Aardvark’s ARD-101 Prader-Willi Study Suspended: What Investors Should Watch Next

Aardvark Therapeutics, Inc. (AARD) announced an update on their ongoing clinical study.

Aardvark Therapeutics, Inc. (AARD) has suspended a Phase 3 trial called the Hunger Elimination or Reduction Objective (HERO) study, testing ARD-101 for high hunger in people with Prader-Willi syndrome. The official goal is to see if ARD-101 reduces food-seeking behavior and remains safe, which could address a serious unmet need and support a new rare-disease revenue stream.

The trial tests ARD-101, an oral drug designed to lower extreme hunger signals linked to Prader-Willi syndrome. Patients receive either ARD-101 or a matching placebo capsule, aiming to show better control of eating behavior and a clean safety profile over 12 weeks of treatment.

This is a randomized study where participants are assigned by chance to ARD-101 or placebo in two parallel groups. It is double-blind for patients, caregivers, doctors, and outcome assessors, and the main purpose is treatment, so any clear benefit in hunger control would be a strong value driver for AARD.

The study was first submitted on February 13, 2025, signaling Aardvark’s push into late-stage development in rare metabolic disease. The most recent update on March 17, 2026, changed the status to suspended, which means dosing is on hold while the company and regulators review next steps.

For investors, the suspension raises near-term risk around ARD-101, as it may delay potential approval and push out revenue timing, which can pressure AARD’s valuation. It also opens space for competitors in obesity and rare metabolic drugs, so sentiment may shift defensive until the reason for the pause and a clear path forward are disclosed.

The ARD-101 HERO trial remains listed as an active but suspended study, and investors can track ongoing updates and details on the ClinicalTrials portal.

To learn more about AARD’s potential, visit the Aardvark Therapeutics, Inc. drug pipeline page.