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MK1903

Phase 2

Dyslipidemia | Small molecule | Metabolic |Merck & Company, Inc.|Last Updated: Dec 21, 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 Enrollment191
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00847197A Study to Evaluate MK1903 in Patients With Dyslipidemia (MK1903-004)PHASE2 COMPLETED 191Jun 1, 2008Sep 1, 2009Dec 21, 2015 -
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Study Endpoints
Primary Endpoints
Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) (mg/dL)
Baseline and Week 4
Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) (mg/dL)
Baseline and Week 4
Secondary Endpoints
Percent Change From Baseline in Triglycerides (mg/dL)
Baseline and 4 Weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTALMK1903
2PLACEBO_COMPARATORPlacebo to MK1903
Interventions
NameTypeDescription
MK1903DRUGThree 50 mg capsules MK1903 by mouth every 8 hours for 4 weeks. All participants will receive placebo for a 2 week run-in period.
Comparator: PlaceboDRUGThree 50 mg capsules placebo to MK1903 every 8 hours for 4 weeks. All participants will receive placebo for a 2 week run-in period.
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Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Participant is not on a statin or other lipid-modifying therapy * Low or moderate risk participant * Male participants, and female participants not of reproductive potential Exclusion Criteria: * Female participant of reproductive potential * Participant is pregnant, breastf...

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