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

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 Overview

• Status: Completed
• Conditions: Hepatic Insufficiency; Hepatic Impairment
• Intervention / Treatment: Drug: Enlicitide

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 32809
      • Orlando Clinical Research Center ( Site 0002)
  • Texas
    • San Antonio, Texas, United States, 78215
      • The Texas Liver Institute ( Site 0001)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

All participants:

• Has been a non-smoker or moderate smoker (≤ 10 cigarettes per day or equivalent) for at least 3 months prior to starting the study
• Has body mass index (BMI) ≥ 18.0 and ≤ 40.0 kg/m2

Participants with moderate or mild HI:

• Diagnosis of chronic (> 6 months) and stable (no sudden or severe episodes of illness due to worsening liver function in the past 2 months) hepatic insufficiency, and features cirrhosis (liver scarring) due to any cause.
• Is generally in good health with the exception of HI.

Healthy Control Participants:

• Medically healthy with no clinically significant medical history, physical examination, or clinical laboratory profiles

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

All participants:

• History of gastrointestinal disease which may affect food and drug absorption, or has had a gastric bypass or similar surgery.
• History of cancer
• Consumes greater than 3 servings of alcoholic beverages per day.
• Is on statin background therapy.

Participants with moderate or mild HI:

• Severe complications of liver disease within 3 months of entering the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Moderate Hepatic Impairment (HI); Participants will receive a single oral dose of enlicitide on Day 1	Drug: Enlicitide; Oral tablet; Other Names: enlicitide decanoate; MK-0616/sodium caprate
Experimental: Healthy Controls; Participants will receive a single oral dose of enlicitide on Day 1	Drug: Enlicitide; Oral tablet; Other Names: enlicitide decanoate; MK-0616/sodium caprate
Experimental: Mild HI; Participants will receive a single oral dose of enlicitide on Day 1	Drug: Enlicitide; Oral tablet; Other Names: enlicitide decanoate; MK-0616/sodium caprate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area Under the Concentration Versus Time Curve From Time 0 to Infinity (AUC0-inf) of Enlicitide	Blood samples were collected at pre-specified time points to determine the AUC0-inf of enlicitide in plasma. AUC0-inf was defined as AUC0-last + (Cest,last/λz) where Cest, last was the estimated last measurable concentration, and λz was the apparent first-order terminal elimination rate constant.	Predose and 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 72, 120, and 168 hours postdose
Maximum Concentration (Cmax) of Enlicitide	Blood samples were collected at pre-specified time points to determine the Cmax of enlicitide in participant's plasma. Cmax was defined as the maximum observed concentration of enlicitide in plasma after the administration of a given dose.	Predose and 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 72, 120, and 168 hours postdose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area Under the Concentration Versus Time Curve From Time 0 to 24 Hours (AUC0-24) of Enlicitide	Blood samples were collected at pre-specified time points to determine the AUC0-24 of encilitide. AUC0-24 of encilitide was defined as the area under the concentration-time curve from time 0 to the 24 hours after the dosing of encilitide.	Predose and 0.5, 1, 1.5, 2, 3, 5, 8, 12, and 24 hours postdose
Area Under the Concentration Versus Time Curve From Time 0 to Last (AUC0-last) of Enlicitide in Plasma	Blood samples were collected at pre-specified time points to determine the AUC0-last of enlicitide in participant's plasma. AUC0 to last of enlicitide was defined as the area under the concentration-time curve from time 0 to the time of the last quantifiable (above lower limit of quantitation) concentration. AUC0-last was calculated using noncompartmental analysis.	Predose and 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 72, 120, and 168 hours postdose
Time to Maximum (Tmax) Observed Plasma Drug Concentration of Enlicitide	Blood samples were collected at pre-specified time points to determine the tmax of enlicitide in participant's plasma. Tmax was defined as time to the maximum concentration of enlicitide reached.	Predose and 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 72, 120, and 168 hours postdose
Apparent Terminal Half-life (t1/2) of Enlicitide	Blood samples were collected at pre-specified timepoints to determine the t1/2 of enlicitide. t1/2 was defined as the time required to divide the enlicitide plasma concentration by two after reaching pseudo-equilibrium, following a single dose of enlicitide.	Predose and 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 72, 120, and 168 hours postdose
Apparent Clearance (CL/F) of Enlicitide	Blood samples were collected at pre-specified timepoints to determine the CL/F of enlicitide. CL/F was the apparent total clearance of enlicitide in plasma over time, assessed as the rate at which enlicitide was removed from the plasma.	Predose and 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 72, 120, and 168 hours postdose
Apparent Volume of Distribution During Terminal Phase (Vz/F) of Enlicitide	Blood samples were collected at pre-specified timepoints to determine the Vz/F of enlicitide. Vz/F was the apparent volume of distribution of enlicitide between the plasma and the rest of the body, after dose, assessed as the total volume of enlicitide that would need to be uniformly distributed to achieve the desired plasma drug concentration.	Predose and 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 72, 120, and 168 hours postdose
Number of Participants Who Experienced a Treatment Emergent Adverse Event (TEAE)	An adverse event (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. An AE was considered treatment-emergent if the onset date and time is at the time of or after the first study drug administration. The number of participants who experienced a TEAE were reported.	Up to approximately 6 weeks
Number of Participants Who Experienced An Adverse Event (AE)	An AE was 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. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. Number of participants who experienced an AE were reported.	Up to approximately 6 weeks
Number of Participants Who Discontinued Study Due to an AE	An AE was 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. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. Number of participants who discontinued from the study due to an AE were reported..	Up to approximately 6 weeks

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC
• Investigators: Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

Helpful Links

• Merck Clinical Trials Information

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2024
• Primary Completion (Actual): May 1, 2025
• Study Completion (Actual): May 8, 2025

Study Registration Dates

• First Submitted: August 26, 2024
• First Submitted That Met QC Criteria: August 26, 2024
• First Posted (Actual): August 28, 2024

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 28, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Hepatic Insufficiency; Anti-Infective Agents; Antifungal Agents; Decanoic acid
• Other Study ID Numbers: 0616-030; MK-0616-030 (Other Identifier: MSD)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No