Hunger Elimination or Reduction Objective (HERO) Study for Treatment of Hyperphagia in Prader-Willi Syndrome (PWS)
Eligibility
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Documented diagnosis of Prader-Willi syndrome (PWS)
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Age 10 years old or older
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Primary carer that can commit to the trial requirements for 12 weeks
Study Details
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Eligible participants will either receive investigational medication or placebo (no active investigational medication ingredients)
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Investigational medication will be taken orally twice daily for 12 weeks
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Approximately 4 in-person visits and 3 telehealth visits are required
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Travel and accommodation (if required) for the participant and a primary carer will be covered
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No fasting required
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All participants who complete the HERO study will have the option to participate in a follow-up study where everyone will receive the investigational medication
The HERO Study Details
Why are we testing an investigational medication (ARD-101)?
For most people, when they eat, food triggers a signal to be sent to the brain that they should no longer be hungry.
Individuals with PWS are suspected to be missing the signal that suppresses hunger.
This investigational medication is being studied to see if it can help the body release certain gut hormones that may help reduce excessive hunger and food-seeking behaviours in people with PWS.
Eligibility
To be eligible for the HERO study, male or female participants must be diagnosed withāÆPrader-Willi syndromeāÆandāÆbe at least 10 years old. They will also need aāÆsingle, designated carer who can communicate well with the investigator, attend in-person visits, complete questionnaires, and monitor food and behaviour changes for the entire duration of the study.
Study Details
Eligible participants will receive eitherāÆthe investigational medication or placeboāÆ(no active investigational medication ingredients). Participants willāÆtake the investigational medication orally twice daily for 12 weeks. The study requires approximatelyāÆfour in-person visits and three telehealth visits, withāÆtravel and accommodation coveredāÆif needed.āÆNo fastingāÆis necessary. All participants who complete the HERO study will have theāÆoption to receive the investigational medication in a follow-up study.
Study Locations
Use the map below to locate participating study centres.
Our Heroes
We recognise that progress in groundbreaking research is driven by collaboration.
That’s why we actively partner with patient groups and foundations dedicated to improving care, advancing treatment options and supporting the communities we serve. These established relationships allow us to design clinical studies prioritising patient needs, ensuring that our research is impactful and family- and patient-friendly.
By working together with these trusted organisations, we are committed to making a difference—because every research study for a potential new therapy needs a HERO to forge the way forward.
