A Clinical Study of Enlicitide Decanoate in People With Liver Function Problems (MK-0616-030)
- Conditions
- Hepatic InsufficiencyHepatic Impairment
- Interventions
- Registration Number
- NCT06575959
- Lead Sponsor
- Merck Sharp & Dohme LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 40
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
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Moderate Hepatic Impairment (HI) Enlicitide Participants will receive a single oral dose of enlicitide on Day 1 Healthy Controls Enlicitide Participants will receive a single oral dose of enlicitide on Day 1 Mild HI Enlicitide Participants will receive a single oral dose of enlicitide on Day 1
- Primary Outcome Measures
Name Time Method Part 1: Area under the concentration versus time curve from 0 to infinity (AUC0-inf)AUC0-inf of enlicitide Pre-dose and at designated time points up to 168 hours post dose AUC0-inf of enlicitide in plasma will be determined.
Part 1: Maximum concentration (Cmax) of enlicitide Predose, and at designated timepoints up to 168 hours post-dose Cmax of enlicitide in plasma will be determined
Part 2: AUC 0-inf of enlicitide Pre-dose and at designated timepoints up to 168 hours post dose AUC 0-inf of enlicitide in plasma will be determined
Part 2: Cmax of enlicitide Predose, and at designated timepoints up to 168 hours post-dose Cmax of enlicitide in plasma will be determined
- Secondary Outcome Measures
Name Time Method Part 1: Area under the concentration versus time curve from 0 to the time of the last quantifiable sample (AUC0-last) of enlicitide Pre-dose and at designated timepoints up to 168 hours post dose AUC0-last of enlicitide in plasma will be determined
Part 1: Number of participants who experience one or more adverse events (AEs) Up to approximately 6 weeks 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.
Part 1: Number of participants who discontinue study intervention due to an AE Up to approximately 6 weeks 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.
Part 2: AUC0-24 of enlicitide Pre-dose and at designated timepoints up to 168 hours post dose AUC0-24 of enlicitide in plasma will be determined.
Part 2: AUC0-last of enlicitide Pre-dose and at designated timepoints up to 168 hours post dose AUC0-last of enlicitide in plasma will be determined
Part 2: Tmax observed plasma drug concentration of enlicitide Pre-dose and at designated timepoints up to 168 hours post dose Tmax of enlicitide in plasma will be determined
Part 2: t1/2 of enlicitide Pre-dose and at designated timepoints up to 168 hours post dose t1/2 of enlicitide in plasma will be determined
Part 2: CL/F of enlicitide Pre-dose and at designated timepoints up to 168 hours post dose CL/F of enlicitide in plasma will be determined
Part 2: Vz/F of enlicitide Pre-dose and at designated timepoints up to 168 hours post dose Vz/F of enlicitide in plasma will be determined
Part 2 Number of participants who experience one or more adverse events (AEs) Up to approximately 6 weeks 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.
Part 1: Time to maximum (Tmax) observed plasma drug concentration of enlicitide Pre-dose and at designated timepoints up to 168 hours post dose Tmax of enlicitide in plasma will be determined
Part 1: Area under the concentration versus time curve from 0 to 24 hours (AUC0-24) of enlicitide Pre-dose and at designated timepoints up to 168 hours post dose AUC0-24 of enlicitide in plasma will be determined.
Part 1: Apparent clearance (CL/F) of enlicitide Pre-dose and at designated timepoints up to 168 hours post dose CL/F of enlicitide in plasma will be determined
Part 1: Apparent volume of distribution during terminal phase (Vz/F) of enlicitide Pre-dose and at designated timepoints up to 168 hours post dose Vz/F of enlicitide in plasma will be determined
Part 1: Apparent terminal half-life (t1/2) of enlicitide Pre-dose and at designated timepoints up to 168 hours post dose t1/2 of enlicitide in plasma will be determined
Part 2: Number of participants who discontinue study intervention due to an AE Up to approximately 6 weeks 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.
Trial Locations
- Locations (2)
Orlando Clinical Research Center ( Site 0002)
🇺🇸Orlando, Florida, United States
The Texas Liver Institute ( Site 0001)
🇺🇸San Antonio, Texas, United States