Recent Updates
Recently added Catalysts

Liraglutide

Phase 1

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

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment61

FDA Designations

No designations recorded

Clinical trial landscape

Liraglutide · 1 trial · 1 indication

Phase 1 1
NCT03041792Methodology Study To Examine 6-Week Food Intake With Liraglutide In Obese SubjectsObesity
COMPLETED61 Analytics
PHASE1COMPLETED
Methodology Study To Examine 6-Week Food Intake With Liraglutide In Obese Subjects
ObesityUnlock trial analytics

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)
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
ActiveEXPERIMENTALLiraglutide
PlaceboPLACEBO_COMPARATORPlacebo comparator

Interventions

NameTypeDescription
LiraglutideDRUGLiraglutide
PlaceboOTHERPlacebo
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 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
Unlock Eligibility Criteria

Frequently asked questions about Liraglutide

What is Liraglutide used for?

Liraglutide is being studied for the treatment of obesity. It is an investigational small molecule in Phase 1 clinical development. A completed Phase 1 trial examined its effects on food intake in obese subjects over a 6-week period.

Who makes Liraglutide?

Liraglutide is being developed by Pfizer, Inc., which is listed on the New York Stock Exchange under the ticker symbol PFE. The company is conducting clinical research to evaluate the drug's potential in treating obesity.

What phase is Liraglutide in?

Liraglutide is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed, and the drug is not yet available for clinical use.

What clinical trials is Liraglutide in?

Liraglutide has one completed Phase 1 trial, identified as NCT03041792, titled "Methodology Study To Examine 6-Week Food Intake With Liraglutide In Obese Subjects." This randomized, double-blind, placebo-controlled study enrolled 61 participants in the United States.

Is Liraglutide FDA approved?

Liraglutide is not FDA approved for obesity. It is an investigational drug currently in Phase 1 clinical development. The completed Phase 1 trial was a methodology study, and further clinical trials would be needed before any regulatory approval could be considered.