Ignite Creation Date:
2025-12-24 @ 4:38 PM
Ignite Modification Date:
2025-12-29 @ 9:09 PM
Study NCT ID:
NCT06052566
Status:
COMPLETED
Last Update Posted:
2025-10-22
First Post:
2023-09-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Efinopegdutide in Participants With Hepatic Impairment (MK-6024-014)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}], 'ancestors': [{'id': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, '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': 'If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. Authorship will be determined by mutual agreement and in line with International Committee of Medical Journal Editors authorship requirements.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 35 days', 'description': 'All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Efinopegdutide in Participants With Moderate Hepatic Impairment', 'description': 'Participants with moderate hepatic impairment received a single 7 mg dose of efinopegdutide 14 mg/ml by subcutaneous (SC) injection.', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 2, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Efinopegdutide in Participants With Severe Hepatic Impairment', 'description': 'Participants with severe hepatic impairment received a single 7 mg dose of efinopegdutide 14 mg/ml by SC injection.', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 4, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Efinopegdutide in Healthy-Matched Control Group', 'description': 'Healthy matched participants received a single 7 mg dose of efinopegdutide 14 mg/ml by SC injection.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 4, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Hyperbilirubinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Hepatic encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}], 'seriousEvents': [{'term': 'Multiple injuries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Area Under the Curve From Time 0 to Infinity (AUC0-inf) of Efinopegdutide', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Efinopegdutide in Participants With Moderate Hepatic Impairment', 'description': 'Participants with moderate hepatic impairment received a single 7 mg dose of efinopegdutide 14 mg/ml by subcutaneous (SC) injection.'}, {'id': 'OG001', 'title': 'Efinopegdutide in Participants With Severe Hepatic Impairment', 'description': 'Participants with severe hepatic impairment received a single 7 mg dose of efinopegdutide 14 mg/ml by SC injection.'}, {'id': 'OG002', 'title': 'Efinopegdutide in Healthy-Matched Control Group', 'description': 'Healthy matched participants received a single 7 mg dose of efinopegdutide 14 mg/ml by SC injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '143', 'groupId': 'OG000', 'lowerLimit': '120', 'upperLimit': '169'}, {'value': '152', 'groupId': 'OG001', 'lowerLimit': '106', 'upperLimit': '219'}, {'value': '146', 'groupId': 'OG002', 'lowerLimit': '81.8', 'upperLimit': '262'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.97', 'ciLowerLimit': '0.61', 'ciUpperLimit': '1.54', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.04', 'ciLowerLimit': '0.63', 'ciUpperLimit': '1.71', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At pre-specified timepoints on Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 11, Day 14, Day 21, and Day 35', 'description': 'Blood samples collected at multiple timepoints post-dose were used to determine the AUC0-inf.', 'unitOfMeasure': 'hr*μg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who complied with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model.'}, {'type': 'PRIMARY', 'title': 'Area Under the Curve From Time 0 to Last Sampling Time (AUC0-last) of Efinopegdutide', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Efinopegdutide in Participants With Moderate Hepatic Impairment', 'description': 'Participants with moderate hepatic impairment received a single 7 mg dose of efinopegdutide 14 mg/ml by subcutaneous (SC) injection.'}, {'id': 'OG001', 'title': 'Efinopegdutide in Participants With Severe Hepatic Impairment', 'description': 'Participants with severe hepatic impairment received a single 7 mg dose of efinopegdutide 14 mg/ml by SC injection.'}, {'id': 'OG002', 'title': 'Efinopegdutide in Healthy-Matched Control Group', 'description': 'Healthy matched participants received a single 7 mg dose of efinopegdutide 14 mg/ml by SC injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '133', 'groupId': 'OG000', 'lowerLimit': '113', 'upperLimit': '156'}, {'value': '125', 'groupId': 'OG001', 'lowerLimit': '80.8', 'upperLimit': '193'}, {'value': '134', 'groupId': 'OG002', 'lowerLimit': '70.2', 'upperLimit': '255'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.99', 'ciLowerLimit': '0.60', 'ciUpperLimit': '1.65', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.93', 'ciLowerLimit': '0.53', 'ciUpperLimit': '1.65', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At pre-specified timepoints on Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 11, Day 14, Day 21, and Day 35', 'description': 'Blood samples collected at multiple timepoints post-dose were used to determine the AUC0-last.', 'unitOfMeasure': 'hr*μg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who complied with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model.'}, {'type': 'PRIMARY', 'title': 'Maximum Plasma Concentration (Cmax) of Efinopegdutide', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Efinopegdutide in Participants With Moderate Hepatic Impairment', 'description': 'Participants with moderate hepatic impairment received a single 7 mg dose of efinopegdutide 14 mg/ml by subcutaneous (SC) injection.'}, {'id': 'OG001', 'title': 'Efinopegdutide in Participants With Severe Hepatic Impairment', 'description': 'Participants with severe hepatic impairment received a single 7 mg dose of efinopegdutide 14 mg/ml by SC injection.'}, {'id': 'OG002', 'title': 'Efinopegdutide in Healthy-Matched Control Group', 'description': 'Healthy matched participants received a single 7 mg dose of efinopegdutide 14 mg/ml by SC injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.348', 'groupId': 'OG000', 'lowerLimit': '0.282', 'upperLimit': '0.429'}, {'value': '0.404', 'groupId': 'OG001', 'lowerLimit': '0.242', 'upperLimit': '0.675'}, {'value': '0.474', 'groupId': 'OG002', 'lowerLimit': '0.253', 'upperLimit': '0.890'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.73', 'ciLowerLimit': '0.44', 'ciUpperLimit': '1.21', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.85', 'ciLowerLimit': '0.47', 'ciUpperLimit': '1.53', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At pre-specified timepoints on Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 11, Day 14, Day 21, and Day 35', 'description': 'Blood samples collected at multiple timepoints post-dose were used to determine the Cmax.', 'unitOfMeasure': 'μg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who complied with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model.'}, {'type': 'PRIMARY', 'title': 'Time to Maximum Concentration (Tmax) of Efinopegdutide', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Efinopegdutide in Participants With Moderate Hepatic Impairment', 'description': 'Participants with moderate hepatic impairment received a single 7 mg dose of efinopegdutide 14 mg/ml by subcutaneous (SC) injection.'}, {'id': 'OG001', 'title': 'Efinopegdutide in Participants With Severe Hepatic Impairment', 'description': 'Participants with severe hepatic impairment received a single 7 mg dose of efinopegdutide 14 mg/ml by SC injection.'}, {'id': 'OG002', 'title': 'Efinopegdutide in Healthy-Matched Control Group', 'description': 'Healthy matched participants received a single 7 mg dose of efinopegdutide 14 mg/ml by SC injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '120.00', 'groupId': 'OG000', 'lowerLimit': '96.00', 'upperLimit': '310.93'}, {'value': '72.04', 'groupId': 'OG001', 'lowerLimit': '24.00', 'upperLimit': '144.00'}, {'value': '83.78', 'groupId': 'OG002', 'lowerLimit': '48.00', 'upperLimit': '167.25'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At pre-specified timepoints on Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 11, Day 14, Day 21, and Day 35', 'description': 'Blood samples collected at multiple timepoints post-dose were used to determine the Tmax of efinopegdutide.', 'unitOfMeasure': 'hour', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who complied with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model.'}, {'type': 'PRIMARY', 'title': 'Apparent Terminal Half-life (t/12) of Efinopegdutide', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Efinopegdutide in Participants With Moderate Hepatic Impairment', 'description': 'Participants with moderate hepatic impairment received a single 7 mg dose of efinopegdutide 14 mg/ml by subcutaneous (SC) injection.'}, {'id': 'OG001', 'title': 'Efinopegdutide in Participants With Severe Hepatic Impairment', 'description': 'Participants with severe hepatic impairment received a single 7 mg dose of efinopegdutide 14 mg/ml by SC injection.'}, {'id': 'OG002', 'title': 'Efinopegdutide in Healthy-Matched Control Group', 'description': 'Healthy matched participants received a single 7 mg dose of efinopegdutide 14 mg/ml by SC injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '146', 'spread': '13.5', 'groupId': 'OG000'}, {'value': '149', 'spread': '26.0', 'groupId': 'OG001'}, {'value': '115', 'spread': '32.3', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At pre-specified timepoints on Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 11, Day 14, Day 21, and Day 35', 'description': 'Blood samples collected at multiple timepoints post-dose were used to determine the t1/2.', 'unitOfMeasure': 'hour', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who complied with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model.'}, {'type': 'PRIMARY', 'title': 'Apparent Total Clearance (CL/F) of Efinopegdutide', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Efinopegdutide in Participants With Moderate Hepatic Impairment', 'description': 'Participants with moderate hepatic impairment received a single 7 mg dose of efinopegdutide 14 mg/ml by subcutaneous (SC) injection.'}, {'id': 'OG001', 'title': 'Efinopegdutide in Participants With Severe Hepatic Impairment', 'description': 'Participants with severe hepatic impairment received a single 7 mg dose of efinopegdutide 14 mg/ml by SC injection.'}, {'id': 'OG002', 'title': 'Efinopegdutide in Healthy-Matched Control Group', 'description': 'Healthy matched participants received a single 7 mg dose of efinopegdutide 14 mg/ml by SC injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0491', 'spread': '16.5', 'groupId': 'OG000'}, {'value': '0.0460', 'spread': '40.8', 'groupId': 'OG001'}, {'value': '0.0478', 'spread': '60.0', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At pre-specified timepoints on Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 11, Day 14, Day 21, and Day 35', 'description': 'Blood samples collected at multiple timepoints post-dose were used to determine the CL/F.', 'unitOfMeasure': 'L/hr', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who complied with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model.'}, {'type': 'PRIMARY', 'title': 'Apparent Volume of Distribution (Vz/F) of Efinopegdutide', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Efinopegdutide in Participants With Moderate Hepatic Impairment', 'description': 'Participants with moderate hepatic impairment received a single 7 mg dose of efinopegdutide 14 mg/ml by subcutaneous (SC) injection.'}, {'id': 'OG001', 'title': 'Efinopegdutide in Participants With Severe Hepatic Impairment', 'description': 'Participants with severe hepatic impairment received a single 7 mg dose of efinopegdutide 14 mg/ml by SC injection.'}, {'id': 'OG002', 'title': 'Efinopegdutide in Healthy-Matched Control Group', 'description': 'Healthy matched participants received a single 7 mg dose of efinopegdutide 14 mg/ml by SC injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.3', 'spread': '17.9', 'groupId': 'OG000'}, {'value': '9.88', 'spread': '57.8', 'groupId': 'OG001'}, {'value': '7.94', 'spread': '91.7', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At pre-specified timepoints on Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 11, Day 14, Day 21, and Day 35', 'description': 'Blood samples collected at multiple timepoints post-dose were used to determine the Vz/F.', 'unitOfMeasure': 'Liters', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who complied with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model.'}, {'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': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Efinopegdutide in Participants With Moderate Hepatic Impairment', 'description': 'Participants with moderate hepatic impairment received a single 7 mg dose of efinopegdutide 14 mg/ml by subcutaneous (SC) injection.'}, {'id': 'OG001', 'title': 'Efinopegdutide in Participants With Severe Hepatic Impairment', 'description': 'Participants with severe hepatic impairment received a single 7 mg dose of efinopegdutide 14 mg/ml by SC injection.'}, {'id': 'OG002', 'title': 'Efinopegdutide in Healthy-Matched Control Group', 'description': 'Healthy matched participants received a single 7 mg dose of efinopegdutide 14 mg/ml by SC injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 35 days', 'description': 'An AE is defined as any untoward medical occurrence associated with the use of a drug in a participant, whether or not considered drug related. 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 medicinal product and does not imply any judgment about causality.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of study treatment.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Discontinued Study Intervention Due to an AE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Efinopegdutide in Participants With Moderate Hepatic Impairment', 'description': 'Participants with moderate hepatic impairment received a single 7 mg dose of efinopegdutide 14 mg/ml by subcutaneous (SC) injection.'}, {'id': 'OG001', 'title': 'Efinopegdutide in Participants With Severe Hepatic Impairment', 'description': 'Participants with severe hepatic impairment received a single 7 mg dose of efinopegdutide 14 mg/ml by SC injection.'}, {'id': 'OG002', 'title': 'Efinopegdutide in Healthy-Matched Control Group', 'description': 'Healthy matched participants received a single 7 mg dose of efinopegdutide 14 mg/ml by SC injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 35 days', 'description': 'An AE is defined as any untoward medical occurrence associated with the use of a drug in a participant, whether or not considered drug related. 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 medicinal product and does not imply any judgment about causality.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of study treatment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Efinopegdutide in Participants With Moderate Hepatic Impairment', 'description': 'Participants with moderate hepatic impairment received a single 7 mg dose of efinopegdutide 14 mg/ml by subcutaneous (SC) injection.'}, {'id': 'FG001', 'title': 'Efinopegdutide in Participants With Severe Hepatic Impairment', 'description': 'Participants with severe hepatic impairment received a single 7 mg dose of efinopegdutide 14 mg/ml by SC injection.'}, {'id': 'FG002', 'title': 'Efinopegdutide in Healthy-Matched Control Group', 'description': 'Healthy matched participants received a single 7 mg dose of efinopegdutide 14 mg/ml by SC injection.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Efinopegdutide in Participants With Moderate Hepatic Impairment', 'description': 'Participants with moderate hepatic impairment received a single 7 mg dose of efinopegdutide 14 mg/ml by subcutaneous (SC) injection.'}, {'id': 'BG001', 'title': 'Efinopegdutide in Participants With Severe Hepatic Impairment', 'description': 'Participants with severe hepatic impairment received a single 7 mg dose of efinopegdutide 14 mg/ml by SC injection.'}, {'id': 'BG002', 'title': 'Efinopegdutide in Healthy-Matched Control Group', 'description': 'Healthy matched participants received a single 7 mg dose of efinopegdutide 14 mg/ml by SC injection.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.5', 'spread': '9.5', 'groupId': 'BG000'}, {'value': '48.5', 'spread': '10.5', 'groupId': 'BG001'}, {'value': '56.2', 'spread': '7.1', 'groupId': 'BG002'}, {'value': '53.9', 'spread': '9.8', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], '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'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-07-31', 'size': 792423, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-10-03T09:24', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-11-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2024-12-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-03', 'studyFirstSubmitDate': '2023-09-18', 'resultsFirstSubmitDate': '2025-10-03', 'studyFirstSubmitQcDate': '2023-09-18', 'lastUpdatePostDateStruct': {'date': '2025-10-22', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-10-03', 'studyFirstPostDateStruct': {'date': '2023-09-25', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-10-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-12-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under the Curve From Time 0 to Infinity (AUC0-inf) of Efinopegdutide', 'timeFrame': 'At pre-specified timepoints on Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 11, Day 14, Day 21, and Day 35', 'description': 'Blood samples collected at multiple timepoints post-dose were used to determine the AUC0-inf.'}, {'measure': 'Area Under the Curve From Time 0 to Last Sampling Time (AUC0-last) of Efinopegdutide', 'timeFrame': 'At pre-specified timepoints on Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 11, Day 14, Day 21, and Day 35', 'description': 'Blood samples collected at multiple timepoints post-dose were used to determine the AUC0-last.'}, {'measure': 'Maximum Plasma Concentration (Cmax) of Efinopegdutide', 'timeFrame': 'At pre-specified timepoints on Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 11, Day 14, Day 21, and Day 35', 'description': 'Blood samples collected at multiple timepoints post-dose were used to determine the Cmax.'}, {'measure': 'Time to Maximum Concentration (Tmax) of Efinopegdutide', 'timeFrame': 'At pre-specified timepoints on Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 11, Day 14, Day 21, and Day 35', 'description': 'Blood samples collected at multiple timepoints post-dose were used to determine the Tmax of efinopegdutide.'}, {'measure': 'Apparent Terminal Half-life (t/12) of Efinopegdutide', 'timeFrame': 'At pre-specified timepoints on Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 11, Day 14, Day 21, and Day 35', 'description': 'Blood samples collected at multiple timepoints post-dose were used to determine the t1/2.'}, {'measure': 'Apparent Total Clearance (CL/F) of Efinopegdutide', 'timeFrame': 'At pre-specified timepoints on Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 11, Day 14, Day 21, and Day 35', 'description': 'Blood samples collected at multiple timepoints post-dose were used to determine the CL/F.'}, {'measure': 'Apparent Volume of Distribution (Vz/F) of Efinopegdutide', 'timeFrame': 'At pre-specified timepoints on Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 11, Day 14, Day 21, and Day 35', 'description': 'Blood samples collected at multiple timepoints post-dose were used to determine the Vz/F.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Who Experienced an Adverse Event (AE)', 'timeFrame': 'Up to 35 days', 'description': 'An AE is defined as any untoward medical occurrence associated with the use of a drug in a participant, whether or not considered drug related. 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 medicinal product and does not imply any judgment about causality.'}, {'measure': 'Number of Participants Who Discontinued Study Intervention Due to an AE', 'timeFrame': 'Up to 35 days', 'description': 'An AE is defined as any untoward medical occurrence associated with the use of a drug in a participant, whether or not considered drug related. 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 medicinal product and does not imply any judgment about causality.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Non-alcoholic Steatohepatitis', 'Hepatic Impairment']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.merckclinicaltrials.com', 'label': 'Merck Clinical Trials Information'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to evaluate the pharmacokinetics of efinopegdutide in participants with hepatic impairment compared to healthy participants, and to examine the safety and tolerability of efinopegdutide.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'The main inclusion and exclusion criteria include but are not limited to the following:\n\nInclusion Criteria:\n\n* A participant assigned female at birth is eligible to participate if not pregnant or breastfeeding, is not a participant of childbearing potential (POCBP), or is a POCBP and agrees to follow contraceptive guidance during the study intervention period and for at least 35 days after the last dose of study intervention.\n* For participants with moderate or severe hepatic impairment: Have a diagnosis of chronic (\\>6 months), stable, hepatic impairment with features of cirrhosis due to any etiology (stability of hepatic disease should correspond to no acute episodes of illness within the previous 2 months due to deterioration in hepatic function).\n\nExclusion Criteria:\n\n* History of cancer (malignancy).\n* Had major surgery and/or donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to the prestudy (screening) visit.\n* Participants with moderate or severe hepatic impairment who are positive for human immunodeficiency virus (HIV)-1 or HIV-2 at the prestudy (screening) visit.\n* Participants with moderate or severe hepatic impairment who received antiviral and/or immune modulating therapy for hepatitis B virus (HBV) or hepatitis C virus (HCV) within 90 days prior to study start.\n* Healthy participants who are unable to refrain from or anticipate the use of any medication, including prescription and nonprescription drugs or herbal remedies beginning approximately 2 weeks (or 5 half-lives) prior to administration of the initial dose of study intervention, throughout the study (including washout intervals between treatment periods), until the poststudy visit.'}, 'identificationModule': {'nctId': 'NCT06052566', 'briefTitle': 'A Study of Efinopegdutide in Participants With Hepatic Impairment (MK-6024-014)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'An Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of Efinopegdutide (MK-6024) in Participants With Moderate and Severe Hepatic Impairment', 'orgStudyIdInfo': {'id': '6024-014'}, 'secondaryIdInfos': [{'id': 'MK-6024-014', 'type': 'REGISTRY', 'domain': 'MSD'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Efinopegdutide in Participants with Moderate Hepatic Impairment', 'description': 'Participants with moderate hepatic impairment received a single 7 mg dose of efinopegdutide 14 mg/ml by subcutaneous (SC) injection.', 'interventionNames': ['Drug: Efinopegdutide']}, {'type': 'EXPERIMENTAL', 'label': 'Efinopegdutide in Participants with Severe Hepatic Impairment', 'description': 'Participants with severe hepatic impairment received a single 7 mg dose of efinopegdutide 14 mg/ml by SC injection.', 'interventionNames': ['Drug: Efinopegdutide']}, {'type': 'EXPERIMENTAL', 'label': 'Efinopegdutide in Healthy-Matched Control Group', 'description': 'Healthy matched participants received a single 7 mg dose of efinopegdutide 14 mg/ml by SC injection.', 'interventionNames': ['Drug: Efinopegdutide']}], 'interventions': [{'name': 'Efinopegdutide', 'type': 'DRUG', 'otherNames': ['MK-6024', 'HM12525A', 'JNJ-64565111'], 'description': 'Subcutaneous injection administered at a dose of 7 mg', 'armGroupLabels': ['Efinopegdutide in Healthy-Matched Control Group', 'Efinopegdutide in Participants with Moderate Hepatic Impairment', 'Efinopegdutide in Participants with Severe Hepatic Impairment']}]}, 'contactsLocationsModule': {'locations': [{'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': '33603', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Genesis Clinical Research, LLC ( Site 0006)', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '78215', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'American Research Corporation ( Site 0002)', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'ipdSharingStatementModule': {'url': 'https://externaldatasharing-msd.com/', 'ipdSharing': 'YES', 'description': 'https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}