Trial Outcomes & Findings for Saxenda® in Obese or Overweight Patients With Stable Bipolar Disorder (Investigator Initiated) (NCT NCT03158805)
NCT ID: NCT03158805
Last Updated: 2025-03-12
Results Overview
Percent change in body weight over 40 weeks
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
60 participants
Primary outcome timeframe
40 week
Results posted on
2025-03-12
Participant Flow
Participant milestones
| Measure |
Active Drug
LIRAGLUTIDE 3 Mg/0.5 mL (18 Mg/3 mL) SUB-Q PEN INJECTOR (ML) N=29
|
Placebo
Placebo (no active drug) N=31
|
|---|---|---|
|
Overall Study
STARTED
|
29
|
31
|
|
Overall Study
COMPLETED
|
13
|
8
|
|
Overall Study
NOT COMPLETED
|
16
|
23
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Saxenda® in Obese or Overweight Patients With Stable Bipolar Disorder (Investigator Initiated)
Baseline characteristics by cohort
| Measure |
Active Drug
n=29 Participants
LIRAGLUTIDE 3 Mg/0.5 mL (18 Mg/3 mL) SUB-Q PEN INJECTOR (ML)
LIRAGLUTIDE: 3 Mg/0.5 mL (18 Mg/3 mL) SUB-Q PEN INJECTOR (ML)
|
Placebo
n=31 Participants
Placebo (no active drug)
Placebo: Placebo injection
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
29 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
43.9 years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
41.4 years
STANDARD_DEVIATION 12.3 • n=7 Participants
|
42.6 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
29 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Body weight
|
110.6 kg
STANDARD_DEVIATION 24.0 • n=5 Participants
|
101.9 kg
STANDARD_DEVIATION 14.8 • n=7 Participants
|
106.2 kg
STANDARD_DEVIATION 19.1 • n=5 Participants
|
PRIMARY outcome
Timeframe: 40 weekPopulation: ≥ 5% of baseline body weight
Percent change in body weight over 40 weeks
Outcome measures
| Measure |
Active Drug
n=29 Participants
LIRAGLUTIDE 3 Mg/0.5 mL (18 Mg/3 mL) SUB-Q PEN INJECTOR (ML)
LIRAGLUTIDE: 3 Mg/0.5 mL (18 Mg/3 mL) SUB-Q PEN INJECTOR (ML)
|
Placebo
n=31 Participants
Placebo (no active drug)
Placebo: Placebo injection
|
|---|---|---|
|
Percent Change in Body Weight
|
-3.3 % change
Standard Deviation 5.2
|
0.2 % change
Standard Deviation 4.2
|
Adverse Events
Active Drug
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Active Drug
n=29 participants at risk
Significantly more placebo recipients (n=11) than liraglutide recipients (n=3) stopped study medication for a side effect (p=0.02). Those who discontinued liraglutide stopped because of gastrointestinal issues (n=1), mood dysregulation (n=1), and suicidal ideation (n=1). No adverse event was judged to reflect an interaction between liraglutide and participants' BD medications. There were no changes in psychopathology safety scales or vital signs. No participants experienced psychosis, displayed suicidal behaviour, or had ECG changes during the study.
|
Placebo
n=31 participants at risk
Significantly more placebo recipients (n=11) than liraglutide recipients (n=3) stopped study medication for a side effect (p=0.02). Those who discontinued placebo did so for mood dysregulation (n=5), gastrointestinal issues (n=4), and suicidal ideation (n=2). Two participants receiving placebo had a serious adverse event- one was medically hospitalized for a bowel obstruction presumed due to past bariatric surgery while the other was psychiatrically hospitalized for mood dysregulation-neither adverse event was attributed to study medication. There were no changes in psychopathology safety scales or vital signs . No participants experienced psychosis, displayed suicidal behaviour, or had ECG changes during the study.
|
|---|---|---|
|
Gastrointestinal disorders
Bowel obstruction
|
0.00%
0/29 • Through study completion, for the total duration of the trial, including up to 27 days of screening , the 40 study treatment weeks and one week of follow up
|
3.2%
1/31 • Number of events 1 • Through study completion, for the total duration of the trial, including up to 27 days of screening , the 40 study treatment weeks and one week of follow up
|
|
Psychiatric disorders
Mood dysregylation
|
0.00%
0/29 • Through study completion, for the total duration of the trial, including up to 27 days of screening , the 40 study treatment weeks and one week of follow up
|
3.2%
1/31 • Number of events 1 • Through study completion, for the total duration of the trial, including up to 27 days of screening , the 40 study treatment weeks and one week of follow up
|
Other adverse events
| Measure |
Active Drug
n=29 participants at risk
Significantly more placebo recipients (n=11) than liraglutide recipients (n=3) stopped study medication for a side effect (p=0.02). Those who discontinued liraglutide stopped because of gastrointestinal issues (n=1), mood dysregulation (n=1), and suicidal ideation (n=1). No adverse event was judged to reflect an interaction between liraglutide and participants' BD medications. There were no changes in psychopathology safety scales or vital signs. No participants experienced psychosis, displayed suicidal behaviour, or had ECG changes during the study.
|
Placebo
n=31 participants at risk
Significantly more placebo recipients (n=11) than liraglutide recipients (n=3) stopped study medication for a side effect (p=0.02). Those who discontinued placebo did so for mood dysregulation (n=5), gastrointestinal issues (n=4), and suicidal ideation (n=2). Two participants receiving placebo had a serious adverse event- one was medically hospitalized for a bowel obstruction presumed due to past bariatric surgery while the other was psychiatrically hospitalized for mood dysregulation-neither adverse event was attributed to study medication. There were no changes in psychopathology safety scales or vital signs . No participants experienced psychosis, displayed suicidal behaviour, or had ECG changes during the study.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
65.5%
19/29 • Number of events 19 • Through study completion, for the total duration of the trial, including up to 27 days of screening , the 40 study treatment weeks and one week of follow up
|
45.2%
14/31 • Number of events 14 • Through study completion, for the total duration of the trial, including up to 27 days of screening , the 40 study treatment weeks and one week of follow up
|
|
Respiratory, thoracic and mediastinal disorders
URI
|
34.5%
10/29 • Number of events 10 • Through study completion, for the total duration of the trial, including up to 27 days of screening , the 40 study treatment weeks and one week of follow up
|
19.4%
6/31 • Number of events 10 • Through study completion, for the total duration of the trial, including up to 27 days of screening , the 40 study treatment weeks and one week of follow up
|
|
Gastrointestinal disorders
Constipation
|
41.4%
12/29 • Number of events 12 • Through study completion, for the total duration of the trial, including up to 27 days of screening , the 40 study treatment weeks and one week of follow up
|
9.7%
3/31 • Number of events 3 • Through study completion, for the total duration of the trial, including up to 27 days of screening , the 40 study treatment weeks and one week of follow up
|
|
Gastrointestinal disorders
Heartburn
|
34.5%
10/29 • Number of events 10 • Through study completion, for the total duration of the trial, including up to 27 days of screening , the 40 study treatment weeks and one week of follow up
|
6.5%
2/31 • Number of events 2 • Through study completion, for the total duration of the trial, including up to 27 days of screening , the 40 study treatment weeks and one week of follow up
|
|
Psychiatric disorders
Mood dysregulation
|
24.1%
7/29 • Number of events 7 • Through study completion, for the total duration of the trial, including up to 27 days of screening , the 40 study treatment weeks and one week of follow up
|
25.8%
8/31 • Number of events 8 • Through study completion, for the total duration of the trial, including up to 27 days of screening , the 40 study treatment weeks and one week of follow up
|
|
Gastrointestinal disorders
Gastroenteritis
|
24.1%
7/29 • Number of events 7 • Through study completion, for the total duration of the trial, including up to 27 days of screening , the 40 study treatment weeks and one week of follow up
|
16.1%
5/31 • Number of events 5 • Through study completion, for the total duration of the trial, including up to 27 days of screening , the 40 study treatment weeks and one week of follow up
|
|
Nervous system disorders
Headache
|
20.7%
6/29 • Number of events 6 • Through study completion, for the total duration of the trial, including up to 27 days of screening , the 40 study treatment weeks and one week of follow up
|
29.0%
9/31 • Number of events 9 • Through study completion, for the total duration of the trial, including up to 27 days of screening , the 40 study treatment weeks and one week of follow up
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
24.1%
7/29 • Number of events 7 • Through study completion, for the total duration of the trial, including up to 27 days of screening , the 40 study treatment weeks and one week of follow up
|
16.1%
5/31 • Number of events 5 • Through study completion, for the total duration of the trial, including up to 27 days of screening , the 40 study treatment weeks and one week of follow up
|
|
Skin and subcutaneous tissue disorders
Injection site irritatation
|
17.2%
5/29 • Number of events 5 • Through study completion, for the total duration of the trial, including up to 27 days of screening , the 40 study treatment weeks and one week of follow up
|
19.4%
6/31 • Number of events 6 • Through study completion, for the total duration of the trial, including up to 27 days of screening , the 40 study treatment weeks and one week of follow up
|
|
Nervous system disorders
Sleep disturbance
|
17.2%
5/29 • Number of events 5 • Through study completion, for the total duration of the trial, including up to 27 days of screening , the 40 study treatment weeks and one week of follow up
|
16.1%
5/31 • Number of events 5 • Through study completion, for the total duration of the trial, including up to 27 days of screening , the 40 study treatment weeks and one week of follow up
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place