Ignite Creation Date:
2025-12-24 @ 2:29 PM
Ignite Modification Date:
2025-12-26 @ 10:45 PM
Study NCT ID:
NCT07215559
Status:
RECRUITING
Last Update Posted:
2025-12-24
First Post:
2025-10-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Macupatide (LY3532226) and Eloralintide (LY3841136), Alone or in Combination, in Adults With Obesity or Overweight and 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': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-23', 'studyFirstSubmitDate': '2025-10-09', 'studyFirstSubmitQcDate': '2025-10-09', 'lastUpdatePostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-10-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Change from Baseline in Body Weight', 'timeFrame': 'Baseline, Week 32'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline in Hemoglobin A1c (HbA1c)', 'timeFrame': 'Baseline, Week 32'}, {'measure': 'Change from Baseline in Body Mass Index (BMI)', 'timeFrame': 'Baseline, Week 32'}, {'measure': 'Change from Baseline in Fasting Glucose', 'timeFrame': 'Baseline, Week 32'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['GIP', 'Amylin'], 'conditions': ['Obesity', 'Overweight', 'Diabetes Mellitus, Type 2']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trials.lilly.com/en-US/trial/659876', 'label': 'A Study of Macupatide (LY3532226) and Eloralintide (LY3841136), Alone or in Combination, in Adults With Obesity or Overweight and With Type 2 Diabetes'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate weight reduction with macupatide and eloralintide, alone or in combination, in adult participants with obesity or overweight and with type 2 diabetes. Participation in the study will last about 48 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have type 2 diabetes\n* Have an HbA1c ≥7.5% to ≤10.5% at screening\n* Have been treated with any of the following, alone or in combination, for at least 3 months prior to screening\n\n * Diet and exercise\n * Stable dose of metformin\n * Sodium-glucose cotransporter-2 (SGLT2) inhibitor\n* Have had a stable body weight (\\<5% body weight gain and/or loss) for the 3 months prior to screening\n* Have a BMI of 27 or greater at screening\n\nExclusion Criteria:\n\n* Have any form of diabetes other than type 2 diabetes\n* Have a prior or planned surgical treatment for obesity, except prior liposuction or abdominoplasty, if performed \\>1 year prior to screening\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 an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years, exceptions include\n\n * basal or squamous cell skin cancer\n * in situ carcinomas of the cervix, or\n * in situ prostate cancer\n* Have been prescribed any of the following receptor agonists (RA) or their combination for any indication within the last 6 months:\n\n * amylin RA\n * dual amylin and calcitonin RA\n * glucagon-like peptide-1 receptor (GLP-1) RA\n * glucose-dependent insulinotropic peptide (GIP)/GLP-1 RA\n * GLP-1/glucagon (GCG) RAs, or\n * GIP/GLP-1/GCG RAs\n* Have used excluded antihyperglycemic medications within 3 months prior to screening (including, but not limited to, sulfonylureas, dipeptidyl peptidase-4 inhibitors, alpha-glucosidase inhibitors, thiazolidinediones, and meglitinides\n* Have used insulin for diabetic control within the prior year (short term use in certain situations allowed'}, 'identificationModule': {'nctId': 'NCT07215559', 'briefTitle': 'A Study of Macupatide (LY3532226) and Eloralintide (LY3841136), Alone or in Combination, in Adults With Obesity or Overweight and With Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Phase 2, Parallel-Group, Double-Blind, Placebo-Controlled Study to Investigate Weight Reduction With Macupatide and Eloralintide, Alone or in Combination, in Adult Participants With Obesity or Overweight and With Type 2 Diabetes', 'orgStudyIdInfo': {'id': '27721'}, 'secondaryIdInfos': [{'id': 'J2V-MC-GZLF', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Macupatide (Macupatide + Eloralintide Placebo)', 'description': 'Participants will be administered macupatide subcutaneously (SC) and eloralintide placebo SC', 'interventionNames': ['Drug: Macupatide', 'Drug: Eloralintide Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Eloralintide (Elorlintide + Macupatide Placebo)', 'description': 'Participants will be administered eloralintide SC and macupatide placebo SC', 'interventionNames': ['Drug: Eloralintide', 'Drug: Macupatide Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Macupatide + Eloralintide', 'description': 'Participants will be administered eloralintide SC and macupatide SC', 'interventionNames': ['Drug: Macupatide', 'Drug: Eloralintide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo (Macupatide Placebo + Elorlintide Placebo)', 'description': 'Participants will be administered eloralintide placebo SC and macupatide placebo SC', 'interventionNames': ['Drug: Macupatide Placebo', 'Drug: Eloralintide Placebo']}], 'interventions': [{'name': 'Macupatide', 'type': 'DRUG', 'otherNames': ['LY3532226'], 'description': 'Administered SC', 'armGroupLabels': ['Macupatide (Macupatide + Eloralintide Placebo)', 'Macupatide + Eloralintide']}, {'name': 'Eloralintide', 'type': 'DRUG', 'otherNames': ['LY3841136'], 'description': 'Administered SC', 'armGroupLabels': ['Eloralintide (Elorlintide + Macupatide Placebo)', 'Macupatide + Eloralintide']}, {'name': 'Macupatide Placebo', 'type': 'DRUG', 'description': 'Administered SC', 'armGroupLabels': ['Eloralintide (Elorlintide + Macupatide Placebo)', 'Placebo (Macupatide Placebo + Elorlintide Placebo)']}, {'name': 'Eloralintide Placebo', 'type': 'DRUG', 'description': 'Administered SC', 'armGroupLabels': ['Macupatide (Macupatide + Eloralintide Placebo)', 'Placebo (Macupatide Placebo + Elorlintide Placebo)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85296', 'city': 'Gilbert', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '480-691-2213'}, {'name': 'Sunildat Maheshwari', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Prime Medical Group, LLC dba Gilbert Center for Family Medicine, LLC', 'geoPoint': {'lat': 33.35283, 'lon': -111.78903}}, {'zip': '85020', 'city': 'Phoenix', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '602-200-3814'}, {'name': 'Elysa Shaw', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Central Phoenix Medical Clinic', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85741', 'city': 'Tucson', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '520329-4139'}, {'name': 'Paul Bejarano', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Pima Heart', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '30331', 'city': 'Atlanta', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '888-659-4363'}, {'name': 'Tamara Brown', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'SKY Clinical Research Network Group-Brown', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30043', 'city': 'Lawrenceville', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kamar Alabi', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Teak Research Consults', 'geoPoint': {'lat': 33.95621, 'lon': -83.98796}}, {'zip': '30328', 'city': 'Sandy Springs', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Vasundhara Cheekati', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'AGILE Clinical Research Trials, LLC', 'geoPoint': {'lat': 33.92427, 'lon': -84.37854}}, {'zip': '30038', 'city': 'Stonecrest', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Rabahuddin Syed', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Pivotal Research Solutions', 'geoPoint': {'lat': 33.70849, 'lon': -84.13485}}, {'zip': '30291', 'city': 'Union City', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '470-317-3604'}, {'name': 'Dwight Blake', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Rophe Adult and Pediatric Medicine/SKYCRNG', 'geoPoint': {'lat': 33.58706, 'lon': -84.54243}}, {'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': 'Vector Clinical Trials', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '08611', 'city': 'Trenton', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '609-392-6666'}, {'name': 'Herbert Conaway', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Premier Research', 'geoPoint': {'lat': 40.21705, 'lon': -74.74294}}, {'zip': '75208', 'city': 'Dallas', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '281-944-3610'}, {'name': 'Ebere Israel Azubuike, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mercy Family Clinic', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75230', 'city': 'Dallas', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Dan Lender', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Velocity Clinical Research, Dallas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77079', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '713-973-3415'}, {'name': 'Prashant Koshy', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'PlanIt Research, PLLC', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77407', 'city': 'Richmond', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '713-282-5600'}, {'name': 'Namrata Dass', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Aavon Clinical Trials', 'geoPoint': {'lat': 29.58218, 'lon': -95.76078}}, {'zip': '78231', 'city': 'Shavano Park', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '210-545-4900'}, {'name': 'Michelle Welch', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Consano Clinical Research, LLC', 'geoPoint': {'lat': 29.58495, 'lon': -98.55252}}, {'zip': '78596', 'city': 'Weslaco', 'state': 'Texas', 'status': 'NOT_YET_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': '84120', 'city': 'West Valley City', 'state': 'Utah', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '801-363-7353'}, {'name': 'Cuper Martinez', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kalo Clinical Research', 'geoPoint': {'lat': 40.69161, 'lon': -112.00105}}, {'zip': '23510', 'city': 'Norfolk', 'state': 'Virginia', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '757-446-5291'}, {'name': 'Elias Siraj', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Eastern Virginia Medical School (EVMS) Medical Group', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}, {'zip': '23226', 'city': 'Richmond', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '804-477-3045'}, {'name': 'Robert Call', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Clinical Research Partners, LLC', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '98007', 'city': 'Bellevue', 'state': 'Washington', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Aishwarya Prasad', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Northwest Clinical Research Center', 'geoPoint': {'lat': 47.61038, 'lon': -122.20068}}, {'zip': '98057', 'city': 'Renton', 'state': 'Washington', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '425-251-1720'}, {'name': 'Frances Broyles', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Rainier Clinical Research Center', 'geoPoint': {'lat': 47.48288, 'lon': -122.21707}}, {'zip': '98405', 'city': 'Tacoma', 'state': 'Washington', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '253-882-1070'}, {'name': 'Sabrina Benjamin', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Universal Research Group', 'geoPoint': {'lat': 47.25288, 'lon': -122.44429}}, {'zip': 'C1056ABI', 'city': 'Buenos Aires', 'status': 'NOT_YET_RECRUITING', 'country': 'Argentina', 'contacts': [{'role': 'CONTACT', 'phone': '08003450697'}, {'name': 'Federico Perez Manghi', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centro de Investigaciones Metabólicas (CINME)', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'C1440AAD', 'city': 'Buenos Aires', 'status': 'NOT_YET_RECRUITING', 'country': 'Argentina', 'contacts': [{'role': 'CONTACT', 'phone': '5491128597742'}, {'name': 'Alejandra Oviedo', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CENUDIAB', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'C1060ABN', 'city': 'CABA', 'status': 'NOT_YET_RECRUITING', 'country': 'Argentina', 'contacts': [{'role': 'CONTACT', 'phone': '5491121707326'}, {'name': 'Elizabeth Gelersztein', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CEDIC'}, {'zip': '5000', 'city': 'Córdoba', 'status': 'NOT_YET_RECRUITING', 'country': 'Argentina', 'contacts': [{'role': 'CONTACT', 'phone': '543514253456'}, {'name': 'Ines Bartolacci', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Instituto de Investigaciones Clínicas Córdoba', 'geoPoint': {'lat': -31.40648, 'lon': -64.18853}}, {'zip': 'X50004FHP', 'city': 'Córdoba', 'status': 'NOT_YET_RECRUITING', 'country': 'Argentina', 'contacts': [{'role': 'CONTACT', 'phone': '35196098294'}, {'name': 'Silvina Dominguez Matheu', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Clínica Universitaria Reina Fabiola', 'geoPoint': {'lat': -31.40648, 'lon': -64.18853}}, {'zip': '2900', 'city': 'San Nicolás', 'status': 'NOT_YET_RECRUITING', 'country': 'Argentina', 'contacts': [{'role': 'CONTACT', 'phone': '5493364571637'}, {'name': 'Paulina Lanchiotti', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Go Centro Medico San Nicolás', 'geoPoint': {'lat': -31.43628, 'lon': -64.45288}}, {'zip': '2019', 'city': 'Botany', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Paul Bird', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Emeritus Research', 'geoPoint': {'lat': -33.94599, 'lon': 151.19591}}, {'zip': '4064', 'city': 'Brisbane', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'role': 'CONTACT', 'phone': '61738765688'}, {'name': 'David Colquhoun', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Core Research Group', 'geoPoint': {'lat': -27.46794, 'lon': 153.02809}}, {'zip': '3124', 'city': 'Camberwell', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Sam Francis', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Emeritus Research', 'geoPoint': {'lat': -37.84205, 'lon': 145.0694}}, {'zip': '4151', 'city': 'Coorparoo', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'role': 'CONTACT', 'phone': '07 3397 3200'}, {'name': 'Young Jin Kim', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cornerstone Dermatology', 'geoPoint': {'lat': -27.49325, 'lon': 153.05826}}, {'zip': '2010', 'city': 'Darlinghurst, Sydney', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'role': 'CONTACT', 'phone': '61 2 9331 7228'}, {'name': 'Mark Bloch', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Momentum Darlinghurst'}, {'zip': '4558', 'city': 'Maroochydore', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'role': 'CONTACT', 'phone': '07 5408 0900'}, {'name': 'Hansjoerg Seltenreich', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CDH Research Institute Pty Ltd', 'geoPoint': {'lat': -26.66008, 'lon': 153.09953}}, {'zip': '3021', 'city': 'Melbourne', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'role': 'CONTACT', 'phone': '0395096166'}, {'name': 'King Cheung', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Momentum Sunshine', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': '2291', 'city': 'Merewether', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'role': 'CONTACT', 'phone': '+61 2 4963 2323'}, {'name': 'Claire Morbey', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'AIM Research', 'geoPoint': {'lat': -32.94801, 'lon': 151.74325}}, {'zip': '00726', 'city': 'Caguas', 'status': 'RECRUITING', 'country': 'Puerto Rico', 'contacts': [{'role': 'CONTACT', 'phone': '787-743-3038 ext 278'}, {'name': 'Loida Gonzalez-Rodriguez', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'San Juan Bautista School of Medicine - Clinical Research Unit', 'geoPoint': {'lat': 18.23412, 'lon': -66.0485}}, {'zip': '00921', 'city': 'San Juan', 'status': 'RECRUITING', 'country': 'Puerto Rico', 'contacts': [{'role': 'CONTACT', 'phone': '7874842757'}, {'name': 'Martha Gomez-Cuellar', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mgcendo Llc', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}], 'centralContacts': [{'name': 'Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or', 'role': 'CONTACT', 'email': 'LillyTrials@Lilly.com', 'phone': '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': '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'}}}}