Study of ARO-APOC3 in Adults With Dyslipidemia
- Registration Number
- NCT05413135
- Lead Sponsor
- Arrowhead Pharmaceuticals
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 418
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ARO-APOC3 ARO-APOC3 1 dose of ARO-APOC3 by subcutaneous (sc) injection every 3 months
- Primary Outcome Measures
Name Time Method Number of Participants with Treatment-Emergent Adverse Events (TEAEs) Through 24 months
- Secondary Outcome Measures
Name Time Method Percent Change from Baseline in Fasting HDL-C Over Time Through 24 months Change from Baseline in Fasting Triglycerides (TG) Over Time Through 24 months Change from Baseline in Fasting Total Apolipoprotein B (ApoB) Over Time Through 24 months Percent Change from Baseline in Fasting Total ApoB Over Time Through 24 months Change from Baseline in Apolipoprotein (Apo) C-III Over Time Through 24 months Change from Baseline in Fasting High-Density Lipoprotein-Cholesterol (HDL-C) Over Time Through 24 months Percent Change from Baseline in Fasting TG Over Time Through 24 months Change from Baseline in Fasting Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) Over Time Through 24 months Percent Change from Baseline in Fasting Non-HDL-C Over Time Through 24 months Percent Change from Baseline in ApoC-III Over Time Through 24 months Change from Baseline in Fasting Low-Density Lipoprotein-Cholesterol (LDL-C) Over Time Using Ultracentrifugation Through 24 months Percent Change from Baseline in Fasting LDL-C Over Time Using Ultracentrifugation Through 24 months
Trial Locations
- Locations (60)
Westside Medical Associates of Los Angeles
🇺🇸Beverly Hills, California, United States
Valley Clinical Trials; Inc.
🇺🇸Northridge, California, United States
Desert Medical Group, Inc.
🇺🇸Palm Springs, California, United States
Preventive Cardiology Inc.
🇺🇸Boca Raton, Florida, United States
Invesclinic U,S, LLC
🇺🇸Fort Lauderdale, Florida, United States
Ocean Blue Medical Research Center Inc.
🇺🇸Miami Springs, Florida, United States
AppleMed Res Group
🇺🇸Miami, Florida, United States
A Positive Research, Inc
🇺🇸Miami, Florida, United States
A&R Research Group
🇺🇸Pembroke Pines, Florida, United States
Progressive Medical Research
🇺🇸Port Orange, Florida, United States
Alta Pharmaceutical Research Center
🇺🇸Dunwoody, Georgia, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Cardiology Assoc Res LLC
🇺🇸Tupelo, Mississippi, United States
Methodist Physicians Clinic Heart Consultants
🇺🇸Omaha, Nebraska, United States
Clinical Res of South Nevada
🇺🇸Las Vegas, Nevada, United States
NYC Research Inc.
🇺🇸Long Island City, New York, United States
Mid Hudson Medical Research; PLLC
🇺🇸New Windsor, New York, United States
Icahn School of Medicine at Mount Sinai (ISMMS)
🇺🇸New York, New York, United States
Lucas Research, Inc.
🇺🇸Morehead City, North Carolina, United States
Lillestol Research LLC
🇺🇸Fargo, North Dakota, United States
Marion Area Health Center
🇺🇸Marion, Ohio, United States
Advanced Medical Research
🇺🇸Maumee, Ohio, United States
South Oklahoma Heart Res;LLC
🇺🇸Oklahoma City, Oklahoma, United States
Tribe Clinical Research
🇺🇸Greenville, South Carolina, United States
ClinSearch, LLC
🇺🇸Chattanooga, Tennessee, United States
East Texas Cardiology PA
🇺🇸Houston, Texas, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Pioneer Research Solutions, Inc.
🇺🇸Houston, Texas, United States
BFHC Research
🇺🇸San Antonio, Texas, United States
Manassas Clinical Research Center
🇺🇸Manassas, Virginia, United States
Royal Prince Alfred Hospital
🇦🇺Camperdown, New South Wales, Australia
Core Research Group Pty Ltd
🇦🇺Milton, Queensland, Australia
USC Clinical Trials - Sippy Downs
🇦🇺Sippy Downs, Queensland, Australia
Royal Adelaide Hospital
🇦🇺Adelaide, South Australia, Australia
Monash Health
🇦🇺Clayton, Victoria, Australia
Genesis Care changing to Advara heartcare
🇦🇺Joondalup, Western Australia, Australia
Linear Clinical Research
🇦🇺Nedlands, Western Australia, Australia
LMC Clinical Research Inc
🇨🇦Concord, Ontario, Canada
Lawson Health Research Institute
🇨🇦London, Ontario, Canada
Centre d'Etudes Cliniques ECOGENE-21
🇨🇦Chicoutimi, Quebec, Canada
Institut de Recherches Cliniques de Montreal
🇨🇦Montréal, Quebec, Canada
Recherche Clinique Sigma Inc
🇨🇦Québec, Quebec, Canada
DRC Gyogyszervizsgalo Kozpont Balatonfured
🇭🇺Balatonfüred, Hungary
Belgyogyaszati Kardiologiai Maganrendelo
🇭🇺Békéscsaba, Hungary
Debreceni Egyetem Klinikai K
🇭🇺Debrecen, Hungary
Pharma4trial Ltd
🇭🇺Gyöngyös, Hungary
Selye Janos Korhaz
🇭🇺Komárom, Hungary
Borbanya Praxis Kft
🇭🇺Nyíregyháza, Hungary
AMC
🇳🇱Amsterdam, Netherlands
D and A Research
🇳🇱Sneek, Netherlands
Albert Schweitzer Ziekenhuis
🇳🇱Zwijndrecht, Netherlands
Middlemore Clinical Trials
🇳🇿Papatoetoe, Aukland, New Zealand
NZCR OpCo Ltd
🇳🇿Christchurch, New Zealand
Southern Clinical Trials Christchurch
🇳🇿Christchurch, New Zealand
Centrum Medyczne Intercor
🇵🇱Bydgoszcz, Poland
Medicome Sp. z o.o.
🇵🇱Oświęcim, Poland
Praktyka Lekarska Ewa Krzyzagorska
🇵🇱Poznań, Poland
Centrum Medyczne Medyk
🇵🇱Rzeszów, Poland
Instytut Centrum Zdrowia Matki Polki
🇵🇱Łódź, Poland
All MED Centrum Medyczne
🇵🇱Łódź, Poland