Ignite Creation Date:
2025-12-24 @ 3:45 PM
Ignite Modification Date:
2025-12-27 @ 5:56 AM
Study NCT ID:
NCT05934292
Status:
COMPLETED
Last Update Posted:
2025-02-17
First Post:
2023-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) Renal Impairment Study (MK-0616-020)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006937', 'term': 'Hypercholesterolemia'}], 'ancestors': [{'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000728674', 'term': 'MK-0616'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@msd.com', 'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme LLC'}, 'certainAgreement': {'otherDetails': '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.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to approximately 30 days', 'description': '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.', 'eventGroups': [{'id': 'EG000', 'title': 'Panel A: Moderate Renal Impairment (RI)', 'description': 'Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1.', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 2, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Panel B: Severe RI', 'description': 'Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1.', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 2, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Panel C: End-Stage Renal Disease (ESRD) on Hemodialysis (HD)', 'description': 'Participants received Enlicitide Decanoate 20 mg tablet orally on Day 1 and Day 16.', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 0, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Panel D: Healthy Controls', 'description': 'Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1.', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 0, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Animal bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}], 'seriousEvents': [{'term': 'Hypervolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-Inf) of Enlicitide Decanoate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Panel A: Moderate Renal Impairment (RI)', 'description': 'Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1.'}, {'id': 'OG001', 'title': 'Panel B: Severe RI', 'description': 'Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1.'}, {'id': 'OG002', 'title': 'Panel C: ESRD - Enlicitide Decanoate Pre-Hemodialysis', 'description': 'Participants received Enlicitide Decanoate 20 mg tablet orally on Day 1.'}, {'id': 'OG003', 'title': 'Panel C: ESRD - Enlicitide Decanoate Post-Hemodialysis', 'description': 'Participants received Enlicitide Decanoate 20 mg tablet orally on Day 16.'}, {'id': 'OG004', 'title': 'Panel D: Healthy Controls', 'description': 'Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '733', 'groupId': 'OG000', 'lowerLimit': '499', 'upperLimit': '1080'}, {'value': '554', 'groupId': 'OG001', 'lowerLimit': '379', 'upperLimit': '809'}, {'value': '850', 'groupId': 'OG002', 'lowerLimit': '538', 'upperLimit': '1350'}, {'value': '570', 'groupId': 'OG003', 'lowerLimit': '404', 'upperLimit': '804'}, {'value': '487', 'groupId': 'OG004', 'lowerLimit': '316', 'upperLimit': '752'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG004'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.50', 'ciLowerLimit': '0.98', 'ciUpperLimit': '2.31', 'estimateComment': 'Geometric mean ratio (GMR) and 90% confidence interval (CI) were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel A-Moderate Renal Impairment (RI)/Panel D-Healthy controls', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG004'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.14', 'ciLowerLimit': '0.74', 'ciUpperLimit': '1.74', 'estimateComment': 'GMR and 90% confidence interval (CI) were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel B-Severe RI/Panel D-Healthy controls', 'statisticalMethod': 'Geometric Mean Ratio', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG004'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.75', 'ciLowerLimit': '1.10', 'ciUpperLimit': '2.78', 'estimateComment': 'GMR and 90% CI were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel C-ESRD Enlicitide Decanoate Pre-Hemodialysis/ Panel D-Healthy Controls', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG003', 'OG004'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.17', 'ciLowerLimit': '0.77', 'ciUpperLimit': '1.77', 'estimateComment': 'GMR and 90% CI were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel C-ESRD Enlicitide Decanoate Post-Hemodialysis/ Panel D-Healthy Controls', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose and 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 120, 168, and 240 hours postdose', 'description': '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.', 'unitOfMeasure': 'hr*nmol/Liter', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'AUC From Time 0 to Last Measurable Concentration (AUClast) of Enlicitide Decanoate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Panel A: Moderate Renal Impairment (RI)', 'description': 'Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1.'}, {'id': 'OG001', 'title': 'Panel B: Severe RI', 'description': 'Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1.'}, {'id': 'OG002', 'title': 'Panel C: ESRD - Enlicitide Decanoate Pre-Hemodialysis', 'description': 'Participants received Enlicitide Decanoate 20 mg tablet orally on Day 1.'}, {'id': 'OG003', 'title': 'Panel C: ESRD - Enlicitide Decanoate Post-Hemodialysis', 'description': 'Participants received Enlicitide Decanoate 20 mg tablet orally on Day 16.'}, {'id': 'OG004', 'title': 'Panel D: Healthy Controls', 'description': 'Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '735', 'groupId': 'OG000', 'lowerLimit': '506', 'upperLimit': '1070'}, {'value': '362', 'groupId': 'OG001', 'lowerLimit': '145', 'upperLimit': '904'}, {'value': '649', 'groupId': 'OG002', 'lowerLimit': '343', 'upperLimit': '1230'}, {'value': '538', 'groupId': 'OG003', 'lowerLimit': '376', 'upperLimit': '769'}, {'value': '456', 'groupId': 'OG004', 'lowerLimit': '297', 'upperLimit': '701'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG004'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.61', 'ciLowerLimit': '1.05', 'ciUpperLimit': '2.46', 'estimateComment': 'GMR and 90% confidence interval (CI) were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel A-Moderate Renal Impairment (RI)/Panel D-Healthy controls', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG004'], 'paramType': 'Geometric Mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.79', 'ciLowerLimit': '0.37', 'ciUpperLimit': '1.72', 'estimateComment': 'GMR and 90% confidence interval (CI) were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel B-Severe RI/Panel D-Healthy controls', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG004'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.42', 'ciLowerLimit': '0.80', 'ciUpperLimit': '2.54', 'estimateComment': 'GMR and 90% CI were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel C-ESRD Enlicitide Decanoate Pre-Hemodialysis/ Panel D-Healthy Controls', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG003', 'OG004'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.18', 'ciLowerLimit': '0.78', 'ciUpperLimit': '1.78', 'estimateComment': 'GMR and 90% CI were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel C-ESRD Enlicitide Decanoate Post-Hemodialysis/ Panel D-Healthy Controls', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose and 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 120, 168, and 240 hours postdose', 'description': '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.', 'unitOfMeasure': 'hr*nmol/Liter', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants of Panel A, B, C, and D who received at least a dose of study treatment and had data available for AUClast.'}, {'type': 'PRIMARY', 'title': 'Maximum Plasma Concentration (Cmax) of Enlicitide Decanoate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Panel A: Moderate Renal Impairment (RI)', 'description': 'Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1.'}, {'id': 'OG001', 'title': 'Panel B: Severe RI', 'description': 'Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1.'}, {'id': 'OG002', 'title': 'Panel C: ESRD - Enlicitide Decanoate Pre-Hemodialysis', 'description': 'Participants received Enlicitide Decanoate 20 mg tablet orally on Day 1.'}, {'id': 'OG003', 'title': 'Panel C: ESRD - Enlicitide Decanoate Post-Hemodialysis', 'description': 'Participants received Enlicitide Decanoate 20 mg tablet orally on Day 16.'}, {'id': 'OG004', 'title': 'Panel D: Healthy Controls', 'description': 'Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.56', 'groupId': 'OG000', 'lowerLimit': '6.95', 'upperLimit': '13.2'}, {'value': '5.8', 'groupId': 'OG001', 'lowerLimit': '3.03', 'upperLimit': '11.1'}, {'value': '8.73', 'groupId': 'OG002', 'lowerLimit': '6.23', 'upperLimit': '12.2'}, {'value': '9.08', 'groupId': 'OG003', 'lowerLimit': '6.13', 'upperLimit': '13.4'}, {'value': '9.72', 'groupId': 'OG004', 'lowerLimit': '7.1', 'upperLimit': '13.3'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG004'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.98', 'ciLowerLimit': '0.71', 'ciUpperLimit': '1.37', 'estimateComment': 'GMR and 90% confidence interval (CI) were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel A-Moderate Renal Impairment (RI)/Panel D-Healthy controls.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG004'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.60', 'ciLowerLimit': '0.34', 'ciUpperLimit': '1.04', 'estimateComment': 'GMR and 90% confidence interval (CI) were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel B-Severe RI/Panel D-Healthy controls.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG004'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.90', 'ciLowerLimit': '0.64', 'ciUpperLimit': '1.27', 'estimateComment': 'GMR and 90% confidence interval (CI) were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel C-ESRD Enlicitide Decanoate Pre-Hemodialysis/ Panel D-Healthy Controls.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG003', 'OG004'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.18', 'ciLowerLimit': '0.78', 'ciUpperLimit': '1.78', 'estimateComment': 'GMR and 90% confidence interval (CI) were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel C-ESRD Enlicitide Decanoate Post-Hemodialysis/ Panel D-Healthy Controls.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose and 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 120, 168, and 240 hours postdose', 'description': '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.', 'unitOfMeasure': 'nmol/Liter', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants of Panel A, B, C, and D who received at least a dose of study treatment and had data available for Cmax.'}, {'type': 'PRIMARY', 'title': 'Time to Maximum Plasma Concentration (Tmax) of Enlicitide Decanoate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Panel A: Moderate Renal Impairment (RI)', 'description': 'Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1.'}, {'id': 'OG001', 'title': 'Panel B: Severe RI', 'description': 'Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1.'}, {'id': 'OG002', 'title': 'Panel C: ESRD - Enlicitide Decanoate Pre-Hemodialysis', 'description': 'Participants received Enlicitide Decanoate 20 mg tablet orally on Day 1.'}, {'id': 'OG003', 'title': 'Panel C: ESRD - Enlicitide Decanoate Post-Hemodialysis', 'description': 'Participants received Enlicitide Decanoate 20 mg tablet orally on Day 16.'}, {'id': 'OG004', 'title': 'Panel D: Healthy Controls', 'description': 'Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '24.25'}, {'value': '2.75', 'groupId': 'OG001', 'lowerLimit': '0.5', 'upperLimit': '24'}, {'value': '18.01', 'groupId': 'OG002', 'lowerLimit': '0.50', 'upperLimit': '48'}, {'value': '1.00', 'groupId': 'OG003', 'lowerLimit': '0.50', 'upperLimit': '24'}, {'value': '1.0', 'groupId': 'OG004', 'lowerLimit': '0.5', 'upperLimit': '12.03'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Predose and 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 120, 168, and 240 hours postdose', 'description': '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.', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants of Panel A, B, C and D who received at least a dose of study treatment and had data available for Tmax.'}, {'type': 'PRIMARY', 'title': 'Apparent Terminal Half-life (t1/2) of Enlicitide Decanoate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Panel A: Moderate Renal Impairment (RI)', 'description': 'Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1.'}, {'id': 'OG001', 'title': 'Panel B: Severe RI', 'description': 'Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1.'}, {'id': 'OG002', 'title': 'Panel C: ESRD - Enlicitide Decanoate Pre-Hemodialysis', 'description': 'Participants received Enlicitide Decanoate 20 mg tablet orally on Day 1.'}, {'id': 'OG003', 'title': 'Panel C: ESRD - Enlicitide Decanoate Post-Hemodialysis', 'description': 'Participants received Enlicitide Decanoate 20 mg tablet orally on Day 16.'}, {'id': 'OG004', 'title': 'Panel D: Healthy Controls', 'description': 'Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '81.5', 'spread': '70.4', 'groupId': 'OG000'}, {'value': '56.4', 'spread': '32.7', 'groupId': 'OG001'}, {'value': '53.6', 'spread': '36.9', 'groupId': 'OG002'}, {'value': '75.6', 'spread': '62.9', 'groupId': 'OG003'}, {'value': '46', 'spread': '60.8', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose and 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 120, 168, and 240 hours postdose', 'description': '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.', 'unitOfMeasure': 'hours', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Apparent Clearance (CL/F) of Enlicitide Decanoate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Panel A: Moderate Renal Impairment (RI)', 'description': 'Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1.'}, {'id': 'OG001', 'title': 'Panel B: Severe RI', 'description': 'Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1.'}, {'id': 'OG002', 'title': 'Panel C: ESRD - Enlicitide Decanoate Pre-Hemodialysis', 'description': 'Participants received Enlicitide Decanoate 20 mg tablet orally on Day 1.'}, {'id': 'OG003', 'title': 'Panel C: ESRD - Enlicitide Decanoate Post-Hemodialysis', 'description': 'Participants received Enlicitide Decanoate 20 mg tablet orally on Day 16.'}, {'id': 'OG004', 'title': 'Panel D: Healthy Controls', 'description': 'Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.6', 'groupId': 'OG000', 'lowerLimit': '12', 'upperLimit': '25.9'}, {'value': '23.3', 'groupId': 'OG001', 'lowerLimit': '15.9', 'upperLimit': '34'}, {'value': '15.2', 'groupId': 'OG002', 'lowerLimit': '9.58', 'upperLimit': '24'}, {'value': '22.6', 'groupId': 'OG003', 'lowerLimit': '16', 'upperLimit': '31.9'}, {'value': '26.5', 'groupId': 'OG004', 'lowerLimit': '17.2', 'upperLimit': '40.8'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG004'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.67', 'ciLowerLimit': '0.43', 'ciUpperLimit': '1.02', 'estimateComment': 'GMR and 90% CI were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel A-Moderate Renal Impairment (RI)/Panel D-Healthy controls', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG004'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.88', 'ciLowerLimit': '0.58', 'ciUpperLimit': '1.35', 'estimateComment': 'GMR and 90% confidence interval (CI) were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel B-Severe RI/Panel D-Healthy controls', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG004'], 'paramType': 'Geomtric Mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.57', 'ciLowerLimit': '0.36', 'ciUpperLimit': '0.91', 'estimateComment': 'GMR and 90% CI were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel C-ESRD Enlicitide Decanoate Pre-Hemodialysis/ Panel D-Healthy Controls', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG003', 'OG004'], 'paramType': 'Geomtric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.86', 'ciLowerLimit': '0.57', 'ciUpperLimit': '1.29', 'estimateComment': 'GMR and 90% CI were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel C-ESRD Enlicitide Decanoate Post-Hemodialysis/ Panel D-Healthy Controls', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose and 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 120, 168, and 240 hours postdose', 'description': '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.', 'unitOfMeasure': 'Liter/hr', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Apparent Volume of Distribution (Vz/F) of Enlicitide Decanoate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Panel A: Moderate Renal Impairment (RI)', 'description': 'Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1.'}, {'id': 'OG001', 'title': 'Panel B: Severe RI', 'description': 'Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1.'}, {'id': 'OG002', 'title': 'Panel C: ESRD - Enlicitide Decanoate Pre-Hemodialysis', 'description': 'Participants received Enlicitide Decanoate 20 mg tablet orally on Day 1.'}, {'id': 'OG003', 'title': 'Panel C: ESRD - Enlicitide Decanoate Post-Hemodialysis', 'description': 'Participants received Enlicitide Decanoate 20 mg tablet orally on Day 16.'}, {'id': 'OG004', 'title': 'Panel D: Healthy Controls', 'description': 'Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '2070', 'groupId': 'OG000', 'lowerLimit': '1370', 'upperLimit': '3120'}, {'value': '1890', 'groupId': 'OG001', 'lowerLimit': '1300', 'upperLimit': '2760'}, {'value': '1170', 'groupId': 'OG002', 'lowerLimit': '845', 'upperLimit': '1620'}, {'value': '2470', 'groupId': 'OG003', 'lowerLimit': '1680', 'upperLimit': '3620'}, {'value': '1760', 'groupId': 'OG004', 'lowerLimit': '1400', 'upperLimit': '2210'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG004'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.18', 'ciLowerLimit': '0.83', 'ciUpperLimit': '1.67', 'estimateComment': 'GMR and 90% CI were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel A-Moderate Renal Impairment (RI)/Panel D-Healthy controls', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG004'], 'paramType': 'Geometric Mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.08', 'ciLowerLimit': '0.78', 'ciUpperLimit': '1.50', 'estimateComment': 'GMR and 90% confidence interval (CI) were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel B-Severe RI/Panel D-Healthy controls', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG004'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.66', 'ciLowerLimit': '0.50', 'ciUpperLimit': '0.89', 'estimateComment': 'GMR and 90% CI were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel C-ESRD Enlicitide Decanoate Pre-Hemodialysis/ Panel D-Healthy Controls', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG003', 'OG004'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.40', 'ciLowerLimit': '1.00', 'ciUpperLimit': '1.97', 'estimateComment': 'GMR and 90% CI for AUC0-inf were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel C-ESRD Enlicitide Decanoate Post-Hemodialysis/ Panel D-Healthy Controls', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose and 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 120, 168, and 240 hours postdose', 'description': '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.', 'unitOfMeasure': 'Liter', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Panel C: Dialysate Clearance (CLd) of Enlicitide Decanoate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Panel C: ESRD - Enlicitide Decanoate Pre-Hemodialysis', 'description': 'Participants received Enlicitide Decanoate 20 mg tablet orally on Day 1.'}, {'id': 'OG001', 'title': 'Panel C: ESRD - Enlicitide Decanoate Post-Hemodialysis', 'description': 'Participants received Enlicitide Decanoate 20 mg tablet orally on Day 16.'}], 'timeFrame': 'Predose and 0, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, and 48 hours postdose', 'description': '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.', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Panel C: Dialysate Concentration (Cd) of Enlicitide Decanoate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Panel C: ESRD - Enlicitide Decanoate Pre-Hemodialysis', 'description': 'Participants received Enlicitide Decanoate 20 mg tablet orally on Day 1.'}, {'id': 'OG001', 'title': 'Panel C: ESRD - Enlicitide Decanoate Post-hemodialysis', 'description': 'Participants received Enlicitide Decanoate 20 mg tablet orally on Day 16.'}], 'timeFrame': 'Predose and 0, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, and 48 hours postdose', 'description': '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.', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Panel C: Amount of Enlicitide Decanoate Excreted (AEd) in Dialysate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Panel C: ESRD - Enlicitide Decanoate Pre-Hemodialysis', 'description': 'Participants received Enlicitide Decanoate 20 mg tablet orally on Day 1.'}, {'id': 'OG001', 'title': 'Panel C: ESRD - Enlicitide Decanoate Post-hemodialysis', 'description': 'Participants received Enlicitide Decanoate 20 mg tablet orally on Day 16.'}], 'timeFrame': 'Predose and 0, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, and 48 hours postdose', 'description': '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.', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Panel C: Percentage of Dose (%Dose) of Enlicitide Decanoate Excreted in Dialysate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Panel C: ESRD - Enlicitide Decanoate Pre-Hemodialysis', 'description': 'Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1.'}, {'id': 'OG001', 'title': 'Panel C: ESRD - Enlicitide Decanoate Post-hemodialysis', 'description': 'Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 16.'}], 'timeFrame': 'Predose and 0, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, and 48 hours postdose', 'description': '%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.', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Amount of Enlicitide Decanoate Excreted in Urine From 0 to 24 Hours (AE0-24) After Administration of Enlicitide Decanoate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Panel A: Moderate Renal Impairment (RI)', 'description': 'Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1.'}, {'id': 'OG001', 'title': 'Panel B: Severe RI', 'description': 'Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1.'}, {'id': 'OG002', 'title': 'Panel C: ESRD - Enlicitide Decanoate Pre-Hemodialysis', 'description': 'Participants received Enlicitide Decanoate 20 mg tablet orally on Day 1.'}, {'id': 'OG003', 'title': 'Panel C: ESRD - Enlicitide Decanoate Post-Hemodialysis', 'description': 'Participants received Enlicitide Decanoate 20 mg tablet orally on Day 16.'}, {'id': 'OG004', 'title': 'Panel D: Healthy Controls', 'description': 'Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0213', 'groupId': 'OG000', 'lowerLimit': '0.00846', 'upperLimit': '0.0538'}, {'value': '0.00592', 'groupId': 'OG001', 'lowerLimit': '0.00211', 'upperLimit': '0.0166'}, {'value': '0.0662', 'groupId': 'OG004', 'lowerLimit': '0.0371', 'upperLimit': '0.118'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG004'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.32', 'ciLowerLimit': '0.14', 'ciUpperLimit': '0.74', 'estimateComment': 'GMR and 90% CI were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel A-Moderate Renal Impairment (RI)/Panel D-Healthy controls', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG004'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.09', 'ciLowerLimit': '0.04', 'ciUpperLimit': '0.22', 'estimateComment': 'GMR and 90% confidence interval (CI) were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel B-Severe RI/Panel D-Healthy controls', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose and 0, 0.5, 1, 1.5, 2, 4, 8, 12, and 24 hours postdose', 'description': '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.', 'unitOfMeasure': 'mg', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Percentage of Unchanged Enlicitide Decanoate Excreted in Urine (Fe)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Panel A: Moderate Renal Impairment (RI)', 'description': 'Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1.'}, {'id': 'OG001', 'title': 'Panel B: Severe RI', 'description': 'Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1.'}, {'id': 'OG002', 'title': 'Panel C: ESRD - Enlicitide Decanoate Pre-Hemodialysis', 'description': 'Participants received Enlicitide Decanoate 20 mg tablet orally on Day 1.'}, {'id': 'OG003', 'title': 'Panel C: ESRD - Enlicitide Decanoate Post-Hemodialysis', 'description': 'Participants received Enlicitide Decanoate 20 mg tablet orally on Day 16.'}, {'id': 'OG004', 'title': 'Panel D: Healthy Controls', 'description': 'Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.107', 'groupId': 'OG000', 'lowerLimit': '0.0423', 'upperLimit': '0.269'}, {'value': '0.0296', 'groupId': 'OG001', 'lowerLimit': '0.0105', 'upperLimit': '0.0831'}, {'value': '0.331', 'groupId': 'OG004', 'lowerLimit': '0.185', 'upperLimit': '0.591'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG004'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.32', 'ciLowerLimit': '0.14', 'ciUpperLimit': '0.74', 'estimateComment': 'GMR and 90% CI were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel A-Moderate Renal Impairment (RI)/Panel D-Healthy controls', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG004'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.09', 'ciLowerLimit': '0.04', 'ciUpperLimit': '0.22', 'estimateComment': 'GMR and 90% confidence interval (CI) were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel B-Severe RI/Panel D-Healthy controls', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose and 0, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, and 48 hours postdose', 'description': '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.', 'unitOfMeasure': 'Percentage of Enlicitide Decanoate', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Renal Clearance (CLr) of Enlicitide Decanoate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Panel A: Moderate Renal Impairment (RI)', 'description': 'Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1.'}, {'id': 'OG001', 'title': 'Panel B: Severe RI', 'description': 'Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1.'}, {'id': 'OG002', 'title': 'Panel C: ESRD - Enlicitide Decanoate Pre-Hemodialysis', 'description': 'Participants received Enlicitide Decanoate 20 mg tablet orally on Day 1.'}, {'id': 'OG003', 'title': 'Panel C: ESRD - Enlicitide Decanoate Post-Hemodialysis', 'description': 'Participants received Enlicitide Decanoate 20 mg tablet orally on Day 16.'}, {'id': 'OG004', 'title': 'Panel D: Healthy Controls', 'description': 'Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0716', 'groupId': 'OG000', 'lowerLimit': '0.0349', 'upperLimit': '0.147'}, {'value': '0.0347', 'groupId': 'OG001', 'lowerLimit': '0.0114', 'upperLimit': '0.106'}, {'value': '0.243', 'groupId': 'OG004', 'lowerLimit': '0.161', 'upperLimit': '0.366'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG004'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.29', 'ciLowerLimit': '0.16', 'ciUpperLimit': '0.55', 'estimateComment': 'GMR and 90% CI were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel A-Moderate Renal Impairment (RI)/Panel D-Healthy controls', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG004'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.14', 'ciLowerLimit': '0.06', 'ciUpperLimit': '0.36', 'estimateComment': 'GMR and 90% confidence interval (CI) were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel B-Severe RI/Panel D-Healthy controls', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose and 0, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, and 48 hours postdose', 'description': '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.', 'unitOfMeasure': 'Liter/hr', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Experienced an Adverse Event (AE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Panel A: Moderate Renal Impairment (RI)', 'description': 'Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1.'}, {'id': 'OG001', 'title': 'Panel B: Severe RI', 'description': 'Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1.'}, {'id': 'OG002', 'title': 'Panel C: End-Stage Renal Disease (ESRD) on Hemodialysis (HD)', 'description': 'Participants received Enlicitide Decanoate 20 mg tablet orally on Day 1 and Day 16.'}, {'id': 'OG003', 'title': 'Panel D: Healthy Controls', 'description': 'Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to approximately 30 days', '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 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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Panels A, B, and D: Number of Participants Who Discontinued From the Study Due to an AE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Panel A: Moderate Renal Impairment (RI)', 'description': 'Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1.'}, {'id': 'OG001', 'title': 'Panel B: Severe RI', 'description': 'Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1.'}, {'id': 'OG002', 'title': 'Panel D: Healthy Controls', 'description': 'Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to approximately 30 days', '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 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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All allocated participants in Panels A, B and D who received a dose of study treatment.'}, {'type': 'SECONDARY', 'title': 'Panel C: Number of Participants Who Discontinued From the Study Treatment Due to an AE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Panel C: End-Stage Renal Disease (ESRD) on Hemodialysis (HD)', 'description': 'Participants received Enlicitide Decanoate 20 mg tablet orally on Day 1 and Day 16.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to approximately 30 days', '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 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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Panel A: Moderate Renal Impairment (RI)', 'description': 'Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1.'}, {'id': 'FG001', 'title': 'Panel B: Severe RI', 'description': 'Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1.'}, {'id': 'FG002', 'title': 'Panel C: End-Stage Renal Disease (ESRD) on Hemodialysis (HD)', 'description': 'Participants received Enlicitide Decanoate 20 mg tablet orally on Day 1 and Day 16.'}, {'id': 'FG003', 'title': 'Panel D: Healthy Controls', 'description': 'Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': '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.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '33', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Panel A: Moderate Renal Impairment (RI)', 'description': 'Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1.'}, {'id': 'BG001', 'title': 'Panel B: Severe RI', 'description': 'Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1.'}, {'id': 'BG002', 'title': 'Panel C: End-Stage Renal Disease (ESRD) on Hemodialysis (HD)', 'description': 'Participants received Enlicitide Decanoate 20 mg tablet orally on Day 1 and Day 16.'}, {'id': 'BG003', 'title': 'Panel D: Healthy Controls', 'description': 'Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '67', 'spread': '9.6', 'groupId': 'BG000'}, {'value': '66.8', 'spread': '12.1', 'groupId': 'BG001'}, {'value': '60.1', 'spread': '9.6', 'groupId': 'BG002'}, {'value': '62.8', 'spread': '4', 'groupId': 'BG003'}, {'value': '64', 'spread': '9.3', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '15', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '18', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All allocated participants'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-08-10', 'size': 2760170, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-12-12T12:06', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-07-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2024-01-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-12', 'studyFirstSubmitDate': '2023-06-05', 'resultsFirstSubmitDate': '2024-12-12', 'studyFirstSubmitQcDate': '2023-06-28', 'lastUpdatePostDateStruct': {'date': '2025-02-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-02-12', 'studyFirstPostDateStruct': {'date': '2023-07-06', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-Inf) of Enlicitide Decanoate', 'timeFrame': 'Predose and 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 120, 168, and 240 hours postdose', 'description': '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.'}, {'measure': 'AUC From Time 0 to Last Measurable Concentration (AUClast) of Enlicitide Decanoate', 'timeFrame': 'Predose and 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 120, 168, and 240 hours postdose', 'description': '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.'}, {'measure': 'Maximum Plasma Concentration (Cmax) of Enlicitide Decanoate', 'timeFrame': 'Predose and 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 120, 168, and 240 hours postdose', 'description': '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.'}, {'measure': 'Time to Maximum Plasma Concentration (Tmax) of Enlicitide Decanoate', 'timeFrame': 'Predose and 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 120, 168, and 240 hours postdose', 'description': '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.'}, {'measure': 'Apparent Terminal Half-life (t1/2) of Enlicitide Decanoate', 'timeFrame': 'Predose and 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 120, 168, and 240 hours postdose', 'description': '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.'}, {'measure': 'Apparent Clearance (CL/F) of Enlicitide Decanoate', 'timeFrame': 'Predose and 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 120, 168, and 240 hours postdose', 'description': '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.'}, {'measure': 'Apparent Volume of Distribution (Vz/F) of Enlicitide Decanoate', 'timeFrame': 'Predose and 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, 120, 168, and 240 hours postdose', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Panel C: Dialysate Clearance (CLd) of Enlicitide Decanoate', 'timeFrame': 'Predose and 0, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, and 48 hours postdose', 'description': '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.'}, {'measure': 'Panel C: Dialysate Concentration (Cd) of Enlicitide Decanoate', 'timeFrame': 'Predose and 0, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, and 48 hours postdose', 'description': '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.'}, {'measure': 'Panel C: Amount of Enlicitide Decanoate Excreted (AEd) in Dialysate', 'timeFrame': 'Predose and 0, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, and 48 hours postdose', 'description': '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.'}, {'measure': 'Panel C: Percentage of Dose (%Dose) of Enlicitide Decanoate Excreted in Dialysate', 'timeFrame': 'Predose and 0, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, and 48 hours postdose', 'description': '%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.'}, {'measure': 'Amount of Enlicitide Decanoate Excreted in Urine From 0 to 24 Hours (AE0-24) After Administration of Enlicitide Decanoate', 'timeFrame': 'Predose and 0, 0.5, 1, 1.5, 2, 4, 8, 12, and 24 hours postdose', 'description': '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.'}, {'measure': 'Percentage of Unchanged Enlicitide Decanoate Excreted in Urine (Fe)', 'timeFrame': 'Predose and 0, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, and 48 hours postdose', 'description': '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.'}, {'measure': 'Renal Clearance (CLr) of Enlicitide Decanoate', 'timeFrame': 'Predose and 0, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, and 48 hours postdose', 'description': '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.'}, {'measure': 'Number of Participants Who Experienced an Adverse Event (AE)', 'timeFrame': 'Up to approximately 30 days', '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 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.'}, {'measure': 'Panels A, B, and D: Number of Participants Who Discontinued From the Study Due to an AE', 'timeFrame': 'Up to approximately 30 days', '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 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.'}, {'measure': 'Panel C: Number of Participants Who Discontinued From the Study Treatment Due to an AE', 'timeFrame': 'Up to approximately 30 days', '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 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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypercholesterolaemia']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.merckclinicaltrials.com/', 'label': 'Merck Clinical Trials Information'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of the study is to compare the plasma pharmacokinetics (PK) of enlicitide decanoate following a single 20 mg dose in participants on a background of statin therapy with varying degrees of renal impairment (moderate, severe, end stage renal disease \\[ESRD\\]) to those of healthy mean matched control participants on a background of statin therapy. There is no formal hypothesis.', 'detailedDescription': 'Panel C included participants with 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Be in good health with the exception of renal impairment (RI) and hypercholesterolemia for participants in Panels A, B, and C. Participants with RI that have stable, chronic medical or psychiatric conditions, including but not limited to hypertension, hypercholesterolemia, diabetes mellitus, hyper- or hypothyroidism, gout, and chronic anxiety or depression may be included at the discretion of the investigator\n* Body Mass Index (BMI) ≥ 18 kg/m\\^2 and ≤ 40 kg/m\\^2, inclusive\n* Be on a stable dose of any statin therapy defined as: no changes to dose or type of statin therapy for at least 2 months prior to Screening and participant anticipates no changes to statin therapy throughout the study until the poststudy visit\n\nExclusion Criteria:\n\n* History or presence of renal artery stenosis\n* Had a functioning renal transplant in the past 5 years and is taking transplant medication\n* Participants in panels A, B and D: Has rapidly fluctuating renal function as determined by historical measurements\n* Has a history gastrointestinal disease which might affect food and drug absorption, as determined by the investigator, or has had gastric bypass or similar surgery\n* History of cancer (malignancy)\n* History of significant multiple and/or severe allergies, or has had an anaphylactic reaction or significant intolerability to prescription or nonprescription drugs or food\n* Has received an anti-proprotein convertase subtilisin/kexin type 9 (PCSK9) small molecule treatment, monoclonal antibody, or short interfering RNA (siRNA) or RNA interference (ie, Inclisiran) within 12 months prior to Screening\n* Participants with RI (Panels A, B, and C): Taking medications to treat chronic medical conditions and/or conditions associated with renal disease, if participant has not been on a stable regimen for at least 1 month (other than statins, which require a stable dose for at least 2 months) prior to administration of the initial dose of study intervention, and/or is unable to withhold the use of the medication(s) within 4 hours prior to and 4 hours after administration of study intervention\n* Participated in another investigational study within 4 weeks prior to the prestudy (screening) visit\n* Consumes greater than 3 servings of alcoholic beverages per day\n* Consumes excessive amounts, defined as greater than 6 servings of caffeinated beverages per day'}, 'identificationModule': {'nctId': 'NCT05934292', 'briefTitle': 'Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) Renal Impairment Study (MK-0616-020)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'An Open-Label, Single-Dose Clinical Study to Evaluate the Pharmacokinetics of MK-0616 in Participants With Varying Degrees of Renal Impairment', 'orgStudyIdInfo': {'id': '0616-020'}, 'secondaryIdInfos': [{'id': 'MK-0616-020', 'type': 'OTHER', 'domain': 'MSD'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Panel A: Moderate Renal Impairment (RI)', 'description': 'Participants receive Enlicitide Decanoate 20 mg tablet single dose orally on Day 1', 'interventionNames': ['Drug: Enlicitide Decanoate']}, {'type': 'EXPERIMENTAL', 'label': 'Panel B: Severe RI', 'description': 'Participants receive Enlicitide Decanoate 20 mg tablet single dose orally on Day 1', 'interventionNames': ['Drug: Enlicitide Decanoate']}, {'type': 'EXPERIMENTAL', 'label': 'Panel C: End-Stage Renal Disease (ESRD) on Hemodialysis (HD)', 'description': 'Participants receive Enlicitide Decanoate 20 mg tablet orally on Day 1 and Day 16.', 'interventionNames': ['Drug: Enlicitide Decanoate']}, {'type': 'EXPERIMENTAL', 'label': 'Panel D: Healthy Controls', 'description': 'Participants receive Enlicitide Decanoate 20 mg tablet single dose orally on Day 1.', 'interventionNames': ['Drug: Enlicitide Decanoate']}], 'interventions': [{'name': 'Enlicitide Decanoate', 'type': 'DRUG', 'otherNames': ['MK-0616'], 'description': 'Oral dose', 'armGroupLabels': ['Panel A: Moderate Renal Impairment (RI)', 'Panel B: Severe RI', 'Panel C: End-Stage Renal Disease (ESRD) on Hemodialysis (HD)', 'Panel D: Healthy Controls']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33009', 'city': 'Hallandale', 'state': 'Florida', 'country': 'United States', 'facility': 'Velocity Clinical Research, Hallandale Beach ( Site 0003)', 'geoPoint': {'lat': 25.9812, 'lon': -80.14838}}, {'zip': '33014-3616', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Pharmacology of Miami ( Site 0005)', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33147', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Advanced Pharma CR, LLC ( Site 0001)', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '32809', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Orlando Clinical Research Center ( Site 0004)', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '33603', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Genesis Clinical Research, LLC ( Site 0002)', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'ipdSharingStatementModule': {'url': 'http://engagezone.msd.com/ds_documentation.php', 'ipdSharing': 'YES', 'description': 'http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}