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
Overview
- Phase
- Phase 1
- Intervention
- Liraglutide
- Conditions
- Obesity
- Sponsor
- Pfizer
- Enrollment
- 61
- Locations
- 1
- Primary Endpoint
- Change From Baseline (Visit 3) in Mean Energy Intake During Ad Libitum Lunches at Visits 4 and 5
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
Eligibility 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)
Arms & Interventions
Active
Liraglutide
Intervention: Liraglutide
Placebo
Placebo comparator
Intervention: Placebo
Outcomes
Primary Outcomes
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 Outcomes
- Number of Participants With Vital Signs Data Meeting Categorical Criteria(Baseline (Visit 3) up to Visit 6 (Study Day 53))
- Number of Participants With Treatment-Emergent Adverse Events (All-Causality)(Baseline (Visit 3) up to 31 days post last dose (75 days))
- Number of Participants With Abnormal 12-lead Electrocardiogram (ECG)(Baseline (Visit 3) up to Visit 6 (Study Day 53))
- Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality)(Baseline (Visit 3) up to Visit 6 (Study Day 53))
- Change From Baseline in Mean 48-hour Energy Intake at Visits 4 and 5(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(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(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(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))