A Clinical Trial of Enlicitide (MK-0616) Formulations in Healthy Participants (MK-0616-044)

NCTNCT07776665Other id0616-044

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Active, not recruiting
Phase: Phase 1
Enrollment: 30 participants (estimated)
Sponsor: Merck Sharp & Dohme LLC · Industry
Design: Randomized · Open label (no masking)
Countries: 1 country
United States
Start: 31 Aug 2026
Primary completion: 14 Dec 2026 (estimated)
Completion: 21 Dec 2026 (estimated)
First posted: 20 Aug 2026
Last update posted: 18 Sept 2026
Conditions: Healthy

Timeline

1 trial · 1 ongoing

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20262027

Ph 1
A Clinical Trial of Enlicitide (MK-0616) Formulations in Healthy Participants (MK-0616-044)
NCT07776665
31 Aug 2026 to est. 21 Dec 2026

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

EnlicitideDrug

Arms5

Experimental
Treatment A: Enlicitide Reference
Participants will receive a single oral dose of enlicitide reference formulation.
Experimental
Treatment B: Enlicitide Formulation Test 1 - Fed
Participants will receive a single oral dose of enlicitide formulation test 1 after a high-fat breakfast.
Experimental
Treatment C: Enlicitide Formulation Test 1 - Fasted
Participants will receive a single oral dose of enlicitide formulation test 1 under fasted conditions.
Experimental
Treatment D: Enlicitide Formulation Test 2 - Fed
Participants will receive a single oral dose of enlicitide formulation test 2 after a high-fat breakfast.
Experimental
Treatment E: Enlicitide Formulation Test 2 - Fasted
Participant will receive a single oral dose of enlicitide formulation test 2 under fasted conditions.

Primary outcomes2

Outcomes the sponsor listed as primary.

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)
Registry description
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)
Registry description
Blood samples will be collected to determine the Cmax of enlicitide.

Secondary outcomes(4)

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)
Registry description
Blood samples will be collected to determine the AUC0-inf of enlicitide under fed and fasted conditions.
Cmax of Enlicitide in Plasma Under Fed vs Fasted Conditions
Time frame · Pre-dose and at designated timepoints (up to 168 hours post dose)
Registry description
Blood samples will be collected to determine the Cmax of enlicitide under fed and fasted conditions.
Number of Participants Who Experience an Adverse Event (AE)
Time frame · Up to approximately 98 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. The number of participants who experience an AE will be reported.
Number of Participants Who Discontinue Study Treatment Due to an AE
Time frame · Up to approximately 98 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. The number of participants who discontinue study treatment due to an AE will be reported.

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.

A trial that is still running, or that stopped early, may post results later.

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

Inclusion Criteria: * Is in good health * Has a body-mass index (BMI) between ≥18.0 and ≤32.0 kg/m\^2 Exclusion Criteria: * 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

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