Ignite Creation Date:
2025-12-24 @ 3:45 PM
Ignite Modification Date:
2025-12-28 @ 12:50 PM
Study NCT ID:
NCT04944992
Status:
COMPLETED
Last Update Posted:
2023-11-15
First Post:
2021-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Efinopegdutide (MK-6024) in Participants With Nonalcoholic Fatty Liver Disease (NAFLD) (MK-6024-001)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-10-23', 'type': 'ACTUAL'}}}}, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000591245', 'term': 'semaglutide'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.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. This allows the Sponsor to protect proprietary information and to provide comments. Authorship will be determined by mutual agreement and in line with ICMJE authorship requirements.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Death and adverse events up to ~29 weeks', 'description': 'Every participant is counted a single time for each applicable non-serious adverse event. A specific non-serious adverse event appears on this report only if its incidence in one or more of the columns is greater than the percent incidence specified in the report title, prior to rounding. A system organ class appears on this report only if one or more specific non-serious adverse events in that system organ class occurred during the study period.', 'eventGroups': [{'id': 'EG000', 'title': 'Efinopegdutide', 'description': 'Efinopegdutide 20 mg/mL administered by injection once weekly for 24 weeks in a dose-escalation regimen: 2.4 mg from day 1 to week 3, 5.0 mg from week 4 to 7, and 10.0 mg from week 8 to 24.', 'otherNumAtRisk': 72, 'deathsNumAtRisk': 72, 'otherNumAffected': 57, 'seriousNumAtRisk': 72, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Semaglutide', 'description': 'Semaglutide 1.34 mg/mL administered by injection once weekly for 24 weeks in a dose-escalation regimen: 0.25 mg from day 1 to week 3, 0.5 mg from week 4 to 7, and 1.0 mg from week 8 to 24.', 'otherNumAtRisk': 73, 'deathsNumAtRisk': 73, 'otherNumAffected': 44, 'seriousNumAtRisk': 73, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 15, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 10, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 16, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 32, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 29, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 38, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 36, 'numAffected': 23}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 23, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 12, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Lipase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 13, 'numAffected': 11}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 7, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 8, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}], 'seriousEvents': [{'term': 'Spinal osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Calculus urinary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Relative Reduction From Baseline in Liver Fat Content (LFC) Measured by Magnetic Resonance Imaging-Estimated Proton Density Fat Fraction (MRI-PDFF), Evaluated by Blinded Independent Central Review (BICR) After 24 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Efinopegdutide', 'description': 'Efinopegdutide 20 mg/mL administered by injection once weekly for 24 weeks in a dose-escalation regimen: 2.4 mg from day 1 to week 3, 5.0 mg from week 4 to 7, and 10.0 mg from week 8 to 24.'}, {'id': 'OG001', 'title': 'Semaglutide', 'description': 'Semaglutide 1.34 mg/mL administered by injection once weekly for 24 weeks in a dose-escalation regimen: 0.25 mg from day 1 to week 3, 0.5 mg from week 4 to 7, and 1.0 mg from week 8 to 24.'}], 'classes': [{'categories': [{'measurements': [{'value': '72.7', 'groupId': 'OG000', 'lowerLimit': '66.8', 'upperLimit': '78.7'}, {'value': '42.3', 'groupId': 'OG001', 'lowerLimit': '36.5', 'upperLimit': '48.1'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in least squared means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '30.4', 'ciLowerLimit': '22.1', 'ciUpperLimit': '38.7', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and up to ~24 Weeks', 'description': 'LFC was measured with liver images taken by MRI-PDFF and analyzed by BICR. Relative Reduction from Baseline to Week 24 = (Baseline - Week 24) / Baseline x 100%. Mean relative reduction from baseline in liver fat content is presented.', 'unitOfMeasure': 'Percent Reduction', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who had received at least 1 injection (including only partial) of study intervention and had at least 1 assessment.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Experienced an Adverse Event (AE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Efinopegdutide', 'description': 'Efinopegdutide 20 mg/mL administered by injection once weekly for 24 weeks in a dose-escalation regimen: 2.4 mg from day 1 to week 3, 5.0 mg from week 4 to 7, and 10.0 mg from week 8 to 24.'}, {'id': 'OG001', 'title': 'Semaglutide', 'description': 'Semaglutide 1.34 mg/mL administered by injection once weekly for 24 weeks in a dose-escalation regimen: 0.25 mg from day 1 to week 3, 0.5 mg from week 4 to 7, and 1.0 mg from week 8 to 24.'}], 'classes': [{'categories': [{'measurements': [{'value': '88.9', 'groupId': 'OG000'}, {'value': '72.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'difference in percentage', 'ciPctValue': '95', 'paramValue': '16.3', 'ciLowerLimit': '3.5', 'ciUpperLimit': '29.1', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Difference (Efinopegdutide - Semaglutide) in %'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to ~29 weeks', 'description': 'An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE 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 percentage of participants who experienced an adverse event is presented.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 injection (including only partial) of study intervention.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Discontinued Study Intervention Due to an AE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Efinopegdutide', 'description': 'Efinopegdutide 20 mg/mL administered by injection once weekly for 24 weeks in a dose-escalation regimen: 2.4 mg from day 1 to week 3, 5.0 mg from week 4 to 7, and 10.0 mg from week 8 to 24.'}, {'id': 'OG001', 'title': 'Semaglutide', 'description': 'Semaglutide 1.34 mg/mL administered by injection once weekly for 24 weeks in a dose-escalation regimen: 0.25 mg from day 1 to week 3, 0.5 mg from week 4 to 7, and 1.0 mg from week 8 to 24.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciPctValue': '95', 'paramValue': '5.6', 'ciLowerLimit': '0.4', 'ciUpperLimit': '13.5', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Difference (Efinopegdutide - Semaglutide) in %'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to ~24 weeks', 'description': 'An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE 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 percentage of participants who discontinued study intervention due to adverse event is presented.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 injection (including only partial) of study intervention.'}, {'type': 'SECONDARY', 'title': 'Mean Absolute Reduction From Baseline in LFC Measured by MRI-PDFF (Evaluated by BICR) After 24 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Efinopegdutide', 'description': 'Efinopegdutide 20 mg/mL administered by injection once weekly for 24 weeks in a dose-escalation regimen: 2.4 mg from day 1 to week 3, 5.0 mg from week 4 to 7, and 10.0 mg from week 8 to 24.'}, {'id': 'OG001', 'title': 'Semaglutide', 'description': 'Semaglutide 1.34 mg/mL administered by injection once weekly for 24 weeks in a dose-escalation regimen: 0.25 mg from day 1 to week 3, 0.5 mg from week 4 to 7, and 1.0 mg from week 8 to 24.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.9', 'groupId': 'OG000', 'lowerLimit': '13.6', 'upperLimit': '16.3'}, {'value': '8.8', 'groupId': 'OG001', 'lowerLimit': '7.5', 'upperLimit': '10.1'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in least squared means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '6.1', 'ciLowerLimit': '4.6', 'ciUpperLimit': '7.7', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and up to ~24 Weeks', 'description': 'LFC was measured by liver images taken by MRI-PDFF and analyzed by BICR. The absolute reduction from baseline to Week 24 = Baseline - Week 24. The mean absolute reduction from baseline in LFC after 24 weeks of treatment is presented.', 'unitOfMeasure': 'Percentage of liver fat', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who had received at least 1 injection (including only partial) of study intervention and had at least 1 assessment.'}, {'type': 'SECONDARY', 'title': 'Mean Percent Change From Baseline in Body Weight After 24 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Efinopegdutide', 'description': 'Efinopegdutide 20 mg/mL administered by injection once weekly for 24 weeks in a dose-escalation regimen: 2.4 mg from day 1 to week 3, 5.0 mg from week 4 to 7, and 10.0 mg from week 8 to 24.'}, {'id': 'OG001', 'title': 'Semaglutide', 'description': 'Semaglutide 1.34 mg/mL administered by injection once weekly for 24 weeks in a dose-escalation regimen: 0.25 mg from day 1 to week 3, 0.5 mg from week 4 to 7, and 1.0 mg from week 8 to 24.'}], 'classes': [{'categories': [{'measurements': [{'value': '-8.5', 'groupId': 'OG000', 'lowerLimit': '-9.5', 'upperLimit': '-7.5'}, {'value': '-7.1', 'groupId': 'OG001', 'lowerLimit': '-8.1', 'upperLimit': '-6.2'}]}]}], 'analyses': [{'pValue': '0.085', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Least Squared Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-1.4', 'ciLowerLimit': '-2.7', 'ciUpperLimit': '-0.1', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and up to ~24 weeks', 'description': 'Body weight in kilograms was measured using a standardized, digital scale. The mean percent change from baseline in body weight after 24 weeks is presented.', 'unitOfMeasure': 'Percent Change', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who had received at least 1 injection (including only partial) of study intervention and had at least 1 assessment.'}, {'type': 'SECONDARY', 'title': 'Mean Percent Change From Baseline in Total Cholesterol After 24 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Efinopegdutide', 'description': 'Efinopegdutide 20 mg/mL administered by injection once weekly for 24 weeks in a dose-escalation regimen: 2.4 mg from day 1 to week 3, 5.0 mg from week 4 to 7, and 10.0 mg from week 8 to 24.'}, {'id': 'OG001', 'title': 'Semaglutide', 'description': 'Semaglutide 1.34 mg/mL administered by injection once weekly for 24 weeks in a dose-escalation regimen: 0.25 mg from day 1 to week 3, 0.5 mg from week 4 to 7, and 1.0 mg from week 8 to 24.'}], 'classes': [{'categories': [{'measurements': [{'value': '-15.2', 'groupId': 'OG000', 'lowerLimit': '-18.2', 'upperLimit': '-12.2'}, {'value': '-8.0', 'groupId': 'OG001', 'lowerLimit': '-11.0', 'upperLimit': '-5.0'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Least Squared Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-7.2', 'ciLowerLimit': '-11.2', 'ciUpperLimit': '-3.1', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Difference (Efinopegdutide - Semaglutide) in %'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and up to ~24 weeks', 'description': 'Fasting blood samples were collected at baseline and after 24 weeks of treatment to assess mean percent change in total cholesterol. The mean percent change in total cholesterol is presented.', 'unitOfMeasure': 'Percent Change', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who had received at least 1 injection (including only partial) of study intervention and had at least 1 assessment.'}, {'type': 'SECONDARY', 'title': 'Mean Percent Change From Baseline in Non-High Density Lipoprotein-Cholesterol (Non-HDL-C) After 24 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Efinopegdutide', 'description': 'Efinopegdutide 20 mg/mL administered by injection once weekly for 24 weeks in a dose-escalation regimen: 2.4 mg from day 1 to week 3, 5.0 mg from week 4 to 7, and 10.0 mg from week 8 to 24.'}, {'id': 'OG001', 'title': 'Semaglutide', 'description': 'Semaglutide 1.34 mg/mL administered by injection once weekly for 24 weeks in a dose-escalation regimen: 0.25 mg from day 1 to week 3, 0.5 mg from week 4 to 7, and 1.0 mg from week 8 to 24.'}], 'classes': [{'categories': [{'measurements': [{'value': '-16.8', 'groupId': 'OG000', 'lowerLimit': '-20.5', 'upperLimit': '-13.0'}, {'value': '-11.0', 'groupId': 'OG001', 'lowerLimit': '-14.8', 'upperLimit': '-7.3'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in least squared means', 'ciPctValue': '90', 'paramValue': '-5.7', 'ciLowerLimit': '-10.9', 'ciUpperLimit': '-0.6', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Difference (Efinopegdutide - Semaglutide) in %'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and up to ~24 weeks', 'description': 'Fasting blood samples were collected at baseline and after 24 weeks of treatment to assess mean percent change in non-HDL-C. The mean percent change in non-HDL-C is presented.', 'unitOfMeasure': 'Percent Change', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who had received at least 1 injection (including only partial) of study intervention and had at least 1 assessment.'}, {'type': 'SECONDARY', 'title': 'Mean Percent Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) After 24 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Efinopegdutide', 'description': 'Efinopegdutide 20 mg/mL administered by injection once weekly for 24 weeks in a dose-escalation regimen: 2.4 mg from day 1 to week 3, 5.0 mg from week 4 to 7, and 10.0 mg from week 8 to 24.'}, {'id': 'OG001', 'title': 'Semaglutide', 'description': 'Semaglutide 1.34 mg/mL administered by injection once weekly for 24 weeks in a dose-escalation regimen: 0.25 mg from day 1 to week 3, 0.5 mg from week 4 to 7, and 1.0 mg from week 8 to 24.'}], 'classes': [{'categories': [{'measurements': [{'value': '-8.1', 'groupId': 'OG000', 'lowerLimit': '-11.2', 'upperLimit': '-5.1'}, {'value': '3.6', 'groupId': 'OG001', 'lowerLimit': '0.6', 'upperLimit': '6.6'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in least squared means', 'ciPctValue': '90', 'paramValue': '-11.7', 'ciLowerLimit': '-15.8', 'ciUpperLimit': '-7.7', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Difference (Efinopegdutide - Semaglutide) in %'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and up to ~24 weeks', 'description': 'Fasting blood samples were collected at baseline and after 24 weeks of treatment to assess mean percent change in HDL-C. Mean percent change in HDL-C is presented.', 'unitOfMeasure': 'Percent Change', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who had received at least 1 injection (including only partial) of study intervention and had at least 1 assessment.'}, {'type': 'SECONDARY', 'title': 'Mean Percent Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) After 24 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Efinopegdutide', 'description': 'Efinopegdutide 20 mg/mL administered by injection once weekly for 24 weeks in a dose-escalation regimen: 2.4 mg from day 1 to week 3, 5.0 mg from week 4 to 7, and 10.0 mg from week 8 to 24.'}, {'id': 'OG001', 'title': 'Semaglutide', 'description': 'Semaglutide 1.34 mg/mL administered by injection once weekly for 24 weeks in a dose-escalation regimen: 0.25 mg from day 1 to week 3, 0.5 mg from week 4 to 7, and 1.0 mg from week 8 to 24.'}], 'classes': [{'categories': [{'measurements': [{'value': '-13.0', 'groupId': 'OG000', 'lowerLimit': '-17.4', 'upperLimit': '-8.6'}, {'value': '-6.9', 'groupId': 'OG001', 'lowerLimit': '-11.3', 'upperLimit': '-2.6'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in least squared means', 'ciPctValue': '90', 'paramValue': '-6.1', 'ciLowerLimit': '-12.0', 'ciUpperLimit': '-0.1', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Difference (Efinopegdutide - Semaglutide) in %'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and up to ~24 weeks', 'description': 'Fasting blood samples were collected at baseline and after 24 weeks of treatment to assess mean percent change in LDL-C. The mean percent change in LDL-C is presented.', 'unitOfMeasure': 'Percent Change', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who had received at least 1 injection (including only partial) of study intervention and had at least 1 assessment.'}, {'type': 'SECONDARY', 'title': 'Mean Percent Change From Baseline in Triglycerides (TG) After 24 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Efinopegdutide', 'description': 'Efinopegdutide 20 mg/mL administered by injection once weekly for 24 weeks in a dose-escalation regimen: 2.4 mg from day 1 to week 3, 5.0 mg from week 4 to 7, and 10.0 mg from week 8 to 24.'}, {'id': 'OG001', 'title': 'Semaglutide', 'description': 'Semaglutide 1.34 mg/mL administered by injection once weekly for 24 weeks in a dose-escalation regimen: 0.25 mg from day 1 to week 3, 0.5 mg from week 4 to 7, and 1.0 mg from week 8 to 24.'}], 'classes': [{'categories': [{'measurements': [{'value': '-30.9', 'groupId': 'OG000', 'lowerLimit': '-35.6', 'upperLimit': '-25.8'}, {'value': '-23.3', 'groupId': 'OG001', 'lowerLimit': '-28.5', 'upperLimit': '-17.7'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in least squared means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-7.6', 'ciLowerLimit': '-14.3', 'ciUpperLimit': '-0.9', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Difference (Efinopegdutide - Semaglutide) in %'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and up to ~24 weeks', 'description': 'Fasting blood samples were collected at baseline and after 24 weeks of treatment to assess mean percent change in triglycerides. The mean percent change in triglycerides is presented.', 'unitOfMeasure': 'Percent Change', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who had received at least 1 injection (including only partial) of study intervention and had at least 1 assessment.'}, {'type': 'SECONDARY', 'title': 'Mean Percent Change From Baseline in Apolipoprotein B (apoB) After 24 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Efinopegdutide', 'description': 'Efinopegdutide 20 mg/mL administered by injection once weekly for 24 weeks in a dose-escalation regimen: 2.4 mg from day 1 to week 3, 5.0 mg from week 4 to 7, and 10.0 mg from week 8 to 24.'}, {'id': 'OG001', 'title': 'Semaglutide', 'description': 'Semaglutide 1.34 mg/mL administered by injection once weekly for 24 weeks in a dose-escalation regimen: 0.25 mg from day 1 to week 3, 0.5 mg from week 4 to 7, and 1.0 mg from week 8 to 24.'}], 'classes': [{'categories': [{'measurements': [{'value': '-14.7', 'groupId': 'OG000', 'lowerLimit': '-18.2', 'upperLimit': '-11.1'}, {'value': '-9.2', 'groupId': 'OG001', 'lowerLimit': '-12.8', 'upperLimit': '-5.7'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in least squared means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-5.4', 'ciLowerLimit': '-10.4', 'ciUpperLimit': '-0.4', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Difference (Efinopegdutide - Semaglutide) in %'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and up to ~24 weeks', 'description': 'Fasting blood samples were collected at baseline and after 24 weeks of treatment to assess mean percent change in apoB. The mean percent change in apoB is presented.', 'unitOfMeasure': 'Percent Change', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who had received at least 1 injection (including only partial) of study intervention and had at least 1 assessment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Efinopegdutide', 'description': 'Efinopegdutide 20 mg/mL administered by injection once weekly for 24 weeks in a dose-escalation regimen: 2.4 mg from day 1 to week 3, 5.0 mg from week 4 to 7, and 10.0 mg from week 8 to 24.'}, {'id': 'FG001', 'title': 'Semaglutide', 'description': 'Semaglutide 1.34 mg/mL administered by injection once weekly for 24 weeks in a dose-escalation regimen: 0.25 mg from day 1 to week 3, 0.5 mg from week 4 to 7, and 1.0 mg from week 8 to 24.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '72'}, {'groupId': 'FG001', 'numSubjects': '73'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '64'}, {'groupId': 'FG001', 'numSubjects': '71'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'This study was conducted at 51 clinical sites in 16 countries.', 'preAssignmentDetails': 'Participant flow as per the database cutoff date of 19OCT2022.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '145', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Efinopegdutide', 'description': 'Efinopegdutide 20 mg/mL administered by injection once weekly for 24 weeks in a dose-escalation regimen: 2.4 mg from day 1 to week 3, 5.0 mg from week 4 to 7, and 10.0 mg from week 8 to 24.'}, {'id': 'BG001', 'title': 'Semaglutide', 'description': 'Semaglutide 1.34 mg/mL administered by injection once weekly for 24 weeks in a dose-escalation regimen: 0.25 mg from day 1 to week 3, 0.5 mg from week 4 to 7, and 1.0 mg from week 8 to 24.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '48.0', 'spread': '11.0', 'groupId': 'BG000'}, {'value': '50.7', 'spread': '10.9', 'groupId': 'BG001'}, {'value': '49.4', 'spread': '11.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '125', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '35.2', 'spread': '5.7', 'groupId': 'BG000'}, {'value': '33.5', 'spread': '5.0', 'groupId': 'BG001'}, {'value': '34.3', 'spread': '5.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Kg/M^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '100.2', 'spread': '18.9', 'groupId': 'BG000'}, {'value': '94.4', 'spread': '18.9', 'groupId': 'BG001'}, {'value': '97.3', 'spread': '19.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-08-26', 'size': 5441131, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-09-27T14:31', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 145}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-08-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2022-10-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-25', 'studyFirstSubmitDate': '2021-06-28', 'resultsFirstSubmitDate': '2023-09-27', 'studyFirstSubmitQcDate': '2021-06-28', 'lastUpdatePostDateStruct': {'date': '2023-11-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-10-25', 'studyFirstPostDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-11-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Relative Reduction From Baseline in Liver Fat Content (LFC) Measured by Magnetic Resonance Imaging-Estimated Proton Density Fat Fraction (MRI-PDFF), Evaluated by Blinded Independent Central Review (BICR) After 24 Weeks', 'timeFrame': 'Baseline and up to ~24 Weeks', 'description': 'LFC was measured with liver images taken by MRI-PDFF and analyzed by BICR. Relative Reduction from Baseline to Week 24 = (Baseline - Week 24) / Baseline x 100%. Mean relative reduction from baseline in liver fat content is presented.'}, {'measure': 'Percentage of Participants Who Experienced an Adverse Event (AE)', 'timeFrame': 'Up to ~29 weeks', 'description': 'An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE 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 percentage of participants who experienced an adverse event is presented.'}, {'measure': 'Percentage of Participants Who Discontinued Study Intervention Due to an AE', 'timeFrame': 'Up to ~24 weeks', 'description': 'An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE 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 percentage of participants who discontinued study intervention due to adverse event is presented.'}], 'secondaryOutcomes': [{'measure': 'Mean Absolute Reduction From Baseline in LFC Measured by MRI-PDFF (Evaluated by BICR) After 24 Weeks', 'timeFrame': 'Baseline and up to ~24 Weeks', 'description': 'LFC was measured by liver images taken by MRI-PDFF and analyzed by BICR. The absolute reduction from baseline to Week 24 = Baseline - Week 24. The mean absolute reduction from baseline in LFC after 24 weeks of treatment is presented.'}, {'measure': 'Mean Percent Change From Baseline in Body Weight After 24 Weeks', 'timeFrame': 'Baseline and up to ~24 weeks', 'description': 'Body weight in kilograms was measured using a standardized, digital scale. The mean percent change from baseline in body weight after 24 weeks is presented.'}, {'measure': 'Mean Percent Change From Baseline in Total Cholesterol After 24 Weeks', 'timeFrame': 'Baseline and up to ~24 weeks', 'description': 'Fasting blood samples were collected at baseline and after 24 weeks of treatment to assess mean percent change in total cholesterol. The mean percent change in total cholesterol is presented.'}, {'measure': 'Mean Percent Change From Baseline in Non-High Density Lipoprotein-Cholesterol (Non-HDL-C) After 24 Weeks', 'timeFrame': 'Baseline and up to ~24 weeks', 'description': 'Fasting blood samples were collected at baseline and after 24 weeks of treatment to assess mean percent change in non-HDL-C. The mean percent change in non-HDL-C is presented.'}, {'measure': 'Mean Percent Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) After 24 Weeks', 'timeFrame': 'Baseline and up to ~24 weeks', 'description': 'Fasting blood samples were collected at baseline and after 24 weeks of treatment to assess mean percent change in HDL-C. Mean percent change in HDL-C is presented.'}, {'measure': 'Mean Percent Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) After 24 Weeks', 'timeFrame': 'Baseline and up to ~24 weeks', 'description': 'Fasting blood samples were collected at baseline and after 24 weeks of treatment to assess mean percent change in LDL-C. The mean percent change in LDL-C is presented.'}, {'measure': 'Mean Percent Change From Baseline in Triglycerides (TG) After 24 Weeks', 'timeFrame': 'Baseline and up to ~24 weeks', 'description': 'Fasting blood samples were collected at baseline and after 24 weeks of treatment to assess mean percent change in triglycerides. The mean percent change in triglycerides is presented.'}, {'measure': 'Mean Percent Change From Baseline in Apolipoprotein B (apoB) After 24 Weeks', 'timeFrame': 'Baseline and up to ~24 weeks', 'description': 'Fasting blood samples were collected at baseline and after 24 weeks of treatment to assess mean percent change in apoB. The mean percent change in apoB is presented.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Nonalcoholic Fatty Liver Disease', 'Nonalcoholic Steatohepatitis']}, 'referencesModule': {'references': [{'pmid': '37355043', 'type': 'RESULT', 'citation': 'Romero-Gomez M, Lawitz E, Shankar RR, Chaudhri E, Liu J, Lam RLH, Kaufman KD, Engel SS; MK-6024 P001 Study Group. A phase IIa active-comparator-controlled study to evaluate the efficacy and safety of efinopegdutide in patients with non-alcoholic fatty liver disease. J Hepatol. 2023 Oct;79(4):888-897. doi: 10.1016/j.jhep.2023.05.013. Epub 2023 Jun 22.'}], 'seeAlsoLinks': [{'url': 'https://www.merckclinicaltrials.com/', 'label': 'Merck Clinical Trials Information'}]}, 'descriptionModule': {'briefSummary': 'The principal goal of this study is to determine the efficacy of efinopegdutide in liver fat reduction in participants with NAFLD. The primary hypotheses are that efinopegdutide is superior to semaglutide, or that efinopegdutide is superior to semaglutide by at least 10% with respect to mean relative reduction from baseline in liver fat content (LFC) after 24 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* LFC ≥10% as assessed by MRI-PDFF at time of screening.\n* Body Mass Index (BMI) ≥25 kg/m² and ≤50 kg/m² at time of screening.\n* Stable weight (based on self-reporting) defined as ≤5% gain or loss of body weight for at least 3 months before screening visit.\n* No history of Type 2 Diabetes Mellitus (T2DM) OR history of T2DM with an Glycated Hemoglobin (A1C) ≤8.5% at screening AND controlled by diet or a stable dose of metformin for the 3 months before screening.\n* A female participant is eligible to participate if she is not pregnant or breastfeeding, is not a woman of childbearing potential (WOCBP), or is a WOCBP and agrees to follow contraceptive guidance during the study intervention period and for at least 5 weeks after the last dose of study intervention.\n* Participants in Taiwan are eligible between the ages of 20 to 70 years of age (inclusive).\n* Participants in South Korea are eligible between the ages of 19 to 70 years of age (inclusive).\n\nExclusion Criteria:\n\n* History of Type 1 Diabetes Mellitus (T1DM), diabetic ketoacidosis, or diabetes secondary to pancreatitis or pancreatectomy.\n* Ongoing, inadequately controlled hypothyroidism or hyperthyroidism.\n* Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasm type-2 syndrome.\n* Recent event (within 6 months prior to screening) of congestive heart failure, unstable angina, myocardial infarction, arterial revascularization, stroke, or transient ischemic attack.\n* History or evidence of chronic liver disease other than NAFLD or Non-Alcoholic SteatoHepatitis (NASH).\n* Known history of cirrhosis.\n* History of acute or chronic pancreatitis.\n* History of a bariatric surgical procedure or a known clinically significant gastric emptying abnormality.\n* History of malignancy ≤5 years prior to screening, except for skin cancer or cervical cancer.\n* Clinically active hematologic disorder.\n* Diagnosis of human immunodeficiency virus (HIV).\n* Surgery requiring general anesthesia within 3 months before screening visit.\n* History of organ transplantation, except for corneal transplant.\n* Active diabetic proliferative retinopathy or a history of maculopathy.\n* Untreated obstructive sleep apnea.\n* History of treatment with any glucagon-like peptide-1 (GLP-1) receptor agonist within 6 months before screening.\n* History of treatment with thiazolidinediones (ie, pioglitazone, rosiglitazone) within 6 months before screening.\n* Previous use (within 3 months before screening) or current use of prescription weight-management medications or over-the-counter weight-loss medications or therapies.\n* Treatment with systemic corticosteroid medication within 3 months before screening.\n* Current treatment with anticoagulants (eg, warfarin, heparin).\n* Inability to have an MRI-PDFF performed due to either severe claustrophobia, metallic implant that prevents MRI-PDFF examination, or any other contraindication to MRI-PDFF examination.\n* Previous or current history of significant alcohol consumption (average of 7 standard drinks per week in females or 14 standard drinks per week in males) for a period of more than 3 consecutive months in the 24 months before screening.'}, 'identificationModule': {'nctId': 'NCT04944992', 'briefTitle': 'A Study of Efinopegdutide (MK-6024) in Participants With Nonalcoholic Fatty Liver Disease (NAFLD) (MK-6024-001)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Phase 2a, Randomized, Active-Comparator-Controlled, Open-Label Study to Evaluate the Efficacy and Safety of Efinopegdutide (MK-6024) in Individuals With Nonalcoholic Fatty Liver Disease', 'orgStudyIdInfo': {'id': '6024-001'}, 'secondaryIdInfos': [{'id': 'MK-6024-001', 'type': 'OTHER', 'domain': 'Merck'}, {'id': '2020-005136-30', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Efinopegdutide', 'description': 'Efinopegdutide 20 mg/mL administered by injection once weekly for 24 weeks in a dose-escalation regimen: 2.4 mg from day 1 to week 3, 5.0 mg from week 4 to 7, and 10.0 mg from week 8 to 24.', 'interventionNames': ['Drug: Efinopegdutide 20 mg/mL']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Semaglutide', 'description': 'Semaglutide 1.34 mg/mL administered by injection once weekly for 24 weeks in a dose-escalation regimen: 0.25 mg from day 1 to week 3, 0.5 mg from week 4 to 7, and 1.0 mg from week 8 to 24.', 'interventionNames': ['Drug: Semaglutide 1.34 mg/mL']}], 'interventions': [{'name': 'Efinopegdutide 20 mg/mL', 'type': 'DRUG', 'otherNames': ['MK-6024', 'HM12525A', 'JNJ-64565111'], 'description': 'Subcutaneous injection in a dose-escalation administration of 2.4 mg, 5.0 mg, and 10.0 mg', 'armGroupLabels': ['Efinopegdutide']}, {'name': 'Semaglutide 1.34 mg/mL', 'type': 'DRUG', 'otherNames': ['Ozempic®'], 'description': 'Subcutaneous injection in a dose-escalation administration of 0.25 mg, 0.5 mg, and 1.0 mg', 'armGroupLabels': ['Semaglutide']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91763', 'city': 'Montclair', 'state': 'California', 'country': 'United States', 'facility': 'Catalina Research Institute, LLC ( Site 1939)', 'geoPoint': {'lat': 34.07751, 'lon': -117.68978}}, {'zip': '33016', 'city': 'Hialeah', 'state': 'Florida', 'country': 'United States', 'facility': 'Sweet Hope Research Specialty, Inc ( Site 1902)', 'geoPoint': {'lat': 25.8576, 'lon': -80.27811}}, {'zip': '33016', 'city': 'Miami Lakes', 'state': 'Florida', 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