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Trial · Interventional

CompletedPhase 1Registry data

A Clinical Study to Evaluate Enlicitide (MK-0616) Formulations in Healthy Adult Participants (MK-0616-035)

NCTNCT06880874 (opens ClinicalTrials.gov in a new tab)Other id0616-035Other idMK-0616-035
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 1
Enrollment
40 participants (actual)
Sponsor
Merck Sharp & Dohme LLC · Industry
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
2 Apr 2025
Primary completion
16 May 2025
Completion
31 May 2025
First posted
18 Mar 2025
Last update posted
15 Jun 2025
Conditions
Healthy

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20252026
  1. Ph 1

    A Clinical Study to Evaluate Enlicitide (MK-0616) Formulations in Healthy Adult Participants (MK-0616-035)

    NCT06880874

    2 Apr 2025 to 31 May 2025

Registry summary

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

The goal of the study is to learn what happens to different forms of enlicitide medications in a healthy person's body over time. Researchers will compare the amount of enlicitide in the healthy person's body over time when enlicitide is given in different formulations.

Interventions

  • EnlicitideDrug

Arms2

  • Experimental

    Treatment A: enlicitide reference tablet

    Participants receive a single oral dose of enlicitide reference tablet.

  • Experimental

    Treatment B: enlicitide test tablet

    Participants receive a single oral dose of enlicitide test tablet.

Primary outcomes4

Outcomes the sponsor listed as primary.

  1. Area Under the Concentration-Time Curve from Time 0 to 24 hours (AUC0-24hrs) of enlicitide in plasma

    Time frame · Pre-dose and at designated time points up to 24 hours post dose

    Registry description

    Blood samples will be collected to determine the AUC0-24hr of enlicitide.

  2. Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of enlicitide in plasma

    Time frame · Pre-dose and at designated time points up to 168 hours post dose

    Registry description

    Blood samples will be collected to determine the AUC0-Last of enlicitide.

  3. Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of enlicitide in plasma

    Time frame · Pre-dose and at designated time points up to 168 hours post dose

    Registry description

    Blood samples will be collected to determine the AUC0-Inf of enlicitide.

  4. Maximum Plasma Concentration (Cmax) of enlicitide in plasma

    Time frame · Pre-dose and at designated time points up to 168 hours post dose

    Registry description

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

Secondary outcomes(2)

  1. Number of Participants Who Experience an Adverse Event (AE)

    Time frame · Up to approximately 14 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.

  2. Number of Participants Who Discontinue Study Treatment Due to an AE

    Time frame · Up to approximately 8 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.

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 18 Years up to 55 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior * Has body mass index (BMI) ≥18 kg/m\^2 and ≤32 kg/m\^2 Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * Has history of gastrointestinal disease which may affect food and drug absorption or has had a gastric bypass or similar surgery * Has history of cancer (malignancy) * Has positive results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV)

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