Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2025-12-30 @ 11:28 PM
Study NCT ID:
NCT07242469
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-21
First Post:
2025-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Trial of MK-1403 in Participants With Type 2 Diabetes Mellitus (MK-1403-006)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 52}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-08-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2025-11-17', 'studyFirstSubmitQcDate': '2025-11-17', 'lastUpdatePostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-08-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants who experience one or more adverse events (AE)', 'timeFrame': 'Up to approximately 28 days', '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. The number of participants who experience one or more AEs will be reported.'}, {'measure': 'Number of participants who discontinue study intervention due to adverse events', 'timeFrame': 'Up to approximately 14 days', '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. The number of participants who discontinue study intervention due to an AE will be reported.'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline in Placebo-Corrected High Sensitivity C-Reactive Protein (hsCRP) Serum Concentration', 'timeFrame': 'Baseline and 24-hours postdose on Day 14', 'description': 'Blood samples will be collected to determine the change from baseline in placebo-corrected hsCRP.'}, {'measure': 'Plasma concentration of MK-1403 at 24 Hours Postdose (C24) on Day 14', 'timeFrame': '24-hour postdose on Day 14', 'description': 'Blood samples will be collected to determine the C24 of MK-1403 in plasma on Day 14.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.merckclinicaltrials.com', 'label': 'Merck Clinical Trials Information'}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to learn about the safety and if people tolerate a study medicine called MK-1403. The study will also measure what happens to MK-1403 in the body of a person with type 2 diabetes (T2D) over time (pharmacokinetic or PK study), and how it affects the amount of high-sensitivity C-reactive protein (hsCRP) in a person's blood."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Has a confirmed diagnosis of Type 2 diabetes mellitus (T2DM)\n* Has body mass index (BMI) between 18 and 40 kg/m\\^2, inclusive\n\nExclusion Criteria:\n\n* Has Type 1 diabetes mellitus or secondary types of diabetes\n* Has a history of congestive heart failure (New York Heart Association \\[NYHA\\] Class 3 or 4)\n* Has history of myocardial infarction, uncontrolled arrhythmias, cardiac revascularization, angina, unstable peripheral arterial disease and/or stroke\n* Has history of cancer (malignancy)\n* Has positive test(s) for hepatitis B surface antigen (HBsAg), hepatitis C antibodies, or human immunodeficiency virus (HIV)\n* Has a history of gastrointestinal (GI) disease which might affect food and drug absorption, or has had gastric bypass or similar surgery'}, 'identificationModule': {'nctId': 'NCT07242469', 'briefTitle': 'A Clinical Trial of MK-1403 in Participants With Type 2 Diabetes Mellitus (MK-1403-006)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Multiple Dose Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MK-1403 in Participants With Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': '1403-006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Panel A MK-1403 + additive coformulation dose 1', 'description': 'Participants will receive MK-1403 + additive coformulation dose 1 orally once daily.', 'interventionNames': ['Drug: MK-1403 + additive coformulation']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Panel A Placebo + additive coformulation dose 1', 'description': 'Participants will receive Placebo + additive coformulation dose 1 orally once daily.', 'interventionNames': ['Drug: Placebo + additive coformulation']}, {'type': 'EXPERIMENTAL', 'label': 'Panel B MK-1403 + additive coformulation dose 2', 'description': 'Participants will receive MK-1403 + additive coformulation dose 2 orally once daily', 'interventionNames': ['Drug: MK-1403 + additive coformulation']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Panel B Placebo + additive coformulation dose 2', 'description': 'Participants will receive Placebo + additive coformulation dose 2 orally once daily', 'interventionNames': ['Drug: Placebo + additive coformulation']}], 'interventions': [{'name': 'MK-1403 + additive coformulation', 'type': 'DRUG', 'description': 'MK-1403 + additive coformulation is a co-formulated product of MK-1403 administered orally.', 'armGroupLabels': ['Panel A MK-1403 + additive coformulation dose 1', 'Panel B MK-1403 + additive coformulation dose 2']}, {'name': 'Placebo + additive coformulation', 'type': 'DRUG', 'description': 'Placebo + additive coformulation is a co-formulated product of placebo administered orally.', 'armGroupLabels': ['Panel A Placebo + additive coformulation dose 1', 'Panel B Placebo + additive coformulation dose 2']}]}, 'contactsLocationsModule': {'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'}}}}