Clinical Trials Logo

Clinical Trial Summary

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.

Clinical Trial Description

The 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. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05035927
Study type Interventional
Source TRYP Therapeutics
Contact Jim Gilligan, PhD
Phone (833) 811-8797
Email [email protected]
Status Not yet recruiting
Phase Phase 2
Start date October 2021
Completion date February 2023

See also
  Status Clinical Trial Phase
Active, not recruiting NCT02629991 - Oxytocin vs. Placebo for the Treatment Hyperphagia in Children and Adolescents With Prader-Willi Syndrome Phase 2
Terminated NCT03790865 - Effects of Livoletide (AZP-531) on Food-related Behaviors in Patients With Prader-Willi Syndrome Phase 2/Phase 3
Active, not recruiting NCT03375853 - Computerized Response Training Obesity Treatment N/A
Recruiting NCT04150991 - Fiber Intervention on Gut Microbiota in Children With Prader-Willi Syndrome N/A
Not yet recruiting NCT05044000 - Effect of Deep Propioception Stimulation in Prader-Willi Syndrome N/A
Terminated NCT00175305 - Prader-Willi Syndrome and Appetite Phase 3
Recruiting NCT02758262 - Effects of Noninvasive Brain Stimulation on Brain Activity and Appetite N/A
Completed NCT01863017 - Pilot Study of Startle-response Test to Assess Transcranial Direct Current Stimulation-induced Modulation of Hyperphagia in Prader-Willi Syndrome N/A
Recruiting NCT03197662 - Intranasal Oxytocin vs. Placebo for the Treatment of Hyperphagia in Prader-Willi Syndrome Phase 2