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.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Part 1: Area under the concentration versus time curve from 0 to infinity (AUC0-inf)AUC0-inf of enlicitide
Timeframe: Pre-dose and at designated time points up to 168 hours post dose
Part 1: Maximum concentration (Cmax) of enlicitide
Timeframe: Predose, and at designated timepoints up to 168 hours post-dose
Part 2: AUC 0-inf of enlicitide
Timeframe: Pre-dose and at designated timepoints up to 168 hours post dose
Part 2: Cmax of enlicitide
Timeframe: Predose, and at designated timepoints up to 168 hours post-dose