This is a single-center phase 2a open-label study to assess the efficacy and safety of a dose of psilocybin in subjects with hyperphagia resulting in overeating during both dosing sessions. Subjects will undergo screening, preparation therapy sessions, dosing, integration therapy sessions, and follow-up for 24 weeks following the second of 2 doses.
The total participation in the study will be up to 7 months. The study will assess change from baseline in body mass index (BMI). Safety will be assessed during dosing sessions and over a 24 week follow-up period.
Trial DetailsThe primary objectives of this study are to: 1. Document the preliminary clinical activity of TRYP-8802 in conjunction with psychotherapy in subjects with overeating disorders including but not limited to hypothalamic obesity, binge-eating disorder, and Prader-Willi Syndrome, as assessed by maximum change from baseline (CFB) in body mass index (BMI) through 8 weeks following the second of 2 doses. 2. Assess the safety of TRYP-8802 under the conditions of this study, both during the 2 TRYP-8802 dosing sessions and through 24 weeks following the second of 2 doses.
NCT Number NCT05035927
Sponsors & CollaboratorsTryp Therapeutics
Tryp Therapeutics is a clinical stage drug development company developing psilocybin products for various diseases/disorders including fibromyalgia.