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

NCT06828861 · Status: SUSPENDED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-04-09

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Aardvark Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
7 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-20
Primary Completion
2027-03-31
Completion
2027-04-30
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • South Korea
  • United Kingdom

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06828861 on ClinicalTrials.gov