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Using ARD-101 to reduce hunger in Prader-Willi syndrome

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

Phase 3 Interventional Aardvark Therapeutics, Inc. · NCT06828861

This study is testing if a new medication called ARD-101 can help reduce hunger in people with Prader-Willi syndrome.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment90 (estimated)
Ages13 Years and up
SexAll
SponsorAardvark Therapeutics, Inc. Industry-sponsored
Locations42 sites (Birmingham, Alabama and 41 other locations)
Trial IDNCT06828861 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of ARD-101 in treating hyperphagia, a significant behavioral issue in patients with Prader-Willi syndrome (PWS). Participants will receive either ARD-101 or a placebo daily for 12 weeks, with regular clinic visits or tele-visits to monitor their progress. The study will assess changes in hyperphagia-related behaviors using the HQCT-9 questionnaire and will also evaluate the safety profile of ARD-101. Caregivers will maintain daily diaries to track participant behaviors and any side effects experienced during the trial.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals diagnosed with Prader-Willi syndrome who have a stable care setting and a designated caregiver.

Not a fit: Patients with severe mood disorders, certain malignancies, or significant comorbidities that could affect their safety during the trial may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life for patients with Prader-Willi syndrome by reducing hyperphagia-related behaviors.

How similar studies have performed: While this approach is focused on a specific treatment for hyperphagia in PWS, similar studies targeting hyperphagia in other conditions have shown promise, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Documented confirmation of Prader-Willi Syndrome (PWS)
* Stable care setting with same, single designated caregiver for at least 6 months prior to Visit 1

Exclusion Criteria:

* Diagnosis of schizophrenia, bipolar disorder, personality disorder or other severe mood, anxiety or eating disorder (other than hyperphagia).
* Presence of any malignancy within 5 years with the exception of basal or squamous cell carcinoma of the skin, in situ carcinoma of the service, or in situations prostate cancer.
* Presence of clinically relevant renal, hepatic, pancreatic, cardiovascular, neurological, psychiatric, hematological, pulmonary, or GI abnormality that, in the opinion of the investigator, may preclude the patient from safe completion of the study
* Adults: systolic blood pressure \>=160 mmHg and/or diastolic blood pressure \>=100 mmHg
* Children and Adolescents: systolic blood pressure \>=140 mmHg and/or diastolic blood pressure \>=90 mmHg.
* Type 1 diabetes mellitus; HbA1c \>8.5%
* Use of agents to promote weight gain or loss, alter hunger or appetite within 30 days of Visit 1 and throughout the study.
* Use of glucocorticoids: oral, intra-articular, or intravenous

Where this trial is running

Birmingham, Alabama and 41 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions HyperphagiaPrader-Willi SyndromeARD-101PWSPrader-WilliPrader WilliPrader Willi Syndrome
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.