Elucidating TAAR-1, Dopamine, and Norepinephrine in Binge Eating Disorder Using Solriamfetol (ENGAGE)

November 20, 2025 updated by: Axsome Therapeutics, Inc.

A Phase 3, Randomized, Double-blind, Placebo-Controlled Trial of Solriamfetol in Adults With Binge Eating Disorder (BED)

ENGAGE (Elucidating TAAR-1, Dopamine, and Norepinephrine in Binge Eating Disorder Using Solriamfetol) is a Phase 3, randomized, double-blind, placebo-controlled, multicenter trial to assess the efficacy and safety of solriamfetol for the treatment of binge eating disorder (BED) in adults.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Eligible subjects must have a diagnosis of BED according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria. Subjects will be randomized in a 1:1:1 ratio to receive solriamfetol (150 or 300 mg) or placebo, once daily for 12 weeks.

Study Type

Interventional

Enrollment (Estimated)

450

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Encino, California, United States, 91316
        • Recruiting
        • Clinical Research Site
      • Garden Grove, California, United States, 92845
        • Recruiting
        • Clinical Research Site
      • Long Beach, California, United States, 90806
        • Recruiting
        • Clinical Research Site
      • Newport Beach, California, United States, 92660
        • Recruiting
        • Clinical Research Site
      • San Diego, California, United States, 92103
        • Terminated
        • Clinical Research Site
      • Santa Ana, California, United States, 92705
        • Recruiting
        • Clinical Research Site
      • Walnut Creek, California, United States, 94596
        • Recruiting
        • Clinical Research Site
      • West Covina, California, United States, 91790
        • Recruiting
        • Clinical Research Site
    • Colorado
      • Colorado Springs, Colorado, United States, 80910
        • Recruiting
        • Clinical Research Site
    • Connecticut
      • Cromwell, Connecticut, United States, 06416
        • Recruiting
        • Clinical Research Site
    • Florida
      • Clermont, Florida, United States, 34711
        • Terminated
        • Clinical Research Site
      • Fort Myers, Florida, United States, 33912
        • Recruiting
        • Clinical Research Site
      • Hialeah, Florida, United States, 33012
        • Recruiting
        • Clinical Research Site
      • Jacksonville, Florida, United States, 32256
        • Recruiting
        • Clinical Research Site
      • Lauderhill, Florida, United States, 33319
        • Recruiting
        • Clinical Research Site
      • Miami, Florida, United States, 33145
        • Recruiting
        • Clinical Research Site
      • Miami, Florida, United States, 33176
        • Recruiting
        • Clinical Research Site
      • Miami Lakes, Florida, United States, 33016
        • Terminated
        • Clinical Research Site
      • Orlando, Florida, United States, 32801
        • Recruiting
        • Clinical Research Site
      • Orlando, Florida, United States, 32806
        • Terminated
        • Clinical Research Site
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Recruiting
        • Clinical Research Site
    • Kansas
      • Overland Park, Kansas, United States, 66210
        • Recruiting
        • Clinical Research Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02131
        • Recruiting
        • Clinical Research Site
      • Methuen, Massachusetts, United States, 01844
        • Terminated
        • Clinical Research Site
    • Missouri
      • Saint Charles, Missouri, United States, 63304
        • Recruiting
        • Clinical Research Site
    • New Jersey
      • Cherry Hill, New Jersey, United States, 08002
        • Recruiting
        • Clinical Research Site
      • Princeton, New Jersey, United States, 08540
        • Recruiting
        • Clinical Research Site
    • New York
      • Mount Kisco, New York, United States, 10549
        • Recruiting
        • Clinical Research Site
      • New York, New York, United States, 10128
        • Recruiting
        • Clinical Research Site
    • North Carolina
      • Raleigh, North Carolina, United States, 27607
        • Recruiting
        • Clinical Research Site
    • Ohio
      • Cincinnati, Ohio, United States, 45215
        • Recruiting
        • Clinical Research Site
      • Mason, Ohio, United States, 45040
        • Recruiting
        • Clinical Research Site
      • Middleburg Heights, Ohio, United States, 44130
        • Recruiting
        • Clinical Research Site
      • North Canton, Ohio, United States, 44720
        • Terminated
        • Clinical Research Site
    • Oregon
      • Portland, Oregon, United States, 97210
        • Recruiting
        • Clinical Research Site
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18104
        • Recruiting
        • Clinical Research Site
      • Media, Pennsylvania, United States, 19063
        • Recruiting
        • Clinical Research Site
    • South Carolina
      • Greenville, South Carolina, United States, 29615
        • Recruiting
        • Clinical Research Site
      • North Charleston, South Carolina, United States, 29405
        • Recruiting
        • Clinical Research Site
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Recruiting
        • Clinical Research Site
    • Texas
      • Austin, Texas, United States, 78731
        • Recruiting
        • Clinical Research Site
      • Austin, Texas, United States, 73787
        • Recruiting
        • Clinical Research Site
      • Dallas, Texas, United States, 75231
        • Recruiting
        • Clinical Research Site
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • Clinical Research Site
    • Utah
      • Draper, Utah, United States, 84020
        • Terminated
        • Clinical Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Primary diagnosis of BED according to DSM-5 criteria.
  • Provides written informed consent to participate in the study before the conduct of any study procedures.
  • Male or female, aged 18 to 55 inclusive.

Exclusion Criteria:

  • Prior exposure to solriamfetol/Sunosi, through either a clinical study or prescription.
  • Unable to comply with study procedures.
  • Medically inappropriate for study participation in the opinion of the investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Solriamfetol 150 mg
Up to 12 weeks
Drug: Solriamfetol 150 mg
Solriamfetol tablets, taken once daily
Experimental: Solriamfetol 300 mg
Up to 12 weeks
Drug: Solriamfetol 300 mg
Solriamfetol tablets, taken once daily
Placebo Comparator: Placebo
Up to 12 weeks
Drug: Placebo
Placebo tablets, taken once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline to Week 12 in number of binge eating episodes
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Axsome Therapeutics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 26, 2024

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

May 9, 2024

First Submitted That Met QC Criteria

May 9, 2024

First Posted (Actual)

May 14, 2024

Study Record Updates

Last Update Posted (Actual)

November 21, 2025

Last Update Submitted That Met QC Criteria

November 20, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SOL-BED-301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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