Aardvark Therapeutics has announced an update to its Phase 3 HERO trial that will allow more children and families affected by Prader-Willi syndrome to participate. The trial evaluating ARD-101 will now allow children as young as 7 years old to enroll in the United States, increasing access to this important research opportunity.
About the HERO Phase 3 Study in Prader-Willi Syndrome
HERO is a global Phase 3 clinical trial evaluating ARD-101’s potential to help control excessive hunger (hyperphagia) in people with PWS. Key features of the trial include:
- Randomized, double-blind, placebo-controlled design — the gold standard for clinical research
- Oral dosing of ARD-101 twice daily over 12 weeks
- Approximately 4 in-person and 3 telehealth visits over the study period
- Travel and lodging support for participants and caregivers when needed
- Option to join a follow-up study with access to the active drug after completion of the main trial
Families can visit the HERO trial site (www.heroforpws.com) to learn more about eligibility, what to expect, and how to find participating locations.
Topline data (high-level results that provide an early summary of how the treatment performed before a detailed analysis is completed) from the study are anticipated in the third quarter of 2026.
