Trial Outcomes & Findings for A Clinical Study of Enlicitide Decanoate in People With Liver Function Problems (MK-0616-030) (NCT NCT06575959)
NCT ID: NCT06575959
Last Updated: 2026-05-29
Results Overview
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.
COMPLETED
PHASE1
20 participants
Predose and 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 72, 120, and 168 hours postdose
2026-05-29
Participant Flow
Participants with chronic, stable hepatic insufficiency (HI) meeting a Child-Pugh score of 7 - 9 corresponding to moderate HI were enrolled.
Optional Part 2 in mild HI was not conducted; no mild hepatic impairment participants were enrolled.
Participant milestones
| Measure |
Moderate Hepatic Impairment (HI)
Participants received a single oral dose of enlicitide on Day 1
|
Healthy Controls
Participants received a single oral dose of enlicitide on Day 1
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Clinical Study of Enlicitide Decanoate in People With Liver Function Problems (MK-0616-030)
Baseline characteristics by cohort
| Measure |
Moderate Hepatic Impairment (HI)
n=10 Participants
Participants received a single oral dose of enlicitide on Day 1
|
Healthy Controls
n=10 Participants
Participants received a single oral dose of enlicitide on Day 1
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.3 Years
STANDARD_DEVIATION 5.36 • n=51 Participants
|
58.7 Years
STANDARD_DEVIATION 6.75 • n=14 Participants
|
59.5 Years
STANDARD_DEVIATION 5.99 • n=65 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=51 Participants
|
4 Participants
n=14 Participants
|
7 Participants
n=65 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=51 Participants
|
6 Participants
n=14 Participants
|
13 Participants
n=65 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=51 Participants
|
6 Participants
n=14 Participants
|
15 Participants
n=65 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=51 Participants
|
4 Participants
n=14 Participants
|
5 Participants
n=65 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=51 Participants
|
1 Participants
n=14 Participants
|
1 Participants
n=65 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=51 Participants
|
9 Participants
n=14 Participants
|
19 Participants
n=65 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
PRIMARY outcome
Timeframe: Predose and 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 72, 120, and 168 hours postdosePopulation: All participants who complied with the protocol sufficiently to ensure that generated data likely exhibited the effects of treatment, according to the underlying scientific model.
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.
Outcome measures
| Measure |
Moderate Hepatic Impairment (HI)
n=10 Participants
Participants received a single oral dose of enlicitide on Day 1
|
Healthy Controls
n=10 Participants
Participants received a single oral dose of enlicitide on Day 1
|
|---|---|---|
|
Area Under the Concentration Versus Time Curve From Time 0 to Infinity (AUC0-inf) of Enlicitide
|
540 nM·hr
Geometric Coefficient of Variation 36.7
|
559 nM·hr
Geometric Coefficient of Variation 43.8
|
PRIMARY outcome
Timeframe: Predose and 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 72, 120, and 168 hours postdosePopulation: All participants who complied with the protocol sufficiently to ensure that generated data likely exhibited the effects of treatment, according to the underlying scientific model.
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.
Outcome measures
| Measure |
Moderate Hepatic Impairment (HI)
n=10 Participants
Participants received a single oral dose of enlicitide on Day 1
|
Healthy Controls
n=10 Participants
Participants received a single oral dose of enlicitide on Day 1
|
|---|---|---|
|
Maximum Concentration (Cmax) of Enlicitide
|
9.07 nM
Geometric Coefficient of Variation 52.6
|
8.81 nM
Geometric Coefficient of Variation 49.2
|
SECONDARY outcome
Timeframe: Predose and 0.5, 1, 1.5, 2, 3, 5, 8, 12, and 24 hours postdosePopulation: All participants who complied with the protocol sufficiently to ensure that generated data likely exhibited the effects of treatment, according to the underlying scientific model.
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.
Outcome measures
| Measure |
Moderate Hepatic Impairment (HI)
n=10 Participants
Participants received a single oral dose of enlicitide on Day 1
|
Healthy Controls
n=10 Participants
Participants received a single oral dose of enlicitide on Day 1
|
|---|---|---|
|
Area Under the Concentration Versus Time Curve From Time 0 to 24 Hours (AUC0-24) of Enlicitide
|
131 nM•hr
Geometric Coefficient of Variation 35.9
|
149 nM•hr
Geometric Coefficient of Variation 32.4
|
SECONDARY outcome
Timeframe: Predose and 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 72, 120, and 168 hours postdosePopulation: All participants who complied with the protocol sufficiently to ensure that generated data likely exhibited the effects of treatment, according to the underlying scientific model.
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.
Outcome measures
| Measure |
Moderate Hepatic Impairment (HI)
n=10 Participants
Participants received a single oral dose of enlicitide on Day 1
|
Healthy Controls
n=10 Participants
Participants received a single oral dose of enlicitide on Day 1
|
|---|---|---|
|
Area Under the Concentration Versus Time Curve From Time 0 to Last (AUC0-last) of Enlicitide in Plasma
|
486 nM•hr
Geometric Coefficient of Variation 38.8
|
506 nM•hr
Geometric Coefficient of Variation 42.7
|
SECONDARY outcome
Timeframe: Predose and 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 72, 120, and 168 hours postdosePopulation: All participants who complied with the protocol sufficiently to ensure that generated data likely exhibited the effects of treatment, according to the underlying scientific model.
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.
Outcome measures
| Measure |
Moderate Hepatic Impairment (HI)
n=10 Participants
Participants received a single oral dose of enlicitide on Day 1
|
Healthy Controls
n=10 Participants
Participants received a single oral dose of enlicitide on Day 1
|
|---|---|---|
|
Time to Maximum (Tmax) Observed Plasma Drug Concentration of Enlicitide
|
0.75 Hour
Interval 0.5 to 24.13
|
1.50 Hour
Interval 0.5 to 24.28
|
SECONDARY outcome
Timeframe: Predose and 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 72, 120, and 168 hours postdosePopulation: All participants who complied with the protocol sufficiently to ensure that generated data likely exhibited the effects of treatment, according to the underlying scientific model.
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.
Outcome measures
| Measure |
Moderate Hepatic Impairment (HI)
n=10 Participants
Participants received a single oral dose of enlicitide on Day 1
|
Healthy Controls
n=10 Participants
Participants received a single oral dose of enlicitide on Day 1
|
|---|---|---|
|
Apparent Terminal Half-life (t1/2) of Enlicitide
|
49.3 Hour
Geometric Coefficient of Variation 14.4
|
48.0 Hour
Geometric Coefficient of Variation 20.4
|
SECONDARY outcome
Timeframe: Predose and 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 72, 120, and 168 hours postdosePopulation: All participants who complied with the protocol sufficiently to ensure that generated data likely exhibited the effects of treatment, according to the underlying scientific model.
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.
Outcome measures
| Measure |
Moderate Hepatic Impairment (HI)
n=10 Participants
Participants received a single oral dose of enlicitide on Day 1
|
Healthy Controls
n=10 Participants
Participants received a single oral dose of enlicitide on Day 1
|
|---|---|---|
|
Apparent Clearance (CL/F) of Enlicitide
|
23.9 Liters/Hour
Geometric Coefficient of Variation 36.7
|
23.1 Liters/Hour
Geometric Coefficient of Variation 43.8
|
SECONDARY outcome
Timeframe: Predose and 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 72, 120, and 168 hours postdosePopulation: All participants who complied with the protocol sufficiently to ensure that generated data likely exhibited the effects of treatment, according to the underlying scientific model.
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.
Outcome measures
| Measure |
Moderate Hepatic Impairment (HI)
n=10 Participants
Participants received a single oral dose of enlicitide on Day 1
|
Healthy Controls
n=10 Participants
Participants received a single oral dose of enlicitide on Day 1
|
|---|---|---|
|
Apparent Volume of Distribution During Terminal Phase (Vz/F) of Enlicitide
|
1700 Liters
Geometric Coefficient of Variation 47.8
|
1600 Liters
Geometric Coefficient of Variation 32.8
|
SECONDARY outcome
Timeframe: Up to approximately 6 weeksPopulation: All allocated participants who received a dose of study intervention.
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.
Outcome measures
| Measure |
Moderate Hepatic Impairment (HI)
n=10 Participants
Participants received a single oral dose of enlicitide on Day 1
|
Healthy Controls
n=10 Participants
Participants received a single oral dose of enlicitide on Day 1
|
|---|---|---|
|
Number of Participants Who Experienced a Treatment Emergent Adverse Event (TEAE)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to approximately 6 weeksPopulation: All allocated participants who received a dose of intervention.
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.
Outcome measures
| Measure |
Moderate Hepatic Impairment (HI)
n=10 Participants
Participants received a single oral dose of enlicitide on Day 1
|
Healthy Controls
n=10 Participants
Participants received a single oral dose of enlicitide on Day 1
|
|---|---|---|
|
Number of Participants Who Experienced An Adverse Event (AE)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to approximately 6 weeksPopulation: All allocated participants who received a dose of study intervention.
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..
Outcome measures
| Measure |
Moderate Hepatic Impairment (HI)
n=10 Participants
Participants received a single oral dose of enlicitide on Day 1
|
Healthy Controls
n=10 Participants
Participants received a single oral dose of enlicitide on Day 1
|
|---|---|---|
|
Number of Participants Who Discontinued Study Due to an AE
|
0 Participants
|
0 Participants
|
Adverse Events
Moderate Hepatic Impairment (HI)
Healthy Controls
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme LLC
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.
- Publication restrictions are in place
Restriction type: OTHER