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

Exclusion Criteria

• •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.
• •Participant has current or past history of cardiovascular or cerebrovascular disease, such as cardiac valvulopathy, pulmonary hypertension, myocardial infarction or stroke, or clinically significant structural cardiac abnormality.
• •Participant has moderate or severe hepatic impairment. Asymptomatic participants with mild hepatic impairment (elevated liver enzymes \< 3x upper limit of normal (ULN) and/or elevated bilirubin \<2x ULN) may be entered into the study after review and approval by the Medical Monitor in conjunction with the sponsor, in consideration of comorbidities and concomitant medications.
• •Participant has severe renal impairment (estimated glomerular filtration rate \<30mL/min/1.73m2).
• •Participant has clinically significant ECG abnormality such as QTcF \>450 msec (males) or \>470 msec (females).
• •Participant has a history of drug or alcohol abuse within the last 12 months or a positive urine drug screen.
• •A current C-SSRS score of 4 or 5 at Visit 1 or history of suicide attempt at any time during the past year.
• •Participant has a clinically significant condition or has had clinically relevant symptoms or a clinically significant illness in the 4 weeks prior to Visit 1, other than PWS, that would negatively impact study participation, collection of study data, evaluation of study endpoints or pose a risk to the participant, in the opinion of the Investigator.
• •Participant is pregnant (determined by a positive urine pregnancy test) or lactating female.
• •Any condition that is thought to be a degenerative neurological disease.