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

Stopped early · Phase 3

Conditions studied: Hyperphagia, Prader-Willi Syndrome, Hyperphagia in Prader-Willi Syndrome

In brief

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.

Key facts

Study ID

NCT07197034

Run by

Aardvark Therapeutics, Inc.

People needed

19

Starts

2024-07-23

Expected to finish

2026-04-15

Last updated by the study team

2026-06-30

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients who have completed treatment on Aardvark Therapeutics clinical study AVK-101-301

You may not qualify if…

• Any complications that makes participation unsafe in the Investigator's opinion

Where it is running

• Children's of Alabama — Birmingham, Alabama, United States
• Children's Hospital of Orange Country — Orange, California, United States
• Stanford Children's Health Specialty Services — Palo Alto, California, United States
• Rady Children's Hospital — San Diego, California, United States
• Children's Hospital Colorado — Denver, Colorado, United States
• Nemours Children's Clinic Wilmington — Wilmington, Delaware, United States
• UF Shands Children's Hospital — Gainesville, Florida, United States
• Emory University School of Medicine — Atlanta, Georgia, United States
• Ann and Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States
• The Johns Hopkins Hospital — Baltimore, Maryland, United States
• University of Minnesota Masonic Children's Hospital — Minneapolis, Minnesota, United States
• Maimonides Medical Center — Brooklyn, New York, United States
• NYU Langone Children's Ambulatory Care Center — Mineola, New York, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Cook Children's Medical Center — Fort Worth, Texas, United States
• Seattle Children's Hospital — Seattle, Washington, United States
• Royal Prince Alfred Hospital — Camperdown, New South Wales, Australia
• The Children's Hospital at Westmead — Westmead, New South Wales, Australia
• Queensland Children's Hospital — South Brisbane, Queensland, Australia
• Alberta Children's Hospital Research Institute — Calgary, Alberta, Canada
• Stollery Children's Hospital — Edmonton, Alberta, Canada
• Children's Hospital at London Health Sciences Centre — London, Ontario, Canada
• Centre Hospitalier Universitaire Sainte-Justine — Montreal, Quebec, Canada
• Inha University Hospital — Incheon, South Korea
• Samsung Medical Center — Seoul, South Korea

Full record on ClinicalTrials.gov

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