NCT06828861

ARD-101 for Treatment of PWS: The Hunger Elimination or Reduction Objective Trial

A Phase 3, Randomized, Double-blind, Placebo-controlled Study of ARD-101 for the Treatment of Hyperphagia in Patients With Prader-Willi Syndrome

• Status: Suspended
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Aardvark Therapeutics, Inc. · Industry
• Sex: All
• Age: 7 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn if ARD-101 works to treat hyperphagia-related behavior in patients with Prader-Willi syndrome (PWS). It will also teach us about the safety of ARD-101. The main questions it aims to answer are: * Does ARD-101 improve the total score of the HQCT-9 (hyperphagia questionnaire for clinical trials, 9 questions)? * What medical problems do participants have when taking ARD-101? Researchers will compare ARD-101 to a placebo (a look-alike substance that contains no drug) to see if ARD-101 works to treat hyperphagia in PWS subjects. Eligible participants will: * Take ARD-101 or a placebo every day for 12 weeks. * Visit the clinic or have a tele-visit once every 2 to 4 weeks during dosing and then have a tele-visit 4 weeks after stopping the ARD-101 or placebo. * Patients/Caregivers will keep a daily diary. Participants who complete the study may be eligible to enter an open-label extension study where everyone will receive ARD-101.

Conditions

• Hyperphagia
• Prader-Willi Syndrome

Interventions

Type	Name	Description
DRUG	Placebo	200 mg BID (twice per day) for 1 week, 400 mg BID for 1 week, 800 mg BID for 10 weeks
DRUG	ARD-101	200 mg BID (twice per day) for 1 week, 400 mg BID for 1 week, 800 mg BID for 10 weeks

Timeline

• Start date: 2024-12-20
• Primary completion: 2027-03-01
• Completion: 2027-04-01
• First posted: 2025-02-17
• Last updated: 2026-04-09

Locations

30 sites across 5 countries: United States, Australia, Canada, South Korea, United Kingdom

Regulatory

• FDA-regulated drug study