Study to Evaluate ARO-APOC3 in Adults With Severe Hypertriglyceridemia
- Registration Number
- NCT04720534
- Lead Sponsor
- Arrowhead Pharmaceuticals
- Brief Summary
The purpose of AROAPOC3-2001 is to evaluate the efficacy and safety of ARO-APOC3 in participants with severe hypertriglyceridemia. Participants will receive 2 subcutaneous injections of ARO-APOC3.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 229
- Based on medical history, evidence of TG ≥ 500 mg/dL and ≤ 4000 mg/dL at Screening
- Fasting TG ≥ 500 mg/dL at Screening
- Willing to follow diet counseling per Investigator judgment based on local standard of care
- Women of childbearing potential must have a negative pregnancy test, cannot be breastfeeding, and must be willing to use contraception
- Willing to provide written informed consent and to comply with study requirements
- Active pancreatitis within 12 weeks prior to first dose
- Any planned bariatric surgery or similar procedures to induce weight loss from consent to end of study
- Acute coronary syndrome event within 24 weeks of first dose
- Major surgery within 12 weeks of first dose
- Planned coronary intervention (e.g., stent placement or heart bypass) or any non-cardiac major surgical procedure throughout the study
- Uncontrolled hypertension
- Human immunodeficiency virus (HIV) infection, seropositive for Hepatitis B (HBV), seropositive for Hepatitis C (HCV)
- Uncontrolled hypothyroidism or hyperthyroidism
- Hemorrhagic stroke within 24 weeks of first dose
- Malignancy within the last 2 years prior to date of consent requiring systemic treatment (some exceptions apply)
Note: additional inclusion/exclusion criteria may apply per protocol
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo, Day 1 and Week 12 Placebo calculated volume to match active treatment by sc injection ARO-APOC3 10 mg, Day 1 and Week 12 ARO-APOC3 2 doses of ARO-APOC3 by subcutaneous (sc) injection ARO-APOC3 50 mg, Day 1 and Week 12 ARO-APOC3 2 doses of ARO-APOC3 by sc injection ARO-APOC3 25 mg, Day 1 and Week 12 ARO-APOC3 2 doses of ARO-APOC3 by sc injection
- Primary Outcome Measures
Name Time Method Percent Change from Baseline in Fasting Triglycerides (TG) at Week 24 Baseline, Week 24
- Secondary Outcome Measures
Name Time Method Percent Change from Baseline in Fasting Total Apolipoprotein B (ApoB) at Week 24 Baseline, Week 24 Percent Change from Baseline in Apolipoprotein (Apo)C-III at Week 24 Baseline, Week 24 Percent Change from Baseline in Fasting High-Density Lipoprotein-Cholesterol (HDL-C) at Week 24 Baseline, Week 24 Percent Change from Baseline in Fasting Total ApoB Over Time Through Week 48 Baseline, up to Week 48 Percent Change from Baseline in Fasting TG Over Time Through Week 48 Baseline, up to Week 48 Percent Change from Baseline in ApoC-III Over Time Through Week 48 Baseline, up to Week 48 Percent Change from Baseline in Fasting Non-HDL-C Over Time Through Week 48 Baseline, up to Week 48 Percent Change from Baseline in Fasting HDL-C Over Time Through Week 48 Baseline, up to Week 48 Change from Baseline in Plasma Concentration of ARO-APOC3 Over Time Through Week 48 Baseline, up to Week 48 Percent Change from Baseline in Fasting Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) at Week 24 Baseline, Week 24 Percent Change from Baseline in Fasting Low-density Lipoprotein-Cholesterol (LDL-C) Using Ultracentrifugation Baseline, Week 24 Percent Change from Baseline in Fasting LDL-C Using Ultracentrifugation Over Time Through Week 48 Baseline, up to Week 48 Number of Participants with Adverse Events (AEs) and/or Serious Adverse Events (SAEs) Possibly or Probably Related to Treatment up to Week 48
Trial Locations
- Locations (74)
Pioneer Research Solutions, Inc.
🇺🇸Houston, Texas, United States
Clinical Research of South Nevada
🇺🇸Las Vegas, Nevada, United States
AppleMed Research Group
🇺🇸Miami, Florida, United States
HeartWell LLP
🇺🇸Miami, Florida, United States
BFHC Research
🇺🇸San Antonio, Texas, United States
Debreceni Egyetem
🇭🇺Debrecen, Hungary
Medifarma-98 Kft.
🇭🇺Nyíregyháza, Hungary
Glacier View Research Institute
🇺🇸Kalispell, Montana, United States
NZOZ TWOJE ZDROWIE EL Sp.z.o.o.
🇵🇱Elbląg, Poland
KO-MED M Konieczny Cent. Wielosp. Opieki
🇵🇱Puławy, Poland
Centre d'Etudes Cliniques ECOGENE-21
🇨🇦Chicoutimi, Quebec, Canada
Institut de Recherches Cliniques de Montreal
🇨🇦Montréal, Quebec, Canada
Lausmed Kft.
🇭🇺Baja, Hungary
Principal SMO Kft
🇭🇺Baja, Hungary
Belgyogyaszati - Kardiologiai Maganrendelo
🇭🇺Bekescsaba, Hungary
WR-CllinSearch, LLC
🇺🇸Chattanooga, Tennessee, United States
Praktyka Lekarska Ewa Krzyzagorska
🇵🇱Poznań, Poland
Centrum Medyczne K2J2
🇵🇱Wołomin, Poland
Centrum Medyczne Medyk
🇵🇱Rzeszów, Poland
Monash Health
🇦🇺Clayton, Victoria, Australia
Albert Schweitzer Ziekenhuis
🇳🇱Dordrecht, Netherlands
Indywidualna Specjalistyczna Praktyka Lekarska w Dziedzinie Kardiologii lek.
🇵🇱Gdynia, Poland
Medicome Sp. z.o.o.
🇵🇱Oświęcim, Poland
Methodist Physicians Clinic Heart Consultants
🇺🇸Omaha, Nebraska, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Preventive Cardiology Inc.
🇺🇸Boca Raton, Florida, United States
A Positive Research, Inc.
🇺🇸Miami, Florida, United States
Mid Hudson Medical Research, PLLC
🇺🇸New Windsor, New York, United States
PriMed Clinical Research
🇺🇸Dayton, Ohio, United States
Tribe Clinical Research
🇺🇸Greenville, South Carolina, 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
Prestige Clinical Research
🇺🇸Franklin, Ohio, United States
Lillestol Research LLC
🇺🇸Fargo, North Dakota, United States
South Oklahoma Heart Research, LLC
🇺🇸Oklahoma City, Oklahoma, United States
Advanced Medical Research, LLC
🇺🇸Maumee, Ohio, United States
Royal Adelaide Hospital
🇦🇺Adelaide, South Australia, Australia
LMC Diabetes & Endocrinology
🇨🇦Concord, Ontario, Canada
LMC Manna Research - Bayview
🇨🇦Toronto, Ontario, Canada
ViaCar Recherches Cliniques Inc.
🇨🇦Greenfield, Quebec, Canada
Universitatsklinikum Leipzig
🇩🇪Leipzig, Germany
Selye Janos Korhaz
🇭🇺Komárom, Hungary
Pharma4trial Ltd
🇭🇺Gyöngyös, Hungary
Borbanya Praxis Kft.
🇭🇺Nyiregyhaza, Hungary
Westside Medical Associates of Los Angeles
🇺🇸Beverly Hills, California, United States
Y&L Advance Health care, Inc. D/B/A Elite Clinical Research
🇺🇸Miami, Florida, United States
Desert Oasis Healthcare (Desert Medical Group, Inc.)
🇺🇸Palm Springs, California, United States
Ocean Blue Medical Research Center Inc.
🇺🇸Miami Springs, Florida, United States
Alta Pharmaceutical Research Center
🇺🇸Dunwoody, Georgia, United States
The Research Group of Lexington, LLC
🇺🇸Lexington, Kentucky, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Invesclinic U.S., LLC
🇺🇸Fort Lauderdale, Florida, United States
Cardiology Associates Research, LLC
🇺🇸Tupelo, Mississippi, United States
Progressive Medical Research
🇺🇸Port Orange, Florida, United States
NYC Research, Inc.
🇺🇸Long Island City, New York, United States
Northwest Heart Clinical Research
🇺🇸Arlington Heights, Illinois, United States
Linear Clinical Research
🇦🇺Perth, Nedlands, Australia
Manassas Clinical Research Center
🇺🇸Manassas, Virginia, United States
Royal Prince Alfred Hospital
🇦🇺Camperdown, New South Wales, Australia
University of the Sunshine Coast
🇦🇺Sippy Downs, Queensland, Australia
Core Research Group
🇦🇺Brisbane, Queensland, Australia
Lawson Health Research Institute
🇨🇦London, Ontario, Canada
Uniklinik RWTH
🇩🇪Aachen, Germany
DRC Gyogyszervizsgalo Kozpont Balatonfured
🇭🇺Balatonföldvár, Hungary
Lakeland Clinical Trials - Waikato
🇳🇿Hamilton, New Zealand
Uni Van Amsterdam Academisch Medisch Centrum
🇳🇱Amsterdam, Netherlands
D&A Research
🇳🇱Sneek, Netherlands
Lipid and Diabetes Research Group
🇳🇿Christchurch, New Zealand
Middlemore Clinical Trials
🇳🇿Papatoetoe, New Zealand
Auckland Clinical Studies
🇳🇿Grafton, Auckland, New Zealand
Spolka Lekarzy Intercor Sp.z.o.o.
🇵🇱Bydgoszcz, Poland
Lakeland Clinical Trials - Rotorua
🇳🇿Rotorua, New Zealand
Zaklad Opieki Zdrowotnej Leczyca
🇵🇱Leczyca, Poland
All-MED Centrum Medyczne
🇵🇱Łódź, Poland