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.
Participant must be aged 18-65 years (both inclusive).
Genetically confirmed diagnosis of Prader Willi Syndrome via standard DNA testing or other commonly approved methods.
Willing and able to provide voluntary written informed consent, or have a Legally Authorized Representative who is able to provide consent.
Moderate to severe hyperphagia as defined by a HQ-CT score ≥ 13 at time of randomization (Visit 3).
Participant has used metabolic agents known to affect appetite within 3 months of Visit 1.
Participant use of psychotropic medications including SSRIs/SNRIs, monoamine-oxidase inhibitors, tricyclic antidepressants, other serotonergic agonists or antagonists (antipsychotics), and other agents which have known Serotonin Syndrome risk (e.g. mirtazapine) within 1 month of Visit 1.
Participant has implementation of new food restrictions or new environmental restrictions within 1 month of Visit 1.
Participant has participated in an interventional clinical trial of any Prader-Willi Syndrome agent within 3 months of Visit 1 or any other investigational agent within 1 month of Visit 1.