HealthyPhase 1NCT07300280
A Clinical Trial of Enlicitide and Rosuvastatin in Healthy Adults (MK-0616-039)
A Phase 1 study testing MK-0616A, Enlicitide and Rosuvastatin in people with Healthy, run by Merck Sharp & Dohme LLC at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- MK-0616A, Enlicitide and Rosuvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Dec 2025to 21 Oct 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
None listed.
Who cannot join
- Is unable to refrain from or anticipates the use of any drugs, including prescription and non-prescription medications, herbal remedies, or vitamin supplements beginning 14 days prior to study entry
- Is a female participant of childbearing potential
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Study to Evaluate the Relative Bioavailability of FDC Tablets Containing Enlicitide and Rosuvastatin, Compared to Enlicitide and Rosuvastatin Administered Concomitantly as Single Entities, in Healthy Adult Participants
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.
- Conditions
- Healthy
- Being tested
- MK-0616A, Enlicitide, Rosuvastatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK-0616ADrug
Also called enlicitide/rosuvastatin calcium
Enlicitide/rosuvastatin fixed dose combination (FDC) or enlicitide/rosuvastatin FDC formulation B oral tablets
EnlicitideDrug
Also called MK-0616
Oral tablet
RosuvastatinDrug
Oral tablet
| Study group | Role | What they receive |
|---|---|---|
| Enlicitide + Rosuvastatin Part 1 | Experimental | Participants in Part 1 will receive a single dose of enlicitide tablet coadministered with a single dose of rosuvastatin tablet Receives: Drug: Enlicitide; Drug: Rosuvastatin |
| MK-0616A Part 1 | Experimental | Participants in Part 1 will receive a single dose of MK-0616A Receives: Drug: MK-0616A |
| Enlicitide + Rosuvastatin Part 2 | Experimental | Participants in Part 2 will receive a single dose of enlicitide tablet coadministered with a single dose of rosuvastatin tablet Receives: Drug: Enlicitide; Drug: Rosuvastatin |
| MK-0616A Part 2 | Experimental | Participants in Part 2 will receive a single dose of MK-0616A formulation B Receives: Drug: MK-0616A |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Pre dose and at designated time points up to 168 hours post dose
Secondary outcomes (2)
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.
Measured: 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.
Measured: Up to approximately 8 days after first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2025
- Study start29 Dec 2025
- Primary completion14 Oct 2026
- Study completion21 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07300280
- Sponsor's protocol ID
- 0616A-039
- Status last verified
- Nov 2026
- First submitted
- 10 Dec 2025
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Evaluate the Relative Bioavailability of FDC Tablets Containing Enlicitide and Rosuvastatin, Compared to Enlicitide and Rosuvastatin Administered Concomitantly as Single Entities, in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT07300280
- Acronym / sponsor ID
- 0616A-039
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 29 Dec 2025 (actual)
- Primary completion
- 14 Oct 2026 (actual)
- Study completion
- 21 Oct 2026 (actual)
- First posted
- 23 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Enlicitide + Rosuvastatin Part 1 | Experimental | Drug: Enlicitide, Drug: RosuvastatinParticipants in Part 1 will receive a single dose of enlicitide tablet coadministered with a single dose of rosuvastatin tablet |
| MK-0616A Part 1 | Experimental | Drug: MK-0616AParticipants in Part 1 will receive a single dose of MK-0616A |
| Enlicitide + Rosuvastatin Part 2 | Experimental | Drug: Enlicitide, Drug: RosuvastatinParticipants in Part 2 will receive a single dose of enlicitide tablet coadministered with a single dose of rosuvastatin tablet |
| MK-0616A Part 2 | Experimental | Drug: MK-0616AParticipants in Part 2 will receive a single dose of MK-0616A formulation B |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- Is unable to refrain from or anticipates the use of any drugs, including prescription and non-prescription medications, herbal remedies, or vitamin supplements beginning 14 days prior to study entry
- Is a female participant of childbearing potential
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MK-0616AAlso: enlicitide/rosuvastatin calciumEnlicitide/rosuvastatin fixed dose combination (FDC) or enlicitide/rosuvastatin FDC formulation B oral tablets | Drug | MK-0616A Part 1, MK-0616A Part 2 |
| EnlicitideAlso: MK-0616Oral tablet | Drug | Enlicitide + Rosuvastatin Part 1, Enlicitide + Rosuvastatin Part 2 |
| RosuvastatinOral tablet | Drug | Enlicitide + Rosuvastatin Part 1, Enlicitide + Rosuvastatin Part 2 |
Primary outcome
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Enlicitide
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
2 secondary outcomes
Number of Participants who Experience an Adverse Event (AE)
Time frame: Up to approximately 9 weeks
Number of Participants Who Discontinue Study Treatment Due to an AE
Time frame: Up to approximately 8 days after first dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Merck Clinical Trials InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Merck Sharp & Dohme LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MK-0616A, Enlicitide and Rosuvastatin in people with Healthy, run by Merck Sharp & Dohme LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Enlicitide (time frame: Pre dose and at designated time points up to 168 hours post dose). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.