A Phase 1 interventional study of MK-0616A and Enlicitide in Healthy, sponsored by Merck Sharp & Dohme LLC. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by Merck Sharp & Dohme LLC · Phase 1, Interventional, and Basic science
This goal of this trial is to learn about two medicines, enlicitide and rosuvastatin, in healthy people. Researchers will compare the amounts of enlicitide and rosuvastatin in a person's body over time, when they are given as separate medicines and when they are combined into one tablet.
Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.
Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
The main inclusion criteria include but are not limited to the following:
Exclusion Criteria:
Participants in Part 1 will receive a single dose of enlicitide tablet coadministered with a single dose of rosuvastatin tablet
Drug: Enlicitide · Drug: Rosuvastatin
Participants in Part 1 will receive a single dose of MK-0616A
Drug: MK-0616A
Participants in Part 2 will receive a single dose of enlicitide tablet coadministered with a single dose of rosuvastatin tablet
Drug: Enlicitide · Drug: Rosuvastatin
Participants in Part 2 will receive a single dose of MK-0616A formulation B
Drug: MK-0616A
Enlicitide/rosuvastatin fixed dose combination (FDC) or enlicitide/rosuvastatin FDC formulation B oral tablets
Also known as: enlicitide/rosuvastatin calcium
Oral tablet
Also known as: MK-0616
Oral tablet
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Enlicitide
Blood samples will be collected to determine the AUC0-inf of enlicitide in plasma
Time frame: Pre dose and at designated time points up to 168 hours post dose
AUC0-Inf of Rosuvastatin
Blood samples will be collected to determine the AUC0-inf of rosuvastatin in plasma
Time frame: Pre dose and at designated time points up to 168 hours post dose
Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Enlicitde
Blood samples will be collected to determine the AUC0-last of enlicitide in plasma
Time frame: Pre dose and at designated time points up to 168 hours post dose
AUC0-Last of Rosuvastatin
Blood samples will be collected to determine the AUC0-last of rosuvastatin in plasma
Time frame: Pre dose and at designated time points up to 168 hours post dose
Maximum Plasma Concentration (Cmax) of Enlicitide
Blood samples will be collected to determine the cmax of enlicitide in plasma
Time frame: Pre dose and at designated time points up to 168 hours post dose
Cmax of Rosuvastatin
Blood samples will be collected to determine the cmax of rosuvastatin in plasma
Time frame: Pre dose and at designated time points up to 168 hours post dose
Number of Participants who Experience an Adverse Event (AE)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be reported.
Time frame: Up to approximately 9 weeks
Number of Participants Who Discontinue Study Treatment Due to an AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study treatment due to an AE will be reported.
Time frame: Up to approximately 8 days after first dose
Plan to share: Yes — https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Merck Sharp & Dohme LLC