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

What Was Tested

The trial (phase 1) is built around Semaglutide.

The goal of this study is to learn what happens in a person's body over time when they take enlicitide decanoate and semaglutide alone or at the same time.

Enlicitide decanoate is a new medicine that lowers the amount of cholesterol in a person's blood.

Semaglutide is a drug used to treat type 2 diabetes.

It had 1 arm (groups): Enlicitide Decanoate and Semaglutide (experimental).

The registry classes the interventions as drug.

Who Took Part

38 actual participants took part.

It was open to people of any sex aged from 19 years up to 55 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m\^2.

The full record lists 2 inclusion and 2 exclusion criteria; among the exclusions: history of gastrointestinal disease which may affect food and drug absorption, or has had a gastric bypass or similar surgery; history of cancer.

How the Study Was Run

It was run as a single-group and open-label study.

Nothing was hidden in this open-label Semaglutide study: the participants and staff both knew the treatment.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2024-01-22 with completion listed for 2024-05-24.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): 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)). 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)). Maximum Plasma Concentration (Cmax) of Enlicitide Decanoate (time frame: At designated timepoints (up to approximately 2 weeks postdose)).

It also tracked 2 secondary outcomes, for example Number of Participants Who Experience a Treatment-Emergent Adverse Event (TEAE) and Number of Participants Who Discontinue Study Due to a TEAE.

What This Means in Plain Language

Put simply, this is a phase 1 trial of Semaglutide in 38 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Semaglutide compound page, all human trials.