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MK 0773

Phase 1

Osteoporosis | Small molecule | Endocrine |Merck & Company, Inc.|Last Updated: Aug 10, 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
RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment67
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01011725Safety, Tolerability and Efficacy of MK0773 in Healthy Postmenopausal Women (0773-003)PHASE1 COMPLETED 67 — — Nov 1, 2005Mar 1, 2009Aug 10, 2016 - —
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Study Endpoints
Primary Endpoints
Number of Participants with Serious Clinical Adverse Events
From date of enrollment through 12 weeks of study
Number of Participants with Nonerserious Clinical Adverse Events
From date of enrollment through 12 weeks of study
Number of Participants with Serious Laboratory Adverse Events
From date of enrollment through 12 weeks of study
Number of Participants with Nonserious Laboratory Adverse Events
From date of enrollment through 12 weeks of study
Number of Participants Who Discontinued Due to Any Adverse Event
From date of enrollment through 12 weeks of study
Number of Participants Who Withdrew Consent and Discontinued the Study
From date of enrollment through 12 weeks of study
Least Squares Mean Change in Lean Body Mass
From baseline, at 12 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Postmenopausal Women- Active Agent GroupEXPERIMENTAL -
Postmenopausal Women- PlaceboPLACEBO_COMPARATORPlacebo
Interventions
NameTypeDescription
MK 0773DRUG25 mg oral tablet b.i.d. MK 0773 or 100 mg oral tablet b.i.d. MK 0773, for 12 weeks
PlaceboDRUGPlacebo oral tablet b.i.d for 12 weeks
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Eligibility Criteria
Age Range18 Years — 65 Years
SexFEMALE
Healthy VolunteersYes

Inclusion Criteria: * Subject is a nonsurgical postmenopausal female * Subject is neither grossly overweight nor underweight for her height * Subject is in good health * Subject is willing to avoid excess alcohol and strenuous physical activity during the study * Subject agrees to refrain from cons...

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Competitive Landscape -Osteoporosis 8 trials
CompanyTickerTrialsLead PhaseDrugs
Zimmer Biomet Holdings, Inc.ZBH1 — Undisclosed
Precision BioSciences, Inc.DTIL1NAUndisclosed
SI-BONE, Inc.SIBN1 — Undisclosed
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