A Clinical Study of Efinopegdutide (MK-6024) in Healthy Chinese Volunteers (MK-6024-011)

What Was Tested

In this phase 1 trial, researchers set out to test Efinopegdutide.

The goal of this study is to learn about the safety and whether people tolerate a study medicine called efinopegdutide.

The study will also measure what happens to efinopegdutide in a healthy person's body over time.

It had five arms (groups): one (experimental), one (experimental), one (experimental), one (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 56 actual participants took part.

It was open to people of any sex aged from 20 years up to 60 years.

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

Examples of who could join: Is in good health before randomization. Has a body mass index (BMI) ≥25 and ≤35 kg/m\^2.

The full record lists 2 inclusion and 2 exclusion criteria.

How the Study Was Run

Design: 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.

Neither the participants nor the staff measuring them knew who was on Efinopegdutide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2022-09-05 with completion listed for 2023-02-02.

It ran at 1 site in China.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Number of Participants Who Experience an Adverse Event (AE) (time frame: Up to approximately 112 days). Number of Participants Who Discontinue Study Treatment Due to an AE (time frame: Up to approximately 78 days).

It also tracked 6 secondary outcomes, for example Change from Baseline in Weight, Change from Baseline in HDL Cholesterol, Change from Baseline in LDL Cholesterol, Change from Baseline in Total Cholesterol, Change from Baseline in Triglycerides and Number of participants with anti drug antibodies (ADA) to efinopegdutide.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Efinopegdutide in 56 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.