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Methodology Study To Examine 6-Week Food Intake With Liraglutide In Obese Subjects

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ClinicalTrials.gov Identifier: NCT03041792
Recruitment Status : Completed
First Posted : February 3, 2017
Results First Posted : July 26, 2019
Last Update Posted : July 26, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Obesity Drug: Liraglutide Other: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: A 6-WEEK, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, TWO-ARM, PARALLEL METHODOLOGY STUDY TO ASSESS THE EFFECT OF LIRAGLUTIDE ON FOOD INTAKE IN OBESE SUBJECTS
Actual Study Start Date : February 20, 2017
Actual Primary Completion Date : January 16, 2018
Actual Study Completion Date : January 16, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Liraglutide

Arm Intervention/treatment
Experimental: Active
Liraglutide
Drug: Liraglutide
Liraglutide

Placebo Comparator: Placebo
Placebo comparator
Other: Placebo
Placebo




Primary Outcome Measures :
  1. Change From Baseline (Visit 3) in Mean Energy Intake During Ad Libitum Lunches at Visits 4 and 5 [ Time Frame: 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).


Secondary Outcome Measures :
  1. Number of Participants With Vital Signs Data Meeting Categorical Criteria [ Time Frame: 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.

  2. Number of Participants With Treatment-Emergent Adverse Events (All-Causality) [ Time Frame: 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.

  3. Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) [ Time Frame: 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 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.

  4. Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality) [ Time Frame: Baseline (Visit 3) up to Visit 6 (Study Day 53) ]
    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.

  5. Change From Baseline in Mean 48-hour Energy Intake at Visits 4 and 5 [ Time Frame: 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).

  6. 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 [ Time Frame: 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 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).

  7. Change From Baseline in Satiety, Fullness, Prospective Food Consumption and Hunger Scores (Mean Rating AUC30-120min) for Mean Lunch at Visits 4 and 5 [ Time Frame: 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 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.

  8. 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 [ Time Frame: 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).



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and female subjects;
  • Body Mass Index 30-40 kg/m2;

Exclusion Criteria:

  • Evidence of history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergises, but excluding untreated, asymptomatic, seasonal allergies at time of dosing)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03041792


Locations
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United States, Florida
Translational Research Institute for Metabolism and Diabetes
Orlando, Florida, United States, 32804
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
  Study Documents (Full-Text)

Documents provided by Pfizer:
Study Protocol  [PDF] November 21, 2016
Statistical Analysis Plan  [PDF] February 16, 2017


Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03041792     History of Changes
Other Study ID Numbers: A9001498
First Posted: February 3, 2017    Key Record Dates
Results First Posted: July 26, 2019
Last Update Posted: July 26, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: 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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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Liraglutide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists