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RM-493

Phase 1

Obesity | Small molecule | Metabolic |Rhythm Pharmaceuticals, Inc.|Last Updated: Apr 20, 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
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment15
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01867437Effects of RM-493 on Energy Expenditure in Obese IndividualsPHASE1 COMPLETED 15May 1, 2013Mar 1, 2014Apr 20, 20171 United States
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Study Endpoints
Primary Endpoints
Resting energy expenditure measured in a room calorimeter during continuous subcutaneous infusion of RM-493 or placebo in obese healthy subjects
day 4 and day 7
Secondary Endpoints
Total energy expenditure measured in a room calorimeter during continuous subcutaneous infusion of RM-493 or placebo in obese healthy subjects
day 4 and day 7
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
RM-493ACTIVE_COMPARATORDouble blind RM-493 will be administered at a dose of 1 mg/24 hrs via subcutaneous infusion for 3 days
PlaceboPLACEBO_COMPARATORDouble blind placebo will be administered via subcutaneous infusion for 3 days
Interventions
NameTypeDescription
PlaceboDRUGSterile solution (vehicle) for subcutaneous infusion
RM-493DRUGSterile solution (2mg/ml) for subcutaneous infusion
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Eligibility Criteria
Age Range18 Years — 50 Years
SexALL
Healthy VolunteersYes
Study Sites1

* INCLUSION CRITERIA: Male and female subjects aged 18 to 50 years at screening who meet the following inclusion and exclusion criteria will be eligible for enrollment: * Able to provide written informed consent prior to any study procedures, and be willing and able to comply with study procedures...

Countries:United States
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