NCT04753164

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

Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group, Proof-of-concept Study to Evaluate the Efficacy and Safety of Oral ACT-539313 in the Treatment of Adults With Moderate to Severe Binge Eating Disorder

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 136 (actual)
• Sponsor: Idorsia Pharmaceuticals Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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

Conditions

• Binge-Eating Disorder

Interventions

Type	Name	Description
DRUG	ACT-539313	ACT-539313 as capsules at a strength of 100 mg, taken orally, b.i.d. in the morning at breakfast and in the evening at dinner, with a glass of water during the treatment period.
DRUG	Placebo	Matching placebo as identical capsules indistinguishable from ACT-539313, taken orally, b.i.d. in the morning at breakfast and in the evening at dinner, with a glass of water during the treatment period.

Timeline

• Start date: 2021-02-16
• Primary completion: 2022-03-21
• Completion: 2022-03-25
• First posted: 2021-02-15
• Last updated: 2023-03-31
• Results posted: 2023-03-31

Locations

30 sites across 1 country: United States

Regulatory

• FDA-regulated drug study