Aardvark Therapeutics pauses Phase 3 HERO trial of ARD-101 for Prader-Willi hyperphagia after reversible cardiac signals in healthy volunteers. Safety review ongoing; topline data delayed to 2026.
Written By: Samiksha Jadhav BPharm
Reviewed By: Pharmacally Editorial Team
Aardvark Therapeutics, Inc. a clinical-stage biopharmaceutical company developing small-molecule therapies to activate innate homeostatic pathways for metabolic diseases, announced a voluntary pause in its Phase 3 HERO trial evaluating ARD-101 for hyperphagia in Prader-Willi Syndrome (PWS). The decision stems from reversible cardiac observations noted during routine safety monitoring in a healthy volunteer study at doses above the target therapeutic range.
The HERO trial (NCT06828861) is a randomized, double-blind, placebo-controlled study assessing ARD-101’s efficacy and safety in PWS patients, a rare genetic disorder characterized by insatiable hunger (hyperphagia), obesity, and behavioral challenges.
Enrollment and dosing have also halted in the open-label extension (NCT07197034). Aardvark is conducting a thorough data review to guide next steps, prioritizing patient safety.
“Our highest priority is the safety of every patient in our studies,” stated Tien Lee, M.D., Founder and CEO of Aardvark. “We’re evaluating optimal therapeutic dosing for ARD-101 while collaborating with the FDA, experts, and the PWS community.”
ARD-101, a gut-restricted TAS2R bitter taste receptor pan-agonist, stimulates enteroendocrine cells to release gut hormones like GLP-1 and cholecystokinin (CCK), promoting satiety via gut-brain signaling. It has shown hunger reduction alone or with GLP-1 therapies and holds FDA Orphan Drug and Rare Pediatric Disease Designations for PWS.
This pauses delays anticipated HERO topline data from Q3 2026, with further updates expected in Q2 2026.
The move underscores Aardvark’s cautious approach amid growing interest in novel hyperphagia treatments for PWS, where unmet needs persist despite recent advances.
References
Aardvark Therapeutics Announces Voluntary Pause of Phase 3 HERO Trial in Prader-Willi Syndrome, 27 February 2026, https://ir.aardvarktherapeutics.com/news-releases/news-release-details/aardvark-therapeutics-announces-voluntary-pause-phase-3-hero
ARD-101 for Treatment of PWS: The Hunger Elimination or Reduction Objective Trial (HERO), ClinicalTrials.gov ID NCT06828861, https://clinicaltrials.gov/study/NCT06828861
About Writer
Samiksha Vikram Jadhav, BPharm
She is a pharmacy graduate with a keen interest in clinical research, pharmacovigilance, and medical writing, with a growing focus on publication and scientific content development. In her words, she is passionate about translating complex medical data into clear, evidence-based communication.