Elucidating TAAR-1, Dopamine, and Norepinephrine in Binge Eating Disorder Using Solriamfetol
ENGAGE
A Phase 3, Randomized, Double-blind, Placebo-Controlled Trial of Solriamfetol in Adults With Binge Eating Disorder (BED)
1 other identifier
interventional
450
1 country
45
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Apr 2024
45 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 26, 2024
CompletedFirst Submitted
Initial submission to the registry
May 9, 2024
CompletedFirst Posted
Study publicly available on registry
May 14, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedNovember 21, 2025
November 1, 2025
1.6 years
May 9, 2024
November 20, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from Baseline to Week 12 in number of binge eating episodes
12 weeks
Study Arms (3)
Solriamfetol 150 mg
EXPERIMENTALUp to 12 weeks
Solriamfetol 300 mg
EXPERIMENTALUp to 12 weeks
Placebo
PLACEBO COMPARATORUp to 12 weeks
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (45)
Clinical Research Site
Encino, California, 91316, United States
Clinical Research Site
Garden Grove, California, 92845, United States
Clinical Research Site
Long Beach, California, 90806, United States
Clinical Research Site
Newport Beach, California, 92660, United States
Clinical Research Site
San Diego, California, 92103, United States
Clinical Research Site
Santa Ana, California, 92705, United States
Clinical Research Site
Walnut Creek, California, 94596, United States
Clinical Research Site
West Covina, California, 91790, United States
Clinical Research Site
Colorado Springs, Colorado, 80910, United States
Clinical Research Site
Cromwell, Connecticut, 06416, United States
Clinical Research Site
Clermont, Florida, 34711, United States
Clinical Research Site
Fort Myers, Florida, 33912, United States
Clinical Research Site
Hialeah, Florida, 33012, United States
Clinical Research Site
Jacksonville, Florida, 32256, United States
Clinical Research Site
Lauderhill, Florida, 33319, United States
Clinical Research Site
Miami, Florida, 33145, United States
Clinical Research Site
Miami, Florida, 33176, United States
Clinical Research Site
Miami Lakes, Florida, 33016, United States
Clinical Research Site
Orlando, Florida, 32801, United States
Clinical Research Site
Orlando, Florida, 32806, United States
Clinical Research Site
Marietta, Georgia, 30060, United States
Clinical Research Site
Overland Park, Kansas, 66210, United States
Clinical Research Site
Boston, Massachusetts, 02131, United States
Clinical Research Site
Methuen, Massachusetts, 01844, United States
Clinical Research Site
Saint Charles, Missouri, 63304, United States
Clinical Research Site
Cherry Hill, New Jersey, 08002, United States
Clinical Research Site
Princeton, New Jersey, 08540, United States
Clinical Research Site
Mount Kisco, New York, 10549, United States
Clinical Research Site
New York, New York, 10128, United States
Clinical Research Site
Raleigh, North Carolina, 27607, United States
Clinical Research Site
Cincinnati, Ohio, 45215, United States
Clinical Research Site
Mason, Ohio, 45040, United States
Clinical Research Site
Middleburg Heights, Ohio, 44130, United States
Clinical Research Site
North Canton, Ohio, 44720, United States
Clinical Research Site
Portland, Oregon, 97210, United States
Clinical Research Site
Allentown, Pennsylvania, 18104, United States
Clinical Research Site
Media, Pennsylvania, 19063, United States
Clinical Research Site
Greenville, South Carolina, 29615, United States
Clinical Research Site
North Charleston, South Carolina, 29405, United States
Clinical Research Site
Memphis, Tennessee, 38119, United States
Clinical Research Site
Austin, Texas, 73787, United States
Clinical Research Site
Austin, Texas, 78731, United States
Clinical Research Site
Dallas, Texas, 75231, United States
Clinical Research Site
San Antonio, Texas, 78229, United States
Clinical Research Site
Draper, Utah, 84020, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 9, 2024
First Posted
May 14, 2024
Study Start
April 26, 2024
Primary Completion
December 1, 2025
Study Completion
December 1, 2025
Last Updated
November 21, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share