This study is for people with Prader-Willi syndrome (PWS), a genetic disorder causing constant hunger, known as hyperphagia. The study tests ARD-101, a drug, to see if it helps reduce hyperphagia. Participants will take ARD-101 or a placebo (a fake treatment) every day for 12 weeks. Visits to the clinic or tele-visits will happen every 2 to 4 weeks, with a final tele-visit 4 weeks after stopping the treatment. Participants or their caregivers will keep a daily diary about their condition.
- Study lasts 12 weeks, with regular visits every 2 to 4 weeks.
- Participants may continue with ARD-101 after the study in an open-label extension.
- Exclusion includes certain health conditions like high blood pressure, diabetes, or recent cancer.
People with PWS and a stable caregiver can join if they don't have certain other conditions like severe mood disorders or recent cancer. If successful, participants might join another study where they all get ARD-101.
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