Feasibility of a Digital Therapeutic for Adults With Bing... | NCT06454123

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

NCT06454123

Sponsor

Oui Therapeutics, Inc.

Status

Unknown status

Last Update Posted

Jun 12, 2024Actual

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Binge Eating
Obesity

Interventions

OTX-401

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
1R41MH134704-01	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Jun 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2024Estimated

Primary Completion Date

Mar 2025Estimated

Completion Date

Jun 2025Estimated

First Submitted Date

Jun 6, 2024

First Submission Date that Met QC Criteria

Jun 6, 2024

First Posted Date

Jun 12, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 6, 2024

Last Update Posted Date

Jun 12, 2024Actual

Name	Class
National Institute of Mental Health (NIMH)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment	Experimental		Device: OTX-401

Interventions

Name	Type	Description	Arm Group Labels	Other Names
OTX-401	Device	Evidence-based treatments for obesity and binge eating	Treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
System Usability Sale (SUS)	The SUS and a semi-structured user feedback interview will be utilized to systematically capture usability and acceptability.	Week 12

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Brian Keenaghan	Contact	2037254024		brian@ouitherapeutics.com

Overall Officials

Not provided

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002032	Bulimia
D009765	Obesity

Ancestor Terms

ID	Term
D006963	Hyperphagia
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided