HyperphagiaPhase 3HERONCT06828861
ARD-101 for Treatment of PWS: The Hunger Elimination or Reduction Objective Trial
A Phase 3 study testing ARD-101 in people with Hyperphagia and Prader-Willi Syndrome, run by Aardvark Therapeutics, Inc. at 31 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). It will also teach us about the safety of ARD-101. Read more about this study
- Who is it for?
- Ages 7 years and older
- Conditions the study is for
- Hyperphagia, Prader-Willi Syndrome
- What is being tested?
- ARD-101
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 31 sitesin 5 countries
- Study dates
- 20 Dec 2024to 7 May 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 7 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Documented confirmation of Prader-Willi Syndrome (PWS)
- Stable care setting with same, single designated caregiver for at least 6 months prior to Visit 1
- At least 7 years of age or older in the US at the time of consent
- At least 10 years of age or older in Australia
- At least 13 years of age or older in countries outside of the US and Australia
Who cannot join
- 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%
Show all 9Show fewer
- 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 any commercially available medication for the treatment of hyperphagia (i.e., Vykat) within 60 days of randomization and throughout the study.
- Very high doses of glucocorticoids in the previous 3 months of Visit 1 and throughout the study.
Trial locations and contacts
31 sites in 5 countries.
31 sites in 5 countries
United States17 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
Rady Children's Hospital
Encinitas, California, 92123
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
Seattle Children's Hospital
Seattle, Washington, 98105
Texas Valley Clinical Research, LLC
Weslaco, Texas, 78596-7288
Nemours Children Clinic Wilmington
Wilmington, Delaware, 19803-3607
Canada4 sites
Alberta Children's Hospital Research Institute
Calgary, Alberta, T3B 6A8
Stollery Children's Hospital
Edmonton, Alberta, T6G 2B7
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, Leicestershire, LE1 5WW
The Royal London Hospital
London, E1 4NS
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, Randomized, Double-blind, Placebo-controlled Study of ARD-101 for the Treatment of Hyperphagia 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). It will also teach us about the safety of ARD-101.
The main questions it aims to answer are:
Read more
- 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.
Participants who complete the study may be eligible to enter an open-label extension study where everyone will receive ARD-101.
- Conditions
- Hyperphagia, Prader-Willi Syndrome
- Being tested
- Placebo, 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.
PlaceboDrug
200 mg BID (twice per day) for 1 week, 400 mg BID for 1 week, 800 mg BID for 10 weeks
ARD-101Drug
200 mg BID (twice per day) for 1 week, 400 mg BID for 1 week, 800 mg BID for 10 weeks
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm A | Experimental | ARD-101 Receives: Drug: ARD-101 |
| Treatment Arm B | Placebo comparator | Placebo for ARD-101 Receives: Drug: Placebo |
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: Baseline to Week 12
Secondary outcomes (2)
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: Baseline to Week 12
Change in Clinical Global Impression of Severity (CGI-S) Score for Hyperphagia in Prader-Willi patients
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.
Measured: Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2025
- Study start20 Dec 2024
- Primary completion7 May 2026
- Study completion7 May 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 68 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
- NCT06828861
- Sponsor's protocol ID
- AVK-101-301
- Acronym
- HERO
- Status last verified
- Jun 2026
- First submitted
- 13 Feb 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, Randomized, Double-blind, Placebo-controlled Study of ARD-101 for the Treatment of Hyperphagia in Patients With Prader-Willi Syndrome
- ClinicalTrials.gov ID
- NCT06828861
- Acronym / sponsor ID
- HERO / AVK-101-301
- Conditions
- Hyperphagia, Prader-Willi Syndrome
- 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
- 68 participants (actual)
- Lead sponsor
- Aardvark Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Dec 2024 (actual)
- Primary completion
- 7 May 2026 (actual)
- Study completion
- 7 May 2026 (actual)
- First posted
- 17 Feb 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). 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.
Participants who complete the study may be eligible to enter an open-label extension study where everyone will receive ARD-101.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm A | Experimental | Drug: ARD-101ARD-101 |
| Treatment Arm B | Placebo comparator | Drug: PlaceboPlacebo for ARD-101 |
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Documented confirmation of Prader-Willi Syndrome (PWS)
- Stable care setting with same, single designated caregiver for at least 6 months prior to Visit 1
- At least 7 years of age or older in the US at the time of consent
- At least 10 years of age or older in Australia
- At least 13 years of age or older in countries outside of the US and Australia
Key exclusion criteria (9 listed)
- 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.
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 |
|---|---|---|
| Placebo200 mg BID (twice per day) for 1 week, 400 mg BID for 1 week, 800 mg BID for 10 weeks | Drug | Treatment Arm B |
| ARD-101200 mg BID (twice per day) for 1 week, 400 mg BID for 1 week, 800 mg BID for 10 weeks | Drug | Treatment Arm A |
Primary outcome
Change in Hyperphagia Questionnaire for Clinical Trials (HQ-CT) Score
Time frame: Baseline to Week 12
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).
2 secondary outcomes
Change in Caregiver Global Impression of Severity (CaGI-S) for Hyperphagia in Prader-Willi patients
Time frame: Baseline to Week 12
Change in Clinical Global Impression of Severity (CGI-S) Score for Hyperphagia in Prader-Willi patients
Time frame: Baseline to Week 12
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.
31 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 31 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 5 inclusion and 9 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 31 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. Some participants in this study may receive a placebo. 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: Baseline to Week 12). 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.