This study tests if ARD-101, a new medicine, helps people with Prader-Willi syndrome (PWS) reduce hyperphagia (extreme hunger). It's important to check both its effectiveness and safety. Participants will either take ARD-101 or a placebo (a fake pill) daily for 12 weeks. Researchers will measure changes using a special quiz called HQCT-9. There will be clinic visits or online check-ins every 2 to 4 weeks during the trial, and another online check-in 4 weeks after you stop the medicine. Participants or their caregivers need to keep a daily diary about their experience.
- Duration: 12 weeks with regular visits or online check-ins.
- Participants take either ARD-101 or a placebo.
- Daily diary keeping is necessary.
To join, you need a confirmed diagnosis of PWS and can't have certain other health problems like severe mood disorders or high blood pressure. You also need a stable caregiver and can't be using drugs that affect weight or hunger. This study aims to provide new treatment options for people with PWS. Please consult your doctor to see if this study is right for you.