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ARD-101 · HERO

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

Ensayo de Aardvark Therapeutics, Inc. en Hiperfagia · Sindrome de Prader-Willi.

Más ensayos de: Síndrome de Prader-Willi.

Fase

Fase 3

Estado

Interrumpido

Participantes

68

previstos

Centros

31

Fin del objetivo primario

may 2026

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en dic 2024.

Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «Due to operational and regulatory considerations.».

Qué mide

Cambio en la puntuacion del Cuestionario de Hiperfagia para Ensayos Clinicos (HQ-CT) (del inicio a la semana 12)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe 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.

Más ensayos de AARD

Todos los de AARD, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT06828861), actualizada en jun 2026.