Queensland
ZIP/Postal Code
4068
Country
Australia
Facility Name
USC Clinical Trials - Sippy Downs
City
Sippy Downs
State/Province
Queensland
ZIP/Postal Code
4556
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Monash Health
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
Genesis Care changing to Advara heartcare
City
Joondalup
State/Province
Western Australia
ZIP/Postal Code
6027
Country
Australia
Facility Name
Linear Clinical Research
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
LMC Clinical Research Inc
City
Concord
State/Province
Ontario
ZIP/Postal Code
L4K4M2
Country
Canada
Facility Name
Lawson Health Research Institute
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Facility Name
Centre d'Etudes Cliniques ECOGENE-21
City
Chicoutimi
State/Province
Quebec
ZIP/Postal Code
G7H 7K9
Country
Canada
Facility Name
ViaCar Recherches Cliniques Inc.
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2G8
Country
Canada
Facility Name
Institut de Recherches Cliniques de Montreal
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2W 1R7
Country
Canada
Facility Name
Recherche Clinique Sigma Inc
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1G 3Z4
Country
Canada
Facility Name
Lausmed Kft
City
Baja
ZIP/Postal Code
6500
Country
Hungary
Facility Name
DRC Gyogyszervizsgalo Kozpont Balatonfured
City
Balatonfüred
ZIP/Postal Code
H-8230
Country
Hungary
Facility Name
Belgyogyaszati Kardiologiai Maganrendelo
City
Békéscsaba
ZIP/Postal Code
5600
Country
Hungary
Facility Name
Debreceni Egyetem Klinikai K
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Pharma4trial Ltd
City
Gyöngyös
ZIP/Postal Code
3200
Country
Hungary
Facility Name
Selye Janos Korhaz
City
Komárom
ZIP/Postal Code
H-2900
Country
Hungary
Facility Name
Borbanya Praxis Kft
City
Nyíregyháza
ZIP/Postal Code
4400
Country
Hungary
Facility Name
AMC
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
D and A Research
City
Sneek
ZIP/Postal Code
8601 ZR
Country
Netherlands
Facility Name
Albert Schweitzer Ziekenhuis
City
Zwijndrecht
ZIP/Postal Code
3331LZ
Country
Netherlands
Facility Name
Middlemore Clinical Trials
City
Papatoetoe
State/Province
Aukland
ZIP/Postal Code
2025
Country
New Zealand
Facility Name
NZCR OpCo Ltd
City
Christchurch
ZIP/Postal Code
8011
Country
New Zealand
Facility Name
Southern Clinical Trials Christchurch
City
Christchurch
ZIP/Postal Code
8013
Country
New Zealand
Facility Name
Centrum Medyczne Intercor
City
Bydgoszcz
ZIP/Postal Code
85-605
Country
Poland
Facility Name
Medicome Sp. z o.o.
City
Oświęcim
ZIP/Postal Code
32-600
Country
Poland
Facility Name
Praktyka Lekarska Ewa Krzyzagorska
City
Poznań
ZIP/Postal Code
61-655
Country
Poland
Facility Name
Centrum Medyczne Medyk
City
Rzeszów
ZIP/Postal Code
35-055
Country
Poland
Facility Name
Instytut Centrum Zdrowia Matki Polki
City
Łódź
ZIP/Postal Code
93-338
Country
Poland
Facility Name
All MED Centrum Medyczne
City
Łódź
ZIP/Postal Code
94 046
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
No

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Study of ARO-APOC3 in Adults With Dyslipidemia

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