Hope for rare hunger disorder: new drug enters final testing phase

NCT ID NCT06828861

Terminated Symptom relief Sponsor: Aardvark Therapeutics, Inc. Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Jul 01, 2026 · Updated 3 times

Summary

This phase 3 trial tests whether ARD-101 can reduce the intense, constant hunger (hyperphagia) seen in Prader-Willi syndrome. About 90 participants will take either ARD-101 or a placebo daily for 12 weeks. Caregivers will track changes in hunger-related behaviors using a standard questionnaire. The study is currently on hold.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: ARD-101
What this could lead to: If it works, this could provide a new treatment to control extreme hunger in people with Prader-Willi syndrome, improving their quality of life and safety.
What could go wrong: This trial is currently suspended, so results are delayed. Even if completed, it may not show a meaningful benefit over placebo, and side effects are unknown.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

Hyperphagia Prader-Willi syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HYPERPHAGIA PRADER-WILLI SYNDROME

Contacts and locations

Locations

Ajou University Hospital

Suwon, 16499, South Korea
Alberta Children's Hospital Research Institute

Calgary, Alberta, T3B 6A8, Canada
Ann and Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611-2991, United States
Centre Hospitalier Universitaire Sainte-Justine

Montreal, Quebec, H3T 1C5, Canada
Children's Hospital Colorado

Denver, Colorado, 80045-7106, United States
Children's Hospital at London Health Sciences Centre

London, Ontario, N6A 5W9, Canada
Children's Hospital of Orange Country

Orange, California, 92868, United States
Children's of Alabama

Birmingham, Alabama, 35233-1711, United States
Cook Children's Medical Center

Fort Worth, Texas, 76104, United States
Emory University School of Medicine

Atlanta, Georgia, 30322-1047, United States
Fulborn Hospital

Cambridge, CB21 5EF, United Kingdom
Inha University Hospital

Incheon, 22332, South Korea
Leicester Royal Infirmary

Leicester, Leicestershire, LE1 5WW, United Kingdom
Maimonides Medical Center

Brooklyn, New York, 11219-2918, United States
NYU Langone Children's Ambulatory Care Center

Mineola, New York, 11501-4077, United States
Nemours Children Clinic Wilmington

Wilmington, Delaware, 19803-3607, United States
Queensland Children's Hospital

South Brisbane, Queensland, 4101, Australia
Rady Children's Hospital

Encinitas, California, 92123, United States
Royal Hospital for Children (Glasgow) - PPDS - PIN

Glasgow, G51 4TF, United Kingdom
Royal Prince Alfred Hospital

Camperdown, New South Wales, 2050, Australia
Samsung Medical Center

Seoul, 06351, South Korea
Seattle Children's Hospital

Seattle, Washington, 98105, United States
Stanford Children's Health Specialty Services

Palo Alto, California, 94304, United States
Stollery Children's Hospital

Edmonton, Alberta, T6G 2B7, Canada
Texas Valley Clinical Research, LLC

Weslaco, Texas, 78596-7288, United States
The Children's Hospital at Westmead

Westmead, New South Wales, 2145, Australia
The Johns Hopkins Hospital

Baltimore, Maryland, 21287-0005, United States
The Royal London Hospital

London, E1 4NS, United Kingdom
UF Shands Children's Hospital

Gainesville, Florida, 32610-3008, United States
University of Minnesota Masonic Children's Hospital

Minneapolis, Minnesota, 55102, United States
Vanderbilt University Medical Center

Nashville, Tennessee, 37232-0005, United States

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