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Comparator: MK-0773

Phase 2

Sarcopenia | Small molecule | Other |Merck & Company, Inc.|Last Updated: Feb 16, 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-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment170
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00529659A Study of the Safety and Efficacy of MK-0773 in Women With Sarcopenia (Loss of Muscle Mass)(MK-0773-005)PHASE2 COMPLETED 170Oct 1, 2007Oct 1, 2009Feb 16, 2015 -
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Study Endpoints
Primary Endpoints
Change From Baseline in Participant Lean Body Mass
Baseline, Month 6
Change From Baseline in Bilateral Leg Press (BLP) Measurement
Baseline, Month 6

BLP measurements were obtained with the participant sitting on the BLP exercise machine with flexed hips and knees. The participant held the handgrips with hips flexion and knees bent at a 90 degree angle and feet placed evenly on the footpad with heels placed approximately shoulder width apart. Participants were asked to slowly push the footpad forward, while keeping the knees slightly flexed, and bend back again slowly for one repetition. The BLP procedure measures the maximum amount of weight that the patient can push through his or her full range of motion one time.

Secondary Endpoints
Change From Baseline in Participant Short Physical Performance Battery (SPPB)
Baseline, Month 6
Change From Baseline in Participant Gait Speed
Baseline, Month 6
Change From Baseline in Stair Climbing Power
Baseline, Month 6
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
MK-0773EXPERIMENTALMK-0773
PlaceboPLACEBO_COMPARATORPlacebo
Interventions
NameTypeDescription
Comparator: MK-0773DRUGMK-0773 50 mg tablets twice daily, 6 month treatment period
Comparator: PlaceboDRUGPlacebo tablets twice daily, 6 month treatment period
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Eligibility Criteria
Age Range65 Years — N/A
SexFEMALE
Healthy VolunteersNo

Inclusion Criteria: * Patient is a woman who is 65 years of age or older * Patient's lean body mass is at least 1 standard deviation below the mean of a healthy young adult population * Patient has difficulty climbing 10 steps or walking outside on level ground for 1/4 mile without resting or Activ...

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