A Clinical Study of Enlicitide Decanoate in People With Liver Function Problems (MK-0616-030)
NCT Number: NCT06575959
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Hepatic Insufficiency|Hepatic Impairment
Interventions: DRUG: Enlicitide
Sponsor: Merck Sharp & Dohme LLC
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-25
Completion Date: 2024-12-16

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.

Primary Outcome Measures: Part 1: Area under the concentration versus time curve from 0 to infinity (AUC0-inf)AUC0-inf of enlicitide, AUC0-inf of enlicitide in plasma will be determined., Pre-dose and at designated time points up to 168 hours post dose|Part 1: Maximum concentration (Cmax) of enlicitide, Cmax of enlicitide in plasma will be determined, Predose, and at designated timepoints up to 168 hours post-dose|Part 2: AUC 0-inf of enlicitide, AUC 0-inf of enlicitide in plasma will be determined, Pre-dose and at designated timepoints up to 168 hours post dose|Part 2: Cmax of enlicitide, Cmax of enlicitide in plasma will be determined, Predose, and at designated timepoints up to 168 hours post-dose
Secondary Outcome Measures: Part 1: Area under the concentration versus time curve from 0 to 24 hours (AUC0-24) of enlicitide, AUC0-24 of enlicitide in plasma will be determined., Pre-dose and at designated timepoints up to 168 hours post dose|Part 1: Area under the concentration versus time curve from 0 to the time of the last quantifiable sample (AUC0-last) of enlicitide, AUC0-last of enlicitide in plasma will be determined, Pre-dose and at designated timepoints up to 168 hours post dose|Part 1: Time to maximum (Tmax) observed plasma drug concentration of enlicitide, Tmax of enlicitide in plasma will be determined, Pre-dose and at designated timepoints up to 168 hours post dose|Part 1: Apparent terminal half-life (t1/2) of enlicitide, t1/2 of enlicitide in plasma will be determined, Pre-dose and at designated timepoints up to 168 hours post dose|Part 1: Apparent clearance (CL/F) of enlicitide, CL/F of enlicitide in plasma will be determined, Pre-dose and at designated timepoints up to 168 hours post dose|Part 1: Apparent volume of distribution during terminal phase (Vz/F) of enlicitide, Vz/F of enlicitide in plasma will be determined, Pre-dose and at designated timepoints up to 168 hours post dose|Part 1: Number of participants who experience one or more adverse events (AEs), An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention., Up to approximately 6 weeks|Part 1: Number of participants who discontinue study intervention due to an AE, An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention., Up to approximately 6 weeks|Part 2: AUC0-24 of enlicitide, AUC0-24 of enlicitide in plasma will be determined., Pre-dose and at designated timepoints up to 168 hours post dose|Part 2: AUC0-last of enlicitide, AUC0-last of enlicitide in plasma will be determined, Pre-dose and at designated timepoints up to 168 hours post dose|Part 2: Tmax observed plasma drug concentration of enlicitide, Tmax of enlicitide in plasma will be determined, Pre-dose and at designated timepoints up to 168 hours post dose|Part 2: t1/2 of enlicitide, t1/2 of enlicitide in plasma will be determined, Pre-dose and at designated timepoints up to 168 hours post dose|Part 2: CL/F of enlicitide, CL/F of enlicitide in plasma will be determined, Pre-dose and at designated timepoints up to 168 hours post dose|Part 2: Vz/F of enlicitide, Vz/F of enlicitide in plasma will be determined, Pre-dose and at designated timepoints up to 168 hours post dose|Part 2 Number of participants who experience one or more adverse events (AEs), An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention., Up to approximately 6 weeks|Part 2: Number of participants who discontinue study intervention due to an AE, An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention., Up to approximately 6 weeks