Trial · NCT03279731
Binge Eating Liraglutide Intervention
NCT03279731, Phase 3, Terminated, Kelly Allison; results first posted 2020-11-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Binge Eating Liraglutide Intervention. Trials, record NCT03279731. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03279731
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Binge Eating Liraglutide Intervention
- NCT number
- NCT03279731
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 36 participants, actual
- Lead sponsor
- Kelly Allison
- Conditions
- Binge-Eating Disorder
- Interventions
- Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml, Placebo
- First posted
- 2017-09-12
- Last updated
- 2020-11-24
- Results first posted
- 2020-11-24
- Limitations and caveats
Error by Investigational Drug Service - randomization key interpreted incorrectly at n=21 n= 6 had 2+ consecutive boxes of same agent and were retained in analyses (data censored after first switch); 6 received same agent consistently; n=9 censored
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Binge Episodes | baseline and 17 weeks (or last observation carried forward) | Change in objective binge episodes per week from randomization (week 0) to study end (week 17) |
| Secondary | Remission From Binge-eating | 13 to 17 weeks | the percentage of participants (completers) who have achieved remission from binge-eating (no binge episodes between weeks 13 - 17) |
| Secondary | Assessment of Improvement of Binge Eating Symptoms | week 17 (or last observation carried forward) | week 17 rating on the interviewer-based Clinical Global Impression of Improvement (CGII) Scale for global assessment of BED symptoms The CGII includes the following rating scale: Compared to the patient's condition at baseline to the project \[prior to medication initiation\], this patient's condition is: 1 very much improved; 2 much improved; 3 improved; 4 no change; 5 worse; 6 much worse; 7 very much worse. |
| Secondary | Change in Body Weight | baseline and 17 weeks (or last observation carried forward) | changes in body weight |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Binge Episodes | baseline and 17 weeks (or last observation carried forward) | objective binge episodes per week | MEAN | |
| SECONDARY | Remission From Binge-eating | 13 to 17 weeks | Remission was calculated for completers who had data from weeks 13-17 | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Assessment of Improvement of Binge Eating Symptoms | week 17 (or last observation carried forward) | units on a scale | MEAN | |
| SECONDARY | Change in Body Weight | baseline and 17 weeks (or last observation carried forward) | Last Observation Carried Forward | kg | MEAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Binge Episodes | Liraglutide | -3.97 | Standard Deviation 0.56 | objective binge episodes per week | |
| Binge Episodes | Placebo | -2.50 | Standard Deviation .053 | objective binge episodes per week | |
| Remission From Binge-eating | Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml | 3 | Participants | ||
| Remission From Binge-eating | Placebo | 4 | Participants | ||
| Assessment of Improvement of Binge Eating Symptoms | Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml | 1.52 | Standard Deviation .27 | units on a scale | |
| Assessment of Improvement of Binge Eating Symptoms | Placebo | 1.93 | Standard Deviation .26 | units on a scale | |
| Change in Body Weight | Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml | -4.7 | Standard Deviation 0.83 | kg | |
| Change in Body Weight | Placebo | -0.94 | Standard Deviation 0.73 | kg |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml | 19 | |
| Overall Study | STARTED | Placebo | 17 | |
| Overall Study | COMPLETED | Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml | 13 | |
| Overall Study | COMPLETED | Placebo | 14 | |
| Overall Study | NOT COMPLETED | Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml | 6 | |
| Overall Study | NOT COMPLETED | Placebo | 3 |
Source ClinicalTrials.gov
Adverse events56
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | nausea | Gastrointestinal disorders | Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml | 5 | 19 | 7 |
| other | nausea | Gastrointestinal disorders | Placebo | 3 | 17 | 3 |
| other | diarrhea | Gastrointestinal disorders | Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml | 5 | 19 | 5 |
| other | diarrhea | Gastrointestinal disorders | Placebo | 0 | 17 | 0 |
| other | dry mouth | General disorders | Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml | 3 | 19 | 3 |
| other | dry mouth | General disorders | Placebo | 0 | 17 | 0 |
| other | upper respiratory infection | Infections and infestations | Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml | 2 | 19 | 2 |
| other | upper respiratory infection | Infections and infestations | Placebo | 1 | 17 | 1 |
| other | indigestion | Gastrointestinal disorders | Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml | 2 | 19 | 2 |
| other | indigestion | Gastrointestinal disorders | Placebo | 2 | 17 | 2 |
1 to 10 of 56Source ClinicalTrials.gov
See all 56 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml | 0 | 19 |
| Total, all-cause mortality | Placebo | 0 | 17 |
| Total, other adverse events | Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml | 17 | 19 |
| Total, other adverse events | Placebo | 11 | 17 |
| Total, serious adverse events | Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml | 2 | 19 |
| Total, serious adverse events | Placebo | 1 | 17 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml vs Placebo: Remission From Binge-eating | Trial comparisons |
| Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml vs Placebo: deaths from any cause | Trial comparisons |
| Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03279731
GET https://conductscience.org/api/trials/v1/NCT03279731/events?page=2