Binge-Eating Disorder
Conditions
Brief 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
Interventions
DRUGACT-539313
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.
DRUGPlacebo
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.
Sponsors
Idorsia Pharmaceuticals Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Multicenter, double-blind, randomized, placebo-controlled, parallel-group, proof-of-concept study
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
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). * 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.
Exclusion criteria
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 * HAMD-17 score ≥ 17 points at Visit 1 and/or Visit 2. * Any of the following conditions related to suicidality: 1. 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. 2. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Week 12 in the Number of Binge Eating (BE) Days Per Week | 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. |
Countries
United States
Participant flow
Recruitment details
The study was conducted at 26 sites in the USA; all 26 sites randomized subjects.
Pre-assignment details
In total, 259 subjects were screened, of which 123 discontinued during the screening period.
Participants by arm
| Arm | Count |
|---|---|
| 100 mg Twice Daily (b.i.d.) ACT-539313 ACT-539313: 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. | 68 |
| Placebo Placebo: 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. | 68 |
| Total | 136 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 2 |
| Overall Study | Lost to Follow-up | 6 | 6 |
| Overall Study | Other | 12 | 5 |
| Overall Study | Withdrawal by Subject | 9 | 7 |
Baseline characteristics
| Characteristic | 100 mg Twice Daily (b.i.d.) ACT-539313 | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 37 years | 42 years | 39 years |
| Body mass index (kg/m^2) at screening | 35.03 kg/m2 STANDARD_DEVIATION 6.99 | 34.93 kg/m2 STANDARD_DEVIATION 6.01 | 34.98 kg/m2 STANDARD_DEVIATION 6.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 14 Participants | 16 Participants | 30 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 53 Participants | 51 Participants | 104 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 2 Participants |
| Sex: Female, Male Female | 55 Participants | 50 Participants | 105 Participants |
| Sex: Female, Male Male | 13 Participants | 18 Participants | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 68 | 0 / 68 |
| other Total, other adverse events | 31 / 68 | 25 / 68 |
| serious Total, serious adverse events | 0 / 68 | 1 / 68 |
Outcome results
Primary
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.
Time frame: From baseline to Week 12; duration approx. 3.5 months
Population: Full Analysis Set; subjects with available data for calculation of the change from baseline at Week 12.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| 100 mg Twice Daily (b.i.d.) ACT-539313 | Change From Baseline to Week 12 in the Number of Binge Eating (BE) Days Per Week | -2.93 BE days per week |
| Placebo | Change From Baseline to Week 12 in the Number of Binge Eating (BE) Days Per Week | -2.93 BE days per week |
p-value: 0.999295% CI: [-0.69, 0.69]Mixed effects model f. repeated measures