ARD-101 for Treatment of PWS: The Hunger Elimination or Reduction Objective Trial
NCT ID: NCT06828861
Last Updated: 2026-02-12
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
2024-12-20
2026-04-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Treatment Arm A
ARD-101
ARD-101
200 mg BID (twice per day) for 1 week, 400 mg BID for 1 week, 800 mg BID for 10 weeks
Treatment Arm B
Placebo for ARD-101
Placebo
200 mg BID (twice per day) for 1 week, 400 mg BID for 1 week, 800 mg BID for 10 weeks
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Stable care setting with same, single designated caregiver for at least 6 months prior to Visit 1
* At least 7 years of age or older in the US at the time of consent
* At least 10 years of age or older in Australia
* At least 13 years of age or older in countries outside of the US and Australia
Exclusion Criteria
* Presence of any malignancy within 5 years with the exception of basal or squamous cell carcinoma of the skin, in situ carcinoma of the service, or in situations prostate cancer.
* Presence of clinically relevant renal, hepatic, pancreatic, cardiovascular, neurological, psychiatric, hematological, pulmonary, or GI abnormality that, in the opinion of the investigator, may preclude the patient from safe completion of the study
* Adults: systolic blood pressure \>=160 mmHg and/or diastolic blood pressure \>=100 mmHg
* Children and Adolescents: systolic blood pressure \>=140 mmHg and/or diastolic blood pressure \>=90 mmHg.
* Type 1 diabetes mellitus; HbA1c \>8.5%
* Use of agents to promote weight gain or loss, alter hunger or appetite within 30 days of Visit 1 and throughout the study.
* Use of any commercially available medication for the treatment of hyperphagia (i.e., Vykat) within 60 days of randomization and throughout the study.
* Very high doses of glucocorticoids in the previous 3 months of Visit 1 and throughout the study.
7 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
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
Samsung Medical Center
Seoul, South Korea, South Korea
Inha University Hospital
Incheon, , 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
Countries
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Central Contacts
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Facility Contacts
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Hussein Abdul-Latif, MD
Role: primary
Lynne Bird, MD
Role: primary
Virginia Kimonis, MD
Role: primary
Diane Stafford, MD
Role: primary
Shawn McCandless, MD
Role: primary
Aaron Chidekel, MD
Role: primary
Michael Gambello, MD
Role: primary
Priya Khanna, MD
Role: primary
Ann Scheimann, MD
Role: primary
Edward Yi, 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
Marina Ybarra, MD
Role: primary
Nathalie Alos, MD
Role: primary
Sung Yoon Cho, MD
Role: primary
Ji Eun Lee, MD
Role: primary
Young Bae Sohn, MD
Role: primary
James Greening, MD
Role: primary
Shahid Zaman, MD
Role: primary
Mohamad Guftar Shaikh, MBBS
Role: primary
Evelien Gevers, MD
Role: primary
Other Identifiers
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AVK-101-301
Identifier Type: -
Identifier Source: org_study_id
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