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A Clinical Study of Enlicitide Decanoate in People With Liver Function Problems (MK-0616-030)
Sponsor: Merck Sharp & Dohme LLC
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
Conditions
Interventions
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