Vanderbilt Clinical Trials

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

Purpose

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

Eligibility

Eligible Ages: Over 13 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

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

Study Design

Phase: Phase 3
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Treatment Arm A	ARD-101	Drug: ARD-101 200 mg BID (twice per day) for 1 week, 400 mg BID for 1 week, 800 mg BID for 10 weeks
Placebo Comparator Treatment Arm B	Placebo for ARD-101	Drug: Placebo 200 mg BID (twice per day) for 1 week, 400 mg BID for 1 week, 800 mg BID for 10 weeks

Recruiting Locations

Vanderbilt University Medical Center
Nashville, Tennessee 37232-0005

Contact:
Ashley Shoemaker, MD

More Details

Status: Recruiting
Sponsor: Aardvark Therapeutics, Inc.

Study Contact

Robin Schmidt, MS
(858) 225-7696
Info@AardvarkTherapeutics.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.