HealthyPhase 1NCT06609512
A Clinical Study of Enlicitide and the Effect of Food in Healthy Adult Participants (MK-0616-033)
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 the study is to learn what happens to enlicitide decanoate in a healthy person's body over time when taken on an empty stomach or with food. Researchers will compare what happens to enlicitide in a healthy person's body over time when enlicitide is taken with or without food. 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
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Oct 2024to 31 Jan 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 main inclusion criteria include but are not limited to the following:
- Has body mass index (BMI) ≥18 kg/m^2 and ≤32 kg/m^2
Who cannot join
- The main exclusion criteria include but are not limited to the following:
- History of gastrointestinal disease which may affect food and drug absorption, or has had a gastric bypass or similar surgery
- History of cancer (malignancy)
- Positive test(s) for Hepatitis B surface antigen (HBsAg), hepatitis C antibodies or Human immunodeficiency virus (HIV)
- History of a major surgery
- Is lactose intolerant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Study to Evaluate the Effect of Fasting Duration on the Pharmacokinetics of the Enlicitide in Healthy Adult Participants
The goal of the study is to learn what happens to enlicitide decanoate in a healthy person's body over time when taken on an empty stomach or with food. Researchers will compare what happens to enlicitide in a healthy person's body over time when enlicitide is taken with or without food. Enlicitide decanoate will be referred to as "enlicitide" throughout.
- 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 |
|---|---|---|
| Enlicitide Treatment A | Experimental | Participants receive single oral dose of enlicitide after 8-hour overnight fast. Receives: Drug: Enlicitide |
| Enlicitide Treatment B | Experimental | Participants receive single oral dose of enlicitide 4 hours after morning meal. Receives: Drug: Enlicitide |
| Enlicitide Treatment C | Experimental | Participants receive single oral dose of enlicitide 3 hours after morning meal. Receives: Drug: Enlicitide |
| Enlicitide Treatment D | Experimental | Participants receive single oral dose of enlicitide 2 hours after morning meal. Receives: Drug: Enlicitide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Concentration versus Time Curve from 0 to Infinity (AUC0-inf) of enlicitide in plasma
AUC0-inf of enlicitide in plasma will be determined.
Measured: Pre-dose and at designated time points up to 168 hours post dose
Area Under the Concentration versus Time Curve from Time 0 to 24 hours (AUC0-24) of enlicitide in plasma
AUC0-24 of enlicitide in plasma will be determined.
Measured: Pre-dose and at designated time points up to 24 hours post dose
Area under the concentration versus time curve from time 0 to last quantifiable sample (AUC0-last) of enlicitide in plasma
AUC0-last of enlicitide in plasma will be determined.
Measured: Pre-dose and at designated time points up to 168 hours post dose
Maximum plasma concentration (Cmax) of enlicitide in plasma
Cmax of enlicitide in plasma will be determined.
Measured: Pre-dose and at designated time points up to 168 hours post dose
Time to maximum plasma concentration (Tmax) of enlicitide in plasma
Tmax of enlicitide in plasma will be determined.
Measured: Pre-dose and at designated time points up to 168 hours post dose
Apparent terminal half-life (t1/2) of enlicitide in plasma
t1/2 of enlicitide in plasma will be determined.
Measured: Pre-dose and at designated time points up to 168 hours post dose
Apparent Clearance (CL/F) of enlicitide in plasma
CL/F of enlicitide in plasma will be determined.
Measured: Pre-dose and at designated time points up to 168 hours post dose
Apparent volume of distribution during terminal phase (Vz/F) of enlicitide in plasma
Vz/F of enlicitide in plasma will be determined.
Measured: Pre-dose and at designated time points up to 168 hours post dose
Lag Time (tlag) of enlicitide in plasma
tlag is the time from dosing to the first appearance in plasma. The tlag of enlicitide in plasma will be determined.
Measured: Pre-dose and at designated time points up to 168 hours post dose
Secondary outcomes (2)
Number of participants who experience one or more adverse events (AEs)
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.
Measured: Up to ~ 14 days
Number of participants who discontinue study intervention 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.
Measured: Up to ~ 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2024
- Study start21 Oct 2024
- Primary completion13 Jan 2025
- Study completion31 Jan 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
- 20 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
- NCT06609512
- Sponsor's protocol ID
- 0616-033
- Other IDs
- MK-0616-033
- Status last verified
- Feb 2025
- First submitted
- 20 Sep 2024
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Evaluate the Effect of Fasting Duration on the Pharmacokinetics of the Enlicitide in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT06609512
- Acronym / sponsor ID
- 0616-033
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 21 Oct 2024 (actual)
- Primary completion
- 13 Jan 2025 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 24 Sep 2024 (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 the study is to learn what happens to enlicitide decanoate in a healthy person's body over time when taken on an empty stomach or with food. Researchers will compare what happens to enlicitide in a healthy person's body over time when enlicitide is taken with or without food. Enlicitide decanoate will be referred to as "enlicitide" throughout.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Enlicitide Treatment A | Experimental | Drug: EnlicitideParticipants receive single oral dose of enlicitide after 8-hour overnight fast. |
| Enlicitide Treatment B | Experimental | Drug: EnlicitideParticipants receive single oral dose of enlicitide 4 hours after morning meal. |
| Enlicitide Treatment C | Experimental | Drug: EnlicitideParticipants receive single oral dose of enlicitide 3 hours after morning meal. |
| Enlicitide Treatment D | Experimental | Drug: EnlicitideParticipants receive single oral dose of enlicitide 2 hours after morning meal. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Has body mass index (BMI) ≥18 kg/m^2 and ≤32 kg/m^2
Key exclusion criteria (6 listed)
- History of gastrointestinal disease which may affect food and drug absorption, or has had a gastric bypass or similar surgery
- History of cancer (malignancy)
- Positive test(s) for Hepatitis B surface antigen (HBsAg), hepatitis C antibodies or Human immunodeficiency virus (HIV)
- History of a major surgery
- 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 | Enlicitide Treatment A, Enlicitide Treatment B, Enlicitide Treatment C, Enlicitide Treatment D |
Primary outcome
Area Under the Concentration versus Time Curve from 0 to Infinity (AUC0-inf) of enlicitide in plasma
Time frame: Pre-dose and at designated time points up to 168 hours post dose
AUC0-inf of enlicitide in plasma will be determined.
Area Under the Concentration versus Time Curve from Time 0 to 24 hours (AUC0-24) of enlicitide in plasma
Time frame: Pre-dose and at designated time points up to 24 hours post dose
AUC0-24 of enlicitide in plasma will be determined.
Area under the concentration versus time curve from time 0 to last quantifiable sample (AUC0-last) of enlicitide in plasma
Time frame: Pre-dose and at designated time points up to 168 hours post dose
AUC0-last of enlicitide in plasma will be determined.
Maximum plasma concentration (Cmax) of enlicitide in plasma
Time frame: Pre-dose and at designated time points up to 168 hours post dose
Cmax of enlicitide in plasma will be determined.
Time to maximum plasma concentration (Tmax) of enlicitide in plasma
Time frame: Pre-dose and at designated time points up to 168 hours post dose
Tmax of enlicitide in plasma will be determined.
Apparent terminal half-life (t1/2) of enlicitide in plasma
Time frame: Pre-dose and at designated time points up to 168 hours post dose
t1/2 of enlicitide in plasma will be determined.
Apparent Clearance (CL/F) of enlicitide in plasma
Time frame: Pre-dose and at designated time points up to 168 hours post dose
CL/F of enlicitide in plasma will be determined.
Apparent volume of distribution during terminal phase (Vz/F) of enlicitide in plasma
Time frame: Pre-dose and at designated time points up to 168 hours post dose
Vz/F of enlicitide in plasma will be determined.
Lag Time (tlag) of enlicitide in plasma
Time frame: Pre-dose and at designated time points up to 168 hours post dose
tlag is the time from dosing to the first appearance in plasma. The tlag of enlicitide in plasma will be determined.
2 secondary outcomes
Number of participants who experience one or more adverse events (AEs)
Time frame: Up to ~ 14 days
Number of participants who discontinue study intervention due to an AE
Time frame: Up to ~ 14 days
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 7 Feb 2025.
- Merck Clinical Trials InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/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 6 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 7 Feb 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?
Area Under the Concentration versus Time Curve from 0 to Infinity (AUC0-inf) of enlicitide in plasma (time frame: Pre-dose and at designated time points up to 168 hours post dose). The study lists 9 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 7 Feb 2025.