Adults 18 to 75, any sex, with Obesity. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change From Baseline (Visit 3) in Mean Energy Intake During Ad Libitum Lunches at Visits 4 and 5Primary· Visit 3, Visit 4 and Visit 5
The mean energy intake was collected to assess the effect of liraglutide on food intake in non-diabetic, obese participants. Observed food intake was measured as the total number of calories consumed during the specified time period, calculated as the difference of the total number of calories provided minus the total number of calories remaining after meals. Mean energy intakes at Visit 4 was defined as the mean values of the measurements at Study Day 20 and 21. Same definition applies to Visit 5 (Study Day 41 and 42). Baseline was defined as the mean of Visit 3 (Study Day -1 and 0).
Visit 4
Group
Value
95% CI
Liraglutide
-254.48
± 160.67
Placebo
-19.93
± 162.12
Visit 5
Group
Value
95% CI
Liraglutide
-278.78
± 190.09
Placebo
-37.43
± 164.49
Number of Participants With Vital Signs Data Meeting Categorical CriteriaSecondary· Baseline (Visit 3) up to Visit 6 (Study Day 53)
Absolute values and changes from baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP), pulse rate (PR) were recorded in supine position. Vital signs categorical summarization criteria were 1), blood pressure: SBP greater than or equal to (\>=) 30 millimeters of mercury (mm Hg) change from baseline, SBP less than (\<) 90 mm Hg; DBP \>=20 mm Hg change from baseline, DBP \<50 mm Hg; 2), PR \<40 or greater than (\>) 120 beats per minute (bpm). Baseline was defined as pre-treatment measurement on Day 1.
Supine DBP <50 mmHg
Group
Value
95% CI
Liraglutide
3
Placebo
5
Supine PR <40 bpm
Group
Value
95% CI
Liraglutide
0
Placebo
0
Supine PR >120 bpm
Group
Value
95% CI
Liraglutide
0
Placebo
0
Supine SBP <90 mmHg
Group
Value
95% CI
Liraglutide
1
Placebo
2
Increase in supine DBP >=20 mmHg
Group
Value
95% CI
Liraglutide
3
Placebo
1
Increase in supine SBP >=30 mmHg
Group
Value
95% CI
Liraglutide
1
Placebo
1
Decrease in supine DBP >=20 mmHg
Group
Value
95% CI
Liraglutide
3
Placebo
9
Decrease in supine SBP >=30 mmHg
Group
Value
95% CI
Liraglutide
1
Placebo
0
Number of Participants With Treatment-Emergent Adverse Events (All-Causality)Secondary· Baseline (Visit 3) up to 31 days post last dose (75 days)
Adverse event (AE) was defined as any untoward medical occurrence in a study participant administered a product or medical device, regardless of its causal relationship with study treatment. An AE is considered treatment-emergent relative to a given treatment if: the event occurs for the first time during the effective duration of treatment and was not seen prior to the start of treatment (for example, during the baseline or run-in period); or the event was seen prior to the start of treatment but increased in severity during treatment.
Group
Value
95% CI
Liraglutide
31
Placebo
20
Number of Participants With Abnormal 12-lead Electrocardiogram (ECG)Secondary· Baseline (Visit 3) up to Visit 6 (Study Day 53)
ECG categorical summarization criteria: 1) PR interval (the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization): absolute value greater than or equal to (\>=) 300 msec, percent change \>=25% if baseline was greater than (\>) 200 msec, and \>=50% if baseline was less than or equal to (\<=) 200 msec; 2) QRS interval (time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization): absolute value \>=200 msec, percent change \>=25% if bas
PR interval >=300 milliseconds (msec)
Group
Value
95% CI
Liraglutide
0
Placebo
0
QRS interval >=200 msec
Group
Value
95% CI
Liraglutide
0
Placebo
0
QTcF >450 - <=480 msec
Group
Value
95% CI
Liraglutide
2
Placebo
2
QTcF >480 - <=500 msec
Group
Value
95% CI
Liraglutide
0
Placebo
0
QTcF >500 msec
Group
Value
95% CI
Liraglutide
0
Placebo
0
PR interval percent increase >=25/50%
Group
Value
95% CI
Liraglutide
0
Placebo
0
QRS interval percent increase >=25/50%
Group
Value
95% CI
Liraglutide
0
Placebo
0
QTcF increase >30 - <=60 msec
Group
Value
95% CI
Liraglutide
2
Placebo
1
Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality)Secondary· Baseline (Visit 3) up to Visit 6 (Study Day 53)
Change From Baseline in Mean 48-hour Energy Intake at Visits 4 and 5Secondary· Visit 3, Visit 4 (Study Day 20 and 21) and Visit 5 (Study Day 41 and 42)
Energy intake was measured over a period of 48 hours to assess day to day variability in food intake. Observed food intake was measured as the total number of calories consumed during the specified time period, calculated as the difference of the total number of calories provided minus the total number of calories remaining after meals. Baseline was defined as the 48 hour period at Visit 3 (Study Day -1 and 0).
Visit 4
Group
Value
95% CI
Liraglutide
-1058.8
± 627.61
Placebo
-205.64
± 608.51
Visit 5
Group
Value
95% CI
Liraglutide
-1152.5
± 745.71
Placebo
-242.84
± 681.37
Change From Baseline in Appetite Score (Mean Rating Area Under Curve From Time 30 to 120 Minutes [AUC30-120min]) for Mean Lunch at Visits 4 and 5Secondary· Visit 3, Visit 4 (Study Day 20 and 21) and Visit 5 (Study Day 41 and 42)
Appetite, satiety, fullness, hunger, and prospective consumption were measured using a validated Visual Analog scale (VAS) questionnaire. VAS was an assessment in which participants place a vertical line across a validated 100 millimeter (mm) line with the example of "Not At All Full" and "Totally Full" at either end, scoring from 0 to 100. The overall appetite score was calculated as the average of the four individual scores \[satiety + fullness + (100 - prospective food consumption)+(100 - hunger)\] divided by 4. The VAS questionnaire was completed by the participant immediately prior to mea
Visit 4
Group
Value
95% CI
Liraglutide
4.52
± 8.65
Placebo
-0.60
± 9.22
Visit 5
Group
Value
95% CI
Liraglutide
4.13
± 9.99
Placebo
-0.99
± 8.17
Change From Baseline in Satiety, Fullness, Prospective Food Consumption and Hunger Scores (Mean Rating AUC30-120min) for Mean Lunch at Visits 4 and 5Secondary· Visit 3, Visit 4 (Study Day 20 and 21) and Visit 5 (Study Day 41 and 42)
Satiety, fullness, hunger, and prospective consumption were measured at the study site using a validated VAS questionnaire. The VAS measurement of the subcomponent scores were the same as that of the appetite score. Baseline of Mean Rating AUC30-120min was defined as the rating for mean lunch at Visit 3 (Study Day -1 and 0).The VAS was an assessment in which subjects place a vertical line across a validated 100 millimeter (mm) line to rank their response to various questions. The line was anchored by responses such as "Not At All Full" and "Totally Full" at either end. Scoring consisted of mea
Satiety (Visit 4)
Group
Value
95% CI
Liraglutide
3.94
± 13.50
Placebo
-0.55
± 10.52
Satiety (Visit 5)
Group
Value
95% CI
Liraglutide
4.51
± 11.79
Placebo
1.02
± 9.26
Fullness (Visit 4)
Group
Value
95% CI
Liraglutide
4.04
± 9.52
Placebo
1.88
± 10.85
Fullness (Visit 5)
Group
Value
95% CI
Liraglutide
2.40
± 10.08
Placebo
1.89
± 9.17
Prospective food consumption (Visit 4)
Group
Value
95% CI
Liraglutide
-7.74
± 12.87
Placebo
1.59
± 12.38
Prospective food consumption (Visit 5)
Group
Value
95% CI
Liraglutide
-6.18
± 16.92
Placebo
4.23
± 14.46
Hunger (Visit 4)
Group
Value
95% CI
Liraglutide
-3.71
± 7.97
Placebo
2.13
± 10.88
Hunger (Visit 5)
Group
Value
95% CI
Liraglutide
-3.41
± 8.96
Placebo
2.63
± 13.00
Change From Baseline in Area Under the Plasma Concentration-Time Profile of Acetaminophen for 0-60 Minutes and 0-300 Minutes (AUC0-60min and AUC0-300min) After Acetaminophen Dose at Visits 4 and 5Secondary· Prior to breakfast and at 30,60,90,120,180 and 300 minutes after intake of the acetaminophen with breakfast on Visit 3,Visit 4 (Study Day 20) and Visit 5 (Study Day 41)
A non investigational medicinal product (acetaminophen 1.5 gram \[g\]) was administered as a challenge agent for the assessment of gastric emptying. The blood sampling for determining acetaminophen concentrations was performed at 7 time points: prior to breakfast and at 30, 60, 90, 120, 180 and 300 minutes after intake of the acetaminophen with breakfast. Baseline was calculated at Visit 3 (Study Day -1).
AUC0-60min (Visit 4)
Group
Value
95% CI
Liraglutide
18.30
± 204.93
Placebo
-4.55
± 262.11
AUC0-60min (Visit 5)
Group
Value
95% CI
Liraglutide
81.19
± 166.47
Placebo
-8.28
± 258.55
AUC0-300min (Visit 4)
Group
Value
95% CI
Liraglutide
197.79
± 491.11
Placebo
-12.92
± 489.50
AUC0-300min (Visit 5)
Group
Value
95% CI
Liraglutide
394.22
± 401.62
Placebo
47.31
± 564.52
Adverse events — posted to ClinicalTrials.gov
Time frame: From Baseline (Visit 3, Study Day -1 and Day 0) to Day 73..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This will be a randomized, double blind, placebo controlled, 2 arm, parallel group, methodology study to assess the effect of 6 weeks of liraglutide administration on food intake in obese subjects.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by Pfizer
Last refreshed: 26 July 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03041792.