Binge-Eating DisorderPhase 3ENGAGENCT06413433
Elucidating TAAR-1, Dopamine, and Norepinephrine in Binge Eating Disorder Using Solriamfetol
A Phase 3 study testing Solriamfetol 150 mg and Solriamfetol 300 mg in people with Binge-Eating Disorder, run by Axsome Therapeutics, Inc. at 45 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Binge-Eating Disorder
- What is being tested?
- Solriamfetol 150 mg and Solriamfetol 300 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 450 participants
- Where
- 45 sitesUnited States
- Study dates
- 26 Apr 2024to Dec 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
45 sites in 1 country. Contact the study team or a site near you to ask about taking part.
45 sites in 1 country
United States45 sites, 38 recruiting
- Recruiting
Clinical Research Site
Allentown, Pennsylvania, 18104
- Recruiting
Clinical Research Site
Austin, Texas, 73787
- Recruiting
Clinical Research Site
Austin, Texas, 78731
- Recruiting
Clinical Research Site
Boston, Massachusetts, 02131
- Recruiting
Clinical Research Site
Cherry Hill, New Jersey, 08002
- Recruiting
Clinical Research Site
Cincinnati, Ohio, 45215
- Terminated
Clinical Research Site
Clermont, Florida, 34711
- Recruiting
Clinical Research Site
Colorado Springs, Colorado, 80910
- Recruiting
Clinical Research Site
Cromwell, Connecticut, 06416
- Recruiting
Clinical Research Site
Dallas, Texas, 75231
- Terminated
Clinical Research Site
Draper, Utah, 84020
- Recruiting
Clinical Research Site
Encino, California, 91316
- Recruiting
Clinical Research Site
Fort Myers, Florida, 33912
- Recruiting
Clinical Research Site
Garden Grove, California, 92845
- Recruiting
Clinical Research Site
Greenville, South Carolina, 29615
- Recruiting
Clinical Research Site
Jacksonville, Florida, 32256
- Recruiting
Clinical Research Site
Lauderhill, Florida, 33319
- Recruiting
Clinical Research Site
Long Beach, California, 90806
- Recruiting
Clinical Research Site
Marietta, Georgia, 30060
- Recruiting
Clinical Research Site
Mason, Ohio, 45040
- Recruiting
Clinical Research Site
Media, Pennsylvania, 19063
- Recruiting
Clinical Research Site
Memphis, Tennessee, 38119
- Terminated
Clinical Research Site
Methuen, Massachusetts, 01844
- Recruiting
Clinical Research Site
Miami, Florida, 33145
- Recruiting
Clinical Research Site
Miami, Florida, 33176
- Recruiting
Clinical Research Site
Miami Lakes, Florida, 33016
- Terminated
Clinical Research Site
Miami Lakes, Florida, 33016
- Recruiting
Clinical Research Site
Middleburg Heights, Ohio, 44130
- Recruiting
Clinical Research Site
Mission Viejo, California, 92691
- Recruiting
Clinical Research Site
Mount Kisco, New York, 10549
- Recruiting
Clinical Research Site
New York, New York, 10128
- Terminated
Clinical Research Site
North Canton, Ohio, 44720
- Recruiting
Clinical Research Site
North Charleston, South Carolina, 29405
- Recruiting
Clinical Research Site
Orlando, Florida, 32801
- Terminated
Clinical Research Site
Orlando, Florida, 32806
- Recruiting
Clinical Research Site
Overland Park, Kansas, 66210
- Recruiting
Clinical Research Site
Portland, Oregon, 97210
- Recruiting
Clinical Research Site
Princeton, New Jersey, 08540
- Recruiting
Clinical Research Site
Raleigh, North Carolina, 27607
- Recruiting
Clinical Research Site
Saint Charles, Missouri, 63304
- Recruiting
Clinical Research Site
San Antonio, Texas, 78229
- Terminated
Clinical Research Site
San Diego, California, 92103
- Recruiting
Clinical Research Site
Santa Ana, California, 92705
- Recruiting
Clinical Research Site
Walnut Creek, California, 94596
- Recruiting
Clinical Research Site
West Covina, California, 91790
About this study
Official title: 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.
Read the 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.
- Conditions
- Binge-Eating Disorder
- Being tested
- Solriamfetol 150 mg, Solriamfetol 300 mg, Placebo
- Keywords
- Binge eating disorder, BED, Solriamfetol, Sunosi, Axsome, Non-stimulant therapy, Dopamine norepinephrine reuptake inhibitor, Trace amine-associated receptor 1 (TAAR1) agonist
- Medical subject headings
- Binge-Eating Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Solriamfetol 150 mgDrug
Solriamfetol tablets, taken once daily
Solriamfetol 300 mgDrug
Solriamfetol tablets, taken once daily
PlaceboDrug
Placebo tablets, taken once daily
| Study group | Role | What they receive |
|---|---|---|
| Solriamfetol 150 mg | Experimental | Up to 12 weeks Receives: Drug: Solriamfetol 150 mg |
| Solriamfetol 300 mg | Experimental | Up to 12 weeks Receives: Drug: Solriamfetol 300 mg |
| Placebo | Placebo comparator | Up to 12 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline to Week 12 in number of binge eating episodes
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2024
- Study start26 Apr 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Binge-Eating DisorderStudies of the same condition, open and under way.
- More trials run by Axsome Therapeutics, Inc.The sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Axsome Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06413433
- Sponsor's protocol ID
- SOL-BED-301
- Acronym
- ENGAGE
- Status last verified
- Jul 2026
- First submitted
- 9 May 2024
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Double-blind, Placebo-Controlled Trial of Solriamfetol in Adults With Binge Eating Disorder (BED)
- ClinicalTrials.gov ID
- NCT06413433
- Acronym / sponsor ID
- ENGAGE / SOL-BED-301
- Conditions
- Binge-Eating Disorder
- Keywords
- Binge eating disorder, BED, Solriamfetol, Sunosi, Axsome, Non-stimulant therapy, Dopamine norepinephrine reuptake inhibitor, Trace amine-associated receptor 1 (TAAR1) agonist
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Axsome Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Apr 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 14 May 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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Solriamfetol 150 mg | Experimental | Drug: Solriamfetol 150 mgUp to 12 weeks |
| Solriamfetol 300 mg | Experimental | Drug: Solriamfetol 300 mgUp to 12 weeks |
| Placebo | Placebo comparator | Drug: PlaceboUp to 12 weeks |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| Solriamfetol 150 mgSolriamfetol tablets, taken once daily | Drug | Solriamfetol 150 mg |
| Solriamfetol 300 mgSolriamfetol tablets, taken once daily | Drug | Solriamfetol 300 mg |
| PlaceboPlacebo tablets, taken once daily | Drug | Placebo |
Primary outcome
Change from Baseline to Week 12 in number of binge eating episodes
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Axsome Therapeutics WebsiteLink provided by the sponsor.
- ENGAGE Study WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
45 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Solriamfetol 150 mg and Solriamfetol 300 mg in people with Binge-Eating Disorder, run by Axsome Therapeutics, Inc. at 45 sites in United States.
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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Director (212-332-5061, sol-bed-301@axsome.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline to Week 12 in number of binge eating episodes (time frame: 12 weeks). 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 28 Jul 2026.