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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04720534
Other study ID # AROAPOC3-2001
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date May 31, 2021
Est. completion date August 31, 2023

Study information

Verified date April 2024
Source Arrowhead Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 229
Est. completion date August 31, 2023
Est. primary completion date March 9, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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


Related Conditions & MeSH terms


Intervention

Drug:
ARO-APOC3
2 doses of ARO-APOC3 by subcutaneous (sc) injection
Placebo
calculated volume to match active treatment by sc injection

Locations

Country Name City State
Australia Royal Adelaide Hospital Adelaide South Australia
Australia Core Research Group Brisbane Queensland
Australia Royal Prince Alfred Hospital Camperdown New South Wales
Australia Monash Health Clayton Victoria
Australia Linear Clinical Research Perth Nedlands
Australia University of the Sunshine Coast Sippy Downs Queensland
Canada Centre d'Etudes Cliniques ECOGENE-21 Chicoutimi Quebec
Canada LMC Diabetes & Endocrinology Concord Ontario
Canada ViaCar Recherches Cliniques Inc. Greenfield Quebec
Canada Lawson Health Research Institute London Ontario
Canada Institut de Recherches Cliniques de Montreal Montréal Quebec
Canada LMC Manna Research - Bayview Toronto Ontario
Germany Uniklinik RWTH Aachen
Germany Universitatsklinikum Leipzig Leipzig
Hungary Lausmed Kft. Baja
Hungary Principal SMO Kft Baja
Hungary DRC Gyogyszervizsgalo Kozpont Balatonfured Balatonföldvár
Hungary Belgyogyaszati - Kardiologiai Maganrendelo Bekescsaba
Hungary Debreceni Egyetem Debrecen
Hungary Pharma4trial Ltd Gyöngyös
Hungary Selye Janos Korhaz Komárom
Hungary Borbanya Praxis Kft. Nyiregyhaza
Hungary Medifarma-98 Kft. Nyíregyháza
Netherlands Uni Van Amsterdam Academisch Medisch Centrum Amsterdam
Netherlands Albert Schweitzer Ziekenhuis Dordrecht
Netherlands D&A Research Sneek
New Zealand Lipid and Diabetes Research Group Christchurch
New Zealand Auckland Clinical Studies Grafton Auckland
New Zealand Lakeland Clinical Trials - Waikato Hamilton
New Zealand Middlemore Clinical Trials Papatoetoe
New Zealand Lakeland Clinical Trials - Rotorua Rotorua
Poland Spolka Lekarzy Intercor Sp.z.o.o. Bydgoszcz
Poland NZOZ TWOJE ZDROWIE EL Sp.z.o.o. Elblag
Poland Indywidualna Specjalistyczna Praktyka Lekarska w Dziedzinie Kardiologii lek. Gdynia
Poland Zaklad Opieki Zdrowotnej Leczyca Leczyca
Poland All-MED Centrum Medyczne Lódz
Poland Medicome Sp. z.o.o. Oswiecim
Poland Praktyka Lekarska Ewa Krzyzagorska Poznan
Poland KO-MED M Konieczny Cent. Wielosp. Opieki Pulawy
Poland Centrum Medyczne Medyk Rzeszów
Poland Centrum Medyczne K2J2 Wolomin
United States Northwest Heart Clinical Research Arlington Heights Illinois
United States Westside Medical Associates of Los Angeles Beverly Hills California
United States Preventive Cardiology Inc. Boca Raton Florida
United States WR-CllinSearch, LLC Chattanooga Tennessee
United States PriMed Clinical Research Dayton Ohio
United States Alta Pharmaceutical Research Center Dunwoody Georgia
United States Lillestol Research LLC Fargo North Dakota
United States Invesclinic U.S., LLC Fort Lauderdale Florida
United States Prestige Clinical Research Franklin Ohio
United States Tribe Clinical Research Greenville South Carolina
United States Baylor College of Medicine Houston Texas
United States Pioneer Research Solutions, Inc. Houston Texas
United States Glacier View Research Institute Kalispell Montana
United States Clinical Research of South Nevada Las Vegas Nevada
United States The Research Group of Lexington, LLC Lexington Kentucky
United States NYC Research, Inc. Long Island City New York
United States Manassas Clinical Research Center Manassas Virginia
United States Advanced Medical Research, LLC Maumee Ohio
United States A Positive Research, Inc. Miami Florida
United States AppleMed Research Group Miami Florida
United States HeartWell LLP Miami Florida
United States Y&L Advance Health care, Inc. D/B/A Elite Clinical Research Miami Florida
United States Ocean Blue Medical Research Center Inc. Miami Springs Florida
United States University of Minnesota Minneapolis Minnesota
United States Lucas Research, Inc Morehead City North Carolina
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 South Oklahoma Heart Research, LLC Oklahoma City Oklahoma
United States Methodist Physicians Clinic Heart Consultants Omaha Nebraska
United States Desert Oasis Healthcare (Desert Medical Group, Inc.) Palm Springs California
United States Progressive Medical Research Port Orange Florida
United States BFHC Research San Antonio Texas
United States Cardiology Associates Research, LLC Tupelo Mississippi

Sponsors (1)

Lead Sponsor Collaborator
Arrowhead Pharmaceuticals

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Germany,  Hungary,  Netherlands,  New Zealand,  Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percent Change from Baseline in Fasting Triglycerides (TG) at Week 24 Baseline, Week 24
Secondary Percent Change from Baseline in Fasting TG Over Time Through Week 48 Baseline, up to Week 48
Secondary Percent Change from Baseline in Apolipoprotein (Apo)C-III at Week 24 Baseline, Week 24
Secondary Percent Change from Baseline in ApoC-III Over Time Through Week 48 Baseline, up to Week 48
Secondary Percent Change from Baseline in Fasting Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) at Week 24 Baseline, Week 24
Secondary Percent Change from Baseline in Fasting Non-HDL-C Over Time Through Week 48 Baseline, up to Week 48
Secondary Percent Change from Baseline in Fasting High-Density Lipoprotein-Cholesterol (HDL-C) at Week 24 Baseline, Week 24
Secondary Percent Change from Baseline in Fasting HDL-C Over Time Through Week 48 Baseline, up to Week 48
Secondary Percent Change from Baseline in Fasting Total Apolipoprotein B (ApoB) at Week 24 Baseline, Week 24
Secondary Percent Change from Baseline in Fasting Total ApoB Over Time Through Week 48 Baseline, up to Week 48
Secondary Percent Change from Baseline in Fasting Low-density Lipoprotein-Cholesterol (LDL-C) Using Ultracentrifugation Baseline, Week 24
Secondary Percent Change from Baseline in Fasting LDL-C Using Ultracentrifugation Over Time Through Week 48 Baseline, up to Week 48
Secondary Change from Baseline in Plasma Concentration of ARO-APOC3 Over Time Through Week 48 Baseline, up to Week 48
Secondary Number of Participants with Adverse Events (AEs) and/or Serious Adverse Events (SAEs) Possibly or Probably Related to Treatment up to Week 48
See also
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Active, not recruiting NCT01229566 - Efficacy Study to Treat Subjects With Severe Hypertriglyceridemia Phase 3
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