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MK-0616A

Phase 1

Undisclosed | Small molecule | Other |Merck & Company, Inc.|Trials Updated: Sep 23, 2026

MK-0616A development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Dec 2025

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment60

FDA Designations

No designations recorded

MK-0616A clinical trials

MK-0616A · 1 trial · 1 indication

Phase 1 1
NCT07300280A Clinical Trial of Enlicitide and Rosuvastatin in Healthy Adults (MK-0616-039)Healthy
ACTIVE NOT_RECRUITING60 Analytics
PHASE1ACTIVE NOT_RECRUITING
A Clinical Trial of Enlicitide and Rosuvastatin in Healthy Adults (MK-0616-039)
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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 to 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)

MEDIUMSep 23, 2026NCT07300280Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMSep 23, 2026NCT07300280Status: RECRUITING → ACTIVE_NOT_RECRUITING

Frequently asked questions about MK-0616A

What is MK-0616A?

MK-0616A is an investigational small molecule being developed by Merck & Company, Inc. (ticker MRK). It is in Phase 1 clinical development, and the specific therapeutic indication has not been disclosed. One Phase 1 trial has been registered for the program, and that trial is currently active.

Who is developing MK-0616A?

MK-0616A is being developed by Merck & Company, Inc., which trades under the ticker MRK. Merck is the sponsor of the registered Phase 1 clinical trial for this small molecule asset. The program remains in early clinical development.

What phase is MK-0616A in?

MK-0616A is in Phase 1 clinical development. One Phase 1 trial has been registered for the program, and it is currently active and not recruiting. No later-phase trials for MK-0616A have been registered.

What clinical trials is MK-0616A in?

MK-0616A is being studied in one registered Phase 1 trial, NCT07300280, titled A Clinical Trial of Enlicitide and Rosuvastatin in Healthy Adults (MK-0616-039). The trial is active but not recruiting, is controlled, and is being conducted in the United States.

What is the enrollment in the MK-0616A Phase 1 trial?

The Phase 1 trial of MK-0616A, NCT07300280, has an enrollment of 60 participants. It is a controlled, randomized trial that is not double blind and enrolls healthy adult volunteers age 18 and older, both male and female, in the United States.