A Phase 3 interventional study of ARD-101 in Hyperphagia, Prader-Willi Syndrome and Hyperphagia in Prader-Willi Syndrome, sponsored by Aardvark Therapeutics, Inc.. Terminated at 30 sites in 5 countries. Open to participants aged 13 Years and older. Per ClinicalTrials.gov, last updated 2026-06-30.
Sponsored by Aardvark Therapeutics, Inc. · Phase 3, Interventional, and Treatment
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) when used in a long term setting. It will also teach us about the safety of ARD-101.
The main questions it aims to answer are:
What medical problems do participants have when taking ARD-101 in a long term setting
Does ARD-101 improve the total score of the HQCT-9 (hyperphagia questionnaire for clinical trials, 9 questions)?
Eligible participants will:
Have completed treatment on the AVK-101-301 study through Week 12/End of Treatment
Take ARD-101 every day for up to 12 months.
Visit the clinic at Months 1, 3, 6 and 12 during dosing and then have tele-visits at Week 2, Months 3 and 9, then 4 weeks after stopping the ARD-101.
Patients/Caregivers will keep a daily diary.
39 studies on the registry are indexed under Hyperphagia; 4 are open to participants now.
This study's enrollment of 19 is below the median of 50 across 34 interventional studies indexed under Hyperphagia.
Browse Hyperphagia studies →Aardvark Therapeutics, Inc. is the lead sponsor of 6 studies on the registry; none are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 3 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
(Open-label)
Drug: ARD-101
200 mg BID (twice per day) for 1 week, 400 mg BID for 1 week, 800 mg BID for 50 weeks
Change in Hyperphagia Questionnaire for Clinical Trials (HQ-CT) Score
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).
Time frame: During treatment period (approximately 12 months)
Change in Caregiver Global Impression of Severity (CaGI-S) for Hyperphagia in Prader-Willi patients
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.
Time frame: During treatment period (approximately 12 months)
Plan to share: No
No publications or documents are linked to this record.
This study is terminated, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Denatonium acetate monohydrate
Aardvark Therapeutics, Inc.