Aardvark Therapeutics recently launched HERO, a global Phase 3 randomized, double-blind, placebo-controlled clinical trial of ARD-101. ARD-101 is a novel, orally administered investigational therapy being studied to see if it can reduce excessive hunger and food-seeking behaviors in individuals with PWS.
About the HERO Trial
As part of the HERO study, participants will be randomly assigned to receive either ARD-101 tablets or a placebo, a look-alike substance that contains no active medication. To ensure unbiased results, neither the participant nor the researchers at the trial site will know which option the participant receives.
To be eligible, participants must be at least 13 years old, have a confirmed diagnosis of Prader-Willi syndrome, and have a single, designated caregiver who can attend clinic visits, communicate with the study team, complete study questionnaires and diaries, and monitor food intake and behavior changes throughout the trial.
Additional Study Details:
- – The study drug will be taken orally twice daily for 12 weeks.
- – Approximately four in-person clinic visits and three telehealth visits (phone or video call) are required.
- – Travel expenses and lodging (if required) for the participant and a primary caregiver will be covered.
- – No fasting required.
- – All participants who complete the HERO study will have the option to participate in a follow-up study where everyone will receive the active study drug.
Learn More
For more information about this trial, please visit www.heroforpws.com or clinicaltrials.gov.
Perry A. Zirkel has written more than 1,500 publications on various aspects of school law, with an emphasis on legal issues in special education. He writes a regular column for NAESP’s Principal magazine and NASP’s Communiqué newsletter, and he did so previously for Phi Delta Kappan and Teaching Exceptional Children.
Jennifer Bolander has been serving as a Special Education Specialist for PWSA (USA) since October of 2015. She is a graduate of John Carroll University and lives in Ohio with her husband Brad and daughters Kate (17), and Sophia (13) who was born with PWS.
Dr. Amy McTighe is the PWS Program Manager and Inpatient Teacher at the Center for Prader-Willi Syndrome at the Children’s Institute of Pittsburgh. She graduated from Duquesne University receiving her Bachelor’s and Master’s degree in Education with a focus on elementary education, special education, and language arts.
Evan has worked with the Prader-Willi Syndrome Association (USA) since 2007 primarily as a Crisis Intervention and Family Support Counselor. Evans works with parents and schools to foster strong collaborative relationships and appropriate educational environments for students with PWS.
Staci Zimmerman works for Prader-Willi Syndrome Association of Colorado as an Individualized Education Program (IEP) consultant. Staci collaborates with the PWS multi-disciplinary clinic at the Children’s Hospital in Denver supporting families and school districts around the United States with their child’s Individual Educational Plan.
Founded in 2001, SDLC is a non-profit legal services organization dedicated to protecting and advancing the legal rights of people with disabilities throughout the South. It partners with the Southern Poverty Law Center, Protection and Advocacy (P&A) programs, Legal Services Corporations (LSC) and disability organizations on major, systemic disability rights issues involving the Individuals with Disabilities Education Act (IDEA), Americans with Disabilities Act (ADA), and the federal Medicaid Act. Recently in November 2014, Jim retired.