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ARD-101 for Treatment of PWS: The Hunger Elimination or Reduction Objective Trial
Sponsor: Aardvark Therapeutics, Inc.
Summary
The goal of this clinical trial is to learn if ARD-101 works to treat hyperphagia-related behavior in patients with Prader-Willi syndrome (PWS). It will also teach us about the safety of ARD-101. The main questions it aims to answer are: * Does ARD-101 improve the total score of the HQCT-9 (hyperphagia questionnaire for clinical trials, 9 questions)? * What medical problems do participants have when taking ARD-101? Researchers will compare ARD-101 to a placebo (a look-alike substance that contains no drug) to see if ARD-101 works to treat hyperphagia in PWS subjects. Eligible participants will: * Take ARD-101 or a placebo every day for 12 weeks. * Visit the clinic or have a tele-visit once every 2 to 4 weeks during dosing and then have a tele-visit 4 weeks after stopping the ARD-101 or placebo. * Patients/Caregivers will keep a daily diary. Participants who complete the study may be eligible to enter an open-label extension study where everyone will receive ARD-101.
Official title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study of ARD-101 for the Treatment of Hyperphagia in Patients With Prader-Willi Syndrome
Key Details
Gender
All
Age Range
7 Years - Any
Study Type
INTERVENTIONAL
Enrollment
68
Start Date
2024-12-20
Completion Date
2026-05-07
Last Updated
2026-06-30
Healthy Volunteers
No
Conditions
Interventions
Placebo
200 mg BID (twice per day) for 1 week, 400 mg BID for 1 week, 800 mg BID for 10 weeks
ARD-101
200 mg BID (twice per day) for 1 week, 400 mg BID for 1 week, 800 mg BID for 10 weeks
Locations (31)
Children's of Alabama
Birmingham, Alabama, United States
Rady Children's Hospital
Encinitas, California, United States
Children's Hospital of Orange Country
Orange, California, United States
Stanford Children's Health Specialty Services
Palo Alto, California, United States
Children's Hospital Colorado
Denver, Colorado, United States
Nemours Children 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
Texas Valley Clinical Research, LLC
Weslaco, 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
Stollery Children's Hospital
Edmonton, Alberta, Canada
Children's Hospital at London Health Sciences Centre
London, Ontario, Canada
Centre Hospitalier Universitaire Sainte-Justine
Montreal, Quebec, Canada
Inha University Hospital
Incheon, South Korea
Samsung Medical Center
Seoul, South Korea
Ajou University Hospital
Suwon, South Korea
Leicester Royal Infirmary
Leicester, Leicestershire, United Kingdom
Fulborn Hospital
Cambridge, United Kingdom
Royal Hospital for Children (Glasgow) - PPDS - PIN
Glasgow, United Kingdom
The Royal London Hospital
London, United Kingdom