Clinical Trial 46855

Garden Grove, CA 92845


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.

Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.