Hunger Elimination or Reduction Objective (HERO) Study for Treatment of Hyperphagia in Prader-Willi Syndrome (PWS)
Eligibility
-
Documented diagnosis of Prader-Willi Syndrome (PWS)
-
Age 13 years old or older
-
Primary caregiver that can commit to the trial requirements for 12 weeks
Study Details
-
Eligible participants will either receive study drug or placebo (no active study drug ingredients).
-
Study drug will be taken orally twice daily for 12 weeks
-
Approximately 4 in-person clinic visits and 3 telehealth visits are required
-
Travel expenses and lodging (if required) for the participant and a primary caregiver will be covered
-
No fasting required
-
All participants who complete the HERO study will have the option to participate in a follow up study where everyone will receive active study drug.
The HERO Study Details
Why are we testing 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
ARD-101 is being studied to see if it can help the body release certain gut hormones that may help reduce excessive hunger and food-seeking behaviors 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 13 years old. They will also need a single, designated caregiver who can communicate well with the investigator, attend clinic visits, complete questionnaires, and monitor food and behavior changes for the entire duration of the study.
Study Details
Eligible participants will receive either active study drug or placebo (no active study drug ingredients). Participants will take the study drug orally twice daily for 12 weeks. The study requires approximately four in-person clinic visits and three telehealth visits, with travel expenses and lodging covered if needed. No fasting is necessary. All participants who complete the HERO study will have the option to receive the active study drug in a follow up study.
Study Locations
Use the map below to locate participating study sites.
Our Heroes
We recognize that progress in ground-breaking 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.
FAQs
-
Are both caregivers and participants provided with travel and lodging support (as needed)?Yes, no-cost travel and lodging support will be provided to all study participants and a designated caregiver to accompany them to study visits throughout the study.
-
Do we have to change our routine during the study?No. Other than the visits to the clinical site, you are encouraged to keep your daily routine as close to normal as possible. Importantly, participants will NOT be asked to fast for any of the visits.
-
What can I expect if I participate in this study?After a screening visit, 3 additional in-person and 3 remote visits will occur over 16 weeks. A primary caregiver will attend study visits with the participant and complete study related questionnaires and daily diaries throughout the study.
-
What is a clinical study?Clinical studies help scientists explore whether new investigational medicines are safe and effective at treating medical conditions and diseases in patients. Before a new medication can be approved for treating a specific condition, it must go through several phases of research with study participants. All studies must be approved by an institutional review board (IRB), which consists of a group of people who review and monitor research studies to ensure they are ethical and safe for participants.