HyperphagiaPhase 3NCT07197034
The Hunger Elimination or Reduction Objective (HERO ) Open -Label Extension (OLE) Trial
A Phase 3 study testing ARD-101 in people with Hyperphagia and Prader-Willi Syndrome, run by Aardvark Therapeutics, Inc. at 30 sites in 5 countries.
Trial 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) when used in a long term setting. It will also teach us about the safety of ARD-101. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Hyperphagia, Prader-Willi Syndrome, Hyperphagia in Prader-Willi Syndrome
- What is being tested?
- ARD-101
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 30 sitesin 5 countries
- Study dates
- 23 Jul 2024to 15 Apr 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients who have completed treatment on Aardvark Therapeutics clinical study AVK-101-301
Who cannot join
- Any complications that makes participation unsafe in the Investigator's opinion
Trial locations and contacts
30 sites in 5 countries.
30 sites in 5 countries
United States16 sites
Emory University School of Medicine
Atlanta, Georgia, 30322-1047
The Johns Hopkins Hospital
Baltimore, Maryland, 21287-0005
Children's of Alabama
Birmingham, Alabama, 35233-1711
Maimonides Medical Center
Brooklyn, New York, 11219-2918
Ann and Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611-2991
Children's Hospital Colorado
Denver, Colorado, 80045-7106
Cook Children's Medical Center
Fort Worth, Texas, 76104
UF Shands Children's Hospital
Gainesville, Florida, 32610-3008
NYU Langone Children's Ambulatory Care Center
Mineola, New York, 11501-4077
University of Minnesota Masonic Children's Hospital
Minneapolis, Minnesota, 55102
Vanderbilt University Medical Center
Nashville, Tennessee, 37232-0005
Children's Hospital of Orange Country
Orange, California, 92868
Stanford Children's Health Specialty Services
Palo Alto, California, 94304
Rady Children's Hospital
San Diego, California, 92123
Seattle Children's Hospital
Seattle, Washington, 98105
Nemours Children's Clinic Wilmington
Wilmington, Delaware, 19803-3607
Canada4 sites
Alberta Children's Hospital Research Institute
Calgary, Alberta, T3B 6A8
Stollery Children's Hospital
Edmonton, Alberta
Children's Hospital at London Health Sciences Centre
London, Ontario, N6A 5W9
Centre Hospitalier Universitaire Sainte-Justine
Montreal, Quebec, H3T 1C5
United Kingdom4 sites
Fulborn Hospital
Cambridge, CB21 5EF
Royal Hospital for Children (Glasgow) - PPDS - PIN
Glasgow, G51 4TF
Leicester Royal Infirmary
Leicester, LE1 5WW
The Royal London Hospital
London, E1 1BB
Australia3 sites
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050
Queensland Children's Hospital
South Brisbane, Queensland, 4101
The Children's Hospital at Westmead
Westmead, New South Wales, 2145
South Korea3 sites
Inha University Hospital
Incheon, 22332
Samsung Medical Center
Seoul, 06351
Ajou University Hospital
Suwon, 16499
About this study
Official title: A Phase 3, Multicenter, Open-Label Extension Study to Assess the Safety and Efficacy of ARD-101 in Patients With Prader-Willi Syndrome
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:
Read more
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.
- Being tested
- ARD-101
- Keywords
- Prader-Willi Syndrome, ARD-101, PWS, Prader-Willi, Prader Willi, Prader Willi Syndrome
- Medical subject headings
- Hyperphagia, Prader-Willi Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARD-101Drug
200 mg BID (twice per day) for 1 week, 400 mg BID for 1 week, 800 mg BID for 50 weeks
| Study group | Role | What they receive |
|---|---|---|
| ARD-101 | Experimental | (Open-label) Receives: Drug: ARD-101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: During treatment period (approximately 12 months)
Secondary outcomes (1)
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.
Measured: During treatment period (approximately 12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2025
- Study start23 Jul 2024
- Primary completion15 Apr 2026
- Study completion15 Apr 2026
Why it stopped: Due to operational and regulatory considerations.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperphagiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aardvark Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07197034
- Sponsor's protocol ID
- AVK-101-302
- Status last verified
- Jun 2026
- First submitted
- 21 Sep 2025
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multicenter, Open-Label Extension Study to Assess the Safety and Efficacy of ARD-101 in Patients With Prader-Willi Syndrome
- ClinicalTrials.gov ID
- NCT07197034
- Acronym / sponsor ID
- AVK-101-302
- Keywords
- Prader-Willi Syndrome, ARD-101, PWS, Prader-Willi, Prader Willi, Prader Willi Syndrome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to operational and regulatory considerations.
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Aardvark Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Jul 2024 (actual)
- Primary completion
- 15 Apr 2026 (actual)
- Study completion
- 15 Apr 2026 (actual)
- First posted
- 29 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ARD-101 | Experimental | Drug: ARD-101(Open-label) |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who have completed treatment on Aardvark Therapeutics clinical study AVK-101-301
Key exclusion criteria (1 listed)
- Any complications that makes participation unsafe in the Investigator's opinion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ARD-101200 mg BID (twice per day) for 1 week, 400 mg BID for 1 week, 800 mg BID for 50 weeks | Drug | ARD-101 |
Primary outcome
Change in Hyperphagia Questionnaire for Clinical Trials (HQ-CT) Score
Time frame: During treatment period (approximately 12 months)
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).
1 secondary outcome
Change in Caregiver Global Impression of Severity (CaGI-S) for Hyperphagia in Prader-Willi patients
Time frame: During treatment period (approximately 12 months)
Results and safety
The study was stopped early (reason given: Due to operational and regulatory considerations.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
30 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ARD-101 in people with Hyperphagia and Prader-Willi Syndrome, run by Aardvark Therapeutics, Inc. at 30 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in United States, Canada, United Kingdom, Australia, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Due to operational and regulatory considerations.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hyperphagia Questionnaire for Clinical Trials (HQ-CT) Score (time frame: During treatment period (approximately 12 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026; AzTrials last refreshed its copy on 1 Nov 2026.