Trial · Interventional
CompletedPhase 1Registry dataA Clinical Study of the Effect of Enlicitide (MK-0616) Formulations in Healthy Participants (MK-0616-041)
Overview
- Status
- Completed
- Phase
- Phase 1
- Enrollment
- 30 participants (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Design
- Randomized · Open label (no masking)
- Countries
1 country
United States
- Start
- 23 Mar 2026
- Primary completion
- 18 May 2026
- Completion
- 25 May 2026
- First posted
- 19 Mar 2026
- Last update posted
- 2 Jun 2026
- Conditions
- Healthy
Timeline
1 trial · 1 completed
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 1
A Clinical Study of the Effect of Enlicitide (MK-0616) Formulations in Healthy Participants (MK-0616-041)
NCT0748170823 Mar 2026 to 25 May 2026
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The goal of this study is to learn what happens to enlicitide (MK-0616) in a healthy person's body over time (pharmacokinetic or PK study). Researchers also want to learn about the safety of enlicitide and if people tolerate it.
Interventions
- EnlicitideDrug
Arms3
Experimental
Dose regimen A
Participants receive enlicitide orally at dose regimen A.
Experimental
Dose regimen B
Participants receive enlicitide orally at dose regimen B.
Active comparator
Dose regimen C
Participants receive enlicitide orally at dose regimen C.
Primary outcomes3
Outcomes the sponsor listed as primary.
Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of enlicitide
Time frame · At designated timepoints up to approximately 50 days
Registry description
Blood samples will be collected to determine the AUC0-Last of enlicitide.
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of enlicitide
Time frame · At designated timepoints up to approximately 50 days
Registry description
Blood samples will be collected to determine the AUC0-Inf of enlicitide.
Maximum Plasma Concentration (Cmax) of enlicitide
Time frame · At designated timepoints up to approximately 50 days
Registry description
Blood samples will be collected to estimate Cmax of enlicitide.
Secondary outcomes(2)
Number of Participants Who Experience an Adverse Event (AE)
Time frame · Up to approximately 56 days
Registry description
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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Number of Participants Who Discontinue Study Intervention Due to an AE
Time frame · Up to approximately 56 days
Registry description
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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
Completed trials do not always post results.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 19 Years up to 55 Years
- Healthy volunteers
- Accepted
Inclusion and exclusion criteria, as posted
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