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Exenatide

Phase 3

Coronary Artery Disease | Small molecule | Cardiovascular |Eli Lilly and Company|Last Updated: Feb 2, 2016

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
RandomizedNO_TREATMENT_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment38
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01373216Glucagon-like Peptide 1 Agonist Exenatide for Improved Glucose Control and Cardiac Function in Patients With Aortocoronary BypassPHASE3 COMPLETED 38Jun 1, 2011Dec 1, 2014Feb 2, 20161 Czechia
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Study Endpoints
Primary Endpoints
Cardiac function - echocardiographic parameters
90 days after administration of exenatide

* cardiac chamber dimensions * left ventricular systolic function * left ventricular diastolic function * right ventricular systolic function

Secondary Endpoints
Number of participants with adverse effects
90 days after administration of exenatide
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ExenatideEXPERIMENTALPatients with decreased left ventricular function undergoing elective coronary artery by-pass grafting receiving perioperatively i.v. exenatide on top of standard treatment
ControlNO_INTERVENTIONPatients with decreased left ventricular function undergoing elective coronary artery by-pass grafting receiving standard treatment
Interventions
NameTypeDescription
ExenatideDRUGPerioperative continuous i.v. administration of exenatide lasting for 72 hours - 40 ng/min for initial 30 min, 20 ng/min for remaining 71.5 hours
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Eligibility Criteria
Age Range18 Years — 85 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * elective coronary artery bypass grafting operation (CABG) * decreased left ventricular (LV) systolic function (EF LV ≤ 50%) * Age 18 to 85 * Signed informed consent * Females with childbearing potential have to use appropriate contraceptive measures during the whole study peri...

Countries:Czechia
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