Clinical trial NCT03041792: Methodology Study To Examine 6-Week Food Intake With Liraglutide In Obese Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Obesity
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2017-02-03
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


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)

Primary outcomes:
measure: Change From Baseline (Visit 3) in Mean Energy Intake During Ad Libitum Lunches at Visits 4 and 5
timeFrame: Visit 3, Visit 4 and Visit 5
Secondary outcomes:
measure: Number of Participants With Vital Signs Data Meeting Categorical Criteria
timeFrame: Baseline (Visit 3) up to Visit 6 (Study Day 53)
measure: Number of Participants With Treatment-Emergent Adverse Events (All-Causality)
timeFrame: Baseline (Visit 3) up to 31 days post last dose (75 days)
measure: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG)
timeFrame: Baseline (Visit 3) up to Visit 6 (Study Day 53)
measure: Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality)
timeFrame: Baseline (Visit 3) up to Visit 6 (Study Day 53)
measure: Change From Baseline in Mean 48-hour Energy Intake at Visits 4 and 5
timeFrame: Visit 3, Visit 4 (Study Day 20 and 21) and Visit 5 (Study Day 41 and 42)
measure: 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
timeFrame: Visit 3, Visit 4 (Study Day 20 and 21) and Visit 5 (Study Day 41 and 42)
measure: Change From Baseline in Satiety, Fullness, Prospective Food Consumption and Hunger Scores (Mean Rating AUC30-120min) for Mean Lunch at Visits 4 and 5
timeFrame: Visit 3, Visit 4 (Study Day 20 and 21) and Visit 5 (Study Day 41 and 42)
measure: 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
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)
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Translational Research Institute for Metabolism and Diabetes
state: Florida
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: