Aardvark Therapeutics Advances PWS Treatment with ARD-101 Study

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

Study Overview: Aardvark Therapeutics, Inc. is conducting a Phase 3 clinical trial titled ‘A Phase 3, Randomized, Double-blind, Placebo-controlled Study of ARD-101 for the Treatment of Hyperphagia in Patients With Prader-Willi Syndrome.’ The study aims to assess the efficacy and safety of ARD-101 in treating hyperphagia-related behavior in patients with Prader-Willi Syndrome (PWS). The trial seeks to determine whether ARD-101 improves the total score of the hyperphagia questionnaire for clinical trials (HQCT-9) and to identify any medical issues participants may encounter while on the drug.

Intervention/Treatment: The intervention being tested is ARD-101, a drug administered to participants to evaluate its effectiveness in reducing hyperphagia symptoms in PWS patients. Participants will receive either ARD-101 or a placebo daily for 12 weeks.

Study Design: This interventional study employs a randomized, parallel assignment model with quadruple masking (participant, care provider, investigator, outcomes assessor) to ensure unbiased results. The primary purpose of the study is treatment-focused.

Study Timeline: The study began on February 13, 2025, and the latest update was submitted on October 7, 2025. These dates mark the study’s progression and the ongoing recruitment phase, highlighting its current active status.

Market Implications: The progress of this study could significantly impact Aardvark Therapeutics’ stock performance and investor sentiment, especially if ARD-101 demonstrates positive results. Success in this trial could position Aardvark as a leader in PWS treatment, potentially affecting competitors in the rare disease treatment market.

The study is ongoing, and further details are available on the ClinicalTrials portal.