A Double-Blind, Placebo-Controlled Phase 2b Study to Evaluate the Efficacy and Safety of ARO-APOC3 in Adults With Severe Hypertriglyceridemia
Who is this study for? Adults with severe hypertriglyceridemia
What treatments are being studied? ARO-APOC3
Status: Completed
Location: See all (74) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
California
Westside Medical Associates of Los Angeles
Beverly Hills
Desert Oasis Healthcare (Desert Medical Group, Inc.)
Palm Springs
Florida
Preventive Cardiology Inc.
Boca Raton
Invesclinic U.S., LLC
Fort Lauderdale
A Positive Research, Inc.
Miami
AppleMed Research Group
Miami
HeartWell LLP
Miami
Y&L Advance Health care, Inc. D/B/A Elite Clinical Research
Miami
Ocean Blue Medical Research Center Inc.
Miami Springs
Progressive Medical Research
Port Orange
Georgia
Alta Pharmaceutical Research Center
Dunwoody
Illinois
Northwest Heart Clinical Research
Arlington Heights
Kentucky
The Research Group of Lexington, LLC
Lexington
Minnesota
University of Minnesota
Minneapolis
Mississippi
Cardiology Associates Research, LLC
Tupelo
Montana
Glacier View Research Institute
Kalispell
North Carolina
Lucas Research, Inc
Morehead City
North Dakota
Lillestol Research LLC
Fargo
Nebraska
Methodist Physicians Clinic Heart Consultants
Omaha
Nevada
Clinical Research of South Nevada
Las Vegas
New York
NYC Research, Inc.
Long Island City
Mid Hudson Medical Research, PLLC
New Windsor
Icahn School of Medicine at Mount Sinai (ISMMS)
New York
Ohio
PriMed Clinical Research
Dayton
Prestige Clinical Research
Franklin
Advanced Medical Research, LLC
Maumee
Oklahoma
South Oklahoma Heart Research, LLC
Oklahoma City
South Carolina
Tribe Clinical Research
Greenville
Tennessee
WR-CllinSearch, LLC
Chattanooga
Texas
Baylor College of Medicine
Houston
Pioneer Research Solutions, Inc.
Houston
BFHC Research
San Antonio
Virginia
Manassas Clinical Research Center
Manassas
Other Locations
Australia
Royal Adelaide Hospital
Adelaide
Core Research Group
Brisbane
Royal Prince Alfred Hospital
Camperdown
Monash Health
Clayton
Linear Clinical Research
Perth
University of the Sunshine Coast
Sippy Downs
Canada
Centre d'Etudes Cliniques ECOGENE-21
Chicoutimi
LMC Diabetes & Endocrinology
Concord
ViaCar Recherches Cliniques Inc.
Greenfield
Lawson Health Research Institute
London
Institut de Recherches Cliniques de Montreal
Montréal
LMC Manna Research - Bayview
Toronto
Germany
Uniklinik RWTH
Aachen
Universitatsklinikum Leipzig
Leipzig
Hungary
Lausmed Kft.
Baja
Principal SMO Kft
Baja
DRC Gyogyszervizsgalo Kozpont Balatonfured
Balatonföldvár
Belgyogyaszati - Kardiologiai Maganrendelo
Bekescsaba
Debreceni Egyetem
Debrecen
Pharma4trial Ltd
Gyöngyös
Selye Janos Korhaz
Komárom
Borbanya Praxis Kft.
Nyiregyhaza
Medifarma-98 Kft.
Nyíregyháza
Netherlands
Uni Van Amsterdam Academisch Medisch Centrum
Amsterdam
Albert Schweitzer Ziekenhuis
Dordrecht
D&A Research
Sneek
New Zealand
Lipid and Diabetes Research Group
Christchurch
Auckland Clinical Studies
Grafton
Lakeland Clinical Trials - Waikato
Hamilton
Middlemore Clinical Trials
Papatoetoe
Lakeland Clinical Trials - Rotorua
Rotorua
Poland
Spolka Lekarzy Intercor Sp.z.o.o.
Bydgoszcz
NZOZ TWOJE ZDROWIE EL Sp.z.o.o.
Elbląg
Indywidualna Specjalistyczna Praktyka Lekarska w Dziedzinie Kardiologii lek.
Gdynia
Zaklad Opieki Zdrowotnej Leczyca
Leczyca
All-MED Centrum Medyczne
Łódź
Medicome Sp. z.o.o.
Oświęcim
Praktyka Lekarska Ewa Krzyzagorska
Poznań
KO-MED M Konieczny Cent. Wielosp. Opieki
Puławy
Centrum Medyczne Medyk
Rzeszów
Centrum Medyczne K2J2
Wołomin
Time Frame
Start Date: 2021-05-31
Completion Date: 2023-08-31
Participants
Target number of participants: 229
Treatments
Experimental: ARO-APOC3 10 mg, Day 1 and Week 12
2 doses of ARO-APOC3 by subcutaneous (sc) injection
Experimental: ARO-APOC3 25 mg, Day 1 and Week 12
2 doses of ARO-APOC3 by sc injection
Experimental: ARO-APOC3 50 mg, Day 1 and Week 12
2 doses of ARO-APOC3 by sc injection
Placebo_comparator: Placebo, Day 1 and Week 12
calculated volume to match active treatment by sc injection
Authors
John Baker, William Randall, Daniel Duprez, Seth Baum, Ronald Mayfield, Christie Ballantyne, Antonio Terrelonge, Ira J. Goldberg, Steven Lupovitch, Matthew Teltser, Jonathan Fialkow, Alexander White, Carlos Ince, Dario Altamirano, Michelle Mallitz, Nizar Daboul, Justin Arambasick, Stanislaw George Sojka, Kathryn Lucas, Bernard Garcia, Ashit Jain, Mark McKenzie, Sashi Makam, William Calhoun, Alan Miller, Agustin Latorre, Ronald Goldenberg, Roger Estevez, Michael Williams, Naeem Tahirkheli, Norman Lepor, Anwar Ahmad, Nabil Andrawis, Michael Lillestol, Ronnie Aronson, Peter Clifton, Witold Zmuda, Christian Schwabe, Denes Pall, Daniel Gaudet, Russell Scott, David Sullivan, Gerald Watts, David Colquhoun, Sophie Bernard, Grzegorz Grzesk, Stephen Nicholls, Robert Hegele
Related Therapeutic Areas
Sponsors
Leads: Arrowhead Pharmaceuticals