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A Study of Efinopegdutide in Participants With Hepatic Impairment (MK-6024-014)
Plain-language guide to NCT06052566: phase 1 non-randomized trial of Efinopegdutide, 22 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT06052566
- Phase
- phase 1
- Status
- completed
- Start
- 2023-11-21
- Completion (planned or actual)
- 2024-12-05
- Participants
- 22 (actual)
- Design
- non-randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Non-alcoholic Steatohepatitis; Hepatic Impairment
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
This registered phase 1 trial tested Efinopegdutide.
It had three arms (groups): Efinopegdutide in Participants with Moderate Hepatic Impairment (experimental), Efinopegdutide in Participants with Severe Hepatic Impairment (experimental) and Efinopegdutide in Healthy-Matched Control Group (experimental).
The registry classes the interventions as drug.
Who Took Part
22 actual participants took part.
It was open to people of any sex aged from 18 years up to 75 years.
Healthy volunteers could join, not only people with the condition.
The full record lists 0 inclusion and 7 exclusion criteria; among the exclusions: history of cancer (malignancy); participants with moderate or severe hepatic impairment who are positive for human immunodeficiency virus (hiv)-1 or hiv-2 at the prestudy (screening) visit.
How the Study Was Run
It was run as a non-randomized, parallel-group and open-label study.
Groups ran in parallel: each of the participants stayed in one arm throughout.
Everyone knew when Efinopegdutide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.
It started in 2023-11-21 with completion listed for 2024-12-05.
It ran at 4 sites in United States (4).
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: Area Under the Curve From Time 0 to Infinity (AUC0-inf) of Efinopegdutide. Area Under the Curve From Time 0 to Last Sampling Time (AUC0-last) of Efinopegdutide. Maximum Plasma Concentration (Cmax) of Efinopegdutide.
It also tracked 2 secondary outcomes, for example Number of Participants Who Experienced an Adverse Event (AE) and Number of Participants Who Discontinued Study Intervention Due to an AE.
What This Means in Plain Language
Put simply, this is a phase 1, non-randomized trial of Efinopegdutide in 22 people.
Its size is small, so on its own it can only give an early look.
The trial is marked completed; results are posted on the registry, and this page does not restate them.
More context: the Efinopegdutide compound page, all human trials.
Our Notes on the Compound
Efinopegdutide: A long-acting GLP-1/glucagon dual agonist from Merck studied for MASH.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.