Binge-Eating DisorderPhase 2NCT04753164
Multicenter Study to Evaluate the Efficacy and Safety of Oral ACT-539313 in the Treatment of Adults With Moderate to Severe Binge Eating Disorder
A Phase 2 study testing ACT-539313 in people with Binge-Eating Disorder, run by Idorsia Pharmaceuticals Ltd. at 30 sites in United States.
Trial summary
Placebo-controlled study to evaluate the efficacy and safety of oral ACT-539313 in the treatment of adults with moderate to severe binge eating disorder 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?
- ACT-539313
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 136 participants
- Where
- 30 sitesUnited States
- Study dates
- 16 Feb 2021to 25 Mar 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Criteria assessed at Visit 1:
- Signed and dated informed consent form prior to any study-mandated procedure.
- Male or female study participants aged 18 to 55 years at the time of signing the informed consent form.
- Binge-eating disorder (BED) in accordance with Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-5) criteria diagnosed using the Structured Clinical Interview for DSM-5 (SCID-5).
- Self-reported BED severity of at least moderate level, defined as at least 4 BE episodes per week, on average, for a duration of at least 6 months.
- BED in accordance with Eating Disorder Examination Questionnaire (EDE-Q).
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- Clinical Global Impression of Severity scale (CGI-S) score of ≥ 4.
- For women of childbearing potential (WOCBP): Negative serum pregnancy test at Visit 1; agreement to undertake monthly urine or serum pregnancy tests during the study and up to the EOS visit; agreement to use an acceptable contraceptive method.
- Criteria assessed at Visit 2:
- Reporting ≥3 BE days for each of the 2 weeks prior to randomization as documented in the participant's BE diary and with BE diary entries completed for at least 6 days per week during this 2-week period (between Visit 1 and 2).
- CGI-S score of ≥ 4.
- For WOCBP: negative urine pregnancy test.
Who cannot join
- Criteria assessed at Visit 1:
- BMI < 18.0 kg/m² or > 45 kg/m².
- Any acute or chronic-persistent psychiatric disorder other than BED diagnosed in the past, including anorexia nervosa, bulimia, psychotic disorders, bipolar disorder, hypomania, or dementia, as defined by the DSM-5 criteria or by the Mini International Neuropsychiatric Interview (MINI©).
- Use of any medications for the treatment of BED (including lisdexamfetamine [Vyvanse®]), any other eating disorder, obesity, or weight gain, or any other medication that could result in weight gain or weight loss, including over-the-counter and herbal products, within 3 months prior to Screening.
- Any clinically unstable medical condition, significant medical disorder or acute illness that, in the investigator's opinion, could interfere with the participants ability to comply with study assessments or abide by study restrictions.
- Criteria assessed at Visit 1 and Visit 2
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- HAMD-17 score ≥ 17 points at Visit 1 and/or Visit 2.
- Any of the following conditions related to suicidality:
- Participant is considered to have a suicide risk in the investigator's opinion or has a previous history of suicide attempt within the past 12 months.
- Participant answers "yes" to "suicidal ideation" item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) on the C-SSRS© assessment at Screening (in the past month). Participants who answer "yes" to this question must be referred to the investigator for follow-up evaluation.
- Female participants: pregnant, lactating or planning to become pregnant during the projected course of the study.
Trial locations and contacts
30 sites in 1 country.
30 sites in 1 country
United States30 sites
NeuorTrials Research Inc
Atlanta, Georgia, 30328
Harvard Medical School - McLean Hospital
Belmont, Massachusetts, 02478
Southern California Research
Beverly Hills, California, 90210
Boston Clinical Trials, Inc
Boston, Massachusetts, 02131
CTI Clinical Research Center
Cincinnati, Ohio, 45212
Patient Priority Clinical Sites
Cincinnati, Ohio, 45221
Connecticut Clinical Research - Cromwell
Cromwell, Connecticut, 06416
Wr-Pri, Llc
Encino, California, 91316
Precise Research Centers
Flowood, Mississippi, 39232
Collaborative Neuroscience Network (CNS)
Garden Grove, California, 92845
Clinical Neurosciences Solutions
Jacksonville, Florida, 32256
M3 Wake Research
Las Vegas, Nevada, 89194
Capstone Clinical Research
Libertyville, Illinois, 60048
Psych Atlanta P.C.
Marietta, Georgia, 30060
University of Cincinnati College of Medicine - Lindner Center of HOPE
Mason, Ohio, 45040
North Star Medical Research, LLC
Middleburg Heights, Ohio, 44130
Bioscience Research
Mount Kisco, New York, 10549
Manhattan Behavioral Medicine PLLC
New York, New York, 10036
The Medical Research Network
New York, New York, 10128
Behavioral Clinical Research
North Miami, Florida, 33161
IPS Research Company
Oklahoma City, Oklahoma, 73106
Clinical Neuroscience Solutions Inc
Orlando, Florida, 31801
Oregon Center For Clinical Inv.
Portland, Oregon, 97214
ActivMed Practices & Research, Inc.
Portsmouth, New Hampshire, 03081
ActivMed Practices & Research
Portsmouth, New Hampshire, 03081
Collective Medical Research
Prairie Village, Kansas, 66208
St. Charles Psychiatric Associates dba Midwest research group
Saint Charles, Missouri, 63304
Oregon Center for Clinical Investigations, Inc. (OCCI, Inc.)
Salem, Oregon, 97304
Clinical Trials of Texas, Inc. (CTT)
San Antonio, Texas, 78229
Syrentis Clinical Research
Santa Ana, California, 92705
About this study
Official title: Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group, Proof-of-concept Study to Evaluate the Efficacy and Safety of Oral ACT-539313 in the Treatment of Adults With Moderate to Severe Binge Eating Disorder
Placebo-controlled study to evaluate the efficacy and safety of oral ACT-539313 in the treatment of adults with moderate to severe binge eating disorder
- Conditions
- Binge-Eating Disorder
- Being tested
- ACT-539313, Placebo
- 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.
ACT-539313Drug
ACT-539313 as capsules at a strength of 100 mg, taken orally, b.i.d. in the morning at breakfast and in the evening at dinner, with a glass of water during the treatment period.
PlaceboDrug
Matching placebo as identical capsules indistinguishable from ACT-539313, taken orally, b.i.d. in the morning at breakfast and in the evening at dinner, with a glass of water during the treatment period.
| Study group | Role | What they receive |
|---|---|---|
| 100 mg twice daily (b.i.d.) ACT-539313 | Experimental | Not described Receives: Drug: ACT-539313 |
| Placebo | Placebo comparator | Not described 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 the Number of Binge Eating (BE) Days Per Week
BE days per week is defined as the number of diary days with at least one confirmed BE episode during the applicable 14-day time interval divided by the total number of diary days, times 7.
Measured: From baseline to Week 12; duration approx. 3.5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2021
- Study start16 Feb 2021
- Primary completion21 Mar 2022
- Study completion25 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Binge-Eating DisorderStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter, double-blind, randomized, placebo-controlled, parallel-group, proof-of-concept study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Idorsia Pharmaceuticals Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Idorsia Pharmaceuticals Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04753164
- Sponsor's protocol ID
- ID-082A201
- Status last verified
- Mar 2023
- First submitted
- 9 Feb 2021
- Last updated
- 31 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- 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 31 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group, Proof-of-concept Study to Evaluate the Efficacy and Safety of Oral ACT-539313 in the Treatment of Adults With Moderate to Severe Binge Eating Disorder
- ClinicalTrials.gov ID
- NCT04753164
- Acronym / sponsor ID
- ID-082A201
- Conditions
- Binge-Eating Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Idorsia Pharmaceuticals Ltd.Industry (pharma, biotech, devices)
- Study start
- 16 Feb 2021 (actual)
- Primary completion
- 21 Mar 2022 (actual)
- Study completion
- 25 Mar 2022 (actual)
- First posted
- 15 Feb 2021 (actual)
- Results
- Posted 31 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Placebo-controlled study to evaluate the efficacy and safety of oral ACT-539313 in the treatment of adults with moderate to severe binge eating disorder
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Multicenter, double-blind, randomized, placebo-controlled, parallel-group, proof-of-concept study
| Arm | Type | Receives |
|---|---|---|
| 100 mg twice daily (b.i.d.) ACT-539313 | Experimental | Drug: ACT-539313 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Signed and dated informed consent form prior to any study-mandated procedure.
- Male or female study participants aged 18 to 55 years at the time of signing the informed consent form.
- Binge-eating disorder (BED) in accordance with Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-5) criteria diagnosed using the Structured Clinical Interview for DSM-5 (SCID-5).
- Self-reported BED severity of at least moderate level, defined as at least 4 BE episodes per week, on average, for a duration of at least 6 months.
- BED in accordance with Eating Disorder Examination Questionnaire (EDE-Q).
Key exclusion criteria (11 listed)
- BMI < 18.0 kg/m² or > 45 kg/m².
- Any acute or chronic-persistent psychiatric disorder other than BED diagnosed in the past, including anorexia nervosa, bulimia, psychotic disorders, bipolar disorder, hypomania, or dementia, as defined by the DSM-5 criteria or by the Mini International Neuropsychiatric Interview (MINI©).
- Use of any medications for the treatment of BED (including lisdexamfetamine [Vyvanse®]), any other eating disorder, obesity, or weight gain, or any other medication that could result in weight gain or weight loss, including over-the-counter and herbal products, within 3 months prior to Screening.
- Any clinically unstable medical condition, significant medical disorder or acute illness that, in the investigator's opinion, could interfere with the participants ability to comply with study assessments or abide by study restrictions.
- Criteria assessed at Visit 1 and Visit 2
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 |
|---|---|---|
| ACT-539313ACT-539313 as capsules at a strength of 100 mg, taken orally, b.i.d. in the morning at breakfast and in the evening at dinner, with a glass of water during the treatment period. | Drug | 100 mg twice daily (b.i.d.) ACT-539313 |
| PlaceboMatching placebo as identical capsules indistinguishable from ACT-539313, taken orally, b.i.d. in the morning at breakfast and in the evening at dinner, with a glass of water during the treatment period. | Drug | Placebo |
Primary outcome
Change From Baseline to Week 12 in the Number of Binge Eating (BE) Days Per Week
Time frame: From baseline to Week 12; duration approx. 3.5 months
BE days per week is defined as the number of diary days with at least one confirmed BE episode during the applicable 14-day time interval divided by the total number of diary days, times 7.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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. This study is not recruiting at the moment.
Clinical Trials study director
Idorsia Pharmaceuticals Ltd.
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ACT-539313 in people with Binge-Eating Disorder, run by Idorsia Pharmaceuticals Ltd. at 30 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 12 inclusion and 11 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: finished, as of the sponsor's last update on 31 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline to Week 12 in the Number of Binge Eating (BE) Days Per Week (time frame: From baseline to Week 12; duration approx. 3.5 months). 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 31 Mar 2023.