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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: Clinical Trial Phase 3 study, sponsored by Aardvark Therapeutics.
NCT07197034 is a Phase 3 study that was terminated before completion, run by Aardvark Therapeutics. The registered enrollment target is 19 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
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 ARD-101
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2024-07-23 |
| Est. Completion | 2026-04-15 |
| Phase | Phase 3 |
Why NCT07197034 stopped before completion
NCT07197034 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which ARD-101 is the first listed.
NCT07197034 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07197034's enrollment target sits among peer trials
19 1969th of 2000 higher than 31 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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