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Oxyntomodulin

Phase 1

Obesity | Small molecule | Metabolic |Merck & Company, Inc.|Last Updated: May 29, 2015

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-BlindCONTROLLEDBiomarker
Total Trials1
Total Enrollment12
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01055340A Study That Will Evaluate Ketogenesis and Glucose-Dependent Insulin Secretion Methodologies in Healthy Male Subjects (MK-0000-159)(COMPLETED)PHASE1 COMPLETED 12Apr 1, 2010Jun 1, 2010May 29, 2015 -
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Study Endpoints
Primary Endpoints
Ambient plasma glucose concentration during the GGI
Last 160 minutes of OXM/placebo infusion
plasma βOHB + AcAc concentrations
First 300 minutes of OXM/placebo infusion
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Treatment sequence 1EXPERIMENTALOXM 3.0 pmol/kg/min - OXM 0.6 pmol/kg/min - Placebo
Treatment sequence 2EXPERIMENTALOXM 0.6 pmol/kg/min - Placebo - OXM 3.0 pmol/kg/min
Treatment sequence 3EXPERIMENTALPlacebo - OXM 3.0 pmol/kg/min - OXM 0.6 pmol/kg/min
Treatment sequence 4EXPERIMENTALOXM 3.0 pmol/kg/min - Placebo - OXM 0.6 pmol/kg/min
Treatment sequence 5EXPERIMENTALPlacebo - OXM 0.6 pmol/kg/min - OXM 3.0 pmol/kg/min
Treatment sequence 6EXPERIMENTALOXM 0.6 pmol/kg/min - OXM 3.0 pmol/kg/min - Placebo
Interventions
NameTypeDescription
Oxyntomodulin (OXM)DRUGSingle infusion of OXM 3.0 pmol/kg/min by IV
Comparator: Oxyntomodulin (OXM)DRUGSingle infusion of OXM 0.6 pmol/kg/min by IV
Comparator: Placebo [ hemaccel-containing saline]DRUGSingle Placebo infusion of hemaccel-containing saline by IV
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Eligibility Criteria
Age Range18 Years — 45 Years
SexMALE
Healthy VolunteersYes

Inclusion Criteria: * Subject is judged to be in good health based on medical history, physical examination, and laboratory safety tests * Subject has a Body Mass Index of ≥27 kg/m\^2 and ≤35 kg/m\^2 and weighs ≥70 kg at the prestudy (screening) visit * Subject has been a nonsmoker and/or has not u...

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