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NCT06575959
PHASE1

A Clinical Study of Enlicitide Decanoate in People With Liver Function Problems (MK-0616-030)

Sponsor: Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

Summary

Researchers have designed a new study medicine called enlicitide decanoate as a new way to lower the amount of low-density lipoprotein cholesterol (LDL-C) in a person's blood. Enlicitide decanoate will be called "enlicitide" from this point forward, The purpose of this study is to learn what happens to enlicitide in a person's body over time (a pharmacokinetic or PK study). Researchers will compare what happens to enlicitide in the body when it is given to people with hepatic impairment (HI- meaning the liver does not work properly) and people who are in good health. This study will have 2 parts. In Part 1, enlicitide will be given to people with moderate HI and people who are in good health. After Part 1, researchers may decide to include people who have mild HI and compare what happens to enlicitide in the body with people who are in good health.

Official title: An Open-Label, Single-Dose Clinical Study to Evaluate the Pharmacokinetics of Enlicitide in Participants With Hepatic Impairment

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2024-09-20

Completion Date

2025-05-08

Last Updated

2026-05-29

Healthy Volunteers

Yes

Interventions

DRUG

Enlicitide

Oral tablet

Locations (2)

Orlando Clinical Research Center ( Site 0002)

Orlando, Florida, United States

The Texas Liver Institute ( Site 0001)

San Antonio, Texas, United States