A Phase 3 Study to Evaluate the Efficacy and Safety of ARO-APOC3 in Adults With Familial Chylomicronemia Syndrome

Who is this study for? Adults with familial chylomicronemia syndrome
What treatments are being studied? ARO-APOC3
Status: Recruiting
Location: See all (55) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The purpose or AROAPOC3-3001 is to evaluate the efficacy and safety of ARO-APOC3 in adult participants with familial chylomicronemia syndrome (FCS). Participants who have met all eligibility criteria will be randomized to receive 4 doses of ARO-APOC3 or matching placebo administered subcutaneously. Participants who complete the randomized period will continue in a 2-year open-label extension period where all participants will receive ARO-APOC3.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• Fasting TG ≥ 10 mmol/L (≥ 880 mg/dL) at screening refractory to standard lipid lowering therapy

• Diagnosis of FCS

• Willing to follow dietary counseling as per investigator judgement based on local standard of care

• Participants of childbearing potential (males & females) must use highly-effective contraception during the study and for at least 24 weeks following the last dose of study medication. Males must not donate sperm during the study and for at least 24 weeks following the last dose of study medication

• Women of childbearing potential must have a negative pregnancy test at Screening and cannot be breastfeeding

• Women of childbearing potential on hormonal contraceptives must be stable on the medication for ≥ 2 menstrual cycles prior to Day 1

Locations
United States
Florida
Excel Medical Clinical Trials, LLC
Recruiting
Boca Raton
Georgia
Herman Clinical Research, LLC
Recruiting
Suwanee
Indiana
Ascension St. Vincent Cardiovascular Research Institute
Recruiting
Indianapolis
Maryland
Centennial Medical Group
Recruiting
Elkridge
Missouri
Washington University School of Medicine, Division of Endocrinology, Metabolism and Lipid Research
Recruiting
Saint Louis
New York
Icahn School of Medicine at Mt. Sinai
Recruiting
New York
New York University Langone Medical Center
Recruiting
New York
Texas
Texas Diabetes and Endocrinology
Recruiting
Austin
Virginia
York Clinical Research, LLC
Recruiting
Norfolk
Other Locations
Argentina
Instituto Medico DAMIC
Recruiting
Córdoba
Instituto Modelo de Gastroenterologia
Recruiting
Formosa
Australia
Royal Prince Alfred Hospital
Recruiting
Camperdown
Austin Health
Recruiting
Melbourne
Baker Heart and Diabetes Institute
Recruiting
Melbourne
Linear Clinical Research Ltd
Recruiting
Nedlands
Royal North Shore Hospital
Recruiting
St. Leonards
Austria
Medizinische Universitaet Graz
Recruiting
Graz
Belgium
Universitair Ziekenhuis Antwerpen (UZA)
Recruiting
Edegem
University Hospital Ghent
Recruiting
Ghent
Universitaire Ziekenhuizen Leuven
Recruiting
Leuven
Centre Hospitalier Universitaire (CHU) de Liege
Recruiting
Liège
Canada
Ecogene-21
Recruiting
Chicoutimi
Robarts Research Institute
Recruiting
London
Institute de Recherches Cliniques de Montreal
Recruiting
Montreal
Clinique des Maladies Lipidiques de Quebec Inc.
Recruiting
Québec
Toronto General Hospital
Recruiting
Toronto
Croatia
University Hospital Center Zagreb -Rebro, Department for Metabolic Diseases
Recruiting
Zagreb
France
AP-HM-Hopital de La Conception
Recruiting
Marseille
AP-HP Hopital Pitie-Salpetriere
Recruiting
Paris
Germany
Universitaetsklinikum Jena
Recruiting
Jena
Universitaetsklinikum Leipzig
Recruiting
Leipzig
Ireland
University Hospital Galway
Recruiting
Galway
Japan
Chiba University Hospital
Recruiting
Chiba
Kanazawa University Hospital
Recruiting
Ishikawa
Rinku General Medical Center
Recruiting
Osaka
Jichi Medical University Hospital
Recruiting
Tochigi
Nippon Medical School Hospital
Recruiting
Tokyo
Tokyo University Hospital
Recruiting
Tokyo
Mexico
Instituto de Diabetes Obesidad y Nutrición S.C.
Recruiting
Cuernavaca
Centro Especializado en Diabetes Obesidad y Prevención de entermedades Cardiovasculares (CEDOPEC)
Recruiting
Mexico City
National Institute of Medical Sciences and Nutrition - Salvador Zubiran (INCMNSZ)
Recruiting
Tlalpan
New Zealand
Middlemore Clinical Trials
Recruiting
Auckland
NZCR OPCO Ltd
Recruiting
Auckland
New Zealand Clinical Research
Recruiting
Christchurch
Oman
Sultan Qaboos University Hospital
Recruiting
Muscat
Poland
Instytut Centrum Zdrowia Matki Polki
Recruiting
Łódź
Republic of Korea
Chonnam National University Hospital
Recruiting
Gwangju
Seoul National University Hospital
Recruiting
Seoul
Serbia
Clinical Center of Serbia, Institute of Endocrinology, Diabetes and Metabolic Diseases
Recruiting
Belgrade
Clinical Centre Nis
Recruiting
Niš
Singapore
National University Hospital
Recruiting
Singapore
Spain
Complejo Hospitalario Universitario de Granada - Hospital Universitario Virgen de las Nieves
Recruiting
Granada
Hospital General Universitario Gregorio Maranon
Recruiting
Madrid
Hospital Clinico Universitario de Santiago
Recruiting
Santiago De Compostela
Turkey
Erciyes University Faculty of Medicine
Recruiting
Melikgazi
Contact Information
Primary
Clinical Operations Lead
AROAPOC@arrowheadpharma.com
626-304-3400
Time Frame
Start Date: January 11, 2022
Estimated Completion Date: April 2026
Participants
Target number of participants: 72
Treatments
Experimental: ARO-APOC3
4 doses of ARO-APOC3 by subcutaneous (sc) injection (randomized period)~8 doses of ARO-APOC3 by sc injection (open-label period)
Placebo Comparator: Placebo
calculated volume to match active treatment by sc injection (randomized period)
Sponsors
Leads: Arrowhead Pharmaceuticals

This content was sourced from clinicaltrials.gov

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