parallel randomized trial
NCT03041792
A 6-WEEK, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, TWO-ARM, PARALLEL METHODOLOGY STUDY TO ASSESS THE EFFECT OF LIRAGLUTIDE ON FOOD INTAKE IN OBESE SUBJECTS
Design
Conduct and analysis
Arms
| Arm | Treatment | Background | Randomized | Analyzed | Completed treatment |
|---|---|---|---|---|---|
| A1 | Liraglutide 3.0 mg subcutaneous once daily Liraglutide 3.0 mg | lifestyle: none | 32 | 30 | |
| A2 | Placebo Placebo | lifestyle: none | 29 | 26 |
Baseline characteristics
As printed in the trial reports or registry, per arm or for the whole trial.
| Characteristic | Statistic | Liraglutide 3.0 mg subcutaneous once daily A1 | Placebo A2 |
|---|---|---|---|
| age | mean (years) | 43.0 | 48.1 |
| age | sd (years) | 10.88 | 12.63 |
| asian | n | 0 | 1 |
| asian | percent | 0.0 | 3.8 |
| black | n | 9 | 6 |
| black | percent | 30.0 | 23.1 |
| bmi | mean (kg/m2) | 34.18 | 34.77 |
| bmi | sd (kg/m2) | 2.62 | 2.92 |
| female | n | 22 | 16 |
| female | percent | 73.3 | 61.5 |
| hispanic | n | 8 | 9 |
| hispanic | percent | 26.7 | 34.6 |
| weight | mean (kg) | 93.55 | 96.30 |
| weight | sd (kg) | 12.81 | 13.04 |
| white | n | 21 | 19 |
| white | percent | 70.0 | 73.1 |
Analyses this trial contributes to
- Serious adverse eventsOverweight or obesity without diabetes (adults); longest follow-up; network meta-analysis
- Serious adverse eventsOverweight or obesity without diabetes (adults); longest follow-up; network meta-analysis
- Discontinuation due to adverse eventsOverweight or obesity without diabetes (adults); longest follow-up; network meta-analysis
- Discontinuation due to adverse eventsOverweight or obesity without diabetes (adults); longest follow-up; network meta-analysis
- NauseaOverweight or obesity without diabetes (adults); longest follow-up; network meta-analysis
- NauseaOverweight or obesity without diabetes (adults); longest follow-up; network meta-analysis
- VomitingOverweight or obesity without diabetes (adults); longest follow-up; network meta-analysis
- VomitingOverweight or obesity without diabetes (adults); longest follow-up; network meta-analysis
- DiarrheaOverweight or obesity without diabetes (adults); longest follow-up; network meta-analysis
- DiarrheaOverweight or obesity without diabetes (adults); longest follow-up; network meta-analysis
- ConstipationOverweight or obesity without diabetes (adults); longest follow-up; network meta-analysis
- ConstipationOverweight or obesity without diabetes (adults); longest follow-up; network meta-analysis
- Discontinuation due to gastrointestinal adverse eventsOverweight or obesity without diabetes (adults); longest follow-up; network meta-analysis
- Discontinuation due to gastrointestinal adverse eventsOverweight or obesity without diabetes (adults); longest follow-up; network meta-analysis
Results
16 adjudicated result lines, grouped by outcome. Open an outcome to see its values.
All cause mortality (2 lines; O20)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 32 | not stated; safety; registry:adverse_events | ||||
| A2 | events | 0 / 28 | not stated; safety; registry:adverse_events |
Serious adverse events (2 lines; O25)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 32 | not stated; safety; R0023522:Table 2 | ||||
| A2 | events | 0 / 28 | not stated; safety; R0023522:Table 2 |
Discontinuation due to adverse events (2 lines; O26)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 4 / 32 | not stated; safety; R0023522:Table 2 | ||||
| A2 | events | 0 / 28 | not stated; safety; R0023522:Table 2 |
Nausea (2 lines; O27A)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 15 / 32 | not stated; safety; R0023522:Table 2 | ||||
| A2 | events | 1 / 28 | not stated; safety; R0023522:Table 2 |
Vomiting (2 lines; O27B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 6 / 32 | not stated; safety; R0023522:Table 2 | ||||
| A2 | events | 0 / 28 | not stated; safety; R0023522:Table 2 |
Diarrhea (2 lines; O27C)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 11 / 32 | not stated; safety; R0023522:Table 2 | ||||
| A2 | events | 4 / 28 | not stated; safety; R0023522:Table 2 |
Constipation (2 lines; O27D)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 9 / 32 | not stated; safety; R0023522:Table 2 | ||||
| A2 | events | 3 / 28 | not stated; safety; R0023522:Table 2 |
Discontinuation due to gastrointestinal adverse events (2 lines; O27E)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 4 / 32 | not stated; safety; R0023522:Results | ||||
| A2 | events | 0 / 28 | not stated; safety; R0023522:Results |