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

NCT ID NCT06828861

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

68 people

The number who actually took part.

Started

Dec 2024

Finished

May 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

7 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 * At least 7 years of age or older in the US at the time of consent * At least 10 years of age or older in Australia * At least 13 years of age or older in countries outside of the US and Australia 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 any commercially available medication for the treatment of hyperphagia (i.e., Vykat) within 60 days of randomization and throughout the study. * Very high doses of glucocorticoids in the previous 3 months of Visit 1 and throughout the study.

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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

More trials for these conditions

Other studies related to the condition(s) this trial covers.