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GSK716155

Phase 1

Diabetes Mellitus, Type 2 | Small molecule | Metabolic |GSK plc|Last Updated: Aug 17, 2017

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
RandomizedPLACEBO_CONTROLLEDBiomarker
Total Trials2
Total Enrollment74
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00537719Scintigraphy Study to Assess Gastric Emptying in Healthy Subjects Given GSK716155 or Placebo.PHASE1 COMPLETED 34Dec 7, 2007Apr 4, 2008Aug 17, 20171 United States
NCT00530309Clinical Assessment of GSK716155 for Type 2 Diabetes MellitusPHASE1 COMPLETED 40Aug 1, 2007Apr 17, 2008Aug 17, 20173 Japan
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Study Endpoints
Primary Endpoints
Change from baseline of the time to 50% gastric emptying (gastric emptying t½) of the solid and liquid components of a meal at 72 hours after dosing in healthy volunteers.
3 Days
Plasma concentrations and PD parameters over time and at the end of study
Up to Week 9
Secondary Endpoints
Exploratory correlation of % contents remaining in stomach after a meal.GSK716155 concentration before meal & at the time gastric emptying is complete. Safety and tolerability parameters each visit.
3 Days
Other metabolic parameters at the end of study
Up to Week 9
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
GSK716155ACTIVE_COMPARATORalbiglutide subcutaneous injection
placeboPLACEBO_COMPARATORplacebo injection
Subjects receiving GSK716155 + placeboEXPERIMENTALEligible subjects will receive GSK716155 with doses of 15 milligrams once a week, 30 milligrams once a week, 50 milligrams biweekly or 100 milligrams once every four weeks. Subjects will also receive placebo.
Interventions
NameTypeDescription
GSK716155DRUGalbiglutide subcutaneous injection
PlaceboDRUGplacebo injection
GSK716155 for injectionDRUGGSK716155 will be available with doses of 15 milligrams once a week, 30 milligrams once a week, 50 milligrams biweekly or 100 milligrams once every four weeks.
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy men or women, between the ages of 18 and 65, and have a Body Mass Index (BMI) of between 20 and 32. * If female, the subject must be not be capable of having children. Exclusion Criteria: * Subjects must not use tobacco, nicotine, or illegal drugs of abuse, and must ...

Countries:United StatesJapan
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