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 7 years old or older
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Primary caregiver that can commit to the trial requirements for 16 weeks
Study Details
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Eligible participants will either receive investigational drug or placebo (no active investigational drug ingredients)
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Investigational drug 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 caregiver 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 drug
The HERO Study Details
Why are we testing an investigational drug (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 drug 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 with Prader-Willi syndrome and be at least 7 years old. They will also need a single, designated caregiver 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 either the investigational drug or placebo (no active investigational drug ingredients). Participants will take the investigational drug orally twice daily for 12 weeks. The study requires approximately four in-person visits and three telehealth visits, with travel and accommodation covered if needed. No fasting is necessary. All participants who complete the HERO study will have the option to receive the investigational drug in a follow-up study.
Study Locations
Use the map below to locate participating study sites.
Our Heroes
We recognize that progress in groundbreaking research is driven by collaboration.
That’s why we actively partner with patient advocacy 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 prioritizing patient needs, ensuring that our research is impactful and family- and patient-friendly.
By working together with these trusted organizations, we are committed to making a difference—because every research study for a potential new therapy needs a HERO to forge the way forward.
