A Study of Efinopegdutide in Healthy Obese Participants (MK-6024-015)

What Was Tested

This registered phase 1 trial tested Efinopegdutide.

The goal of this study is to learn about the safety of efinopegdutide (MK-6024) and how well overweight healthy people tolerate it.

It had four arms (groups): Part 1: Efinopegdutide (experimental), Part 1: Placebo (placebo comparator), Part 2: Efinopegdutide (experimental) and Part 2: Placebo (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 48 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: Is in good health. Has body mass index (BMI) between 29 kg/m\^2 and 38 kg/m\^2.

The full record lists 2 inclusion and 3 exclusion criteria; among the exclusions: history of cancer (malignancy); positive test(s) for hepatitis b surface antigen (hbsag), hepatitis c antibodies, or human immunodeficiency virus (hiv).

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

Random assignment meant chance, not the researchers, decided who got Efinopegdutide and who got the comparison, which limits bias.

The Efinopegdutide group and the comparison group ran side by side rather than switching.

As a double-blind Efinopegdutide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2024-06-13 with completion listed for 2025-02-18.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Part 1: Number of Participants Who Experience an Adverse Event (AE) (time frame: Up to approximately 35 days). Part 1: Number of Participants Who Discontinue Study Treatment Due to an AE (time frame: Up to approximately 35 days). Part 1: Maximum Plasma Concentration (Cmax) of Efinopegdutide.

It also tracked 4 secondary outcomes, for example Part 2: AUC0-Inf of Acetaminophen, Part 2: Cmax of Acetaminophen, Part 2: Tmax of Acetaminophen and Part 2: t1/2 of Acetaminophen.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Efinopegdutide in 48 people.

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

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