Trial Outcomes & Findings for Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) Renal Impairment Study (MK-0616-020) (NCT NCT05934292)
NCT ID: NCT05934292
Last Updated: 2025-02-17
Results Overview
AUC0-inf was a measure of the total amount of drug in the plasma from the dose administration extrapolated to infinity. Blood for plasma samples was collected at pre-specified timepoints to determine the AUC0-inf of enlicitide decanoate for Panel A, B, C, and D participants. Per protocol, Panel C ESRD on HD arm was separated into two arms: Panel C ESRD - enlicitide decanoate pre-hemodialysis and Panel C ESRD - enlicitide decanoate post-hemodialysis to report AUC0-inf. Per protocol, mean AUC0-inf was reported.
COMPLETED
PHASE1
33 participants
Predose and 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 120, 168, and 240 hours postdose
2025-02-17
Participant Flow
All allocated participants. Panel C included participants with End-Stage Renal Disease (ESRD). No urine samples could be obtained on Panel C participants and hence no pharmacokinetic (PK) analysis could be performed for Panel C participants as pre-specified in the protocol.
Participant milestones
| Measure |
Panel A: Moderate Renal Impairment (RI)
Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1.
|
Panel B: Severe RI
Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1.
|
Panel C: End-Stage Renal Disease (ESRD) on Hemodialysis (HD)
Participants received Enlicitide Decanoate 20 mg tablet orally on Day 1 and Day 16.
|
Panel D: Healthy Controls
Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
9
|
8
|
|
Overall Study
COMPLETED
|
8
|
8
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Panel A: Moderate Renal Impairment (RI)
Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1.
|
Panel B: Severe RI
Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1.
|
Panel C: End-Stage Renal Disease (ESRD) on Hemodialysis (HD)
Participants received Enlicitide Decanoate 20 mg tablet orally on Day 1 and Day 16.
|
Panel D: Healthy Controls
Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) Renal Impairment Study (MK-0616-020)
Baseline characteristics by cohort
| Measure |
Panel A: Moderate Renal Impairment (RI)
n=8 Participants
Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1.
|
Panel B: Severe RI
n=8 Participants
Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1.
|
Panel C: End-Stage Renal Disease (ESRD) on Hemodialysis (HD)
n=9 Participants
Participants received Enlicitide Decanoate 20 mg tablet orally on Day 1 and Day 16.
|
Panel D: Healthy Controls
n=8 Participants
Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1.
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
67 Years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
66.8 Years
STANDARD_DEVIATION 12.1 • n=7 Participants
|
60.1 Years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
62.8 Years
STANDARD_DEVIATION 4 • n=4 Participants
|
64 Years
STANDARD_DEVIATION 9.3 • n=21 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Predose and 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 120, 168, and 240 hours postdosePopulation: All allocated participants of Panel A, B, C, and D who received at least a dose of study treatment and had data available for AUC0-inf.
AUC0-inf was a measure of the total amount of drug in the plasma from the dose administration extrapolated to infinity. Blood for plasma samples was collected at pre-specified timepoints to determine the AUC0-inf of enlicitide decanoate for Panel A, B, C, and D participants. Per protocol, Panel C ESRD on HD arm was separated into two arms: Panel C ESRD - enlicitide decanoate pre-hemodialysis and Panel C ESRD - enlicitide decanoate post-hemodialysis to report AUC0-inf. Per protocol, mean AUC0-inf was reported.
Outcome measures
| Measure |
Panel A: Moderate Renal Impairment (RI)
n=7 Participants
Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1.
|
Panel B: Severe RI
n=7 Participants
Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1.
|
Panel C: ESRD - Enlicitide Decanoate Pre-Hemodialysis
n=7 Participants
Participants received Enlicitide Decanoate 20 mg tablet orally on Day 1.
|
Panel C: ESRD - Enlicitide Decanoate Post-Hemodialysis
n=8 Participants
Participants received Enlicitide Decanoate 20 mg tablet orally on Day 16.
|
Panel D: Healthy Controls
n=8 Participants
Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1.
|
|---|---|---|---|---|---|
|
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-Inf) of Enlicitide Decanoate
|
733 hr*nmol/Liter
Interval 499.0 to 1080.0
|
554 hr*nmol/Liter
Interval 379.0 to 809.0
|
850 hr*nmol/Liter
Interval 538.0 to 1350.0
|
570 hr*nmol/Liter
Interval 404.0 to 804.0
|
487 hr*nmol/Liter
Interval 316.0 to 752.0
|
PRIMARY outcome
Timeframe: Predose and 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 120, 168, and 240 hours postdosePopulation: All participants of Panel A, B, C, and D who received at least a dose of study treatment and had data available for AUClast.
AUClast was defined as the area under the concentration-time curve of enlicitide decanoate from time zero to last measurable concentration. Blood for plasma samples was collected at pre-specified timepoints to determine the AUClast of enlicitide decanoate in Panel A, B, C, and D participants. Per protocol, Panel C ESRD on HD arm was separated into two arms: Panel C ESRD - enlicitide decanoate pre-hemodialysis and Panel C ESRD - enlicitide decanoate post-hemodialysis to report AUClast. Per protocol, mean AUClast was reported.
Outcome measures
| Measure |
Panel A: Moderate Renal Impairment (RI)
n=8 Participants
Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1.
|
Panel B: Severe RI
n=8 Participants
Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1.
|
Panel C: ESRD - Enlicitide Decanoate Pre-Hemodialysis
n=7 Participants
Participants received Enlicitide Decanoate 20 mg tablet orally on Day 1.
|
Panel C: ESRD - Enlicitide Decanoate Post-Hemodialysis
n=8 Participants
Participants received Enlicitide Decanoate 20 mg tablet orally on Day 16.
|
Panel D: Healthy Controls
n=8 Participants
Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1.
|
|---|---|---|---|---|---|
|
AUC From Time 0 to Last Measurable Concentration (AUClast) of Enlicitide Decanoate
|
735 hr*nmol/Liter
Interval 506.0 to 1070.0
|
362 hr*nmol/Liter
Interval 145.0 to 904.0
|
649 hr*nmol/Liter
Interval 343.0 to 1230.0
|
538 hr*nmol/Liter
Interval 376.0 to 769.0
|
456 hr*nmol/Liter
Interval 297.0 to 701.0
|
PRIMARY outcome
Timeframe: Predose and 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 120, 168, and 240 hours postdosePopulation: All participants of Panel A, B, C, and D who received at least a dose of study treatment and had data available for Cmax.
Cmax was defined as the maximum or peak concentration of enlicitide decanoate observed after its administration. Blood for plasma samples was collected at pre-specified time points to determine the Cmax of enlicitide decanoate in Panel A, B, C and D participants. Per protocol, Panel C ESRD on HD arm was separated into two arms: Panel C enlicitide decanoate pre-hemodialysis and Panel C enlicitide decanoate post-hemodialysis to report Cmax. Per protocol, mean Cmax was reported.
Outcome measures
| Measure |
Panel A: Moderate Renal Impairment (RI)
n=8 Participants
Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1.
|
Panel B: Severe RI
n=8 Participants
Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1.
|
Panel C: ESRD - Enlicitide Decanoate Pre-Hemodialysis
n=7 Participants
Participants received Enlicitide Decanoate 20 mg tablet orally on Day 1.
|
Panel C: ESRD - Enlicitide Decanoate Post-Hemodialysis
n=8 Participants
Participants received Enlicitide Decanoate 20 mg tablet orally on Day 16.
|
Panel D: Healthy Controls
n=8 Participants
Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1.
|
|---|---|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) of Enlicitide Decanoate
|
9.56 nmol/Liter
Interval 6.95 to 13.2
|
5.8 nmol/Liter
Interval 3.03 to 11.1
|
8.73 nmol/Liter
Interval 6.23 to 12.2
|
9.08 nmol/Liter
Interval 6.13 to 13.4
|
9.72 nmol/Liter
Interval 7.1 to 13.3
|
PRIMARY outcome
Timeframe: Predose and 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 120, 168, and 240 hours postdosePopulation: All participants of Panel A, B, C and D who received at least a dose of study treatment and had data available for Tmax.
Tmax was defined as the time required for a study drug to reach maximum concentration in plasma. Blood for plasma samples was collected at pre-specified time points to determine the Tmax of enlicitide decanoate in Panel A, B, C and D participants. Per protocol, Panel C ESRD on HD arm was separated into two arms: Panel C enlicitide decanoate pre-hemodialysis and Panel C enlicitide decanoate post-hemodialysis to report Tmax. Per protocol, mean Tmax was reported.
Outcome measures
| Measure |
Panel A: Moderate Renal Impairment (RI)
n=8 Participants
Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1.
|
Panel B: Severe RI
n=8 Participants
Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1.
|
Panel C: ESRD - Enlicitide Decanoate Pre-Hemodialysis
n=7 Participants
Participants received Enlicitide Decanoate 20 mg tablet orally on Day 1.
|
Panel C: ESRD - Enlicitide Decanoate Post-Hemodialysis
n=8 Participants
Participants received Enlicitide Decanoate 20 mg tablet orally on Day 16.
|
Panel D: Healthy Controls
n=8 Participants
Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1.
|
|---|---|---|---|---|---|
|
Time to Maximum Plasma Concentration (Tmax) of Enlicitide Decanoate
|
16 hours
Interval 1.0 to 24.25
|
2.75 hours
Interval 0.5 to 24.0
|
18.01 hours
Interval 0.5 to 48.0
|
1.00 hours
Interval 0.5 to 24.0
|
1.0 hours
Interval 0.5 to 12.03
|
PRIMARY outcome
Timeframe: Predose and 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 120, 168, and 240 hours postdosePopulation: All participants of Panel A, B, C, and D who received at least a dose of study treatment and had data available for the t1/2.
Half-life (t1/2) was defined as the time required for plasma drug concentration of enclitide decanoate to decrease by 50% from peak. Blood for plasma samples was collected at pre-specified time points to determine the t1/2 of enlicitide decanoate in Panel A, B, C and D participants. Per protocol, Panel C ESRD on HD arm was separated into two arms: Panel C enlicitide decanoate pre-hemodialysis and Panel C enlicitide decanoate post-hemodialysis to report t1/2. Per protocol, mean t1/2 was reported.
Outcome measures
| Measure |
Panel A: Moderate Renal Impairment (RI)
n=7 Participants
Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1.
|
Panel B: Severe RI
n=7 Participants
Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1.
|
Panel C: ESRD - Enlicitide Decanoate Pre-Hemodialysis
n=7 Participants
Participants received Enlicitide Decanoate 20 mg tablet orally on Day 1.
|
Panel C: ESRD - Enlicitide Decanoate Post-Hemodialysis
n=8 Participants
Participants received Enlicitide Decanoate 20 mg tablet orally on Day 16.
|
Panel D: Healthy Controls
n=8 Participants
Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1.
|
|---|---|---|---|---|---|
|
Apparent Terminal Half-life (t1/2) of Enlicitide Decanoate
|
81.5 hours
Geometric Coefficient of Variation 70.4
|
56.4 hours
Geometric Coefficient of Variation 32.7
|
53.6 hours
Geometric Coefficient of Variation 36.9
|
75.6 hours
Geometric Coefficient of Variation 62.9
|
46 hours
Geometric Coefficient of Variation 60.8
|
PRIMARY outcome
Timeframe: Predose and 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 120, 168, and 240 hours postdosePopulation: All participants of Panel A, B, C, and D who received at least a dose of study treatment and had data available for the CL/F.
CL/F was the apparent total clearance of enlicitide decanoate in plasma over time. Blood for plasma samples was collected at pre-specified timepoints to determine the CL/F of enlicitide decanoate for Panel A, B, C, and D participants. Per protocol, Panel C ESRD on HD arm was separated into two arms: Panel C enlicitide decanoate pre-hemodialysis and Panel C enlicitide decanoate post-hemodialysis to report CL/F. Per protocol, mean CL/F was reported.
Outcome measures
| Measure |
Panel A: Moderate Renal Impairment (RI)
n=7 Participants
Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1.
|
Panel B: Severe RI
n=7 Participants
Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1.
|
Panel C: ESRD - Enlicitide Decanoate Pre-Hemodialysis
n=7 Participants
Participants received Enlicitide Decanoate 20 mg tablet orally on Day 1.
|
Panel C: ESRD - Enlicitide Decanoate Post-Hemodialysis
n=8 Participants
Participants received Enlicitide Decanoate 20 mg tablet orally on Day 16.
|
Panel D: Healthy Controls
n=8 Participants
Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1.
|
|---|---|---|---|---|---|
|
Apparent Clearance (CL/F) of Enlicitide Decanoate
|
17.6 Liter/hr
Interval 12.0 to 25.9
|
23.3 Liter/hr
Interval 15.9 to 34.0
|
15.2 Liter/hr
Interval 9.58 to 24.0
|
22.6 Liter/hr
Interval 16.0 to 31.9
|
26.5 Liter/hr
Interval 17.2 to 40.8
|
PRIMARY outcome
Timeframe: Predose and 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 120, 168, and 240 hours postdosePopulation: All participants of Panel A, B, C, and D who received at least a dose of study treatment and had data available for the Vz/F.
Vz/F was the apparent volume of distribution of enlicitide decanoate between the plasma and the rest of the body, after dose, assessed as the total volume of enlicitide decanoate that would need to be uniformly distributed to achieve the desired plasma drug concentration. Blood for plasma samples was collected at pre-specified time points to determine the Vz/F of Enlicitide Decanoate in Panel A, B, C, and D participants. Per protocol, Panel C ESRD on HD arm was separated into two arms: Panel C enlicitide decanoate pre-hemodialysis and Panel C enlicitide decanoate post-hemodialysis to report Vz/F. Per protocol, mean Vz/F was reported.
Outcome measures
| Measure |
Panel A: Moderate Renal Impairment (RI)
n=7 Participants
Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1.
|
Panel B: Severe RI
n=7 Participants
Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1.
|
Panel C: ESRD - Enlicitide Decanoate Pre-Hemodialysis
n=7 Participants
Participants received Enlicitide Decanoate 20 mg tablet orally on Day 1.
|
Panel C: ESRD - Enlicitide Decanoate Post-Hemodialysis
n=8 Participants
Participants received Enlicitide Decanoate 20 mg tablet orally on Day 16.
|
Panel D: Healthy Controls
n=8 Participants
Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1.
|
|---|---|---|---|---|---|
|
Apparent Volume of Distribution (Vz/F) of Enlicitide Decanoate
|
2070 Liter
Interval 1370.0 to 3120.0
|
1890 Liter
Interval 1300.0 to 2760.0
|
1170 Liter
Interval 845.0 to 1620.0
|
2470 Liter
Interval 1680.0 to 3620.0
|
1760 Liter
Interval 1400.0 to 2210.0
|
SECONDARY outcome
Timeframe: Predose and 0, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, and 48 hours postdosePopulation: Per protocol all participants of Panel C who received at least a dose of study treatment and had data available were to be analyzed. However, no urine samples could be collected on Panel C participants, thus no data were reported.
CLd was the measure of the amount of enlicitide decanoate cleared from plasma via dialysis. Per protocol, Panel C ESRD on HD arm was separated into two arms: Panel C enlicitide decanoate pre-hemodialysis and Panel C enlicitide decanoate post-hemodialysis. Urine samples were to be collected for Panel C participants to determine mean CLd.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Predose and 0, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, and 48 hours postdosePopulation: Per protocol all participants of Panel C who received at least a dose of study treatment and had data available were to be analyzed. However, no urine samples could be collected on Panel C participants, thus no data were reported.
Cd was the measure of the concentration of enlicitide decanoate in dialysate. Per protocol, Panel C ESRD on HD arm was separated into two arms: Panel C enlicitide decanoate pre-hemodialysis and Panel C enlicitide decanoate post-hemodialysis. Urine samples were to be collected for Panel C participants to determine mean Cd.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Predose and 0, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, and 48 hours postdosePopulation: Per protocol all participants of Panel C who received at least a dose of study treatment and had data available were to be analyzed. However, no urine samples could be collected on Panel C participants, thus no data were reported.
AEd was the measure of the amount of enlicitide decanoate excreted in the dialysate. Per protocol, Panel C ESRD on HD arm was separated into two arms: Panel C enlicitide decanoate pre-hemodialysis and Panel C enlicitide decanoate post-hemodialysis. Urine samples were to be collected for Panel C participants to determine mean AEd.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Predose and 0, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, and 48 hours postdosePopulation: Per protocol all participants of Panel C who received at least a dose of study treatment and had data available were to be analyzed. However, no urine samples could be collected on Panel C participants, thus no data were reported.
%Dose was the percentage of the dose of enlicitide decanoate excreted in the dialysate. Per protocol, Panel C ESRD on HD arm was separated into two arms: Panel C enlicitide decanoate pre-hemodialysis and Panel C enlicitide decanoate post-hemodialysis. Urine samples were to be collected for Panel C participants to determine %Dose.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Predose and 0, 0.5, 1, 1.5, 2, 4, 8, 12, and 24 hours postdosePopulation: All participants from Panel A, B, C, and D who received a dose of study treatment and had data available for AE0-24 were to be analyzed. No urine samples were collected on Panel C participants; therefore, no data were reported for this group.
AE0-24 was the measure of the amount of enlicitide decanoate excreted at 0 to 24 hours. Urine samples were to be collected to determine the AE0-24 after administration of enlicitide decanoate for Panels A, B, C, and D. Per protocol, Panel C ESRD on HD arm was separated into two arms: Panel C enlicitide decanoate pre-hemodialysis and Panel C enlicitide decanoate post-hemodialysis to report AE0-24. Per protocol, mean AE0-24 was reported.
Outcome measures
| Measure |
Panel A: Moderate Renal Impairment (RI)
n=8 Participants
Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1.
|
Panel B: Severe RI
n=8 Participants
Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1.
|
Panel C: ESRD - Enlicitide Decanoate Pre-Hemodialysis
Participants received Enlicitide Decanoate 20 mg tablet orally on Day 1.
|
Panel C: ESRD - Enlicitide Decanoate Post-Hemodialysis
Participants received Enlicitide Decanoate 20 mg tablet orally on Day 16.
|
Panel D: Healthy Controls
n=8 Participants
Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1.
|
|---|---|---|---|---|---|
|
Amount of Enlicitide Decanoate Excreted in Urine From 0 to 24 Hours (AE0-24) After Administration of Enlicitide Decanoate
|
0.0213 mg
Interval 0.00846 to 0.0538
|
0.00592 mg
Interval 0.00211 to 0.0166
|
—
|
—
|
0.0662 mg
Interval 0.0371 to 0.118
|
SECONDARY outcome
Timeframe: Predose and 0, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, and 48 hours postdosePopulation: All participants from Panel A, B, C, and D who received a dose of study treatment and had data available for Fe were to be analyzed. No urine samples were collected on Panel C participants; therefore, no data were reported for this group.
Fe was the measure of the percentage of unchanged enlicitide decanoate excreted in the urine. The percentage of enlicitide decanoate that was excreted unchanged in urine over the 24-hr collection interval (Fe) was calculated as 100 times the ratio of Ae0-24 and dose. Urine samples were to be collected to determine the Fe after administration of enlicitide decanoate for Panels A, B, C, and D. Per protocol, Panel C ESRD on HD arm was separated into two arms: Panel C enlicitide decanoate pre-hemodialysis and Panel C enlicitide decanoate post-hemodialysis to report Fe.
Outcome measures
| Measure |
Panel A: Moderate Renal Impairment (RI)
n=8 Participants
Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1.
|
Panel B: Severe RI
n=8 Participants
Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1.
|
Panel C: ESRD - Enlicitide Decanoate Pre-Hemodialysis
Participants received Enlicitide Decanoate 20 mg tablet orally on Day 1.
|
Panel C: ESRD - Enlicitide Decanoate Post-Hemodialysis
Participants received Enlicitide Decanoate 20 mg tablet orally on Day 16.
|
Panel D: Healthy Controls
n=8 Participants
Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1.
|
|---|---|---|---|---|---|
|
Percentage of Unchanged Enlicitide Decanoate Excreted in Urine (Fe)
|
0.107 Percentage of Enlicitide Decanoate
Interval 0.0423 to 0.269
|
0.0296 Percentage of Enlicitide Decanoate
Interval 0.0105 to 0.0831
|
—
|
—
|
0.331 Percentage of Enlicitide Decanoate
Interval 0.185 to 0.591
|
SECONDARY outcome
Timeframe: Predose and 0, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, and 48 hours postdosePopulation: All participants from Panel A, B, C, and D who received a dose of study treatment and had data available for CLr were to be analyzed. No urine samples were collected on Panel C participants; therefore, no data were reported for this group.
CLr was the measure of how quickly enlicitide decanoate was removed from the plasma by the kidney and excreted in urine. Urine samples were to be collected to determine the CLr after administration of enlicitide decanoate for Panels A, B, C, and D. Per protocol, Panel C ESRD on HD arm was separated into two arms: Panel C enlicitide decanoate pre-hemodialysis and Panel C enlicitide decanoate post-hemodialysis to report CLr. Per protocol, mean CLr was reported.
Outcome measures
| Measure |
Panel A: Moderate Renal Impairment (RI)
n=8 Participants
Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1.
|
Panel B: Severe RI
n=8 Participants
Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1.
|
Panel C: ESRD - Enlicitide Decanoate Pre-Hemodialysis
Participants received Enlicitide Decanoate 20 mg tablet orally on Day 1.
|
Panel C: ESRD - Enlicitide Decanoate Post-Hemodialysis
Participants received Enlicitide Decanoate 20 mg tablet orally on Day 16.
|
Panel D: Healthy Controls
n=8 Participants
Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1.
|
|---|---|---|---|---|---|
|
Renal Clearance (CLr) of Enlicitide Decanoate
|
0.0716 Liter/hr
Interval 0.0349 to 0.147
|
0.0347 Liter/hr
Interval 0.0114 to 0.106
|
—
|
—
|
0.243 Liter/hr
Interval 0.161 to 0.366
|
SECONDARY outcome
Timeframe: Up to approximately 30 daysPopulation: All allocated participants who received a dose of study treatment. Per protocol, AEs were not collected separately for Panel C ESRD - Enlicitide Decanoate pre-hemodialysis and Panel C ESRD Enlicitide Decanoate post-hemodialysis arms.
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 unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who experienced an AE were reported.
Outcome measures
| Measure |
Panel A: Moderate Renal Impairment (RI)
n=8 Participants
Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1.
|
Panel B: Severe RI
n=8 Participants
Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1.
|
Panel C: ESRD - Enlicitide Decanoate Pre-Hemodialysis
n=9 Participants
Participants received Enlicitide Decanoate 20 mg tablet orally on Day 1.
|
Panel C: ESRD - Enlicitide Decanoate Post-Hemodialysis
n=8 Participants
Participants received Enlicitide Decanoate 20 mg tablet orally on Day 16.
|
Panel D: Healthy Controls
Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1.
|
|---|---|---|---|---|---|
|
Number of Participants Who Experienced an Adverse Event (AE)
|
2 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 30 daysPopulation: All allocated participants in Panels A, B and D who received a dose of study treatment.
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 unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of Panel A, B, and D participants who discontinued study treatment due to an AE were reported.
Outcome measures
| Measure |
Panel A: Moderate Renal Impairment (RI)
n=8 Participants
Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1.
|
Panel B: Severe RI
n=8 Participants
Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1.
|
Panel C: ESRD - Enlicitide Decanoate Pre-Hemodialysis
n=8 Participants
Participants received Enlicitide Decanoate 20 mg tablet orally on Day 1.
|
Panel C: ESRD - Enlicitide Decanoate Post-Hemodialysis
Participants received Enlicitide Decanoate 20 mg tablet orally on Day 16.
|
Panel D: Healthy Controls
Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1.
|
|---|---|---|---|---|---|
|
Panels A, B, and D: Number of Participants Who Discontinued From the Study Due to an AE
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 30 daysPopulation: All allocated participants in Panels C who received a dose of study treatment. Per protocol, AEs were not collected separately for Panel C ESRD - Enlicitide Decanoate pre-hemodialysis and Panel C ESRD Enlicitide Decanoate post-hemodialysis arms.
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 unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of Panel C participants who discontinued study treatment due to an AE were reported.
Outcome measures
| Measure |
Panel A: Moderate Renal Impairment (RI)
n=9 Participants
Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1.
|
Panel B: Severe RI
Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1.
|
Panel C: ESRD - Enlicitide Decanoate Pre-Hemodialysis
Participants received Enlicitide Decanoate 20 mg tablet orally on Day 1.
|
Panel C: ESRD - Enlicitide Decanoate Post-Hemodialysis
Participants received Enlicitide Decanoate 20 mg tablet orally on Day 16.
|
Panel D: Healthy Controls
Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1.
|
|---|---|---|---|---|---|
|
Panel C: Number of Participants Who Discontinued From the Study Treatment Due to an AE
|
0 Participants
|
—
|
—
|
—
|
—
|
Adverse Events
Panel A: Moderate Renal Impairment (RI)
Panel B: Severe RI
Panel C: End-Stage Renal Disease (ESRD) on Hemodialysis (HD)
Panel D: Healthy Controls
Serious adverse events
| Measure |
Panel A: Moderate Renal Impairment (RI)
n=8 participants at risk
Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1.
|
Panel B: Severe RI
n=8 participants at risk
Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1.
|
Panel C: End-Stage Renal Disease (ESRD) on Hemodialysis (HD)
n=9 participants at risk
Participants received Enlicitide Decanoate 20 mg tablet orally on Day 1 and Day 16.
|
Panel D: Healthy Controls
n=8 participants at risk
Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1.
|
|---|---|---|---|---|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.00%
0/8 • Up to approximately 30 days
All-Cause Mortality reported for all allocated participants. Serious and non-serious adverse events (AEs) were reported on all allocated participants who received a dose of study treatment. Per protocol, All-cause mortality, serious and non-serious AEs were not collected separately for Panel C ESRD - Enlicitide Decanoate pre-hemodialysis and Panel C ESRD Enlicitide Decanoate post-hemodialysis arms.
|
0.00%
0/8 • Up to approximately 30 days
All-Cause Mortality reported for all allocated participants. Serious and non-serious adverse events (AEs) were reported on all allocated participants who received a dose of study treatment. Per protocol, All-cause mortality, serious and non-serious AEs were not collected separately for Panel C ESRD - Enlicitide Decanoate pre-hemodialysis and Panel C ESRD Enlicitide Decanoate post-hemodialysis arms.
|
11.1%
1/9 • Number of events 1 • Up to approximately 30 days
All-Cause Mortality reported for all allocated participants. Serious and non-serious adverse events (AEs) were reported on all allocated participants who received a dose of study treatment. Per protocol, All-cause mortality, serious and non-serious AEs were not collected separately for Panel C ESRD - Enlicitide Decanoate pre-hemodialysis and Panel C ESRD Enlicitide Decanoate post-hemodialysis arms.
|
0.00%
0/8 • Up to approximately 30 days
All-Cause Mortality reported for all allocated participants. Serious and non-serious adverse events (AEs) were reported on all allocated participants who received a dose of study treatment. Per protocol, All-cause mortality, serious and non-serious AEs were not collected separately for Panel C ESRD - Enlicitide Decanoate pre-hemodialysis and Panel C ESRD Enlicitide Decanoate post-hemodialysis arms.
|
Other adverse events
| Measure |
Panel A: Moderate Renal Impairment (RI)
n=8 participants at risk
Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1.
|
Panel B: Severe RI
n=8 participants at risk
Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1.
|
Panel C: End-Stage Renal Disease (ESRD) on Hemodialysis (HD)
n=9 participants at risk
Participants received Enlicitide Decanoate 20 mg tablet orally on Day 1 and Day 16.
|
Panel D: Healthy Controls
n=8 participants at risk
Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Dry mouth
|
12.5%
1/8 • Number of events 1 • Up to approximately 30 days
All-Cause Mortality reported for all allocated participants. Serious and non-serious adverse events (AEs) were reported on all allocated participants who received a dose of study treatment. Per protocol, All-cause mortality, serious and non-serious AEs were not collected separately for Panel C ESRD - Enlicitide Decanoate pre-hemodialysis and Panel C ESRD Enlicitide Decanoate post-hemodialysis arms.
|
0.00%
0/8 • Up to approximately 30 days
All-Cause Mortality reported for all allocated participants. Serious and non-serious adverse events (AEs) were reported on all allocated participants who received a dose of study treatment. Per protocol, All-cause mortality, serious and non-serious AEs were not collected separately for Panel C ESRD - Enlicitide Decanoate pre-hemodialysis and Panel C ESRD Enlicitide Decanoate post-hemodialysis arms.
|
0.00%
0/9 • Up to approximately 30 days
All-Cause Mortality reported for all allocated participants. Serious and non-serious adverse events (AEs) were reported on all allocated participants who received a dose of study treatment. Per protocol, All-cause mortality, serious and non-serious AEs were not collected separately for Panel C ESRD - Enlicitide Decanoate pre-hemodialysis and Panel C ESRD Enlicitide Decanoate post-hemodialysis arms.
|
0.00%
0/8 • Up to approximately 30 days
All-Cause Mortality reported for all allocated participants. Serious and non-serious adverse events (AEs) were reported on all allocated participants who received a dose of study treatment. Per protocol, All-cause mortality, serious and non-serious AEs were not collected separately for Panel C ESRD - Enlicitide Decanoate pre-hemodialysis and Panel C ESRD Enlicitide Decanoate post-hemodialysis arms.
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/8 • Up to approximately 30 days
All-Cause Mortality reported for all allocated participants. Serious and non-serious adverse events (AEs) were reported on all allocated participants who received a dose of study treatment. Per protocol, All-cause mortality, serious and non-serious AEs were not collected separately for Panel C ESRD - Enlicitide Decanoate pre-hemodialysis and Panel C ESRD Enlicitide Decanoate post-hemodialysis arms.
|
12.5%
1/8 • Number of events 1 • Up to approximately 30 days
All-Cause Mortality reported for all allocated participants. Serious and non-serious adverse events (AEs) were reported on all allocated participants who received a dose of study treatment. Per protocol, All-cause mortality, serious and non-serious AEs were not collected separately for Panel C ESRD - Enlicitide Decanoate pre-hemodialysis and Panel C ESRD Enlicitide Decanoate post-hemodialysis arms.
|
0.00%
0/9 • Up to approximately 30 days
All-Cause Mortality reported for all allocated participants. Serious and non-serious adverse events (AEs) were reported on all allocated participants who received a dose of study treatment. Per protocol, All-cause mortality, serious and non-serious AEs were not collected separately for Panel C ESRD - Enlicitide Decanoate pre-hemodialysis and Panel C ESRD Enlicitide Decanoate post-hemodialysis arms.
|
0.00%
0/8 • Up to approximately 30 days
All-Cause Mortality reported for all allocated participants. Serious and non-serious adverse events (AEs) were reported on all allocated participants who received a dose of study treatment. Per protocol, All-cause mortality, serious and non-serious AEs were not collected separately for Panel C ESRD - Enlicitide Decanoate pre-hemodialysis and Panel C ESRD Enlicitide Decanoate post-hemodialysis arms.
|
|
Vascular disorders
Hypertension
|
12.5%
1/8 • Number of events 1 • Up to approximately 30 days
All-Cause Mortality reported for all allocated participants. Serious and non-serious adverse events (AEs) were reported on all allocated participants who received a dose of study treatment. Per protocol, All-cause mortality, serious and non-serious AEs were not collected separately for Panel C ESRD - Enlicitide Decanoate pre-hemodialysis and Panel C ESRD Enlicitide Decanoate post-hemodialysis arms.
|
0.00%
0/8 • Up to approximately 30 days
All-Cause Mortality reported for all allocated participants. Serious and non-serious adverse events (AEs) were reported on all allocated participants who received a dose of study treatment. Per protocol, All-cause mortality, serious and non-serious AEs were not collected separately for Panel C ESRD - Enlicitide Decanoate pre-hemodialysis and Panel C ESRD Enlicitide Decanoate post-hemodialysis arms.
|
0.00%
0/9 • Up to approximately 30 days
All-Cause Mortality reported for all allocated participants. Serious and non-serious adverse events (AEs) were reported on all allocated participants who received a dose of study treatment. Per protocol, All-cause mortality, serious and non-serious AEs were not collected separately for Panel C ESRD - Enlicitide Decanoate pre-hemodialysis and Panel C ESRD Enlicitide Decanoate post-hemodialysis arms.
|
0.00%
0/8 • Up to approximately 30 days
All-Cause Mortality reported for all allocated participants. Serious and non-serious adverse events (AEs) were reported on all allocated participants who received a dose of study treatment. Per protocol, All-cause mortality, serious and non-serious AEs were not collected separately for Panel C ESRD - Enlicitide Decanoate pre-hemodialysis and Panel C ESRD Enlicitide Decanoate post-hemodialysis arms.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/8 • Up to approximately 30 days
All-Cause Mortality reported for all allocated participants. Serious and non-serious adverse events (AEs) were reported on all allocated participants who received a dose of study treatment. Per protocol, All-cause mortality, serious and non-serious AEs were not collected separately for Panel C ESRD - Enlicitide Decanoate pre-hemodialysis and Panel C ESRD Enlicitide Decanoate post-hemodialysis arms.
|
12.5%
1/8 • Number of events 1 • Up to approximately 30 days
All-Cause Mortality reported for all allocated participants. Serious and non-serious adverse events (AEs) were reported on all allocated participants who received a dose of study treatment. Per protocol, All-cause mortality, serious and non-serious AEs were not collected separately for Panel C ESRD - Enlicitide Decanoate pre-hemodialysis and Panel C ESRD Enlicitide Decanoate post-hemodialysis arms.
|
0.00%
0/9 • Up to approximately 30 days
All-Cause Mortality reported for all allocated participants. Serious and non-serious adverse events (AEs) were reported on all allocated participants who received a dose of study treatment. Per protocol, All-cause mortality, serious and non-serious AEs were not collected separately for Panel C ESRD - Enlicitide Decanoate pre-hemodialysis and Panel C ESRD Enlicitide Decanoate post-hemodialysis arms.
|
0.00%
0/8 • Up to approximately 30 days
All-Cause Mortality reported for all allocated participants. Serious and non-serious adverse events (AEs) were reported on all allocated participants who received a dose of study treatment. Per protocol, All-cause mortality, serious and non-serious AEs were not collected separately for Panel C ESRD - Enlicitide Decanoate pre-hemodialysis and Panel C ESRD Enlicitide Decanoate post-hemodialysis arms.
|
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 manuscripts or abstracts before submission. Any information identified by the sponsor as confidential must be deleted prior to submission.
- Publication restrictions are in place
Restriction type: OTHER