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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Hyperphagia, Prader-Willi Syndrome

In brief

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.

Key facts

Study ID

NCT06828861

Run by

Aardvark Therapeutics, Inc.

People needed

68

Starts

2024-12-20

Expected to finish

2026-05-07

Last updated by the study team

2026-06-30

Who can join

Age: 7 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Children's of Alabama — Birmingham, Alabama, United States
• Rady Children's Hospital — Encinitas, California, United States
• Children's Hospital of Orange Country — Orange, California, United States
• Stanford Children's Health Specialty Services — Palo Alto, California, United States
• Children's Hospital Colorado — Denver, Colorado, United States
• Nemours Children Clinic Wilmington — Wilmington, Delaware, United States
• UF Shands Children's Hospital — Gainesville, Florida, United States
• Emory University School of Medicine — Atlanta, Georgia, United States
• Ann and Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States
• The Johns Hopkins Hospital — Baltimore, Maryland, United States
• University of Minnesota Masonic Children's Hospital — Minneapolis, Minnesota, United States
• Maimonides Medical Center — Brooklyn, New York, United States
• NYU Langone Children's Ambulatory Care Center — Mineola, New York, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Cook Children's Medical Center — Fort Worth, Texas, United States
• Texas Valley Clinical Research, LLC — Weslaco, Texas, United States
• Seattle Children's Hospital — Seattle, Washington, United States
• Royal Prince Alfred Hospital — Camperdown, New South Wales, Australia
• The Children's Hospital at Westmead — Westmead, New South Wales, Australia
• Queensland Children's Hospital — South Brisbane, Queensland, Australia
• Alberta Children's Hospital Research Institute — Calgary, Alberta, Canada
• Stollery Children's Hospital — Edmonton, Alberta, Canada
• Children's Hospital at London Health Sciences Centre — London, Ontario, Canada
• Centre Hospitalier Universitaire Sainte-Justine — Montreal, Quebec, Canada
• Inha University Hospital — Incheon, South Korea

Full record on ClinicalTrials.gov

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