Trial Outcomes & Findings for Multicenter Study to Evaluate the Efficacy and Safety of Oral ACT-539313 in the Treatment of Adults With Moderate to Severe Binge Eating Disorder (NCT NCT04753164)
NCT ID: NCT04753164
Last Updated: 2023-03-31
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
136 participants
Primary outcome timeframe
From baseline to Week 12; duration approx. 3.5 months
Results posted on
2023-03-31
Participant Flow
The study was conducted at 26 sites in the USA; all 26 sites randomized subjects.
In total, 259 subjects were screened, of which 123 discontinued during the screening period.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
68
|
68
|
|
Overall Study
COMPLETED
|
41
|
48
|
|
Overall Study
NOT COMPLETED
|
27
|
20
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
9
|
7
|
|
Overall Study
Lost to Follow-up
|
6
|
6
|
|
Overall Study
Other
|
12
|
5
|
Baseline Characteristics
Randomized population
Baseline characteristics by cohort
| Measure |
100 mg Twice Daily (b.i.d.) ACT-539313
n=68 Participants
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.
|
Placebo
n=68 Participants
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.
|
Total
n=136 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37 years
n=68 Participants • Randomized population
|
42 years
n=68 Participants • Randomized population
|
39 years
n=136 Participants • Randomized population
|
|
Sex: Female, Male
Female
|
55 Participants
n=68 Participants • Randomized population
|
50 Participants
n=68 Participants • Randomized population
|
105 Participants
n=136 Participants • Randomized population
|
|
Sex: Female, Male
Male
|
13 Participants
n=68 Participants • Randomized population
|
18 Participants
n=68 Participants • Randomized population
|
31 Participants
n=136 Participants • Randomized population
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
14 Participants
n=68 Participants • Randomized population
|
16 Participants
n=68 Participants • Randomized population
|
30 Participants
n=136 Participants • Randomized population
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
53 Participants
n=68 Participants • Randomized population
|
51 Participants
n=68 Participants • Randomized population
|
104 Participants
n=136 Participants • Randomized population
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=68 Participants • Randomized population
|
1 Participants
n=68 Participants • Randomized population
|
2 Participants
n=136 Participants • Randomized population
|
|
Body mass index (kg/m^2) at screening
|
35.03 kg/m2
STANDARD_DEVIATION 6.99 • n=68 Participants • Randomized population; Number analyzed in the "Placebo" group n = 67; missing: n = 1
|
34.93 kg/m2
STANDARD_DEVIATION 6.01 • n=67 Participants • Randomized population; Number analyzed in the "Placebo" group n = 67; missing: n = 1
|
34.98 kg/m2
STANDARD_DEVIATION 6.50 • n=135 Participants • Randomized population; Number analyzed in the "Placebo" group n = 67; missing: n = 1
|
PRIMARY outcome
Timeframe: From baseline to Week 12; duration approx. 3.5 monthsPopulation: Full Analysis Set; subjects with available data for calculation of the change from baseline at Week 12.
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.
Outcome measures
| Measure |
100 mg Twice Daily (b.i.d.) ACT-539313
n=43 Participants
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.
|
Placebo
n=45 Participants
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.
|
|---|---|---|
|
Change From Baseline to Week 12 in the Number of Binge Eating (BE) Days Per Week
|
-2.93 BE days per week
Interval -3.46 to -2.4
|
-2.93 BE days per week
Interval -3.47 to -2.39
|
Adverse Events
100 mg Twice Daily (b.i.d.) ACT-539313
Serious events: 0 serious events
Other events: 31 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
100 mg Twice Daily (b.i.d.) ACT-539313
n=68 participants at risk
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.
|
Placebo
n=68 participants at risk
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.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/68 • AEs reported are AEs occurring or worsening during the treatment period; duration approx. 3 months.
|
1.5%
1/68 • Number of events 1 • AEs reported are AEs occurring or worsening during the treatment period; duration approx. 3 months.
|
Other adverse events
| Measure |
100 mg Twice Daily (b.i.d.) ACT-539313
n=68 participants at risk
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.
|
Placebo
n=68 participants at risk
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.
|
|---|---|---|
|
Nervous system disorders
Somnolence
|
13.2%
9/68 • AEs reported are AEs occurring or worsening during the treatment period; duration approx. 3 months.
|
19.1%
13/68 • AEs reported are AEs occurring or worsening during the treatment period; duration approx. 3 months.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
11.8%
8/68 • AEs reported are AEs occurring or worsening during the treatment period; duration approx. 3 months.
|
10.3%
7/68 • AEs reported are AEs occurring or worsening during the treatment period; duration approx. 3 months.
|
|
General disorders
Fatigue
|
7.4%
5/68 • AEs reported are AEs occurring or worsening during the treatment period; duration approx. 3 months.
|
2.9%
2/68 • AEs reported are AEs occurring or worsening during the treatment period; duration approx. 3 months.
|
|
Gastrointestinal disorders
Nausea
|
7.4%
5/68 • AEs reported are AEs occurring or worsening during the treatment period; duration approx. 3 months.
|
1.5%
1/68 • AEs reported are AEs occurring or worsening during the treatment period; duration approx. 3 months.
|
|
Nervous system disorders
Headache
|
5.9%
4/68 • AEs reported are AEs occurring or worsening during the treatment period; duration approx. 3 months.
|
2.9%
2/68 • AEs reported are AEs occurring or worsening during the treatment period; duration approx. 3 months.
|
Additional Information
Idorsia Clinical Trial Information
Idorsia Pharmaceuticals Ltd
Phone: +18566613721
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Any study-related publication written independently by investigators must be submitted to the sponsor for review at least 30 days prior to submission for publication or presentation at a congress. Upon review, the sponsor may provide comments, and may also request alterations and/or deletions for the sole purpose of protecting its confidential information and/or patent rights. Neither the institution nor the investigator should permit publication during such a review period.
- Publication restrictions are in place
Restriction type: OTHER