Ignite Creation Date:
2025-12-24 @ 2:56 PM
Ignite Modification Date:
2026-02-27 @ 7:07 PM
Study NCT ID:
NCT06575959
Status:
COMPLETED
Last Update Posted:
2025-05-28
First Post:
2024-08-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Study of Enlicitide Decanoate in People With Liver Function Problems (MK-0616-030)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D048550', 'term': 'Hepatic Insufficiency'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-09-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-05-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-26', 'studyFirstSubmitDate': '2024-08-26', 'studyFirstSubmitQcDate': '2024-08-26', 'lastUpdatePostDateStruct': {'date': '2025-05-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Part 1: Area under the concentration versus time curve from 0 to infinity (AUC0-inf)AUC0-inf of enlicitide', 'timeFrame': 'Pre-dose and at designated time points up to 168 hours post dose', 'description': 'AUC0-inf of enlicitide in plasma will be determined.'}, {'measure': 'Part 1: Maximum concentration (Cmax) of enlicitide', 'timeFrame': 'Predose, and at designated timepoints up to 168 hours post-dose', 'description': 'Cmax of enlicitide in plasma will be determined'}, {'measure': 'Part 2: AUC 0-inf of enlicitide', 'timeFrame': 'Pre-dose and at designated timepoints up to 168 hours post dose', 'description': 'AUC 0-inf of enlicitide in plasma will be determined'}, {'measure': 'Part 2: Cmax of enlicitide', 'timeFrame': 'Predose, and at designated timepoints up to 168 hours post-dose', 'description': 'Cmax of enlicitide in plasma will be determined'}], 'secondaryOutcomes': [{'measure': 'Part 1: Area under the concentration versus time curve from 0 to 24 hours (AUC0-24) of enlicitide', 'timeFrame': 'Pre-dose and at designated timepoints up to 168 hours post dose', 'description': 'AUC0-24 of enlicitide in plasma will be determined.'}, {'measure': 'Part 1: Area under the concentration versus time curve from 0 to the time of the last quantifiable sample (AUC0-last) of enlicitide', 'timeFrame': 'Pre-dose and at designated timepoints up to 168 hours post dose', 'description': 'AUC0-last of enlicitide in plasma will be determined'}, {'measure': 'Part 1: Time to maximum (Tmax) observed plasma drug concentration of enlicitide', 'timeFrame': 'Pre-dose and at designated timepoints up to 168 hours post dose', 'description': 'Tmax of enlicitide in plasma will be determined'}, {'measure': 'Part 1: Apparent terminal half-life (t1/2) of enlicitide', 'timeFrame': 'Pre-dose and at designated timepoints up to 168 hours post dose', 'description': 't1/2 of enlicitide in plasma will be determined'}, {'measure': 'Part 1: Apparent clearance (CL/F) of enlicitide', 'timeFrame': 'Pre-dose and at designated timepoints up to 168 hours post dose', 'description': 'CL/F of enlicitide in plasma will be determined'}, {'measure': 'Part 1: Apparent volume of distribution during terminal phase (Vz/F) of enlicitide', 'timeFrame': 'Pre-dose and at designated timepoints up to 168 hours post dose', 'description': 'Vz/F of enlicitide in plasma will be determined'}, {'measure': 'Part 1: Number of participants who experience one or more adverse events (AEs)', 'timeFrame': 'Up to approximately 6 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.'}, {'measure': 'Part 1: Number of participants who discontinue study intervention due to an AE', 'timeFrame': 'Up to approximately 6 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.'}, {'measure': 'Part 2: AUC0-24 of enlicitide', 'timeFrame': 'Pre-dose and at designated timepoints up to 168 hours post dose', 'description': 'AUC0-24 of enlicitide in plasma will be determined.'}, {'measure': 'Part 2: AUC0-last of enlicitide', 'timeFrame': 'Pre-dose and at designated timepoints up to 168 hours post dose', 'description': 'AUC0-last of enlicitide in plasma will be determined'}, {'measure': 'Part 2: Tmax observed plasma drug concentration of enlicitide', 'timeFrame': 'Pre-dose and at designated timepoints up to 168 hours post dose', 'description': 'Tmax of enlicitide in plasma will be determined'}, {'measure': 'Part 2: t1/2 of enlicitide', 'timeFrame': 'Pre-dose and at designated timepoints up to 168 hours post dose', 'description': 't1/2 of enlicitide in plasma will be determined'}, {'measure': 'Part 2: CL/F of enlicitide', 'timeFrame': 'Pre-dose and at designated timepoints up to 168 hours post dose', 'description': 'CL/F of enlicitide in plasma will be determined'}, {'measure': 'Part 2: Vz/F of enlicitide', 'timeFrame': 'Pre-dose and at designated timepoints up to 168 hours post dose', 'description': 'Vz/F of enlicitide in plasma will be determined'}, {'measure': 'Part 2 Number of participants who experience one or more adverse events (AEs)', 'timeFrame': 'Up to approximately 6 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.'}, {'measure': 'Part 2: Number of participants who discontinue study intervention due to an AE', 'timeFrame': 'Up to approximately 6 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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hepatic Insufficiency', 'Hepatic Impairment']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.merckclinicaltrials.com', 'label': 'Merck Clinical Trials Information'}]}, 'descriptionModule': {'briefSummary': 'Researchers have designed a new study medicine called enlicitide decanoate as a new way to lower the amount of low-density lipoprotein cholesterol (LDL-C) in a person\'s blood. Enlicitide decanoate will be called "enlicitide" from this point forward,\n\nThe purpose of this study is to learn what happens to enlicitide in a person\'s body over time (a pharmacokinetic or PK study). Researchers will compare what happens to enlicitide in the body when it is given to people with hepatic impairment (HI- meaning the liver does not work properly) and people who are in good health.\n\nThis study will have 2 parts. In Part 1, enlicitide will be given to people with moderate HI and people who are in good health. After Part 1, researchers may decide to include people who have mild HI and compare what happens to enlicitide in the body with people who are in good health.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\nAll participants:\n\n* Has been a non-smoker or moderate smoker (≤ 10 cigarettes per day or equivalent) for at least 3 months prior to starting the study\n* Has body mass index (BMI) ≥ 18.0 and ≤ 40.0 kg/m2\n\nParticipants with moderate or mild HI:\n\n* Diagnosis of chronic (\\> 6 months) and stable (no sudden or severe episodes of illness due to worsening liver function in the past 2 months) hepatic insufficiency, and features cirrhosis (liver scarring) due to any cause.\n* Is generally in good health with the exception of HI.\n\nHealthy Control Participants:\n\n* Medically healthy with no clinically significant medical history, physical examination, or clinical laboratory profiles\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\nAll participants:\n\n* History of gastrointestinal disease which may affect food and drug absorption, or has had a gastric bypass or similar surgery.\n* History of cancer\n* Consumes greater than 3 servings of alcoholic beverages per day.\n* Is on statin background therapy.\n\nParticipants with moderate or mild HI:\n\n* Severe complications of liver disease within 3 months of entering the study.'}, 'identificationModule': {'nctId': 'NCT06575959', 'briefTitle': 'A Clinical Study of Enlicitide Decanoate in People With Liver Function Problems (MK-0616-030)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'An Open-Label, Single-Dose Clinical Study to Evaluate the Pharmacokinetics of Enlicitide in Participants With Hepatic Impairment', 'orgStudyIdInfo': {'id': '0616-030'}, 'secondaryIdInfos': [{'id': 'MK-0616-030', 'type': 'OTHER', 'domain': 'MSD'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Moderate Hepatic Impairment (HI)', 'description': 'Participants will receive a single oral dose of enlicitide on Day 1', 'interventionNames': ['Drug: Enlicitide']}, {'type': 'EXPERIMENTAL', 'label': 'Healthy Controls', 'description': 'Participants will receive a single oral dose of enlicitide on Day 1', 'interventionNames': ['Drug: Enlicitide']}, {'type': 'EXPERIMENTAL', 'label': 'Mild HI', 'description': 'Participants will receive a single oral dose of enlicitide on Day 1', 'interventionNames': ['Drug: Enlicitide']}], 'interventions': [{'name': 'Enlicitide', 'type': 'DRUG', 'otherNames': ['enlicitide decanoate', 'MK-0616/sodium caprate'], 'description': 'Oral tablet', 'armGroupLabels': ['Healthy Controls', 'Mild HI', 'Moderate Hepatic Impairment (HI)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32809', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Orlando Clinical Research Center ( Site 0002)', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '78215', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'The Texas Liver Institute ( Site 0001)', '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'}}}}