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Liraglutide

Phase 1

Obesity | Small molecule | Metabolic |Pfizer, Inc.|Last Updated: Jul 26, 2019

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment61
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03041792Methodology Study To Examine 6-Week Food Intake With Liraglutide In Obese SubjectsPHASE1 COMPLETED 61Feb 20, 2017Jan 16, 2018Jul 26, 20191 United States
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Study Endpoints
Primary Endpoints
Change From Baseline (Visit 3) in Mean Energy Intake During Ad Libitum Lunches at Visits 4 and 5
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 Endpoints
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)
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
ActiveEXPERIMENTALLiraglutide
PlaceboPLACEBO_COMPARATORPlacebo comparator
Interventions
NameTypeDescription
LiraglutideDRUGLiraglutide
PlaceboOTHERPlacebo
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

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 a...

Countries:United States
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