The Hunger Elimination or Reduction Objective (HERO ) Open -Label Extension (OLE) Trial
NCT ID: NCT07197034
Last Updated: 2026-01-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
90 participants
INTERVENTIONAL
2024-07-23
2027-04-30
Brief Summary
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The main questions it aims to answer are:
What medical problems do participants have when taking ARD-101 in a long term setting
Does ARD-101 improve the total score of the HQCT-9 (hyperphagia questionnaire for clinical trials, 9 questions)?
Eligible participants will:
Have completed treatment on the AVK-101-301 study through Week 12/End of Treatment
Take ARD-101 every day for up to 12 months.
Visit the clinic at Months 1, 3, 6 and 12 during dosing and then have tele-visits at Week 2, Months 3 and 9, then 4 weeks after stopping the ARD-101.
Patients/Caregivers will keep a daily diary.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ARD-101
(Open-label)
ARD-101
200 mg BID (twice per day) for 1 week, 400 mg BID for 1 week, 800 mg BID for 50 weeks
Interventions
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ARD-101
200 mg BID (twice per day) for 1 week, 400 mg BID for 1 week, 800 mg BID for 50 weeks
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
13 Years
ALL
No
Sponsors
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Aardvark Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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Children's of Alabama
Birmingham, Alabama, United States
Stanford Children's Health Specialty Services
Palo Alto, California, United States
Rady Children's Hospital
San Diego, California, United States
Children's Hospital Colorado
Denver, Colorado, United States
Nemours Children's Clinic Wilmington
Wilmington, Delaware, United States
UF Shands Children's Hospital
Gainesville, Florida, United States
Emory University School of Medicine
Atlanta, Georgia, United States
Ann and Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
The Johns Hopkins Hospital
Baltimore, Maryland, United States
University of Minnesota Masonic Children's Hospital
Minneapolis, Minnesota, United States
Maimonides Medical Center
Brooklyn, New York, United States
NYU Langone Children's Ambulatory Care Center
Mineola, New York, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Cook Children's Medical Center
Fort Worth, Texas, United States
Seattle Children's Hospital
Seattle, Washington, United States
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
The Children's Hospital at Westmead
Westmead, New South Wales, Australia
Queensland Children's Hospital
South Brisbane, Queensland, Australia
Alberta Children's Hospital Research Institute
Calgary, Alberta, Canada
Li Ka Shing Centre for Health Research Innovation
Edmonton, Alberta, Canada
Centre Hospitalier Universitaire Sainte-Justine
Montreal, Quebec, Canada
CHU de Toulouse-Hôpital Des Enfants
Toulouse, Haute-Garonne, France
CHU d'Angers
Angers, Maine-et-Loire, France
AP-HP - Hôpital de la Pitié Salpétrière
Paris, , France
AP-HP - Hôpital universitaire Necker-Enfants malades
Paris, , France
CHU de Toulouse- Hôpital de Rangueil
Toulouse, , France
Ospedale Pediatrico Bambino Gesù IRCCS
Rome, Lazio, Italy
Ospedale San Raffaele S.r.l. - PPDS
Milan, Lombardy, Italy
Azienda Ospedaliero Universitaria A Meyer - INCIPIT - PIN
Florence, Tuscany, Italy
National University Hospital for Children's Neurorehabilitation "Dr. Nicolae Robanescu"
Bucharest, București, Romania
Institutul National de Endocrinologie C. I. Parhon
Bucharest, , Romania
Spitalul Clinic de Urgenta Sfantul Spiridon
Iași, , Romania
Inha University Hospital
Incheon, , South Korea
Samsung Medical Center
Seoul, , South Korea
Ajou University Hospital
Suwon, , South Korea
Corporacio Sanitaria Parc Tauli
Sabadell, Barcelona, Spain
Hospital Universitario Vall d'Hebron - PPDS
Barcelona, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Fulborn Hospital
Cambridge, , United Kingdom
Royal Hospital for Children (Glasgow) - PPDS - PIN
Glasgow, , United Kingdom
Leicester Royal Infirmary
Leicester, , United Kingdom
The Royal London Hospital
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Aaron Chidekel, MD
Role: primary
Jennifer Miller, MD
Role: primary
Priya Khanna, MD
Role: primary
Ann Scheimann, MD
Role: primary
Bradley Miller, MD
Role: primary
Ashley Shoemaker, MD
Role: primary
Sani Roy, MD
Role: primary
Isabella Niu, MD
Role: primary
Tania Markovic, MD
Role: primary
Yoon Hi Cho, MD
Role: primary
Helen Heussler, MD
Role: primary
Josephine Ho, MD
Role: primary
Andrea Haqq, MD
Role: primary
Nathalie Alos, MD
Role: primary
Gwenaelle Diene, MD
Role: primary
Frederic Illouz, MD
Role: primary
Christine Poitou-Bernert, MD
Role: primary
Graziella Pinto, MD
Role: primary
Emilie Montastier, MD
Role: primary
Danilo Fintini, MD
Role: primary
Roberta Pajno, MD
Role: primary
Stefano Stagi, MD
Role: primary
Madalina Leanca, MD
Role: primary
Iuliana Gherlan, MD
Role: primary
Cristina Preda, MD
Role: primary
Ji Eun Lee, MD
Role: primary
Sung Yoon Cho, MD
Role: primary
Young Bae Sohn, MD
Role: primary
Raquel Corripio Collado, MD
Role: primary
Eduard Mogas Vinals, MD
Role: primary
Irene Lazaro Rodriquez, MD
Role: primary
Shahid Zaman, MD
Role: primary
Mohamad Guftar Shaikh, MBBS
Role: primary
James Greening, MD
Role: primary
Evelien Gevers, MD
Role: primary
Other Identifiers
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AVK-101-302
Identifier Type: -
Identifier Source: org_study_id
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