Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2025-12-28 @ 6:24 PM
Study NCT ID:
NCT06143956
Status:
RECRUITING
Last Update Posted:
2025-12-23
First Post:
2023-11-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Master Protocol Study (LY900038) of Multiple Intervention-Specific-Appendices (ISAs) in Adult Participants With Obesity or Overweight
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['India']}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000719829', 'term': 'mazdutide'}, {'id': 'D000098860', 'term': 'Tirzepatide'}], 'ancestors': [{'id': 'D000067757', 'term': 'Glucagon-Like Peptide-1 Receptor'}, {'id': 'D000067756', 'term': 'Glucagon-Like Peptide Receptors'}, {'id': 'D043562', 'term': 'Receptors, G-Protein-Coupled'}, {'id': 'D011956', 'term': 'Receptors, Cell Surface'}, {'id': 'D008565', 'term': 'Membrane Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011964', 'term': 'Receptors, Gastrointestinal Hormone'}, {'id': 'D018000', 'term': 'Receptors, Peptide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The CWMM protocol includes screening assessments plus a framework for the subsequent intervention, which is the primary purpose of the protocol.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1217}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-22', 'studyFirstSubmitDate': '2023-11-06', 'studyFirstSubmitQcDate': '2023-11-21', 'lastUpdatePostDateStruct': {'date': '2025-12-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-11-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Allocated to Each ISA', 'timeFrame': 'Baseline to Week 48', 'description': 'Each ISA will detail the intervention specific analysis.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity', 'Overweight']}, 'descriptionModule': {'briefSummary': "The purpose of this Phase-2 chronic weight management master protocol (CWMM) is to create a framework to evaluate the safety and efficacy of various investigational interventions for chronic weight management with intervention-specific appendices (ISAs). The CWMM establishes entry criteria for newly enrolled participants across the master and the ISAs. The ISAs may start independently of other ISAs as interventions become available for clinical testing. The results for the CWMM screening record will be reported when all the ISA's complete."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have a body mass index (BMI)\n\n * ≥30 kilogram/square meter (kg/m²), or\n * ≥27 kg/m² and \\<30 kg/m², or with at least 1 weight-related comorbidity\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\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 any of the following cardiovascular conditions within 3 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* Have a history of symptomatic gallbladder disease within the past 2 years.\n* Have a lifetime history of suicide attempts.'}, 'identificationModule': {'nctId': 'NCT06143956', 'briefTitle': 'A Master Protocol Study (LY900038) of Multiple Intervention-Specific-Appendices (ISAs) in Adult Participants With Obesity or Overweight', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Master Protocol for a Randomized, Controlled, Clinical Trial of Multiple Interventions for Chronic Weight Management in Adult Participants With Obesity or Overweight', 'orgStudyIdInfo': {'id': '18685'}, 'secondaryIdInfos': [{'id': 'W8M-MC-CWMM', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}, {'id': 'W8M-MC-OXA1', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}, {'id': 'W8M-MC-LAA1', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}, {'id': 'W8M-MC-LAA2', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}, {'id': 'W8M-MC-GN01', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}, {'id': 'W8M-MC-GN02', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LY3305677 Obesity ISA OXA1', 'description': 'Participants will receive LY3305677 or placebo subcutaneously (SC).\n\nEach ISA will detail the intervention specific analysis.', 'interventionNames': ['Drug: LY3305677', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'LY3841136 Obesity ISA LAA1', 'description': 'Participants will receive LY3841136 or placebo SC.\n\nEach ISA will detail the intervention specific analysis.', 'interventionNames': ['Drug: LY3841136', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'LY3841136 Obesity ISA LAA2', 'description': 'Participants will receive LY3841136, tirzepatide and placebo SC.\n\nEach ISA will detail the intervention specific analysis.', 'interventionNames': ['Drug: LY3841136', 'Drug: Tirzepatide', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'LY3549492 Obesity ISA GN01', 'description': 'Participants will receive LY3549492 orally.\n\nEach ISA will detail the intervention specific analysis.', 'interventionNames': ['Drug: Placebo', 'Drug: LY3549492']}, {'type': 'EXPERIMENTAL', 'label': 'LY3549492 Obesity ISA GN02', 'description': 'Participants will receive LY3549492 or placebo orally.\n\nEach ISA will detail the intervention specific analysis.', 'interventionNames': ['Drug: Placebo', 'Drug: LY3549492']}], 'interventions': [{'name': 'LY3305677', 'type': 'DRUG', 'description': 'Administered SC. ISA specific interventions will be listed in the ISA.', 'armGroupLabels': ['LY3305677 Obesity ISA OXA1']}, {'name': 'LY3841136', 'type': 'DRUG', 'description': 'Administered SC. ISA specific interventions will be listed in the ISA.', 'armGroupLabels': ['LY3841136 Obesity ISA LAA1', 'LY3841136 Obesity ISA LAA2']}, {'name': 'Tirzepatide', 'type': 'DRUG', 'description': 'Administered SC. ISA specific interventions will be listed in the ISA.', 'armGroupLabels': ['LY3841136 Obesity ISA LAA2']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered SC. ISA specific interventions will be listed in the ISA.', 'armGroupLabels': ['LY3305677 Obesity ISA OXA1', 'LY3549492 Obesity ISA GN01', 'LY3549492 Obesity ISA GN02', 'LY3841136 Obesity ISA LAA1', 'LY3841136 Obesity ISA LAA2']}, {'name': 'LY3549492', 'type': 'DRUG', 'description': 'Administered orally. ISA specific interventions will be listed in the ISA.', 'armGroupLabels': ['LY3549492 Obesity ISA GN01', 'LY3549492 Obesity ISA GN02']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85225', 'city': 'Chandler', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Yessica Sachdeva', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Institute for Liver Health II dba Arizona Clinical Trials - Mesa', 'geoPoint': {'lat': 33.30616, 'lon': -111.84125}}, {'zip': '85032', 'city': 'Phoenix', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Matthew Doust', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'HOPE Research Institute', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85260', 'city': 'Scottsdale', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '480-725-8708'}, {'name': 'Benjamin Clark', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Headlands Research - Scottsdale', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '85712', 'city': 'Tucson', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '480-470-4000'}, {'name': 'Anita Kohli', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Institute for Liver Health II dba Arizona Liver Health-Tucson', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '94904', 'city': 'Greenbrae', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '415-461-1585'}, {'name': 'Linda Gaudiani', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'NorCal Medical Research, Inc', 'geoPoint': {'lat': 37.94854, 'lon': -122.5247}}, {'zip': '90255', 'city': 'Huntington Park', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '323-588-1990'}, {'name': 'Stanley Hsia', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Velocity Clinical Research, Huntington Park', 'geoPoint': {'lat': 33.98168, 'lon': -118.22507}}, {'zip': '90274', 'city': 'Rolling Hills Estates', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '310-265-1623'}, {'name': 'Lawrence Sher', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Peninsula Research Associates', 'geoPoint': {'lat': 33.78779, 'lon': -118.35813}}, {'zip': '94598', 'city': 'Walnut Creek', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '925-930-7267'}, {'name': 'Mark Christiansen', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Diablo Clinical Research, Inc.', 'geoPoint': {'lat': 37.90631, 'lon': -122.06496}}, {'zip': '06905', 'city': 'Stamford', 'state': 'Connecticut', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'David Radin', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Stamford Therapeutics Consortium', 'geoPoint': {'lat': 41.05343, 'lon': -73.53873}}, {'zip': '32003', 'city': 'Fleming Island', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '904-541-8225'}, {'name': 'Senan Sultan', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Northeast Research Institute (NERI)', 'geoPoint': {'lat': 30.0933, 'lon': -81.71898}}, {'zip': '33012', 'city': 'Hialeah', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '305-825-6588'}, {'name': 'Jose Cardona', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Indago Research & Health Center, Inc', 'geoPoint': {'lat': 25.8576, 'lon': -80.27811}}, {'zip': '33165', 'city': 'Miami', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '305-226-3933'}, {'name': 'Lazaro Nunez', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'New Horizon Research Center', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '34652', 'city': 'New Port Richey', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '727-849-4131'}, {'name': 'Cathy Barnes', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Suncoast Clinical Research, Inc.', 'geoPoint': {'lat': 28.24418, 'lon': -82.71927}}, {'zip': '32803', 'city': 'Orlando', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '407-337-1000'}, {'name': 'Edgardo Rivera-Rivera', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Charter Research - Winter Park', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '32162', 'city': 'The Villages', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '352-441-2000'}, {'name': 'Jeffrey Norton', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Charter Research - Lady Lake', 'geoPoint': {'lat': 28.93408, 'lon': -81.95994}}, {'zip': '96817', 'city': 'Honolulu', 'state': 'Hawaii', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '808-526-0303'}, {'name': 'ALAN PARSA', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Pacific Diabetes & Endocrine Center', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}, {'zip': '83406', 'city': 'Ammon', 'state': 'Idaho', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '208-681-9070'}, {'name': 'Joseph Moore', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Medical Research Partners', 'geoPoint': {'lat': 43.46964, 'lon': -111.96664}}, {'zip': '60640', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '773-275-3500 Ext 126'}, {'name': 'Rupal Trivedi', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Great Lakes Clinical Trials - Andersonville', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60640', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '773-275-3500'}, {'name': 'Manish Jain', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Great Lakes Clinical Trials - Ravenswood', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60077', 'city': 'Skokie', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '847-663-8540'}, {'name': 'Liana Billings', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'NorthShore University Health System', 'geoPoint': {'lat': 42.03336, 'lon': -87.73339}}, {'zip': '50266', 'city': 'West Des Moines', 'state': 'Iowa', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '515-329-6800'}, {'name': 'Anuj Bhargava', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Iowa Diabetes and Endocrinology Research Center', 'geoPoint': {'lat': 41.57721, 'lon': -93.71133}}, {'zip': '66606', 'city': 'Topeka', 'state': 'Kansas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '785-354-9591'}, {'name': 'susan brian', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Cotton O'Neil Diabetes & Endocrinology", 'geoPoint': {'lat': 39.04833, 'lon': -95.67804}}, {'zip': '40213', 'city': 'Louisville', 'state': 'Kentucky', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '502-515-5672'}, {'name': 'Harold Bays', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'L-MARC Research Center', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '02492', 'city': 'Needham', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '339-793-8998'}, {'name': 'Angela Fitch', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Knownwell', 'geoPoint': {'lat': 42.28343, 'lon': -71.23283}}, {'zip': '02740', 'city': 'New Bedford', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '508-720-2015'}, {'name': 'David Shih', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Lucida Clinical Trials', 'geoPoint': {'lat': 41.63526, 'lon': -70.92701}}, {'zip': '48034', 'city': 'Southfield', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '248-243-1870'}, {'name': 'David Strong', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Headlands Research - Detroit', 'geoPoint': {'lat': 42.47337, 'lon': -83.22187}}, {'zip': '48098', 'city': 'Troy', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '248-312-0025'}, {'name': 'Neil Fraser', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Arcturus Healthcare , PLC, Troy Internal Medicine Research Division', 'geoPoint': {'lat': 42.60559, 'lon': -83.14993}}, {'zip': '63303', 'city': 'City of Saint Peters', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '636-387-5100'}, {'name': 'Timothy Smith', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'StudyMetrix Research', 'geoPoint': {'lat': 38.80033, 'lon': -90.62651}}, {'zip': '65807', 'city': 'Springfield', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '417-883-7889'}, {'name': 'Ralph Duda', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Clinvest Headlands Llc', 'geoPoint': {'lat': 37.21533, 'lon': -93.29824}}, {'zip': '89128', 'city': 'Las Vegas', 'state': 'Nevada', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '702-750-0000'}, {'name': 'Cornell Calinescu', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Las Vegas Medical Research', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '14226', 'city': 'Amherst', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Laszlo Mechtler', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Dent Neurologic Institute', 'geoPoint': {'lat': 42.97839, 'lon': -78.79976}}, {'zip': '13057', 'city': 'East Syracuse', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '315-447-6359'}, {'name': 'Barbara Connor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Velocity Clinical Research, Syracuse', 'geoPoint': {'lat': 43.06534, 'lon': -76.07853}}, {'zip': '11776', 'city': 'Port Jefferson Station', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '631-364-9119'}, {'name': 'Warren Spinner', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'North Suffolk Neurology', 'geoPoint': {'lat': 40.92538, 'lon': -73.04733}}, {'zip': '14609', 'city': 'Rochester', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '585-288-0890'}, {'name': 'Patrick Connors', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Rochester Clinical Research, LLC', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '27405', 'city': 'Greensboro', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '336-763-6968'}, {'name': 'James Franklin', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Medication Management', 'geoPoint': {'lat': 36.07264, 'lon': -79.79198}}, {'zip': '28112', 'city': 'Monroe', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '704-283-7359'}, {'name': 'Awawu Igbinadolor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Monroe Biomedical Research', 'geoPoint': {'lat': 34.98543, 'lon': -80.54951}}, {'zip': '28557', 'city': 'Morehead City', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '252-222-5700'}, {'name': 'Kathryn Lucas', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Lucas Research, Inc', 'geoPoint': {'lat': 34.72294, 'lon': -76.72604}}, {'zip': '28562', 'city': 'New Bern', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '252-649-1944'}, {'name': 'Claire Presswood', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Lucas Research, Inc.', 'geoPoint': {'lat': 35.10849, 'lon': -77.04411}}, {'zip': '45212', 'city': 'Cincinnati', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '513-721-3868'}, {'name': 'James Maynard', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CTI Clinical Research Center', 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{'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '210-996-2600'}, {'name': 'Jara McDonald', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Tekton Research - Fredericksburg Road', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78240', 'city': 'San Antonio', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '518-428-6859'}, {'name': 'Nitendra Agarwal', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Endeavor Clinical Trials', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78596', 'city': 'Weslaco', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '956-431-8090'}, {'name': 'Eduardo Luna', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Texas Valley Clinical Research', 'geoPoint': {'lat': 26.15952, 'lon': -97.99084}}, {'zip': '24541', 'city': 'Danville', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '434-793-4711'}, {'name': 'Stephan Jannach', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sovah Clinical Research-River District', 'geoPoint': {'lat': 36.58597, 'lon': -79.39502}}, {'zip': '98801', 'city': 'Wenatchee', 'state': 'Washington', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '509-436-4050'}, {'name': 'Kathryn Eren', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Central Washington Health Services Association d/b/a Confluence Health', 'geoPoint': {'lat': 47.42346, 'lon': -120.31035}}, {'zip': 'C1056ABI', 'city': 'Buenos Aires', 'status': 'RECRUITING', 'country': 'Argentina', 'contacts': [{'role': 'CONTACT', 'phone': '08003450697'}, {'name': 'Federico Perez Manghi', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centro de Investigaciones Metabólicas (CINME)', 'geoPoint': {'lat': 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Laura Maffei- Investigacion Clinica Aplicada', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}], 'centralContacts': [{'name': 'Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or', 'role': 'CONTACT', 'email': 'LillyTrials@Lilly.com', 'phone': '1-317-615-4559'}, {'name': 'Physicians interested in becoming principal investigators please contact', 'role': 'CONTACT', 'email': 'clinical_inquiry_hub@lilly.com'}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'ipdSharingStatementModule': {'url': 'http://vivli.org/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (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'}}}}