Binge EatingNCT06454123
Feasibility of a Digital Therapeutic for Adults With Binge Eating and Obesity
A study testing OTX-401 in people with Binge Eating and Obesity, run by Oui Therapeutics, Inc..
Trial 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 more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Binge Eating, Obesity
- What is being tested?
- OTX-401
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Sep 2024to Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Feasibility Study of a Digital Therapeutic for Adults With Recurrent Binge Eating and Obesity
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.
- Conditions
- Binge Eating, Obesity
- Being tested
- OTX-401
- Medical subject headings
- Bulimia, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OTX-401Device
Evidence-based treatments for obesity and binge eating
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Not described Receives: Device: OTX-401 |
What is being measured
The primary outcome is the main question the study is designed to answer.
System Usability Sale (SUS)
The SUS and a semi-structured user feedback interview will be utilized to systematically capture usability and acceptability.
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2024
- Study startSep 2024 (estimated)
- Primary completionMar 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Binge EatingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oui Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06454123
- Sponsor's protocol ID
- 2023-Oui-001
- Other IDs
- 1R41MH134704-01
- Status last verified
- Jun 2024
- First submitted
- 6 Jun 2024
- Last updated
- 12 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study of a Digital Therapeutic for Adults With Recurrent Binge Eating and Obesity
- ClinicalTrials.gov ID
- NCT06454123
- Acronym / sponsor ID
- 2023-Oui-001
- Conditions
- Binge Eating, Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Oui Therapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Sep 2024 (estimated)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 12 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: OTX-401 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OTX-401Evidence-based treatments for obesity and binge eating | Device | Treatment |
Primary outcome
System Usability Sale (SUS)
Time frame: Week 12
The SUS and a semi-structured user feedback interview will be utilized to systematically capture usability and acceptability.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing OTX-401 in people with Binge Eating and Obesity, run by Oui Therapeutics, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Brian Keenaghan (2037254024, brian@ouitherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
System Usability Sale (SUS) (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2024.