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Feasibility of a Digital Therapeutic for Adults With Binge Eating and Obesity | Clinical Trials | Clareo Health

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Feasibility of a Digital Therapeutic for Adults With Binge Eating and Obesity

A Feasibility Study of a Digital Therapeutic for Adults With Recurrent Binge Eating and Obesity

NCT06454123•Oui Therapeutics, Inc.

Summary

The primary objective of this study is to test the feasibility of a digital therapeutic to address comorbid binge eating and obesity in adults.

Detailed Description

This single-arm, open-label clinical trial will test the feasibility, usability, acceptability, and preliminary efficacy of a digital therapeutic in reducing binge eating and weight in 30 adults with comorbid recurrent binge eating and obesity.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. English speaking male or female patients, 18-70 years
•2. Patients with recurrent binge eating (≥12 episodes in 3 months) and obesity (BMI ≥30)
•3. Understand written and spoken English
•4. Own an iPhone with iOS 11 or higher, or Android with OS 8.1 or higher
•5. Willing and able to complete enrollment procedures
•6. Able to understand the nature of the study and provide written informed consent

Exclusion Criteria

•1. Patients with active psychosis
•2. Patients who are acutely intoxicated at the time of enrollment
•3. Currently enrolled in other treatment studies for the symptoms and behaviors targeted
•4. Patients who are cognitively impaired
•5. Patients who, in the judgment of the investigator, would have an unfavorable risk/benefit profile with respect to the digital therapeutic

Key Dates

Start Date

September 1, 2024

Primary Completion Date

March 1, 2025

Completion Date

June 1, 2025

Last Updated

June 12, 2024

Enrollment

ESTIMATED participants

Conditions

Binge EatingObesity

Interventions

OTX-401

DEVICE

Contacts

Brian Keenaghan

CONTACT

2037254024 brian@ouitherapeutics.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 12, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Feasibility of a Digital Therapeutic for Adults With Binge Eating and Obesity

Inclusion Criteria

Exclusion Criteria

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