Aardvark Therapeutics Gains FDA Alignment On Protocol Amendment To Expand Phase 3 HERO Trial For Prader-Willi Syndrome

Aardvark Therapeutics, Inc., a clinical-stage biopharmaceutical company developing novel small-molecule therapies that target innate homeostatic pathways for metabolic diseases, has announced that it has reached an agreement with the U.S. Food and Drug Administration (FDA) on a protocol amendment for its Phase 3 HERO trial. The trial is evaluating ARD-101 for the treatment of hyperphagia associated with Prader-Willi Syndrome (PWS).

The approved amendment lowers the minimum age for trial participation from 13 to 10 years, allowing younger patients with PWS to take part in the study. This change is expected to broaden the eligible patient population and support the company’s efforts to evaluate the safety and efficacy of ARD-101 across a wider age range.

Tien Lee, M.D., Founder and Chief Executive Officer of Aardvark, stated, “Expansion of the Phase 3 HERO trial to include children 10 years of age and older will allow us to reach a larger segment of the PWS patient population to potentially serve more patients in need. This decision to expand eligibility is driven by support from the PWS community, alongside historical data showing that younger patients are more likely to benefit from early intervention. We look forward to our topline data readout for this potentially pivotal trial in the third quarter of 2026.”