The Hunger Elimination or Reduction Objective Trial

Description

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.

Conditions

Hyperphagia, Prader-Willi Syndrome

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Study Overview

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Study Details

Study overview

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.

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

The Hunger Elimination or Reduction Objective Trial

Condition
Hyperphagia
Intervention / Treatment

-

Contacts and Locations

Birmingham

Children's of Alabama, Birmingham, Alabama, United States, 35233-1711

Encinitas

Rady Children's Hospital, Encinitas, California, United States, 92024

Palo Alto

Stanford Childrens Health Specialty Services, Palo Alto, California, United States, 94304

Denver

Childrens Hospital Colorado, Denver, Colorado, United States, 80045-7106

Wilmington

Nemours Children Clinic Wilmington, Wilmington, Delaware, United States, 19803-3607

Gainesville

UF Shands Childrens Hospital, Gainesville, Florida, United States, 32610-3008

Atlanta

Emory University School of Medicine, Atlanta, Georgia, United States, 30322-1047

Minneapolis

University of Minnesota Masonic Children's Hospital, Minneapolis, Minnesota, United States, 55102

Brooklyn

Maimonides Medical Center, Brooklyn, New York, United States, 11219-2918

Mineola

NYU Langone Children's Ambulatory Care Center, Mineola, New York, United States, 11501-4077

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

13 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Aardvark Therapeutics, Inc.,

Study Record Dates

2026-04