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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Experimental | Liraglutide |
|
| Placebo | Placebo Comparator | Placebo comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liraglutide | Drug | Liraglutide |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline (Visit 3) in Mean Energy Intake During Ad Libitum Lunches at Visits 4 and 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 3, Visit 4 and Visit 5 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Vital Signs Data Meeting Categorical Criteria | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Translational Research Institute for Metabolism and Diabetes | Orlando | Florida | 32804 | United States |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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Overall, a total of 61 potential participants were randomized to the study, and 60 of them received study treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Liraglutide | Liraglutide was administered subcutaneously via pen injection with dose titration to 3.0 milligram (mg) daily per Saxenda prescribing instructions. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All participants who met the criteria stated below were included in the full analysis set (FAS): completed baseline assessment of food intake; received at least one dose of randomized, blinded investigational product (IP); and completed at least one post baseline measurement (after taking randomized IP).
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| ID | Title | Description |
|---|---|---|
| BG000 | Liraglutide | Liraglutide was administered subcutaneously via pen injection with dose titration to 3.0 milligram (mg) daily per Saxenda prescribing instructions. |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline (Visit 3) in Mean Energy Intake During Ad Libitum Lunches at Visits 4 and 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). | 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. | Posted | Mean | Standard Deviation | kilocalories (kcal) | Visit 3, Visit 4 and Visit 5 |
|
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Liraglutide | Liraglutide was administered subcutaneously via pen injection with dose titration to 3.0 milligram (mg) daily per Saxenda prescribing instructions. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA v20.1 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 21, 2016 | Jan 14, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 16, 2017 | Jan 14, 2019 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000069450 | Liraglutide |
| ID | Term |
|---|---|
| D052216 | Glucagon-Like Peptide 1 |
| D004763 | Glucagon-Like Peptides |
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |
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| Other |
Placebo |
|
| Baseline (Visit 3) up to Visit 6 (Study Day 53) |
| Number of Participants With Treatment-Emergent Adverse Events (All-Causality) | 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. | Baseline (Visit 3) up to 31 days post last dose (75 days) |
| Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) | 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. | Baseline (Visit 3) up to Visit 6 (Study Day 53) |
| Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality) | 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. | Baseline (Visit 3) up to Visit 6 (Study Day 53) |
| Change From Baseline in Mean 48-hour Energy Intake at Visits 4 and 5 | 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 3, Visit 4 (Study Day 20 and 21) and Visit 5 (Study Day 41 and 42) |
| 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 | 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). | Visit 3, Visit 4 (Study Day 20 and 21) and Visit 5 (Study Day 41 and 42) |
| 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, 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. | Visit 3, Visit 4 (Study Day 20 and 21) and Visit 5 (Study Day 41 and 42) |
| 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 | 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). | 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) |
| Randomized but not treated |
|
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.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| OG000 | Liraglutide | Liraglutide was administered subcutaneously via pen injection with dose titration to 3.0 milligram (mg) daily per Saxenda prescribing instructions. |
| OG001 | 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. |
|
|
|
| Secondary | Number of Participants With Vital Signs Data Meeting Categorical Criteria | 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. | 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. | Posted | Count of Participants | Participants | Baseline (Visit 3) up to Visit 6 (Study Day 53) |
|
|
|
| Secondary | Number of Participants With Treatment-Emergent Adverse Events (All-Causality) | 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. | The safety analysis population included all participants who received at least one dose of study medication classified according to the actual study treatment received. | Posted | Count of Participants | Participants | Baseline (Visit 3) up to 31 days post last dose (75 days) |
|
|
|
| Secondary | Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) | 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. | 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. | Posted | Count of Participants | Participants | Baseline (Visit 3) up to Visit 6 (Study Day 53) |
|
|
|
| Secondary | Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality) | 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. | All participants who received at least one dose of study medication classified according to the actual study treatment received. | Posted | Count of Participants | Participants | Baseline (Visit 3) up to Visit 6 (Study Day 53) |
|
|
|
| Secondary | Change From Baseline in Mean 48-hour Energy Intake at Visits 4 and 5 | 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). | 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. | Posted | Mean | Standard Deviation | kcal | Visit 3, Visit 4 (Study Day 20 and 21) and Visit 5 (Study Day 41 and 42) |
|
|
|
|
| Secondary | 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 | 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). | 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. | Posted | Mean | Standard Deviation | units on a scale | Visit 3, Visit 4 (Study Day 20 and 21) and Visit 5 (Study Day 41 and 42) |
|
|
|
|
| Secondary | 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, 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Visit 3, Visit 4 (Study Day 20 and 21) and Visit 5 (Study Day 41 and 42) |
|
|
|
|
| Secondary | 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 | 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). | 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. | Posted | Mean | Standard Deviation | microgram*minute/milliliter (ug*min/mL) | 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) |
|
|
|
|
| 0 |
| 32 |
| 0 |
| 32 |
| 30 |
| 32 |
| EG001 | 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. | 0 | 28 | 0 | 28 | 18 | 28 |
| Abdominal distension | Gastrointestinal disorders | MedDRA v20.1 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA v20.1 | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA v20.1 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA v20.1 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA v20.1 | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA v20.1 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA v20.1 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA v20.1 | Non-systematic Assessment |
|
| Injection site bruising | General disorders | MedDRA v20.1 | Non-systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA v20.1 | Non-systematic Assessment |
|
| Injection site mass | General disorders | MedDRA v20.1 | Non-systematic Assessment |
|
| Injection site pain | General disorders | MedDRA v20.1 | Non-systematic Assessment |
|
| Injection site pruritus | General disorders | MedDRA v20.1 | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v20.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA v20.1 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v20.1 | Non-systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | MedDRA v20.1 | Non-systematic Assessment |
|
| Eructation | Gastrointestinal disorders | MedDRA v20.1 | Non-systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA v20.1 | Non-systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA v20.1 | Non-systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA v20.1 | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA v20.1 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA v20.1 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v20.1 | Non-systematic Assessment |
|
| Amylase increased | Investigations | MedDRA v20.1 | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA v20.1 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA v20.1 | Non-systematic Assessment |
|
| Asthenia | General disorders | MedDRA v20.1 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA v20.1 | Non-systematic Assessment |
|
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.
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| Supine PR >120 bpm |
|
| Supine SBP <90 mmHg |
|
| Increase in supine DBP >=20 mmHg |
|
| Increase in supine SBP >=30 mmHg |
|
| Decrease in supine DBP >=20 mmHg |
|
| Decrease in supine SBP >=30 mmHg |
|
| QTcF >450 - <=480 msec |
|
| QTcF >480 - <=500 msec |
|
| QTcF >500 msec |
|
| PR interval percent increase >=25/50% |
|
| QRS interval percent increase >=25/50% |
|
| QTcF increase >30 - <=60 msec |
|
| QTcF increase >60 msec |
|
| Visit 5 |
|
|
Visit 5 |
| Mixed Models Analysis |
| 0.0000 |
The p-value was calculated and was rounded to 4th decimal presenting as 0.0000, which was smaller than the required threshold of <0.05. |
| Least Square Mean Difference |
| -928.56 |
| Standard Error of the Mean |
| 193.80 |
| 2-Sided |
| 95 |
| -1317.3 |
| -539.86 |
| Superiority |
| Visit 5 |
|
|
| 0.0121 |
| Least Square Mean Difference |
| 5.35 |
| Standard Error of the Mean |
| 2.06 |
| 2-Sided |
| 95 |
| 1.22 |
| 9.48 |
| Superiority |
| Satiety (Visit 5) |
|
|
| Fullness (Visit 4) |
|
|
| Fullness (Visit 5) |
|
|
| Prospective food consumption (Visit 4) |
|
|
| Prospective food consumption (Visit 5) |
|
|
| Hunger (Visit 4) |
|
|
| Hunger (Visit 5) |
|
|
| Mixed Models Analysis |
| 0.1137 |
| Least Square Mean Difference |
| 3.43 |
| Standard Error of the Mean |
| 2.13 |
| 2-Sided |
| 95 |
| -0.85 |
| 7.70 |
| Superiority |
| Fullness (Visit 4) | Mixed Models Analysis | 0.1858 | Least Square Mean Difference | 2.85 | Standard Error of the Mean | 2.12 | 2-Sided | 95 | -1.41 | 7.11 | Superiority |
| Fullness (Visit 5) | Mixed Models Analysis | 0.5288 | Least Square Mean Difference | 1.41 | Standard Error of the Mean | 2.22 | 2-Sided | 95 | -3.05 | 5.86 | Superiority |
| Prospective food consumption (Visit 4) | Mixed Models Analysis | 0.0054 | Least Square Mean Difference | -8.46 | Standard Error of the Mean | 2.91 | 2-Sided | 95 | -14.30 | -2.61 | Superiority |
| Prospective food consumption (Visit 5) | Mixed Models Analysis | 0.0117 | Least Square Mean Difference | -9.78 | Standard Error of the Mean | 3.75 | 2-Sided | 95 | -17.29 | -2.27 | Superiority |
| Hunger (Visit 4) | Mixed Models Analysis | 0.0093 | Least Square Mean Difference | -6.58 | Standard Error of the Mean | 2.44 | 2-Sided | 95 | -11.48 | -1.69 | Superiority |
| Hunger (Visit 5) | Mixed Models Analysis | 0.0296 | Least Square Mean Difference | -6.39 | Standard Error of the Mean | 2.86 | 2-Sided | 95 | -12.12 | -0.66 | Superiority |
| AUC0-60min (Visit 5) |
|
|
| AUC0-300min (Visit 4) |
|
|
| AUC0-300min (Visit 5) |
|
|
| Mixed Models Analysis |
| 0.0348 |
| Least Square Mean Difference |
| 106.15 |
| Standard Error of the Mean |
| 48.95 |
| 2-Sided |
| 95 |
| 7.86 |
| 204.44 |
| Superiority |
| AUC0-300min (Visit 4) | Mixed Models Analysis | 0.1040 | Least Square Mean Difference | 214.24 | Standard Error of the Mean | 129.48 | 2-Sided | 95 | -45.59 | 474.07 | Superiority |
| AUC0-300min (Visit 5) | Mixed Models Analysis | 0.0152 | Least Square Mean Difference | 348.43 | Standard Error of the Mean | 138.29 | 2-Sided | 95 | 70.20 | 626.66 | Superiority |