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Completed

NCT Number: NCT06575959

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

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.

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Key information

Conditions

Hepatic Insufficiency Digestive System Diseases Hepatic Impairment Liver Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Orlando Clinical Research Center ( Site 0002), Orlando, Florida, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Enlicitide

Drug

Oral tablet

Other names: enlicitide decanoate, MK-0616/sodium caprate

Primary outcomes

  1. Area Under the Concentration Versus Time Curve From Time 0 to Infinity (AUC0-inf) of Enlicitide

    Time frame: Predose and 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 72, 120, and 168 hours postdose

    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.

  2. Maximum Concentration (Cmax) of Enlicitide

    Time frame: Predose and 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 72, 120, and 168 hours postdose

    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.

Secondary outcomes

  1. Area Under the Concentration Versus Time Curve From Time 0 to 24 Hours (AUC0-24) of Enlicitide

    Time frame: Predose and 0.5, 1, 1.5, 2, 3, 5, 8, 12, and 24 hours postdose

    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.

  2. Area Under the Concentration Versus Time Curve From Time 0 to Last (AUC0-last) of Enlicitide in Plasma

    Time frame: Predose and 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 72, 120, and 168 hours postdose

    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.

  3. Time to Maximum (Tmax) Observed Plasma Drug Concentration of Enlicitide

    Time frame: Predose and 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 72, 120, and 168 hours postdose

    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.

  4. Apparent Terminal Half-life (t1/2) of Enlicitide

    Time frame: Predose and 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 72, 120, and 168 hours postdose

    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.

  5. Apparent Clearance (CL/F) of Enlicitide

    Time frame: Predose and 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 72, 120, and 168 hours postdose

    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.

  6. Apparent Volume of Distribution During Terminal Phase (Vz/F) of Enlicitide

    Time frame: Predose and 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 72, 120, and 168 hours postdose

    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.

  7. Number of Participants Who Experienced a Treatment Emergent Adverse Event (TEAE)

    Time frame: Up to approximately 6 weeks

    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.

  8. Number of Participants Who Experienced An Adverse Event (AE)

    Time frame: Up to approximately 6 weeks

    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.

  9. Number of Participants Who Discontinued Study Due to an AE

    Time frame: Up to approximately 6 weeks

    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..

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 28, 2024
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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