CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 136 enrolled
Drug / intervention
ACT-539313 +1 moredrug
Likely dose
ACT-539313 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04753164
NCT04753164Phase 2Completed
CompareCT.gov

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

Idorsia Pharmaceuticals Ltd.·interventional·Posted Feb 15, 2021·Updated Mar 31, 2023

In Brief

A Phase 2 clinical trial evaluating ACT-539313 and Placebo for Binge-Eating Disorder. Completed, enrolled 136 participants across 30 sites.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBinge-Eating Disorder
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedFeb 15, 2021
Enrollment StartFeb 16, 2021
Primary CompletionMar 21, 2022
Study CompletionMar 25, 2022
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 5.4 years ago

Interventions

ACT-539313drug

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.

Placebodrug

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.