Multicenter Study to Evaluate the Efficacy and Safety of Oral ACT-539313 in the Treatment of Adults With Moderate to Severe Binge Eating Disorder

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

Timeline

Start

2021-02-16

Primary completion

2022-03-21

Completion

2022-03-25

Outcome

Missed primary endpoint

registry analysis (other test); 100 mg Twice Daily (b.i.d.) ACT-539313 vs Placebo; p = 0.9992; LS Mean Difference to Placebo 0.00 (95% CI -0.69 to 0.69) NCT04753164 ↗

release “ACT-539313, a selective orexin-1 receptor antagonist, did not show an improvement over placebo in reducing the number of binge eating days per week” idorsia.com ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	nivasorexant	Small molecule	100 mg	Oral

Indications