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HERO Clinical Trial for ARD-101 Now Enrolling Open-Label Extension (OLE)

Earlier this year, Aardvark Therapeutics launched HERO, a global Phase 3 clinical trial investigating ARD-101, an innovative, orally administered treatment designed to help reduce hyperphagia (excessive hunger) and food-seeking behaviors in individuals with Prader-Willi syndrome (PWS).

All patients who have completed treatment on the AVK-101-301 study through Week 12/End of Treatment will have the option to join the OLE AVK-101-302 study, to receive ARD-101 for up to 12 months.

Study Overview:

(As stated on the National Library of Medicine page.)

The goal of this clinical trial is to learn if ARD-101 works to treat hyperphagia-related behavior in patients with Prader-Willi syndrome 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.

HERO Clinical Trial:

If you are interested in enrolling in the HERO ARD-101 Clinical Trial and would like to learn more about it, click the button below.

Current OLE Sites Now Enrolling

New York Locations
Mineola, New York

NYU Langone Children’s Ambulatory Care Center
Contact: Jorge Mejia-Corletto, MD
Phone: (516) 663-4600
Email: jorge.mejia-corletto@nyulangone.org

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