Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 2:28 AM
Study NCT ID:
NCT07388667
Status:
RECRUITING
Last Update Posted:
2026-03-24
First Post:
2026-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Study of MK-4082 in Healthy Overweight Participants (MK-4082-002)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-03-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-08-19', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-20', 'studyFirstSubmitDate': '2026-01-29', 'studyFirstSubmitQcDate': '2026-01-29', 'lastUpdatePostDateStruct': {'date': '2026-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-19', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Who Experience an Adverse Event (AE)', 'timeFrame': 'Up to approximately 98 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 an AE will be reported.'}, {'measure': 'Number of Participants Who Discontinue Study Treatment Due to an AE', 'timeFrame': 'Up to approximately 84 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 treatment due to an AE will be reported.'}], 'secondaryOutcomes': [{'measure': 'Area Under the Curve from Time 0 to 24 hours (AUC0-24) of MK-4082', 'timeFrame': 'At designated timepoints (up to 24 hours postdose)', 'description': 'Blood samples will be collected to determine the AUC0-24hr of MK-4082.'}, {'measure': 'Time to Maximum Plasma Concentration (Tmax) of MK-4082', 'timeFrame': 'Predose and at designated timepoints up to 84 Days postdose', 'description': 'Blood samples will be collected to determine the Tmax of MK-4082.'}, {'measure': 'Maximum Plasma Concentration (Cmax) of MK-4082', 'timeFrame': 'Predose and at designated timepoints up to 84 Days postdose', 'description': 'Blood samples will be collected to determine the Cmax of MK-4082.'}, {'measure': 'Plasma Concentration at 24 Hours (C24) of MK-4082', 'timeFrame': 'At designated timepoints up to 24 hours postdose', 'description': 'Blood samples will be collected to determine the C24 of MK-4082.'}, {'measure': 'Area Under the Curve from Time 0 to Infinity (AUC0-Inf) of MK-4082', 'timeFrame': 'Predose and at designated timepoints up to 84 Days postdose', 'description': 'Blood samples will be collected to determine the AUC0-Inf of MK-4082.'}, {'measure': 'Area Under the Curve from Time 0 to Last (AUC0-Last) of MK-4082', 'timeFrame': 'Predose and at designated timepoints up to 84 Days postdose', 'description': 'Blood samples will be collected to determine the AUC0-last of MK-4082.'}, {'measure': 'Apparent Clearance (CL/F) of MK-4082', 'timeFrame': 'Predose and at designated timepoints up to 84 Days postdose', 'description': 'Blood samples will be collected to determine the CL/F of MK-4082.'}, {'measure': 'Apparent Volume of Distribution During Terminal Phase (Vz/F) of MK-4082', 'timeFrame': 'Predose and at designated timepoints up to 84 Days postdose', 'description': 'Blood samples will be collected to determine the Vz/F of MK-4082.'}, {'measure': 'Apparent Terminal Half-life (t1/2) of MK-4082', 'timeFrame': 'Predose and at designated timepoints up to 84 Days postdose', 'description': 'Blood samples will be collected to determine the t1/2of MK-4082.'}, {'measure': 'Change from Baseline in Body Weight', 'timeFrame': 'Baseline and up to approximately 84 Days', 'description': 'Change from baseline in body weight will be reported.'}, {'measure': 'Change from Baseline in Body Mass Index (BMI)', 'timeFrame': 'Baseline and up to approximately 84 Days', 'description': 'Change from baseline in body mass index (BMI) will be reported.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.merckclinicaltrials.com', 'label': 'Merck Clinical Trials Information'}]}, 'descriptionModule': {'briefSummary': "Researchers are looking for new weight loss medicines for people with higher body weight. The study medicine, MK-4082, is different from similar weight loss medicines because people take it as a pill instead of an injection. Before giving a study medicine to people with a health condition, researchers first do studies to find a safe dose level (amount) of the study medicine that can be used in future studies.\n\nThe goals of this study are to learn about:\n\n* The safety of MK-4082 and if people tolerate it\n* What happens to different MK-4082 dose levels in a person's body over time"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Is in good health\n* Has body mass index (BMI) between 25 and 40 kg/m\\^2, inclusive. Participants must weigh at least 60 kg\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* has a history of previous surgical treatment for obesity (bariatric surgery, gastric banding, etc.) or any other gastrointestinal (GI) surgery that may induce malabsorption, history of bowel resection \\>20 cm, any malabsorption disorder, severe gastroparesis, or any GI procedure for weight loss (including LAP-BAND®), as well as clinically significant GI disorders (eg, peptic ulcers, severe gastroesophageal reflux disease)\n* has an individual or family history of medullary thyroid carcinoma or multiple endocrine neoplasia 2'}, 'identificationModule': {'nctId': 'NCT07388667', 'briefTitle': 'A Clinical Study of MK-4082 in Healthy Overweight Participants (MK-4082-002)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of MK-4082 in Healthy Overweight/Obese Participants', 'orgStudyIdInfo': {'id': '4082-002'}, 'secondaryIdInfos': [{'id': 'MK-4082-002', 'type': 'OTHER', 'domain': 'MSD'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Panel A: Dose Escalation to Dosage 1', 'description': 'Participants receive escalating doses of oral MK-4082 once daily (QD) or a dose-matched placebo to reach maintenance dose 1.', 'interventionNames': ['Drug: MK-4082', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Panel B: Dose Escalation to Dosage 2', 'description': 'Participants receive escalating doses of oral MK-4082 QD or a dose-matched placebo to reach maintenance dose 2.', 'interventionNames': ['Drug: MK-4082', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Panel C: Dose Escalation to Dosage 3', 'description': 'Participants receive escalating doses of oral MK-4082 once daily (QD) or a dose-matched placebo to reach maintenance dose 3.', 'interventionNames': ['Drug: MK-4082', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Panel D: Dose Escalation to Dosage 4', 'description': 'Participants receive escalating doses of oral MK-4082 once daily (QD) or a dose-matched placebo to reach maintenance dose 4.', 'interventionNames': ['Drug: MK-4082', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Panel E: Dose Escalation to Dosage 5', 'description': 'Participants receive escalating doses of oral MK-4082 once daily (QD) or a dose-matched placebo to reach maintenance dose 5.', 'interventionNames': ['Drug: MK-4082', 'Drug: Placebo']}], 'interventions': [{'name': 'MK-4082', 'type': 'DRUG', 'description': 'Oral Tablet', 'armGroupLabels': ['Panel A: Dose Escalation to Dosage 1', 'Panel B: Dose Escalation to Dosage 2', 'Panel C: Dose Escalation to Dosage 3', 'Panel D: Dose Escalation to Dosage 4', 'Panel E: Dose Escalation to Dosage 5']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Oral Tablet', 'armGroupLabels': ['Panel A: Dose Escalation to Dosage 1', 'Panel B: Dose Escalation to Dosage 2', 'Panel C: Dose Escalation to Dosage 3', 'Panel D: Dose Escalation to Dosage 4', 'Panel E: Dose Escalation to Dosage 5']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91911', 'city': 'Chula Vista', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '619-427-1300'}], 'facility': 'ProSciento Inc. ( Site 0002)', 'geoPoint': {'lat': 32.64005, 'lon': -117.0842}}, {'zip': '33143', 'city': 'South Miami', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '305-722-0970'}], 'facility': 'QPS-MRA, LLC ( Site 0003)', 'geoPoint': {'lat': 25.7076, 'lon': -80.29338}}, {'zip': '65802', 'city': 'Springfield', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '417-831-2048'}], 'facility': 'Bio-Kinetic Clinical Applications, LLD dba QPS-MO ( Site 0004)', 'geoPoint': {'lat': 37.21533, 'lon': -93.29824}}, {'zip': '08053', 'city': 'Marlton', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '856-452-9901'}], 'facility': 'Hassman Research Institute Marlton Site ( Site 0006)', 'geoPoint': {'lat': 39.89122, 'lon': -74.92183}}], 'centralContacts': [{'name': 'Toll Free Number', 'role': 'CONTACT', 'email': 'Trialsites@msd.com', 'phone': '1-888-577-8839'}], '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'}}}}