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Could a new pill curb binge eating? phase 2 trial underway

NCT ID NCT05113953

Symptom relief Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This Phase 2 trial tested two doses of centanafadine sustained-release tablets against a placebo in 147 adults with moderate to severe binge eating disorder. The main goal was to see if the drug could reduce the number of binge eating days per week. Researchers also looked at changes in overall illness severity.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
centanafadine sustained-release tablets
What this could lead to
If it works, this could point toward a new medication to help reduce binge eating episodes in people with binge eating disorder.
What could go wrong
This is an early Phase 2 trial with only 147 participants, so results may not apply to everyone. The drug may not work better than placebo, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

147 people

The number who actually took part.

Started

Dec 2021

Finished

Aug 2022

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Adult participants 18 to 65 years of age (inclusive) at the time of informed consent. * A primary diagnosis of BED, or is diagnosed at screening, according to Diagnostic and Statistical Manual of Mental Disorders - 5th Edition (DSM-5) criteria and confirmed by the Structured Clinical Interview for DSM-5 (SCID). * BED with a history of at least 2 binge eating days per week for 6 months prior to screening. * A rating of 4 or higher on the Clinical Global Impression - Severity (CGI-S) at screening and baseline. * Body mass index (BMI) of 18 to 45 kg/m\^2, inclusive. Exclusion Criteria: * Lifetime history of bulimia nervosa or anorexia nervosa. * Participation in a formal weight loss program within 3 months of screening or planning to start a weight loss program during the trial. * History of bariatric surgery. * Montgomery-Asberg Depression Rating Scale (MADRS) score ≥ 18.

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Conditions

The condition(s) this trial relates to.

binge eating disorder Binge-Eating Disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Binge-eating disorder

Contacts and locations

Locations

  • ActivMed Practices and Research - Portsmouth

    Portsmouth, New Hampshire, 03801, United States

  • Boston Clinical Trials

    Boston, Massachusetts, 02131, United States

  • Center for Emotional Fitness

    Cherry Hill, New Jersey, 08002, United States

  • Clinical Neuroscience Solutions - Jacksonville

    Jacksonville, Florida, 32256, United States

  • Clinical Neuroscience Solutions, Inc.

    Memphis, Tennessee, 38119, United States

  • Collaborative Neuroscience Research, LLC

    Garden Grove, California, 92845, United States

  • Collective Medical Research

    Prairie Village, Kansas, 66208, United States

  • Craig and Frances Linder Center of Hope

    Mason, Ohio, 45040, United States

  • FutureSearch Trials - Dallas

    Dallas, Texas, 75231, United States

  • Manhattan Behavioral Medicine

    New York, New York, 10036, United States

  • Medical Research Network, LLC

    New York, New York, 10128, United States

  • Miami Dade Medical Research Institute

    Miami, Florida, 33176, United States

  • Midwest Clinical Research Center

    Dayton, Ohio, 45417, United States

  • Mountain View Clinical Research, LLC

    Denver, Colorado, 80209, United States

  • NoesisPharma, LLC

    Phoenix, Arizona, 85016, United States

  • Pacific Clinical Research Management Group LLC

    Upland, California, 91786, United States

  • Pharmacology Research Institute - San Fernando Valley

    Encino, California, 91316, United States

  • Princeton Medical Institute

    Princeton, New Jersey, 08540, United States

  • Psych Atlanta, PC

    Marietta, Georgia, 30060, United States

  • Psychiatric Associates

    Overland Park, Kansas, 66211, United States

  • Psychiatry + Psychotherapy Partners Austin

    Austin, Texas, 78737, United States

  • Richmond Behavioral Associates

    Staten Island, New York, 10312, United States

  • Southern California Research LLC

    Beverly Hills, California, 90210, United States

  • St. Charles Psychiatric Associates & Midwest Research Group

    Weldon Spring, Missouri, 63304, United States

  • iResearch Atlanta

    Decatur, Georgia, 30030, United States

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