At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-Label, Single-Dose Clinical Study to Evaluate the Pharmacokinetics of Enlicitide in Participants With Hepatic Impairment
In Brief
A Phase 1 clinical trial evaluating Enlicitide for Hepatic Insufficiency and Hepatic Impairment. Completed, enrolled 20 participants across 2 sites.
Detailed 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.
Study Details
Timeline
Interventions
Oral tablet