Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 3 study that was terminated before completion, run by Aardvark Therapeutics. The registered enrollment target is 68 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06828861
The ClinicalTrials.gov registry entry for NCT06828861 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 68 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Aardvark Therapeutics, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT06828861 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.