Trial · Interventional

CompletedPhase 1Results postedRegistry data

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

NCTNCT06575959Other id0616-030Other idMK-0616-030

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 1
Enrollment: 20 participants (actual)
Sponsor: Merck Sharp & Dohme LLC · Industry
Design: Not randomized · Open label (no masking)
Countries: 1 country
United States
Start: 20 Sept 2024
Primary completion: 1 May 2025
Completion: 8 May 2025
First posted: 28 Aug 2024
Last update posted: 29 May 2026
Conditions: Hepatic Insufficiency · Hepatic Impairment

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

202420252026

Ph 1
A Clinical Study of Enlicitide Decanoate in People With Liver Function Problems (MK-0616-030)
NCT06575959
20 Sept 2024 to 8 May 2025

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

EnlicitideDrug

Arms3

Experimental
Moderate Hepatic Impairment (HI)
Participants will receive a single oral dose of enlicitide on Day 1
Experimental
Healthy Controls
Participants will receive a single oral dose of enlicitide on Day 1
Experimental
Mild HI
Participants will receive a single oral dose of enlicitide on Day 1

Primary outcomes2

Outcomes the sponsor listed as primary.

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
Registry description
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.
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
Registry description
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(9)

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
Registry description
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.
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
Registry description
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.
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
Registry description
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.
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
Registry description
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.
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
Registry description
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.
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
Registry description
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.
Number of Participants Who Experienced a Treatment Emergent Adverse Event (TEAE)
Time frame · Up to approximately 6 weeks
Registry description
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.
Number of Participants Who Experienced An Adverse Event (AE)
Time frame · Up to approximately 6 weeks
Registry description
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.
Number of Participants Who Discontinued Study Due to an AE
Time frame · Up to approximately 6 weeks
Registry description
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..

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Secondary and other outcome results(8)

Secondary outcomeGeometric mean· 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 24 Hours (AUC0-24) of Enlicitide

Group	Value (nM•hr)	Spread
Moderate Hepatic Impairment (HI)	131	35.9
Healthy Controls	149	32.4

Secondary outcomeGeometric mean· Predose and 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 72, 120, and 168 hours postdose

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

Group	Value (nM•hr)	Spread
Moderate Hepatic Impairment (HI)	486	38.8
Healthy Controls	506	42.7

Secondary outcomeMedian· 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

Group	Value (Hour)
Moderate Hepatic Impairment (HI)	0.75
Healthy Controls	1.50

Secondary outcomeGeometric mean· 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

Group	Value (Hour)	Spread
Moderate Hepatic Impairment (HI)	49.3	14.4
Healthy Controls	48.0	20.4

Secondary outcomeGeometric mean· 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

Group	Value (Liters/Hour)	Spread
Moderate Hepatic Impairment (HI)	23.9	36.7
Healthy Controls	23.1	43.8

Secondary outcomeGeometric mean· 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

Group	Value (Liters)	Spread
Moderate Hepatic Impairment (HI)	1700	47.8
Healthy Controls	1600	32.8

Secondary outcomeCount of participants· Up to approximately 6 weeks

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

Group	Value (Participants)
Moderate Hepatic Impairment (HI)	0
Healthy Controls	0

Secondary outcomeCount of participants· Up to approximately 6 weeks

Number of Participants Who Experienced An Adverse Event (AE)

Group	Value (Participants)
Moderate Hepatic Impairment (HI)	0
Healthy Controls	0

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Moderate Hepatic Impairment (HI)Participants received a single oral dose of enlicitide on Day 1	0 / 10	0 / 10	0 / 10
Healthy ControlsParticipants received a single oral dose of enlicitide on Day 1	0 / 10	0 / 10	0 / 10

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 75 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

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.

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