A 2-Part Study to Assess Efficacy, Safety and Tolerability of BMB-101 for the Treatment of Patients With Prader-Willi Syndrome.

The goal of this clinical trial is to evaluate the safety and effects of a new drug called BMB-101 in people with Prader-Willi Syndrome (PWS). This study is designed as a multi-centre, double-blind, randomized, placebo controlled 2-part study with a blinded main phase followed up an open label extension phase.

NCT Number	NCT07266324
Lead Sponsor	Bright Minds Biosciences Pty Ltd
Conditions	Prader-Willi Syndrome
Enrollment	16 participants
Start Date	2026-01
Primary Completion	2026-11 (estimated)
Study Completion	2027-03 (estimated)
Updated on ClinicalTrials.gov	2025-12-05