NCT06575959

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Hepatic Insufficiency
• Hepatic Impairment

Interventions

Type	Name	Description
DRUG	Enlicitide	Oral tablet

Timeline

• Start date: 2024-09-20
• Primary completion: 2025-05-01
• Completion: 2025-05-08
• First posted: 2024-08-28
• Last updated: 2025-05-28

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study