ARD-101 for Treatment of PWS: The Hunger Elimination or Reduction Objective Trial
Public ClinicalTrials.gov record NCT06828861. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06828861
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 68 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 7 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 20, 2024 (Actual)
- Primary completion
- May 7, 2026 (Actual)
- Completion
- May 7, 2026 (Actual)
- Last update posted
- Jun 30, 2026
2024 – 2026
United States locations
- U.S. sites
- 17
- U.S. states
- 13
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Children's of Alabama | Birmingham | Alabama | 35233-1711 | — |
| Rady Children's Hospital | Encinitas | California | 92123 | — |
| Children's Hospital of Orange Country | Orange | California | 92868 | — |
| Stanford Children's Health Specialty Services | Palo Alto | California | 94304 | — |
| Children's Hospital Colorado | Denver | Colorado | 80045-7106 | — |
| Nemours Children Clinic Wilmington | Wilmington | Delaware | 19803-3607 | — |
| UF Shands Children's Hospital | Gainesville | Florida | 32610-3008 | — |
| Emory University School of Medicine | Atlanta | Georgia | 30322-1047 | — |
| Ann and Robert H. Lurie Children's Hospital of Chicago | Chicago | Illinois | 60611-2991 | — |
| The Johns Hopkins Hospital | Baltimore | Maryland | 21287-0005 | — |
| University of Minnesota Masonic Children's Hospital | Minneapolis | Minnesota | 55102 | — |
| Maimonides Medical Center | Brooklyn | New York | 11219-2918 | — |
| NYU Langone Children's Ambulatory Care Center | Mineola | New York | 11501-4077 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232-0005 | — |
| Cook Children's Medical Center | Fort Worth | Texas | 76104 | — |
| Texas Valley Clinical Research, LLC | Weslaco | Texas | 78596-7288 | — |
| Seattle Children's Hospital | Seattle | Washington | 98105 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 14 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06828861, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 30, 2026 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06828861 live on ClinicalTrials.gov.