HealthyPhase 1NCT07044479
A Clinical Study of How Coffee and Tea Affect Enlicitide in Healthy Volunteers (MK-0616-040)
A Phase 1 study testing Enlicitide in people with Healthy, run by Merck Sharp & Dohme LLC at 1 site in United States.
Trial summary
The goal of this study is to learn what happens to enlicitide in a person's body over time when enlicitide is taken at the same time as coffee or tea. Researchers will measure the amount of enlicitide in the blood when taken with coffee or tea compared with enlicitide taken with water. 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?
- Enlicitide
- 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
- 3 Jul 2025to 28 Aug 2025
- 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
- The key inclusion criteria include but are not limited to the following:
- Is in good health
- Is a non-smoker for at least 3 months prior to study entry
- Part 1 only: Consumes at least 1 cup of caffeinated coffee per day
- Part 2 only: Consumes at least 1 cup of caffeinated tea per day
Who cannot join
- The key exclusion criteria include but are not limited to the following:
- Has a history or presence of clinically significant medical or psychiatric condition or disease
- History of gastrointestinal disease which might affect food and drug absorption, or has had gastric bypass or similar surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Study to Evaluate the Effects of Coffee and Tea on the Pharmacokinetics of Enlicitide in Healthy Adult Participants
The goal of this study is to learn what happens to enlicitide in a person's body over time when enlicitide is taken at the same time as coffee or tea. Researchers will measure the amount of enlicitide in the blood when taken with coffee or tea compared with enlicitide taken with water.
- Conditions
- Healthy
- Being tested
- Enlicitide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnlicitideDrug
Also called MK-0616, enlicitide decanoate
Single dose of enlicitide is administered orally on day 1 of each testing period
| Study group | Role | What they receive |
|---|---|---|
| Enlicitide Coffee Sequence 1 | Experimental | Participants will be randomized to receive enlicitide administered with water in period 1 and enlicitide with coffee in period 2. Receives: Drug: Enlicitide |
| Enlicitide Coffee Sequence 2 | Experimental | Participants will be randomized to receive enlicitide administered with coffee in period 1 and enlicitide with water in period 2. Receives: Drug: Enlicitide |
| Enlicitide Tea Sequence 1 | Experimental | Participants will be randomized to receive enlicitide administered with water in period 1 and enlicitide with tea in period 2. Receives: Drug: Enlicitide |
| Enlicitide Tea Sequence 2 | Experimental | Participants will be randomized to receive enlicitide administered with tea in period 1 and enlicitide with water in period 2. Receives: Drug: Enlicitide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1-Coffee: 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 when administered with coffee
Measured: Predose and at designated time points up to 168 hours
Part 1-Coffee: Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-last) of Enlicitide
Blood samples will be collected to determine the AUC from time 0 to the time of last quantifiable sample of enlicitide when administered with coffee
Measured: Predose and at designated time points up to 168 hours
Part 1 -Coffee : Maximum Plasma Concentration (Cmax) of Enlicitide
Blood samples will be collected to determine the maximum observed drug concentration of enlicitide when administered with coffee
Measured: Predose and at designated time points up to 168 hours
Part 2 -Tea: AUC0-last of Enlicitide
Blood samples will be collected to determine the AUC from time 0 to the time of last quantifiable sample of enlicitide when administered with tea
Measured: Predose and at designated time points up to 168 hours
Part 2 - Tea: AUC0-Inf of Enlicitide
Blood samples will be collected to determine the AUC0-inf of enlicitide when administered with tea.
Measured: Predose and at designated time points up to 168 hours
Part 2 -Tea: Cmax of Enlicitide
Blood samples will be collected to determine the maximum observed drug concentration of enlicitide when administered with tea
Measured: Predose and at designated time points up to 168 hours
Secondary outcomes (4)
Part 1 - Coffee: Number of Participants Who Experience an Adverse Event (AE)
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be reported.
Measured: Up to approximately 7 weeks
Part 2 - Tea: Number of Participants Who Experience an Adverse Event (AE)
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be reported.
Measured: Up to approximately 7 weeks
Part 1 - Coffee: 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 7 weeks
Part 2 - Tea: 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 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study start3 Jul 2025
- Primary completion13 Aug 2025
- Study completion28 Aug 2025
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
- NCT07044479
- Sponsor's protocol ID
- 0616-040
- Other IDs
- MK-0616-040
- Status last verified
- Aug 2025
- First submitted
- 26 Jun 2025
- Last updated
- 3 Sep 2025
- 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 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Evaluate the Effects of Coffee and Tea on the Pharmacokinetics of Enlicitide in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT07044479
- Acronym / sponsor ID
- 0616-040
- 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
- 3 Jul 2025 (actual)
- Primary completion
- 13 Aug 2025 (actual)
- Study completion
- 28 Aug 2025 (actual)
- First posted
- 1 Jul 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.
The goal of this study is to learn what happens to enlicitide in a person's body over time when enlicitide is taken at the same time as coffee or tea. Researchers will measure the amount of enlicitide in the blood when taken with coffee or tea compared with enlicitide taken with water.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Enlicitide Coffee Sequence 1 | Experimental | Drug: EnlicitideParticipants will be randomized to receive enlicitide administered with water in period 1 and enlicitide with coffee in period 2. |
| Enlicitide Coffee Sequence 2 | Experimental | Drug: EnlicitideParticipants will be randomized to receive enlicitide administered with coffee in period 1 and enlicitide with water in period 2. |
| Enlicitide Tea Sequence 1 | Experimental | Drug: EnlicitideParticipants will be randomized to receive enlicitide administered with water in period 1 and enlicitide with tea in period 2. |
| Enlicitide Tea Sequence 2 | Experimental | Drug: EnlicitideParticipants will be randomized to receive enlicitide administered with tea in period 1 and enlicitide with water in period 2. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Is in good health
- Is a non-smoker for at least 3 months prior to study entry
- Part 1 only: Consumes at least 1 cup of caffeinated coffee per day
- Part 2 only: Consumes at least 1 cup of caffeinated tea per day
Key exclusion criteria (3 listed)
- Has a history or presence of clinically significant medical or psychiatric condition or disease
- History of gastrointestinal disease which might affect food and drug absorption, or has had gastric bypass or similar surgery.
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 |
|---|---|---|
| EnlicitideAlso: MK-0616, enlicitide decanoateSingle dose of enlicitide is administered orally on day 1 of each testing period | Drug | Enlicitide Coffee Sequence 1, Enlicitide Coffee Sequence 2, Enlicitide Tea Sequence 1, Enlicitide Tea Sequence 2 |
Primary outcome
Part 1-Coffee: Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Enlicitide
Time frame: Predose and at designated time points up to 168 hours
Blood samples will be collected to determine the AUC0-inf of enlicitide when administered with coffee
Part 1-Coffee: Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-last) of Enlicitide
Time frame: Predose and at designated time points up to 168 hours
Blood samples will be collected to determine the AUC from time 0 to the time of last quantifiable sample of enlicitide when administered with coffee
Part 1 -Coffee : Maximum Plasma Concentration (Cmax) of Enlicitide
Time frame: Predose and at designated time points up to 168 hours
Blood samples will be collected to determine the maximum observed drug concentration of enlicitide when administered with coffee
Part 2 -Tea: AUC0-last of Enlicitide
Time frame: Predose and at designated time points up to 168 hours
Blood samples will be collected to determine the AUC from time 0 to the time of last quantifiable sample of enlicitide when administered with tea
Part 2 - Tea: AUC0-Inf of Enlicitide
Time frame: Predose and at designated time points up to 168 hours
Blood samples will be collected to determine the AUC0-inf of enlicitide when administered with tea.
Part 2 -Tea: Cmax of Enlicitide
Time frame: Predose and at designated time points up to 168 hours
Blood samples will be collected to determine the maximum observed drug concentration of enlicitide when administered with tea
4 secondary outcomes
Part 1 - Coffee: Number of Participants Who Experience an Adverse Event (AE)
Time frame: Up to approximately 7 weeks
Part 2 - Tea: Number of Participants Who Experience an Adverse Event (AE)
Time frame: Up to approximately 7 weeks
Part 1 - Coffee: Number of Participants Who Discontinue Study Treatment Due to an AE
Time frame: Up to approximately 7 weeks
Part 2 - Tea: Number of Participants Who Discontinue Study Treatment Due to an AE
Time frame: Up to approximately 7 weeks
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 3 Sep 2025.
- 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 Enlicitide 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 5 inclusion and 3 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 3 Sep 2025. 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?
Part 1-Coffee: Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Enlicitide (time frame: Predose and at designated time points up to 168 hours). 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 3 Sep 2025.