Trial Outcomes & Findings for Methodology Study To Examine 6-Week Food Intake With Liraglutide In Obese Subjects (NCT NCT03041792)
NCT ID: NCT03041792
Last Updated: 2019-07-26
Results Overview
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).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
61 participants
Primary outcome timeframe
Visit 3, Visit 4 and Visit 5
Results posted on
2019-07-26
Participant Flow
Overall, a total of 61 potential participants were randomized to the study, and 60 of them received study treatment.
Participant milestones
| Measure |
Liraglutide
Liraglutide was administered subcutaneously via pen injection with dose titration to 3.0 milligram (mg) daily per Saxenda prescribing instructions.
|
Placebo
0.9% weight/volume (w/v) sodium chloride, United States Pharmacopeia (USP), was administered subcutaneously as placebo via syringe injection daily with matching volume to liraglutide dose.
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
29
|
|
Overall Study
Received Treatment
|
32
|
28
|
|
Overall Study
COMPLETED
|
28
|
26
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
Reasons for withdrawal
| Measure |
Liraglutide
Liraglutide was administered subcutaneously via pen injection with dose titration to 3.0 milligram (mg) daily per Saxenda prescribing instructions.
|
Placebo
0.9% weight/volume (w/v) sodium chloride, United States Pharmacopeia (USP), was administered subcutaneously as placebo via syringe injection daily with matching volume to liraglutide dose.
|
|---|---|---|
|
Overall Study
Adverse Event
|
4
|
0
|
|
Overall Study
Death in the family
|
0
|
2
|
|
Overall Study
Randomized but not treated
|
0
|
1
|
Baseline Characteristics
Methodology Study To Examine 6-Week Food Intake With Liraglutide In Obese Subjects
Baseline characteristics by cohort
| Measure |
Liraglutide
n=30 Participants
Liraglutide was administered subcutaneously via pen injection with dose titration to 3.0 milligram (mg) daily per Saxenda prescribing instructions.
|
Placebo
n=26 Participants
0.9% weight/volume (w/v) sodium chloride, United States Pharmacopeia (USP), was administered subcutaneously as placebo via syringe injection daily with matching volume to liraglutide dose.
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.0 years
STANDARD_DEVIATION 10.88 • n=5 Participants
|
48.1 years
STANDARD_DEVIATION 12.63 • n=7 Participants
|
45.4 years
STANDARD_DEVIATION 11.89 • n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
21 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Visit 3, Visit 4 and Visit 5Population: Number of participants analyzed includes participants who met the criteria: completed baseline assessment of food intake;received at least 1 dose of randomized, blinded IP;completed at least 1 post baseline measurement(after taking randomized IP).Number analyzed includes participants contributing to mean energy intake at specified visits.
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).
Outcome measures
| Measure |
Liraglutide
n=30 Participants
Liraglutide was administered subcutaneously via pen injection with dose titration to 3.0 milligram (mg) daily per Saxenda prescribing instructions.
|
Placebo
n=26 Participants
0.9% weight/volume (w/v) sodium chloride, United States Pharmacopeia (USP), was administered subcutaneously as placebo via syringe injection daily with matching volume to liraglutide dose.
|
|---|---|---|
|
Change From Baseline (Visit 3) in Mean Energy Intake During Ad Libitum Lunches at Visits 4 and 5
Visit 4
|
-254.48 kilocalories (kcal)
Standard Deviation 160.67
|
-19.93 kilocalories (kcal)
Standard Deviation 162.12
|
|
Change From Baseline (Visit 3) in Mean Energy Intake During Ad Libitum Lunches at Visits 4 and 5
Visit 5
|
-278.78 kilocalories (kcal)
Standard Deviation 190.09
|
-37.43 kilocalories (kcal)
Standard Deviation 164.49
|
SECONDARY outcome
Timeframe: Baseline (Visit 3) up to Visit 6 (Study Day 53)Population: All participants who received at least 1 dose of study medication classified according to the actual study treatment received. Follow-up readings have been excluded from presentation, and 4 participants have been excluded from presentation because they only have follow up readings in post-dose phase.
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.
Outcome measures
| Measure |
Liraglutide
n=30 Participants
Liraglutide was administered subcutaneously via pen injection with dose titration to 3.0 milligram (mg) daily per Saxenda prescribing instructions.
|
Placebo
n=26 Participants
0.9% weight/volume (w/v) sodium chloride, United States Pharmacopeia (USP), was administered subcutaneously as placebo via syringe injection daily with matching volume to liraglutide dose.
|
|---|---|---|
|
Number of Participants With Vital Signs Data Meeting Categorical Criteria
Decrease in supine DBP >=20 mmHg
|
3 Participants
|
9 Participants
|
|
Number of Participants With Vital Signs Data Meeting Categorical Criteria
Supine DBP <50 mmHg
|
3 Participants
|
5 Participants
|
|
Number of Participants With Vital Signs Data Meeting Categorical Criteria
Supine PR <40 bpm
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs Data Meeting Categorical Criteria
Supine PR >120 bpm
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs Data Meeting Categorical Criteria
Supine SBP <90 mmHg
|
1 Participants
|
2 Participants
|
|
Number of Participants With Vital Signs Data Meeting Categorical Criteria
Increase in supine DBP >=20 mmHg
|
3 Participants
|
1 Participants
|
|
Number of Participants With Vital Signs Data Meeting Categorical Criteria
Increase in supine SBP >=30 mmHg
|
1 Participants
|
1 Participants
|
|
Number of Participants With Vital Signs Data Meeting Categorical Criteria
Decrease in supine SBP >=30 mmHg
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (Visit 3) up to 31 days post last dose (75 days)Population: The safety analysis population included all participants who received at least one dose of study medication classified according to the actual study treatment received.
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.
Outcome measures
| Measure |
Liraglutide
n=32 Participants
Liraglutide was administered subcutaneously via pen injection with dose titration to 3.0 milligram (mg) daily per Saxenda prescribing instructions.
|
Placebo
n=28 Participants
0.9% weight/volume (w/v) sodium chloride, United States Pharmacopeia (USP), was administered subcutaneously as placebo via syringe injection daily with matching volume to liraglutide dose.
|
|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (All-Causality)
|
31 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: Baseline (Visit 3) up to Visit 6 (Study Day 53)Population: All participants who received at least one dose of study medication classified according to the actual study treatment received. Follow-up readings have been excluded from presentation, and 4 participants have been excluded from presentation because they only have follow up readings in post-dose phase.
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 baseline was 100 msec, and \>=50% if baseline was \<=100 msec; 3) QTcF interval (QT corrected for heart rate using Fridericia's formula): absolute value \>450 to \<=480 msec, \>480 to \<=500 msec, \>500 msec, an increase from baseline \>30 to \<=60 msec or \>60 msec. Baseline was defined as pre-treatment measurement on Day -2.
Outcome measures
| Measure |
Liraglutide
n=30 Participants
Liraglutide was administered subcutaneously via pen injection with dose titration to 3.0 milligram (mg) daily per Saxenda prescribing instructions.
|
Placebo
n=26 Participants
0.9% weight/volume (w/v) sodium chloride, United States Pharmacopeia (USP), was administered subcutaneously as placebo via syringe injection daily with matching volume to liraglutide dose.
|
|---|---|---|
|
Number of Participants With Abnormal 12-lead Electrocardiogram (ECG)
PR interval >=300 milliseconds (msec)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal 12-lead Electrocardiogram (ECG)
QRS interval >=200 msec
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal 12-lead Electrocardiogram (ECG)
QTcF >450 - <=480 msec
|
2 Participants
|
2 Participants
|
|
Number of Participants With Abnormal 12-lead Electrocardiogram (ECG)
QTcF >480 - <=500 msec
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal 12-lead Electrocardiogram (ECG)
QTcF >500 msec
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal 12-lead Electrocardiogram (ECG)
PR interval percent increase >=25/50%
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal 12-lead Electrocardiogram (ECG)
QRS interval percent increase >=25/50%
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal 12-lead Electrocardiogram (ECG)
QTcF increase >30 - <=60 msec
|
2 Participants
|
1 Participants
|
|
Number of Participants With Abnormal 12-lead Electrocardiogram (ECG)
QTcF increase >60 msec
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (Visit 3) up to Visit 6 (Study Day 53)Population: All participants who received at least one dose of study medication classified according to the actual study treatment received.
Below parameters were evaluated:1), Hematology: hemoglobin (HGB), hematocrit, erythrocytes (absolute value/mean corpuscular volume/mean corpuscular HGB/mean corpuscular HGB concentration), platelets, leukocytes, lymphocytes, neutrophils, basophils, monocytes; 2), clinical chemistry: bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, protein, albumin, blood urea nitrogen, creatinine, cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, triglycerides, sodium, potassium, chloride, calcium, bicarbonate, amylase, triacylglycerol lipase; 3), urinalysis: pH, urine glucose, ketones, urine protein, urine hemoglobin, urobilinogen, urine bilirubin, nitrite, leukocyte esterase, urine erythrocytes, urine leukocytes, hyaline casts, bacteria.
Outcome measures
| Measure |
Liraglutide
n=32 Participants
Liraglutide was administered subcutaneously via pen injection with dose titration to 3.0 milligram (mg) daily per Saxenda prescribing instructions.
|
Placebo
n=28 Participants
0.9% weight/volume (w/v) sodium chloride, United States Pharmacopeia (USP), was administered subcutaneously as placebo via syringe injection daily with matching volume to liraglutide dose.
|
|---|---|---|
|
Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality)
|
32 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: Visit 3, Visit 4 (Study Day 20 and 21) and Visit 5 (Study Day 41 and 42)Population: Number of participants analyzed includes participants who met the criteria: completed baseline assessment of food intake;received at least 1 dose of randomized, blinded IP;completed at least 1 post baseline measurement(after taking randomized IP).Number analyzed includes participants contributing to mean 48-hour energy intake at specified visits.
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).
Outcome measures
| Measure |
Liraglutide
n=30 Participants
Liraglutide was administered subcutaneously via pen injection with dose titration to 3.0 milligram (mg) daily per Saxenda prescribing instructions.
|
Placebo
n=26 Participants
0.9% weight/volume (w/v) sodium chloride, United States Pharmacopeia (USP), was administered subcutaneously as placebo via syringe injection daily with matching volume to liraglutide dose.
|
|---|---|---|
|
Change From Baseline in Mean 48-hour Energy Intake at Visits 4 and 5
Visit 4
|
-1058.8 kcal
Standard Deviation 627.61
|
-205.64 kcal
Standard Deviation 608.51
|
|
Change From Baseline in Mean 48-hour Energy Intake at Visits 4 and 5
Visit 5
|
-1152.5 kcal
Standard Deviation 745.71
|
-242.84 kcal
Standard Deviation 681.37
|
SECONDARY outcome
Timeframe: Visit 3, Visit 4 (Study Day 20 and 21) and Visit 5 (Study Day 41 and 42)Population: Number of participants analyzed includes participants who met the criteria: completed baseline assessment of food intake;received at least 1 dose of randomized, blinded IP;completed at least 1 post baseline measurement(after taking randomized IP).Number analyzed includes participants contributing to appetite score at specified visits.
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 meal administration, and at 30, 60 and 120 minutes after start of the specified meals. Baseline of Mean Rating AUC30-120min was defined as the rating for mean lunch at Visit 3 (Study Day -1 and 0).
Outcome measures
| Measure |
Liraglutide
n=30 Participants
Liraglutide was administered subcutaneously via pen injection with dose titration to 3.0 milligram (mg) daily per Saxenda prescribing instructions.
|
Placebo
n=26 Participants
0.9% weight/volume (w/v) sodium chloride, United States Pharmacopeia (USP), was administered subcutaneously as placebo via syringe injection daily with matching volume to liraglutide dose.
|
|---|---|---|
|
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 5
Visit 4
|
4.52 units on a scale
Standard Deviation 8.65
|
-0.60 units on a scale
Standard Deviation 9.22
|
|
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 5
Visit 5
|
4.13 units on a scale
Standard Deviation 9.99
|
-0.99 units on a scale
Standard Deviation 8.17
|
SECONDARY outcome
Timeframe: Visit 3, Visit 4 (Study Day 20 and 21) and Visit 5 (Study Day 41 and 42)Population: Number of participants analyzed includes participants who met the criteria: completed baseline assessment of food intake;received at least 1 dose of randomized, blinded IP;completed at least 1 post baseline measurement(after taking randomized IP).Number analyzed includes participants contributing to VAS scores at specified visits.
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 measuring the distance in mm of the vertical line from the response at the left end. The scores (total and subscale) ranged from 0 to 100. The lower values represent the better outcomes.The overall appetite score was calculated as the average of the 4 individual scores \[satiety+fullness+(100-prospective food consumption)+(100-hunger)\] divided by 4.
Outcome measures
| Measure |
Liraglutide
n=30 Participants
Liraglutide was administered subcutaneously via pen injection with dose titration to 3.0 milligram (mg) daily per Saxenda prescribing instructions.
|
Placebo
n=26 Participants
0.9% weight/volume (w/v) sodium chloride, United States Pharmacopeia (USP), was administered subcutaneously as placebo via syringe injection daily with matching volume to liraglutide dose.
|
|---|---|---|
|
Change From Baseline in Satiety, Fullness, Prospective Food Consumption and Hunger Scores (Mean Rating AUC30-120min) for Mean Lunch at Visits 4 and 5
Satiety (Visit 4)
|
3.94 units on a scale
Standard Deviation 13.50
|
-0.55 units on a scale
Standard Deviation 10.52
|
|
Change From Baseline in Satiety, Fullness, Prospective Food Consumption and Hunger Scores (Mean Rating AUC30-120min) for Mean Lunch at Visits 4 and 5
Satiety (Visit 5)
|
4.51 units on a scale
Standard Deviation 11.79
|
1.02 units on a scale
Standard Deviation 9.26
|
|
Change From Baseline in Satiety, Fullness, Prospective Food Consumption and Hunger Scores (Mean Rating AUC30-120min) for Mean Lunch at Visits 4 and 5
Fullness (Visit 4)
|
4.04 units on a scale
Standard Deviation 9.52
|
1.88 units on a scale
Standard Deviation 10.85
|
|
Change From Baseline in Satiety, Fullness, Prospective Food Consumption and Hunger Scores (Mean Rating AUC30-120min) for Mean Lunch at Visits 4 and 5
Fullness (Visit 5)
|
2.40 units on a scale
Standard Deviation 10.08
|
1.89 units on a scale
Standard Deviation 9.17
|
|
Change From Baseline in Satiety, Fullness, Prospective Food Consumption and Hunger Scores (Mean Rating AUC30-120min) for Mean Lunch at Visits 4 and 5
Prospective food consumption (Visit 4)
|
-7.74 units on a scale
Standard Deviation 12.87
|
1.59 units on a scale
Standard Deviation 12.38
|
|
Change From Baseline in Satiety, Fullness, Prospective Food Consumption and Hunger Scores (Mean Rating AUC30-120min) for Mean Lunch at Visits 4 and 5
Prospective food consumption (Visit 5)
|
-6.18 units on a scale
Standard Deviation 16.92
|
4.23 units on a scale
Standard Deviation 14.46
|
|
Change From Baseline in Satiety, Fullness, Prospective Food Consumption and Hunger Scores (Mean Rating AUC30-120min) for Mean Lunch at Visits 4 and 5
Hunger (Visit 4)
|
-3.71 units on a scale
Standard Deviation 7.97
|
2.13 units on a scale
Standard Deviation 10.88
|
|
Change From Baseline in Satiety, Fullness, Prospective Food Consumption and Hunger Scores (Mean Rating AUC30-120min) for Mean Lunch at Visits 4 and 5
Hunger (Visit 5)
|
-3.41 units on a scale
Standard Deviation 8.96
|
2.63 units on a scale
Standard Deviation 13.00
|
SECONDARY outcome
Timeframe: 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)Population: Number of participants analyzed includes participants who met the criteria: completed baseline assessment of food intake;received at least 1 dose of randomized, blinded IP;completed at least 1 post baseline measurement(after taking randomized IP).Number analyzed includes participants contributing to AUC0-60min and AUC0-300min at specified visits.
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).
Outcome measures
| Measure |
Liraglutide
n=30 Participants
Liraglutide was administered subcutaneously via pen injection with dose titration to 3.0 milligram (mg) daily per Saxenda prescribing instructions.
|
Placebo
n=26 Participants
0.9% weight/volume (w/v) sodium chloride, United States Pharmacopeia (USP), was administered subcutaneously as placebo via syringe injection daily with matching volume to liraglutide dose.
|
|---|---|---|
|
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 5
AUC0-60min (Visit 4)
|
18.30 microgram*minute/milliliter (ug*min/mL)
Standard Deviation 204.93
|
-4.55 microgram*minute/milliliter (ug*min/mL)
Standard Deviation 262.11
|
|
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 5
AUC0-60min (Visit 5)
|
81.19 microgram*minute/milliliter (ug*min/mL)
Standard Deviation 166.47
|
-8.28 microgram*minute/milliliter (ug*min/mL)
Standard Deviation 258.55
|
|
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 5
AUC0-300min (Visit 4)
|
197.79 microgram*minute/milliliter (ug*min/mL)
Standard Deviation 491.11
|
-12.92 microgram*minute/milliliter (ug*min/mL)
Standard Deviation 489.50
|
|
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 5
AUC0-300min (Visit 5)
|
394.22 microgram*minute/milliliter (ug*min/mL)
Standard Deviation 401.62
|
47.31 microgram*minute/milliliter (ug*min/mL)
Standard Deviation 564.52
|
Adverse Events
Liraglutide
Serious events: 0 serious events
Other events: 30 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Liraglutide
n=32 participants at risk
Liraglutide was administered subcutaneously via pen injection with dose titration to 3.0 milligram (mg) daily per Saxenda prescribing instructions.
|
Placebo
n=28 participants at risk
0.9% weight/volume (w/v) sodium chloride, United States Pharmacopeia (USP), was administered subcutaneously as placebo via syringe injection daily with matching volume to liraglutide dose.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
6.2%
2/32 • From Baseline (Visit 3, Study Day -1 and Day 0) to Day 73.
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
|
0.00%
0/28 • From Baseline (Visit 3, Study Day -1 and Day 0) to Day 73.
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
|
|
Gastrointestinal disorders
Abdominal distension
|
12.5%
4/32 • From Baseline (Visit 3, Study Day -1 and Day 0) to Day 73.
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
|
0.00%
0/28 • From Baseline (Visit 3, Study Day -1 and Day 0) to Day 73.
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
6.2%
2/32 • From Baseline (Visit 3, Study Day -1 and Day 0) to Day 73.
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
|
0.00%
0/28 • From Baseline (Visit 3, Study Day -1 and Day 0) to Day 73.
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
18.8%
6/32 • From Baseline (Visit 3, Study Day -1 and Day 0) to Day 73.
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
|
3.6%
1/28 • From Baseline (Visit 3, Study Day -1 and Day 0) to Day 73.
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
|
|
Gastrointestinal disorders
Constipation
|
28.1%
9/32 • From Baseline (Visit 3, Study Day -1 and Day 0) to Day 73.
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
|
10.7%
3/28 • From Baseline (Visit 3, Study Day -1 and Day 0) to Day 73.
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
34.4%
11/32 • From Baseline (Visit 3, Study Day -1 and Day 0) to Day 73.
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
|
14.3%
4/28 • From Baseline (Visit 3, Study Day -1 and Day 0) to Day 73.
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
|
|
Gastrointestinal disorders
Dyspepsia
|
21.9%
7/32 • From Baseline (Visit 3, Study Day -1 and Day 0) to Day 73.
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
|
7.1%
2/28 • From Baseline (Visit 3, Study Day -1 and Day 0) to Day 73.
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
|
|
Gastrointestinal disorders
Nausea
|
46.9%
15/32 • From Baseline (Visit 3, Study Day -1 and Day 0) to Day 73.
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
|
3.6%
1/28 • From Baseline (Visit 3, Study Day -1 and Day 0) to Day 73.
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
|
|
Gastrointestinal disorders
Vomiting
|
18.8%
6/32 • From Baseline (Visit 3, Study Day -1 and Day 0) to Day 73.
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
|
0.00%
0/28 • From Baseline (Visit 3, Study Day -1 and Day 0) to Day 73.
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
|
|
General disorders
Injection site bruising
|
21.9%
7/32 • From Baseline (Visit 3, Study Day -1 and Day 0) to Day 73.
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
|
14.3%
4/28 • From Baseline (Visit 3, Study Day -1 and Day 0) to Day 73.
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
|
|
General disorders
Injection site erythema
|
12.5%
4/32 • From Baseline (Visit 3, Study Day -1 and Day 0) to Day 73.
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
|
0.00%
0/28 • From Baseline (Visit 3, Study Day -1 and Day 0) to Day 73.
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
|
|
General disorders
Injection site mass
|
6.2%
2/32 • From Baseline (Visit 3, Study Day -1 and Day 0) to Day 73.
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
|
0.00%
0/28 • From Baseline (Visit 3, Study Day -1 and Day 0) to Day 73.
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
|
|
General disorders
Injection site pain
|
6.2%
2/32 • From Baseline (Visit 3, Study Day -1 and Day 0) to Day 73.
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
|
0.00%
0/28 • From Baseline (Visit 3, Study Day -1 and Day 0) to Day 73.
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
|
|
General disorders
Injection site pruritus
|
6.2%
2/32 • From Baseline (Visit 3, Study Day -1 and Day 0) to Day 73.
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
|
0.00%
0/28 • From Baseline (Visit 3, Study Day -1 and Day 0) to Day 73.
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
25.0%
8/32 • From Baseline (Visit 3, Study Day -1 and Day 0) to Day 73.
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
|
7.1%
2/28 • From Baseline (Visit 3, Study Day -1 and Day 0) to Day 73.
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
|
|
Nervous system disorders
Headache
|
34.4%
11/32 • From Baseline (Visit 3, Study Day -1 and Day 0) to Day 73.
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
|
10.7%
3/28 • From Baseline (Visit 3, Study Day -1 and Day 0) to Day 73.
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.2%
2/32 • From Baseline (Visit 3, Study Day -1 and Day 0) to Day 73.
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
|
0.00%
0/28 • From Baseline (Visit 3, Study Day -1 and Day 0) to Day 73.
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
|
|
Ear and labyrinth disorders
Ear pain
|
6.2%
2/32 • From Baseline (Visit 3, Study Day -1 and Day 0) to Day 73.
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
|
0.00%
0/28 • From Baseline (Visit 3, Study Day -1 and Day 0) to Day 73.
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
|
|
Gastrointestinal disorders
Eructation
|
6.2%
2/32 • From Baseline (Visit 3, Study Day -1 and Day 0) to Day 73.
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
|
0.00%
0/28 • From Baseline (Visit 3, Study Day -1 and Day 0) to Day 73.
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
6.2%
2/32 • From Baseline (Visit 3, Study Day -1 and Day 0) to Day 73.
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
|
0.00%
0/28 • From Baseline (Visit 3, Study Day -1 and Day 0) to Day 73.
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
6.2%
2/32 • From Baseline (Visit 3, Study Day -1 and Day 0) to Day 73.
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
|
0.00%
0/28 • From Baseline (Visit 3, Study Day -1 and Day 0) to Day 73.
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
12.5%
4/32 • From Baseline (Visit 3, Study Day -1 and Day 0) to Day 73.
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
|
0.00%
0/28 • From Baseline (Visit 3, Study Day -1 and Day 0) to Day 73.
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.2%
2/32 • From Baseline (Visit 3, Study Day -1 and Day 0) to Day 73.
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
|
7.1%
2/28 • From Baseline (Visit 3, Study Day -1 and Day 0) to Day 73.
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
|
|
Nervous system disorders
Dizziness
|
18.8%
6/32 • From Baseline (Visit 3, Study Day -1 and Day 0) to Day 73.
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
|
3.6%
1/28 • From Baseline (Visit 3, Study Day -1 and Day 0) to Day 73.
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.4%
3/32 • From Baseline (Visit 3, Study Day -1 and Day 0) to Day 73.
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
|
3.6%
1/28 • From Baseline (Visit 3, Study Day -1 and Day 0) to Day 73.
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
|
|
Investigations
Amylase increased
|
6.2%
2/32 • From Baseline (Visit 3, Study Day -1 and Day 0) to Day 73.
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
|
0.00%
0/28 • From Baseline (Visit 3, Study Day -1 and Day 0) to Day 73.
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
|
|
Injury, poisoning and procedural complications
Contusion
|
3.1%
1/32 • From Baseline (Visit 3, Study Day -1 and Day 0) to Day 73.
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
|
14.3%
4/28 • From Baseline (Visit 3, Study Day -1 and Day 0) to Day 73.
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
|
|
Infections and infestations
Urinary tract infection
|
6.2%
2/32 • From Baseline (Visit 3, Study Day -1 and Day 0) to Day 73.
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
|
0.00%
0/28 • From Baseline (Visit 3, Study Day -1 and Day 0) to Day 73.
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
|
|
General disorders
Asthenia
|
6.2%
2/32 • From Baseline (Visit 3, Study Day -1 and Day 0) to Day 73.
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
|
0.00%
0/28 • From Baseline (Visit 3, Study Day -1 and Day 0) to Day 73.
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
|
|
General disorders
Fatigue
|
15.6%
5/32 • From Baseline (Visit 3, Study Day -1 and Day 0) to Day 73.
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
|
0.00%
0/28 • From Baseline (Visit 3, Study Day -1 and Day 0) to Day 73.
The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonseriousevent during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER