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NCT07197034 · ClinicalTrials.gov registry record · Phase 3
The Hunger Elimination or Reduction Objective (HERO ) Open -Label Extension (OLE) Trial
A Phase 3 study, sponsored by Aardvark Therapeutics.
- Terminated
- Registry status
- Phase 3
- Development phase
- 19
- Enrollment target
NCT07197034 is a Phase 3 study that was terminated before completion, run by Aardvark Therapeutics. The registered enrollment target is 19 participants.
The verdict
NCT07197034, a Phase 3 study, was terminated before completion, sponsored by Aardvark Therapeutics.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 19 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) when used in a long term setting. It will also teach us about the safety of ARD-101. The main questions it aims to answer are: What medical problems do participants have when taking ARD-101 in a long term setting Does ARD-101 improve the total score of the HQCT-9 (hyperphagia questionnaire for clinical trials, 9 questions)? Eligible participants will: Have completed treatment on the AVK-101-301 study through Week 12/End of Treatment Take ARD-101 every day for up to 12 months. Visit the clinic at Months 1, 3, 6 and 12 during dosing and then have tele-visits at Week 2, Months 3 and 9, then 4 weeks after stopping the ARD-101. Patients/Caregivers will keep a daily diary.
Interventions
- DRUG ARD-101
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2024-07-23 |
| Est. Completion | 2026-04-15 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07197034
The ClinicalTrials.gov registry entry for NCT07197034 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 19 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 1 intervention - of which ARD-101 is the first listed.
NCT07197034 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07197034 about?
NCT07197034 is a clinical study titled "The Hunger Elimination or Reduction Objective (HERO ) Open -Label Extension (OLE) 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) when used in a long term setting. It will also teach us about the safety of ARD-101. The main questions it aims to answer are: What medical problems do pa...
What is the current status of trial NCT07197034?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 19 participants. The study started on 2024-07-23. Estimated completion is 2026-04-15.
What interventions are being tested in trial NCT07197034?
The interventions under investigation include: ARD-101 (DRUG).
Who is sponsoring clinical trial NCT07197034?
This trial is sponsored by Aardvark Therapeutics, which has 6 total clinical trials registered on ClinicalTrials.gov.
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