Evaluation of Psilocybin (TRP-8802) to Decrease Hyperphagia

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.

Topic Eating Disorders
Compound Psilocybin
Country United States of America
Visit trial
Status Not yet recruiting
Results Published
Start date 11 October 2021
End date 06 February 2023
Phase Phase II
Design Open
Type Interventional
Generation Second
Participants 10
Sex All
Age 16- 64
Therapy Yes

Trial Details

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.

Trial Number NCT05035927

Sponsors & Collaborators

Tryp Therapeutics
Tryp Therapeutics is a clinical stage drug development company developing psilocybin products for various diseases/disorders including fibromyalgia.

Data attribution

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