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NCT06828861 · ClinicalTrials.gov registry record · Phase 3
ARD-101 for Treatment of PWS: The Hunger Elimination or Reduction Objective Trial
A Phase 3 study, sponsored by Aardvark Therapeutics.
- Terminated
- Registry status
- Phase 3
- Development phase
- 68
- Enrollment target
NCT06828861: Clinical Trial Phase 3 study, sponsored by Aardvark Therapeutics.
NCT06828861 is a Phase 3 study that was terminated before completion, run by Aardvark Therapeutics. The registered enrollment target is 68 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06828861, a Phase 3 study, was terminated before completion, sponsored by Aardvark Therapeutics.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 68 participants
- Enrollment target
Study 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.
Primary Outcome
The HQ-CT score is a 9 question, 5-point scale to describe the PWS patient's hyperphagia food-related problem behaviors. It is completed by the patient's caregiver. Each question is scored from 0 to 4. The minimum total score is 0 (hyperphagia related behavior symptoms not exhibited) and the maximum total score is 36 (hyperphagia related behavior symptoms are observed).
Interventions
- DRUG Placebo
- DRUG ARD-101
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 68 participants |
| Start Date | 2024-12-20 |
| Est. Completion | 2026-05-07 |
| Phase | Phase 3 |
Why NCT06828861 stopped before completion
NCT06828861 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 68 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT06828861 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06828861 about?
NCT06828861 is a clinical study titled "ARD-101 for Treatment of PWS: The Hunger Elimination or Reduction Objective Trial". 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 (hyperp...
What is the current status of trial NCT06828861?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 68 participants. The study started on 2024-12-20. Estimated completion is 2026-05-07.
What interventions are being tested in trial NCT06828861?
The interventions under investigation include: Placebo (DRUG), ARD-101 (DRUG).
Who is sponsoring clinical trial NCT06828861?
This trial is sponsored by Aardvark Therapeutics, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06828861's enrollment target sits among peer trials
68 1796th of 2000 higher than 205 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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