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CompletedPhase 1

A Study of Enlicitide Decanoate (MK-0616) and Semaglutide in Healthy Adult Participants (MK-0616-023)

A Clinical Study to Evaluate the Effect of MK-0616 and Semaglutide on Their Respective Pharmacokinetics in Healthy Adult Participants

Asset

Semaglutide

Oral · GLP-1 agonist

Listed sites

1

Recruiting sites

Enrollment

38

actual

Study population

Healthy volunteers

Key I/E criteria

BMI 18-32Healthy volunteers

Primary endpoints

AUC from Time 0Cmax of Enlicitide DecanoateCmax of Semaglutide

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06699329
Org study ID0616-023
Secondary IDMK-0616-023MSD

Timeline

Milestones

Study start2024-01-22actual
Primary completion2024-05-24actual
Study completion2024-05-24actual
Study first posted2024-11-21actual
Last update posted2024-11-21actual

Assets

Investigational agents

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age19 Years
Maximum age55 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

The key inclusion criteria include but are not limited to the following:

Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m^2
Medically healthy with no clinically significant medical history

Exclusion criteria

The key 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

Endpoints (8)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Safety / tolerability / PK

8 endpoints
Primary/protocol endpoint

Area Under the Concentration-Time Curve from Time 0 to 24 hours (AUC0-24hrs) of Enlicitide Decanoate

Time frame:At designated timepoints (up to 24 hours postdose)

concentration, descriptive

Primary/protocol endpoint

Area Under the Concentration-Time Curve from Time 0 to 24 hours (AUC0-24hrs) of Semaglutide

Time frame:At designated timepoints (up to 24 hours postdose)

concentration, descriptive

Primary/protocol endpoint

Maximum Plasma Concentration (Cmax) of Enlicitide Decanoate

Time frame:At designated timepoints (up to approximately 2 weeks postdose)

Cmax

concentration, descriptive

Primary/protocol endpoint

Maximum Plasma Concentration (Cmax) of Semaglutide

Time frame:At designated timepoints (up to approximately 2 weeks postdose)

Cmax

concentration, descriptive

Primary/protocol endpoint

Time to Maximum Plasma Concentration (Tmax) of Enlicitide Decanoate

Time frame:At designated timepoints (up to approximately 2 weeks postdose)

Tmax

descriptive

Primary/protocol endpoint

Time to Maximum Plasma Concentration (Tmax) of Semaglutide

Time frame:At designated timepoints (up to approximately 2 weeks postdose)

Tmax

descriptive

Secondary/protocol endpoint

Number of Participants Who Experience a Treatment-Emergent Adverse Event (TEAE)

Time frame:Up to approximately 12 weeks

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Number of Participants Who Discontinue Study Due to a TEAE

Time frame:Up to approximately 12 weeks

Discontinuation due to AE

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.