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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06828861
Registration number
NCT06828861
Ethics application status
Date submitted
13/02/2025
Date registered
17/02/2025
Date last updated
16/07/2025
Titles & IDs
Public title
ARD-101 for Treatment of PWS: The Hunger Elimination or Reduction Objective Trial
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Scientific title
A Phase 3, Randomized, Double-blind, Placebo-controlled Study of ARD-101 for the Treatment of Hyperphagia in Patients With Prader-Willi Syndrome
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Secondary ID [1]
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AVK-101-301
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Universal Trial Number (UTN)
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Trial acronym
HERO
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hyperphagia
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Prader-Willi Syndrome
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Condition category
Condition code
Human Genetics and Inherited Disorders
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Other human genetics and inherited disorders
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Mental Health
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Learning disabilities
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Other
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Research that is not of generic health relevance and not applicable to specific health categories listed above
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Metabolic and Endocrine
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Other endocrine disorders
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Mental Health
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Eating disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - ARD-101
Experimental: Treatment Arm A - ARD-101
Placebo comparator: Treatment Arm B - Placebo for ARD-101
Treatment: Drugs: Placebo
200 mg BID (twice per day) for 1 week, 400 mg BID for 1 week, 800 mg BID for 10 weeks
Treatment: Drugs: ARD-101
200 mg BID (twice per day) for 1 week, 400 mg BID for 1 week, 800 mg BID for 10 weeks
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change in Hyperphagia Questionnaire for Clinical Trials (HQ-CT) Score
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Assessment method [1]
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The HQ-CT score is a 9 question, 5-point scale to describe the PWS patient's hyperphagia food-related problem behaviors. It is completed by the patient's caregiver. Each question is scored from 0 to 4. The minimum total score is 0 (hyperphagia related behavior symptoms not exhibited) and the maximum total score is 36 (hyperphagia related behavior symptoms are observed).
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Timepoint [1]
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Baseline to Week 12
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Secondary outcome [1]
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Change in Caregiver Global Impression of Severity (CaGI-S) for Hyperphagia in Prader-Willi patients
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Assessment method [1]
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The CaGI-S is a single-item, 7-point scale to describe the severity of the PWS patient's hyperphagia (excessive hunger). It is completed by the patient's caregiver. The minimum score is 1 (not present) and the maximum score is 7 (extremely severe). A higher score indicates a worse severity of hyperphagia.
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Timepoint [1]
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Baseline to Week 12
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Secondary outcome [2]
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Change in Clinical Global Impression of Severity (CGI-S) Score for Hyperphagia in Prader-Willi patients
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Assessment method [2]
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The CGI-S is a single-item, 7-point scale designed to assess the severity of the PWS patient's hyperphagia (excessive hunger). It is assessed by the clinician and considers the clinician's experience with the PWS population. The minimum score is 1 (normal, not at all ill) and the maximum score is 7 (among the most extremely ill patients). A higher score indicates a worse severity of hyperphagia.
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Timepoint [2]
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Baseline to Week 12
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Eligibility
Key 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
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Minimum age
13
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
20/12/2024
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/04/2026
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Actual
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Sample size
Target
90
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD
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Recruitment hospital [1]
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Royal Prince Alfred Hospital - Camperdown
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Recruitment hospital [2]
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The Children's Hospital at Westmead - Westmead
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Recruitment hospital [3]
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Queensland Children's Hospital - South Brisbane
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Recruitment postcode(s) [1]
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2050 - Camperdown
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Recruitment postcode(s) [2]
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2145 - Westmead
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Recruitment postcode(s) [3]
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4101 - South Brisbane
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Recruitment outside Australia
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United States of America
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Alabama
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California
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Colorado
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Delaware
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Haute-Garonne
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France
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Maine-et-Loire
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France
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Paris
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France
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Toulouse
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Lazio
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Italy
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Italy
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Toscana
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Korea, Republic of
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Incheon
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Suwon-si
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Romania
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Bucuresti
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Romania
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Iasi
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Barcelona
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Spain
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Madrid
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Leicestershire
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Cambridge
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Glasgow
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London
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Aardvark Therapeutics, Inc.
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT06828861
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Contact person for public queries
Name
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Robin Schmidt, MS
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Address
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Phone
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(858) 225-7696
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06828861
Download to PDF