Clinical Trial

The Hunger Elimination or Reduction Objective (HERO ) Open -Label Extension (OLE) Trial

Terminated Phase 3
View on ClinicalTrials.gov →
Why the trial stopped
Due to operational and regulatory considerations.
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.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2025-09-21; most recent amendment 2026-06-26.
Status change: Suspended → Terminated 2026-06-26
Status change: Recruiting → Suspended 2026-03-17
Trial Details
NCT Number NCT07197034
Lead Sponsor Aardvark Therapeutics, Inc.
Conditions Hyperphagia, Prader-Willi Syndrome, Hyperphagia in Prader-Willi Syndrome
Enrollment 19 participants
Start Date 2024-07-23
Primary Completion 2026-04-15 (estimated)
Study Completion 2026-04-15 (estimated)
Updated on ClinicalTrials.gov 2026-06-30