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MK-0616A

Phase 1

Healthy | Small molecule | Other |Merck & Company, Inc.|Last Updated: May 28, 2026

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
RandomizedCONTROLLED
Total Trials1
Total Enrollment60
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07300280A Clinical Trial of Enlicitide and Rosuvastatin in Healthy Adults (MK-0616-039)PHASE1 RECRUITING 60Dec 29, 2025Oct 14, 2026May 28, 20261 United States
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Study Endpoints
Primary Endpoints
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Enlicitide
Pre dose and at designated time points up to 168 hours post dose

Blood samples will be collected to determine the AUC0-inf of enlicitide in plasma

AUC0-Inf of Rosuvastatin
Pre dose and at designated time points up to 168 hours post dose

Blood samples will be collected to determine the AUC0-inf of rosuvastatin in plasma

Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Enlicitde
Pre dose and at designated time points up to 168 hours post dose

Blood samples will be collected to determine the AUC0-last of enlicitide in plasma

AUC0-Last of Rosuvastatin
Pre dose and at designated time points up to 168 hours post dose

Blood samples will be collected to determine the AUC0-last of rosuvastatin in plasma

Maximum Plasma Concentration (Cmax) of Enlicitide
Pre dose and at designated time points up to 168 hours post dose

Blood samples will be collected to determine the cmax of enlicitide in plasma

Cmax of Rosuvastatin
Pre dose and at designated time points up to 168 hours post dose

Blood samples will be collected to determine the cmax of rosuvastatin in plasma

Secondary Endpoints
Number of Participants who Experience an Adverse Event (AE)
Up to approximately 9 weeks
Number of Participants Who Discontinue Study Treatment Due to an AE
Up to approximately 8 days after first dose
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Enlicitide + Rosuvastatin Part 1EXPERIMENTALParticipants in Part 1 will receive a single dose of enlicitide tablet coadministered with a single dose of rosuvastatin tablet
MK-0616A Part 1EXPERIMENTALParticipants in Part 1 will receive a single dose of MK-0616A
Enlicitide + Rosuvastatin Part 2EXPERIMENTALParticipants in Part 2 will receive a single dose of enlicitide tablet coadministered with a single dose of rosuvastatin tablet
MK-0616A Part 2EXPERIMENTALParticipants in Part 2 will receive a single dose of MK-0616A formulation B
Interventions
NameTypeDescription
MK-0616ADRUGEnlicitide/rosuvastatin fixed dose combination (FDC) or enlicitide/rosuvastatin FDC formulation B oral tablets
EnlicitideDRUGOral tablet
RosuvastatinDRUGOral tablet
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

The main inclusion criteria include but are not limited to the following: * Is medically healthy with no clinically significant medical history * Is a non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior to study entry Exclusion Criteria: * Is unable t...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 29, 2026NCT07300280Status: ACTIVE_NOT_RECRUITING → RECRUITING
LOWMay 29, 2026NCT07300280Status: ACTIVE_NOT_RECRUITING → RECRUITING
LOWMay 29, 2026NCT07300280Status: ACTIVE_NOT_RECRUITING → RECRUITING
LOWMay 26, 2026NCT07300280primaryCompletionDate: changed
LOWMay 24, 2026NCT07300280studyFirstPostDate: changed