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MK-0524A

Phase 3

Primary Hypercholesterolemia | Small molecule | Metabolic |Merck & Company, Inc.|Last Updated: Feb 6, 2019

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-BlindCONTROLLED
Total Trials1
Total Enrollment2,414
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00479882MK-0524B Lipid Study (MK-0524B-063)PHASE3 COMPLETED 2,414 — — Jun 15, 2007Jun 16, 2008Feb 6, 2019 - —
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Study Endpoints
Primary Endpoints
Percentage Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)
Baseline (Week 4 for Period II; Week 12 for Period III) and after 8 weeks of treatment during each period (Week 12 for Period II and Week 20 for Period III)

Blood samples taken at baseline (Week 4 for Period II; Week 12 for Period III) and after 8 weeks of treatment during each period to determine the LDL-C levels. The change from baseline after 8 weeks of treatment was recorded.

Secondary Endpoints
Percentage Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C)
Baseline (Week 4 for Period II; Week 12 for Period III) and after 8 weeks of treatment during each period (Week 12 for Period II and Week 20 for Period III)
Percentage of Participants With Consecutive Elevations in Alanine Aminotransferase (ALT) and/or Aspartate Aminotransferase (AST) of >=3 x Upper Limit of Normal (ULN)
up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
Percentage of Participants With Creatine Kinase (CK) >=10 x ULN
up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Sequence 1: MK-0524B 1.8g/20mg→MK-0524A 2g+Simvastatin 20mgEXPERIMENTALAfter a 2-week placebo run-in, participants will receive MK-0524B (0.9 g/simvastatin 10 mg) for 4 weeks, then MK-0524B 1.8g /20 mg combination tablet for 8 weeks. Participant is then co-administered MK-0524A 2 g + simvastatin 20 mg for 8 weeks.
Sequence 2: MK-0524A 2g+Simvastatin 20mg →MK-0524B 1.8g/20mgEXPERIMENTALAfter a 2-week placebo run-in, participants will be co-administered MK-0524A 1g + simvastatin 10 mg for 4 weeks, then co-administered MK-0524A 2g +simvastatin 20 mg for 8 weeks. Participant then receives MK-0524B 1.8 g/20 mg combination tablet for 8 weeks.
Sequence 3: MK-0524B 1.8g/40mg→MK-0524A 2g+Simvastatin 40mgEXPERIMENTALAfter a 2-week placebo run-in, participants will receive MK-0524B 0.9g/40 mg combination tablet for 4 weeks, then MK-0524B 1.8g /40 mg combination tablet for 8 weeks. Participant is then co-administered MK-0524A 2 g + simvastatin 40 mg for 8 weeks.
Sequence 4: MK-0524A 2g+Simvastatin 40mg →MK-0524B 1.8g/40mgEXPERIMENTALAfter a 2-week placebo run-in, participants will be co-administered MK-0524A 1g + simvastatin 40 mg for 4 weeks, then co-administration MK-0524A 2g +simvastatin 40 mg for 8 weeks. Participant then receives MK-0524B 1.8 g/40 mg combination tablet for 8 weeks.
Interventions
NameTypeDescription
Comparator: simvastatinDRUG -
MK-0524ADRUGExtended-release(ER) niacin/Laropiprant (MK-0524) Combination tablet
PlaceboDRUG -
MK-0524BDRUG -
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Eligibility Criteria
Age Range18 Years — 85 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * has primary hypercholesterolemia or mixed dyslipidemia based on medical history (previous diagnosis), historic lipid values, or as otherwise determined through optional lipid measurements at screening visit * meets one of the following triglyceride (TG) criteria: 1. is on n...

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