Summary:
Placebo-controlled study to evaluate the efficacy and safety of oral ACT-539313 in the treatment of adults with moderate to severe binge eating disorder
Criteria assessed at Visit 1:
- Signed and dated informed consent form prior to any study-mandated procedure.
- Male or female study participants aged 18 to 55 years at the time of signing the informed consent form.
- Binge-eating disorder (BED) in accordance with Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-5) criteria diagnosed using the Structured Clinical Interview for DSM-5 (SCID-5).
- Self-reported BED severity of at least moderate level, defined as at least 4 BE episodes per week, on average, for a duration of at least 6 months.
- BED in accordance with Eating Disorder Examination Questionnaire (EDE-Q).
- Clinical Global Impression of Severity scale (CGI-S) score of ≥ 4.
- For women of childbearing potential (WOCBP): Negative serum pregnancy test at Visit 1; agreement to undertake monthly urine or serum pregnancy tests during the study and up to the EOS visit; agreement to use an acceptable contraceptive method.
Criteria assessed at Visit 2:
- Reporting ≥3 BE days for each of the 2 weeks prior to randomization as documented in the participant's BE diary and with BE diary entries completed for at least 6 days per week during this 2-week period (between Visit 1 and 2).
- CGI-S score of ≥ 4.
- For WOCBP: negative urine pregnancy test.
Qualified Participants May Receive:
Monetary compensation for participation.