ClinicalTrials.gg
Not yet recruitingNCT06454123Updated Jun 12, 2024

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

An interventional study of OTX-401 in Binge Eating and Obesity, sponsored by Oui Therapeutics, Inc.. Not yet recruiting. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-06-12.

Sponsored by Oui Therapeutics, Inc. · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Mar 2025, 1 year 8 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Binge Eating
  • Obesity

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03

In context

Bulimia

173 studies on the registry are indexed under Bulimia; 33 are open to participants now.

This study's planned enrollment of 30 is below the median of 60 across 143 interventional studies indexed under Bulimia.

Browse Bulimia studies →

Lead sponsor

Oui Therapeutics, Inc. is the lead sponsor of 6 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 ( ≥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

Exclusion criteria

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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Treatment

    Device: OTX-401

Interventions

  • DeviceOTX-401

    Evidence-based treatments for obesity and binge eating

06

What researchers measure

Primary outcomes

  1. System Usability Sale (SUS)

    The SUS and a semi-structured user feedback interview will be utilized to systematically capture usability and acceptability.

    Time frame: Week 12

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06454123
Lead sponsor
Oui Therapeutics, Inc.
Responsible party
Sponsor
First posted
Jun 12, 2024
Start date
Sep 2024 (estimated)
Primary completion
Mar 2025 (estimated)
Completion
Jun 2025 (estimated)
Last update
Jun 12, 2024

Study contacts

Brian Keenaghan
Contact
brian@ouitherapeutics.com
2037254024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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