HealthyPhase 1NCT07776665
A Clinical Trial of Enlicitide (MK-0616) Formulations in Healthy Participants (MK-0616-044)
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 trial is to learn what happens to different formulations (types) of enlicitide in a healthy person's body over time. Researchers will compare the amount of enlicitide in a healthy person's body over time when different formulations are given on an empty stomach and after a high-fat meal. Read more about this study
- Who is it for?
- Ages 19 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
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 2026to 21 Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 19 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Is in good health
- Has a body-mass index (BMI) between ≥18.0 and ≤32.0 kg/m^2
Who cannot join
- Has history of gastrointestinal (GI) disease which might affect food and drug absorption or has had gastric bypass or similar surgery. Examples of GI disease include (but are not limited to) recurrent vomiting, inflammatory bowel disease, chronic intestinal disease accompanied by a disturbance in digestion and absorption, Roemheld's syndrome, and severe hernia
- Has a history of cancer (malignancy)
- Has positive results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV)
- Is lactose intolerant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Study to Evaluate the Relative Bioavailability of Enlicitide Test Formulations Under Fed and Fasted Conditions and Compare to the Reference FMF Tablet in Healthy Adult Participants
The goal of this trial is to learn what happens to different formulations (types) of enlicitide in a healthy person's body over time. Researchers will compare the amount of enlicitide in a healthy person's body over time when different formulations are given on an empty stomach and after a high-fat meal.
- 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
Oral Tablet
| Study group | Role | What they receive |
|---|---|---|
| Treatment A: Enlicitide Reference | Experimental | Participants will receive a single oral dose of enlicitide reference formulation. Receives: Drug: Enlicitide |
| Treatment B: Enlicitide Formulation Test 1 - Fed | Experimental | Participants will receive a single oral dose of enlicitide formulation test 1 after a high-fat breakfast. Receives: Drug: Enlicitide |
| Treatment C: Enlicitide Formulation Test 1 - Fasted | Experimental | Participants will receive a single oral dose of enlicitide formulation test 1 under fasted conditions. Receives: Drug: Enlicitide |
| Treatment D: Enlicitide Formulation Test 2 - Fed | Experimental | Participants will receive a single oral dose of enlicitide formulation test 2 after a high-fat breakfast. Receives: Drug: Enlicitide |
| Treatment E: Enlicitide Formulation Test 2 - Fasted | Experimental | Participant will receive a single oral dose of enlicitide formulation test 2 under fasted conditions. Receives: Drug: Enlicitide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of Enlicitide in Plasma
Blood samples will be collected to determine the AUC0-inf of enlicitide.
Measured: Pre-dose and at designated timepoints (up to 168 hours post dose)
Maximum Observed Plasma Concentration (Cmax) of Enlicitide in Plasma
Blood samples will be collected to determine the Cmax of enlicitide.
Measured: Pre-dose and at designated timepoints (up to 168 hours post dose)
Secondary outcomes (4)
AUC0-inf of Enlicitide in Plasma Under Fed vs Fasted Conditions
Blood samples will be collected to determine the AUC0-inf of enlicitide under fed and fasted conditions.
Measured: Pre-dose and at designated timepoints (up to 168 hours post dose)
Cmax of Enlicitide in Plasma Under Fed vs Fasted Conditions
Blood samples will be collected to determine the Cmax of enlicitide under fed and fasted conditions.
Measured: Pre-dose and at designated timepoints (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.
Measured: Up to approximately 98 days
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 98 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start31 Aug 2026
- Primary completion14 Dec 2026 (estimated)
- Study completion21 Dec 2026 (estimated)
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
- 30 participants (estimated)
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
- NCT07776665
- Sponsor's protocol ID
- 0616-044
- Status last verified
- Sep 2026
- First submitted
- 17 Aug 2026
- Last updated
- 18 Sep 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 18 Sep 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 Enlicitide Test Formulations Under Fed and Fasted Conditions and Compare to the Reference FMF Tablet in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT07776665
- Acronym / sponsor ID
- 0616-044
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 31 Aug 2026 (actual)
- Primary completion
- 14 Dec 2026 (estimated)
- Study completion
- 21 Dec 2026 (estimated)
- First posted
- 20 Aug 2026 (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 trial is to learn what happens to different formulations (types) of enlicitide in a healthy person's body over time. Researchers will compare the amount of enlicitide in a healthy person's body over time when different formulations are given on an empty stomach and after a high-fat meal.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Treatment A: Enlicitide Reference | Experimental | Drug: EnlicitideParticipants will receive a single oral dose of enlicitide reference formulation. |
| Treatment B: Enlicitide Formulation Test 1 - Fed | Experimental | Drug: EnlicitideParticipants will receive a single oral dose of enlicitide formulation test 1 after a high-fat breakfast. |
| Treatment C: Enlicitide Formulation Test 1 - Fasted | Experimental | Drug: EnlicitideParticipants will receive a single oral dose of enlicitide formulation test 1 under fasted conditions. |
| Treatment D: Enlicitide Formulation Test 2 - Fed | Experimental | Drug: EnlicitideParticipants will receive a single oral dose of enlicitide formulation test 2 after a high-fat breakfast. |
| Treatment E: Enlicitide Formulation Test 2 - Fasted | Experimental | Drug: EnlicitideParticipant will receive a single oral dose of enlicitide formulation test 2 under fasted conditions. |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Is in good health
- Has a body-mass index (BMI) between ≥18.0 and ≤32.0 kg/m^2
Key exclusion criteria (4 listed)
- Has history of gastrointestinal (GI) disease which might affect food and drug absorption or has had gastric bypass or similar surgery. Examples of GI disease include (but are not limited to) recurrent vomiting, inflammatory bowel disease, chronic intestinal disease accompanied by a disturbance in digestion and absorption, Roemheld's syndrome, and severe hernia
- Has a history of cancer (malignancy)
- Has positive results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV)
- Is lactose intolerant
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 decanoateOral Tablet | Drug | Treatment A: Enlicitide Reference, Treatment B: Enlicitide Formulation Test 1 - Fed, Treatment C: Enlicitide Formulation Test 1 - Fasted, Treatment D: Enlicitide Formulation Test 2 - Fed, Treatment E: Enlicitide Formulation Test 2 - Fasted |
Primary outcome
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of Enlicitide in Plasma
Time frame: Pre-dose and at designated timepoints (up to 168 hours post dose)
Blood samples will be collected to determine the AUC0-inf of enlicitide.
Maximum Observed Plasma Concentration (Cmax) of Enlicitide in Plasma
Time frame: Pre-dose and at designated timepoints (up to 168 hours post dose)
Blood samples will be collected to determine the Cmax of enlicitide.
4 secondary outcomes
AUC0-inf of Enlicitide in Plasma Under Fed vs Fasted Conditions
Time frame: Pre-dose and at designated timepoints (up to 168 hours post dose)
Cmax of Enlicitide in Plasma Under Fed vs Fasted Conditions
Time frame: Pre-dose and at designated timepoints (up to 168 hours post dose)
Number of Participants Who Experience an Adverse Event (AE)
Time frame: Up to approximately 98 days
Number of Participants Who Discontinue Study Treatment Due to an AE
Time frame: Up to approximately 98 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 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 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 2 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 18 Sep 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?
This study is still under way. Results are not available in the source record yet.
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 Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of Enlicitide in Plasma (time frame: Pre-dose and at designated timepoints (up to 168 hours post dose)). The study lists 2 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 18 Sep 2026.