Ignite Creation Date:
2025-12-24 @ 5:35 PM
Ignite Modification Date:
2025-12-27 @ 12:19 AM
Study NCT ID:
NCT07030868
Status:
TERMINATED
Last Update Posted:
2025-08-29
First Post:
2025-06-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of LY3549492 in Adults With Obesity or Overweight With Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'whyStopped': 'Study terminated for strategic business reasons', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2025-06-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-07-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-25', 'studyFirstSubmitDate': '2025-06-13', 'studyFirstSubmitQcDate': '2025-06-13', 'lastUpdatePostDateStruct': {'date': '2025-08-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-06-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Change from Baseline in Body Weight', 'timeFrame': 'Baseline, Week 32'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline in Body Weight', 'timeFrame': 'Baseline, Week 32'}, {'measure': 'Percentage of Participants Who Achieve ≥5% Body Weight Reduction', 'timeFrame': 'Baseline, Week 32'}, {'measure': 'Percentage of Participants Who Achieve ≥10% Body Weight Reduction', 'timeFrame': 'Baseline, Week 32'}, {'measure': 'Change from Baseline in Hemoglobin A1c (HbA1c)', 'timeFrame': 'Baseline, Week 32'}, {'measure': 'Pharmacokinetics (PK): Average Concentration of LY3549492', 'timeFrame': 'Week 32'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity', 'Overweight', 'Type 2 Diabetes']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trials.lilly.com/en-US/trial/619929', 'label': 'A Study of LY3549492 in Adults With Obesity or Overweight With Type 2 Diabetes'}]}, 'descriptionModule': {'briefSummary': 'The main purpose of this study, performed under the master protocol W8M-MC-CWMM (NCT06143956), is to evaluate the effects of treatment with LY3549492 compared to placebo in adult participants with obesity or who are overweight with type 2 diabetes.\n\nParticipation in the study will last about 11 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nW8M-MC-GN02:\n\n* Assigned male at birth\n* Assigned female at birth, who are of non-childbearing potential\n* Have type 2 diabetes\n\nW8M-MC-CWMM:\n\n* Have a BMI ≥27 kilograms per square meter (kg/m²)\n* Have had a stable body weight for the 3 months prior to randomization (\\<5% body weight gain and/or loss\n\nExclusion Criteria:\n\nW8M-MC-GN02:\n\n* Individuals who are of childbearing potential\n* Have a history of acute or chronic pancreatitis\n* Have any of the following cardiovascular conditions within 6 months prior to screening:\n\n * acute myocardial infarction\n * cerebrovascular accident (stroke)\n * unstable angina, or\n * hospitalization due to congestive heart failure.\n\nW8M-MC-CWMM:\n\n* Have a prior or planned surgical treatment for obesity, except prior liposuction or abdominoplasty, if performed \\>1 year prior to screening\n* Have type 1 diabetes mellitus, latent autoimmune diabetes in adults, or history of ketoacidosis or hyperosmolar coma\n* Have poorly controlled hypertension\n* Have signs and symptoms of any liver disease other than nonalcoholic fatty liver disease\n* Have a history of symptomatic gallbladder disease within the past 2 years\n* Have a lifetime history of suicide attempts'}, 'identificationModule': {'nctId': 'NCT07030868', 'briefTitle': 'A Study of LY3549492 in Adults With Obesity or Overweight With Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Phase 2, Parallel-Group, Double-Blind 4-arm Study to Investigate the Effects of Treatment With LY3549492 Tablets Compared With Placebo in an Obese or Overweight Population With Type-2 Diabetes (T2D)', 'orgStudyIdInfo': {'id': '27321'}, 'secondaryIdInfos': [{'id': 'W8M-MC-GN02', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}, {'id': 'W8M-MC-CWMM', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LY3549492 Dose 1', 'description': 'Participants will receive LY3549492 orally', 'interventionNames': ['Drug: LY6249492']}, {'type': 'EXPERIMENTAL', 'label': 'LY3549492 Dose 2 Fast Titration', 'description': 'Participants will receive LY3549492 orally', 'interventionNames': ['Drug: LY6249492']}, {'type': 'EXPERIMENTAL', 'label': 'LY3549492 Dose 2 Slow Titration', 'description': 'Participants will receive LY3549492 orally', 'interventionNames': ['Drug: LY6249492']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants will receive placebo orally', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'LY6249492', 'type': 'DRUG', 'description': 'Administered orally', 'armGroupLabels': ['LY3549492 Dose 1', 'LY3549492 Dose 2 Fast Titration', 'LY3549492 Dose 2 Slow Titration']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered orally', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85032', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'HOPE Research Institute', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85260', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Headlands Research - Scottsdale', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '94904', 'city': 'Greenbrae', 'state': 'California', 'country': 'United States', 'facility': 'NorCal Medical Research, Inc', 'geoPoint': {'lat': 37.94854, 'lon': -122.5247}}, {'zip': '90255', 'city': 'Huntington Park', 'state': 'California', 'country': 'United States', 'facility': 'Velocity Clinical Research, Huntington Park', 'geoPoint': {'lat': 33.98168, 'lon': -118.22507}}, {'zip': '90274', 'city': 'Rolling Hills Estates', 'state': 'California', 'country': 'United States', 'facility': 'Peninsula Research Associates', 'geoPoint': {'lat': 33.78779, 'lon': -118.35813}}, {'zip': '94598', 'city': 'Walnut Creek', 'state': 'California', 'country': 'United States', 'facility': 'Diablo Clinical Research, Inc.', 'geoPoint': {'lat': 37.90631, 'lon': -122.06496}}, {'zip': '06905', 'city': 'Stamford', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Stamford Therapeutics Consortium', 'geoPoint': {'lat': 41.05343, 'lon': -73.53873}}, {'zip': '32003', 'city': 'Fleming Island', 'state': 'Florida', 'country': 'United States', 'facility': 'Northeast Research Institute (NERI)', 'geoPoint': {'lat': 30.0933, 'lon': -81.71898}}, {'zip': '33012', 'city': 'Hialeah', 'state': 'Florida', 'country': 'United States', 'facility': 'Indago Research & Health 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'state': 'Illinois', 'country': 'United States', 'facility': 'Great Lakes Clinical Trials - Ravenswood', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '50266', 'city': 'West Des Moines', 'state': 'Iowa', 'country': 'United States', 'facility': 'Iowa Diabetes and Endocrinology Research Center', 'geoPoint': {'lat': 41.57721, 'lon': -93.71133}}, {'zip': '66606', 'city': 'Topeka', 'state': 'Kansas', 'country': 'United States', 'facility': "Cotton O'Neil Diabetes & Endocrinology", 'geoPoint': {'lat': 39.04833, 'lon': -95.67804}}, {'zip': '02492', 'city': 'Needham', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Knownwell', 'geoPoint': {'lat': 42.28343, 'lon': -71.23283}}, {'zip': '02740', 'city': 'New Bedford', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Lucida Clinical Trials', 'geoPoint': {'lat': 41.63526, 'lon': -70.92701}}, {'zip': '48034', 'city': 'Southfield', 'state': 'Michigan', 'country': 'United States', 'facility': 'Headlands Research - Detroit', 'geoPoint': {'lat': 42.47337, 'lon': -83.22187}}, {'zip': '48098', 'city': 'Troy', 'state': 'Michigan', 'country': 'United States', 'facility': 'Arcturus Healthcare , PLC, Troy Internal Medicine Research Division', 'geoPoint': {'lat': 42.60559, 'lon': -83.14993}}, {'zip': '65807', 'city': 'Springfield', 'state': 'Missouri', 'country': 'United States', 'facility': 'Clinvest Headlands Llc', 'geoPoint': {'lat': 37.21533, 'lon': -93.29824}}, {'zip': '89128', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Las Vegas Medical Research', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '13057', 'city': 'East Syracuse', 'state': 'New York', 'country': 'United States', 'facility': 'Velocity Clinical Research, Syracuse', 'geoPoint': {'lat': 43.06534, 'lon': -76.07853}}, {'zip': '14609', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Rochester Clinical Research, LLC', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '28112', 'city': 'Monroe', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Monroe Biomedical Research', 'geoPoint': {'lat': 34.98543, 'lon': -80.54951}}, {'zip': '28557', 'city': 'Morehead City', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Lucas Research, Inc', 'geoPoint': {'lat': 34.72294, 'lon': -76.72604}}, {'zip': '28562', 'city': 'New Bern', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Lucas Research, Inc.', 'geoPoint': {'lat': 35.10849, 'lon': -77.04411}}, {'zip': '37211', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Quality Medical Research', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '78745', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'IMA Clinical Research Austin', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '75230', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Velocity Clinical Research, Dallas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75251', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'FutureSearch Trials of Dallas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77079', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'PlanIt Research, PLLC', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Tekton Research - Fredericksburg Road', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78240', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Endeavor Clinical Trials', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78596', 'city': 'Weslaco', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Valley Clinical Research', 'geoPoint': {'lat': 26.15952, 'lon': -97.99084}}, {'zip': '24541', 'city': 'Danville', 'state': 'Virginia', 'country': 'United States', 'facility': 'Spectrum Medical, Inc.', 'geoPoint': {'lat': 36.58597, 'lon': -79.39502}}, {'zip': '98801', 'city': 'Wenatchee', 'state': 'Washington', 'country': 'United States', 'facility': 'Central Washington Health Services Association d/b/a Confluence Health', 'geoPoint': {'lat': 47.42346, 'lon': -120.31035}}, {'zip': 'C1120AAC', 'city': 'Buenos Aires', 'state': 'Buenos Aires F.D.', 'country': 'Argentina', 'facility': 'Centro Médico Viamonte', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'C1405BUB', 'city': 'Buenos Aires', 'state': 'Buenos Aires F.D.', 'country': 'Argentina', 'facility': 'Consultorio de Investigación Clínica EMO SRL', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'C1425AGC', 'city': 'Buenos Aires', 'state': 'Buenos Aires F.D.', 'country': 'Argentina', 'facility': 'Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'C1056ABI', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Centro de Investigaciones Metabólicas (CINME)', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'Data are available 6 months after the primary publication or approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.', 'ipdSharing': 'YES', 'description': 'Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.', 'accessCriteria': 'A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}