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Aardvark Therapeutics HERO Trial: U.S. Sites Now Open

Aardvark Therapeutics recently 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).

This randomized, double-blind, placebo-controlled trial is an important step toward identifying a potential new treatment option for the PWS community, and now, trial sites across the United States are actively enrolling participants.

Current HERO Trial Sites Now Enrolling:

Birmingham, Alabama
Children’s of Alabama
Contact: Hussein Abdul-Latif, MD / Tushima Reeves
Phone: (205) 638-9173
Email: tfails@uabmc.edu

Wilmington, Delaware
Nemours Children Clinic Wilmington
Contact: Aaron Chidekel, MD / Kerry Smallacombe, DO
Phone: (302) 559-0247
Email: kerry.smallacombe@nemours.org

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

Nashville, Tennessee
Vanderbilt University Medical Center
Contact: Ashley Shoemaker, MD / Celia Núñez
Phone: (615) 322-4559
Email: celia.m.nunez@vumc.org

Weslaco, Texas
Texas Valley Clinical Research, LLC
Contact: Eduardo Luna, MD / Preston Hale
Phone: (956) 554-4003
Email: hale.rn@tvcrtrials.com

Additional trial sites are expected to begin enrolling soon. PWSA | USA will continue to share trial sites as they become available. Please visit www.heroforpws.com or clinicaltrials.gov for the most up-to-date list of participating locations.


About the HERO Study

The HERO trial is exploring whether ARD-101 can effectively reduce symptoms of hyperphagia in individuals with PWS. Participants will be randomly assigned to receive either the active medication or a placebo. To help ensure objective results, neither participants nor the study team will know which treatment is being administered.

Key Eligibility Criteria:

  • – Age 13 or older
  • – Confirmed diagnosis of Prader-Willi syndrome
  • – A single caregiver who can support clinic attendance, complete questionnaires and diaries, and monitor changes in behavior and food intake


What to Expect:

  • – Oral study drug taken twice daily for 12 weeks
  • – 4 in-person clinic visits and 3 telehealth check-ins
  • – Travel and lodging support for the participant and caregiver
  • – No fasting required
  • – Optional follow-up study with guaranteed access to the active study drug for those who complete the initial trial

If your loved one is living with PWS and meets the study criteria, participating in this trial could play a meaningful role in advancing potential treatment options for the entire community.

Visit www.heroforpws.com to learn more or find a trial site near you.

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