Clinical trial NCT06575959: A Clinical Study of Enlicitide Decanoate in People With Liver Function Problems (MK-0616-030)
Official title: An Open-Label, Single-Dose Clinical Study to Evaluate the Pharmacokinetics of Enlicitide in Participants With Hepatic Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatic Insufficiency
Hepatic Impairment
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2024-08-28
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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
measure: Part 1: Maximum concentration (Cmax) of enlicitide
timeFrame: Predose, and at designated timepoints up to 168 hours post-dose
measure: Part 2: AUC 0-inf of enlicitide
timeFrame: Pre-dose and at designated timepoints up to 168 hours post dose
measure: Part 2: Cmax of enlicitide
timeFrame: Predose, and at designated timepoints up to 168 hours post-dose
Secondary outcomes:
measure: Part 1: Area under the concentration versus time curve from 0 to 24 hours (AUC0-24) of enlicitide
timeFrame: Pre-dose and at designated timepoints up to 168 hours post dose
measure: Part 1: Area under the concentration versus time curve from 0 to the time of the last quantifiable sample (AUC0-last) of enlicitide
timeFrame: Pre-dose and at designated timepoints up to 168 hours post dose
measure: Part 1: Time to maximum (Tmax) observed plasma drug concentration of enlicitide
timeFrame: Pre-dose and at designated timepoints up to 168 hours post dose
measure: Part 1: Apparent terminal half-life (t1/2) of enlicitide
timeFrame: Pre-dose and at designated timepoints up to 168 hours post dose
measure: Part 1: Apparent clearance (CL/F) of enlicitide
timeFrame: Pre-dose and at designated timepoints up to 168 hours post dose
measure: Part 1: Apparent volume of distribution during terminal phase (Vz/F) of enlicitide
timeFrame: Pre-dose and at designated timepoints up to 168 hours post dose
measure: Part 1: Number of participants who experience one or more adverse events (AEs)
timeFrame: Up to approximately 6 weeks
measure: Part 1: Number of participants who discontinue study intervention due to an AE
timeFrame: Up to approximately 6 weeks
measure: Part 2: AUC0-24 of enlicitide
timeFrame: Pre-dose and at designated timepoints up to 168 hours post dose
measure: Part 2: AUC0-last of enlicitide
timeFrame: Pre-dose and at designated timepoints up to 168 hours post dose
measure: Part 2: Tmax observed plasma drug concentration of enlicitide
timeFrame: Pre-dose and at designated timepoints up to 168 hours post dose
measure: Part 2: t1/2 of enlicitide
timeFrame: Pre-dose and at designated timepoints up to 168 hours post dose
measure: Part 2: CL/F of enlicitide
timeFrame: Pre-dose and at designated timepoints up to 168 hours post dose
measure: Part 2: Vz/F of enlicitide
timeFrame: Pre-dose and at designated timepoints up to 168 hours post dose
measure: Part 2 Number of participants who experience one or more adverse events (AEs)
timeFrame: Up to approximately 6 weeks
measure: Part 2: Number of participants who discontinue study intervention due to an AE
timeFrame: Up to approximately 6 weeks
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Orlando Clinical Research Center ( Site 0002)
state: Florida
city: San Antonio
country: United States
facility: The Texas Liver Institute ( Site 0001)
state: Texas
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: