A new clinical trial aims to provide relief from hyperphagia for people with Prader-Willi Syndrome. HERO is a global Phase 3 clinical trial investigating ARD‑101, an investigational oral medication aimed at reducing hyperphagia. This trial is currently enrolling people with PWS who are 13 years of age or older.
This trial is a double-blind, placebo-controlled study, meaning participants will be equally divided into two groups. Half of the participants will receive the active drug while the other half will receive a placebo. At the end of the 12-week study, all participants will have the option to receive the active drug in a follow-up study.
What is involved with participation?
- Participants will be randomly assigned to receive either ARD‑101 or a placebo
- The drug is taken orally, twice per day, over a 12-week duration
- The trial requires four in-person clinic visits and three telehealth check-ins (no fasting is required)
- Travel and lodging expenses for participants and their caregivers are covered
- Upon completion, all participants can opt into a follow-up study in which everyone receives the active drug
Where are trial sites located?
This trial will have sites available worldwide; additional trials are expected to open soon. The Hero website, HeroForPWS.com, provides the most up-to-date list of open sites as well as a tool to locate a trial site near you. 5 U.S. locations are currently enrolling participants:
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
More sites are expected to open soon.
Where can I get more information?
More information on the HERO study can be found on the heroforpws.com website.
