Ignite Creation Date:
2025-12-24 @ 4:16 PM
Ignite Modification Date:
2025-12-26 @ 6:47 AM
Study NCT ID:
NCT07219966
Status:
RECRUITING
Last Update Posted:
2025-12-24
First Post:
2025-10-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Brenipatide in Participants With Moderate-to-Severe Alcohol Use Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000437', 'term': 'Alcoholism'}], 'ancestors': [{'id': 'D019973', 'term': 'Alcohol-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2028-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-23', 'studyFirstSubmitDate': '2025-10-13', 'studyFirstSubmitQcDate': '2025-10-21', 'lastUpdatePostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-10-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2028-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Drinking Patterns in Alcohol Use Disorder (AUD) as Assessed by the Timeline Followback Method (TLFB)', 'timeFrame': 'Up to 56 weeks'}], 'secondaryOutcomes': [{'measure': 'Change in Daily Alcohol Consumption as Assessed by the TLFB', 'timeFrame': 'Up to 56 weeks'}, {'measure': 'Mean Change in Alcohol Craving as Assessed by the Penn Alcohol Craving Scale (PACS)', 'timeFrame': 'Baseline up to Week 56'}, {'measure': 'Mean Change in Alcohol Use Disorders Identification Test (AUDIT) Score', 'timeFrame': 'Baseline up to Week 56'}, {'measure': 'Mean Change in Body Weight', 'timeFrame': 'Baseline up to Week 56'}, {'measure': 'Mean Change in Patient Reported Health Outcomes as Measured by Short Form 36, v2 (SF-36) Acute Form Domain and Component Summary Scores', 'timeFrame': 'Baseline up to Week 56'}, {'measure': 'Pharmacokinetic (PK): Average Steady State Plasma Concentration (Cavg) of Brenipatide', 'timeFrame': 'Baseline up to Week 56'}, {'measure': 'Number of Participants with Treatment Emergent Anti-Drug Antibodies (TE-ADA)', 'timeFrame': 'Baseline up to Week 56'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Alcohol Use Disorder']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trials.lilly.com/en-US/trial/662497', 'label': 'A Study of Brenipatide in Participants With Moderate-to-Severe Alcohol Use Disorder (RENEW-ALC-1)'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to see if brenipatide when compared to a placebo works and is safe for participants with moderate-to-severe Alcohol Use Disorder (AUD). Participation in this study will last approximately 56 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Are seeking treatment and are motivated to stop or cut down on drinking.\n* Are reliable and willing to make themselves available for the duration of the study and attend required study visits, and are willing and able to follow study procedures as required, such as\n\n * self-inject study intervention\n * store and use the provided blinded study intervention, as directed\n * maintain electronic and paper study diaries, as applicable, and\n * complete the required questionnaires.\n\nExclusion Criteria:\n\n* Have evidence of current or within the past 180 days prior to screening (V1), history of any substance use disorder(s) of any severity with a pattern of persistent illicit or nonprescribed substance use as indicated by clinical interview, except alcohol, nicotine, or caffeine.\n* Have answered "yes" to either Question 4 or Question 5 on the "Suicidal Ideation" portion of the Columbia-Suicide Severity Rating Scale (C-SSRS) and the ideation occurred within the past 6 months, or have answered "yes" to any of the suicide-related behaviors on the "Suicidal Behavior" portion of the C-SSRS and the behavior occurred within the past 6 months\n* Have a history of advanced liver disease (including advanced liver fibrosis or cirrhosis), or alcohol-associated hepatitis based on either prior liver histology or imaging studies, such as transient elastography, ultrasound, computed tomography (CT) and magnetic resonance imaging (MRI), or Enhanced Liver Fibrosis score.\n* Have participated in a clinical study and have received active treatment, or unknown if they received active treatment, within 90 days or 5 half-lives (whichever is longer) before screening (V1).'}, 'identificationModule': {'nctId': 'NCT07219966', 'acronym': 'RENEW-ALC-1', 'briefTitle': 'A Study of Brenipatide in Participants With Moderate-to-Severe Alcohol Use Disorder', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Phase 3, Multicenter, Randomized, Double-Blind Study to Investigate the Efficacy and Safety of Brenipatide Compared With Placebo for the Treatment of Adult Participants With Moderate-to-Severe Alcohol Use Disorder (RENEW-ALC-1)', 'orgStudyIdInfo': {'id': '27346'}, 'secondaryIdInfos': [{'id': '2025-522313-38-00', 'type': 'CTIS'}, {'id': 'JS2-MC-GZME', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LY3537031 Period 1', 'description': 'Escalating doses administered subcutaneously (SC)', 'interventionNames': ['Drug: LY3537031', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'LY3537031 Period 2', 'description': 'Administered SC', 'interventionNames': ['Drug: LY3537031', 'Drug: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Administered SC', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'LY3537031', 'type': 'DRUG', 'otherNames': ['Brenipatide'], 'description': 'Administered SC', 'armGroupLabels': ['LY3537031 Period 1', 'LY3537031 Period 2']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered SC', 'armGroupLabels': ['LY3537031 Period 1', 'LY3537031 Period 2', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35215', 'city': 'Birmingham', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '205-876-2601'}, {'name': 'James Sullivan', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Parkway Medical Center', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85260', 'city': 'Scottsdale', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Rosika McKinney', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Headlands Research - Scottsdale', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '310-794-5383'}, {'name': 'Lara Ray', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UCLA Clinical & Translational Research Center (CTRC)', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92103', 'city': 'San Diego', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '619-915-0496'}, {'name': 'Eric Chavez', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Artemis Institute for Clinical Research', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '94158', 'city': 'San Francisco', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Khaled Moussawi', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UCSF Weill Institute for Neurosciences - Substance Use Disorders Clinic - Mission Bay', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '80202', 'city': 'Denver', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Larry Sanders', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mountain Mind - Denver', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '32751', 'city': 'Maitland', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sejal Patel', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'K2 Medical Research - Maitland', 'geoPoint': {'lat': 28.62778, 'lon': -81.36312}}, {'zip': '32751', 'city': 'Maitland', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '407-500-5252'}, {'name': 'Brandon Lenox', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'K2 Medical Research ORLANDO', 'geoPoint': {'lat': 28.62778, 'lon': -81.36312}}, {'zip': '33126', 'city': 'Miami', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '305-874-7401'}, {'name': 'Damian Casadesus', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Life Arc Research Centers - Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33135', 'city': 'Miami', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '305-300-2623'}, {'name': 'Emilio Mantero-Atienza', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Wellness Research Center', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '32803', 'city': 'Orlando', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jorel Martinez', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Charter Research - Orlando', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': 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'United States', 'contacts': [{'name': 'Shama Farooq', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Adams Clinical Bronx', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '44130', 'city': 'Middleburg Heights', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mark Woyshville', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'North Star Medical Research', 'geoPoint': {'lat': 41.36144, 'lon': -81.81291}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '215-746-1943'}, {'name': 'Henry Kranzler', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Penn Medicine: University of Pennsylvania Health System', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '57108', 'city': 'Sioux Falls', 'state': 'South Dakota', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '605-504-3154'}, {'name': 'Vivek Anand', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Avera Research Institute - Sioux Falls', 'geoPoint': {'lat': 43.54369, 'lon': -96.72796}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '214-645-6950'}, {'name': 'Sherwood Brown', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UT Southwestern Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75115', 'city': 'DeSoto', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Benji Kurian', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Adams Clinical Dallas', 'geoPoint': {'lat': 32.58986, 'lon': -96.85695}}, {'zip': '75080', 'city': 'Richardson', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '214-396-4844'}, {'name': 'Scott Bartley', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Pillar Clinical Research - Richardson', 'geoPoint': {'lat': 32.94818, 'lon': -96.72972}}, {'zip': '84015', 'city': 'Clinton', 'state': 'Utah', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '801-928-3292'}, {'name': 'Michael Roundy', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Alpine Research Organization', 'geoPoint': {'lat': 41.13967, 'lon': -112.0505}}, {'zip': '22031', 'city': 'Fairfax', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Scott Williams', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Re:Cognition Health', 'geoPoint': {'lat': 38.84622, 'lon': -77.30637}}, {'zip': '98195', 'city': 'Seattle', 'state': 'Washington', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mark Duncan', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Washington Medical Center - Montlake', 'geoPoint': {'lat': 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'city': 'Buenos Aires', 'status': 'NOT_YET_RECRUITING', 'country': 'Argentina', 'contacts': [{'role': 'CONTACT', 'phone': '+549115 800 5058'}, {'name': 'Pablo Doreski', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Fundación Respirar', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': '5000', 'city': 'Córdoba', 'status': 'NOT_YET_RECRUITING', 'country': 'Argentina', 'contacts': [{'role': 'CONTACT', 'phone': '+5493516858696'}, {'name': 'Carlos Morra', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sanatorio Morra S.A.', 'geoPoint': {'lat': -31.40648, 'lon': -64.18853}}, {'zip': 'X5004AOA', 'city': 'Córdoba', 'status': 'NOT_YET_RECRUITING', 'country': 'Argentina', 'contacts': [{'name': 'TAMARA YERCOVICH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Instituto Kremer', 'geoPoint': {'lat': -31.40648, 'lon': -64.18853}}, {'zip': 'X5006CBI', 'city': 'Córdoba', 'status': 'NOT_YET_RECRUITING', 'country': 'Argentina', 'contacts': [{'role': 'CONTACT', 'phone': '+5493517481586'}, {'name': 'Juan Luquez', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centro Médico Luquez', 'geoPoint': {'lat': -31.40648, 'lon': -64.18853}}, {'zip': '1904', 'city': 'La Plata', 'status': 'NOT_YET_RECRUITING', 'country': 'Argentina', 'contacts': [{'name': 'Hernan Alessandria', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Global Psy Asociación Civil', 'geoPoint': {'lat': -34.92126, 'lon': -57.95442}}, {'zip': 'B7600FZO', 'city': 'Mar del Plata', 'status': 'NOT_YET_RECRUITING', 'country': 'Argentina', 'contacts': [{'role': 'CONTACT', 'phone': '54 223 496 3224'}, {'name': 'Sergio Nemi', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Instituto de Investigaciones Clínicas Mar del Plata', 'geoPoint': {'lat': -38.00042, 'lon': -57.5562}}, {'zip': '5502', 'city': 'Mendoza', 'status': 'NOT_YET_RECRUITING', 'country': 'Argentina', 'contacts': [{'role': 'CONTACT', 'phone': '+54 9 2615861633'}, {'name': 'Eugenio Velasco', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Resolution Psychopharmacology Research Institute', 'geoPoint': {'lat': -32.88946, 'lon': -68.84582}}, {'zip': '2000', 'city': 'Rosario', 'status': 'NOT_YET_RECRUITING', 'country': 'Argentina', 'contacts': [{'role': 'CONTACT', 'phone': '03415290041'}, {'name': 'Javier Travella', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Fundacion Estudios Clinicos', 'geoPoint': {'lat': -32.94682, 'lon': -60.63932}}, {'zip': '2000', 'city': 'Rosario', 'status': 'NOT_YET_RECRUITING', 'country': 'Argentina', 'contacts': [{'role': 'CONTACT', 'phone': '+5493413585259'}, {'name': 'Sergio Grottasanta', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Fundación Innovaciencia', 'geoPoint': {'lat': -32.94682, 'lon': -60.63932}}, {'zip': '2000', 'city': 'Rosario', 'status': 'NOT_YET_RECRUITING', 'country': 'Argentina', 'contacts': [{'role': 'CONTACT', 'phone': '(0341) 425 8695'}, {'name': 'María Cappiello', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'INECO Neurociencias Oroño', 'geoPoint': 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{'lat': -31.64881, 'lon': -60.70868}}, {'zip': '4200', 'city': 'Santiago del Estero', 'status': 'NOT_YET_RECRUITING', 'country': 'Argentina', 'contacts': [{'role': 'CONTACT', 'phone': '+5493854027710'}, {'name': 'Gaston Noriega', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Clinica El Jardin', 'geoPoint': {'lat': -27.80047, 'lon': -64.26285}}, {'zip': '3570', 'city': 'Alken', 'status': 'NOT_YET_RECRUITING', 'country': 'Belgium', 'contacts': [{'role': 'CONTACT', 'phone': '003211316272'}, {'name': 'Erik Buntinx', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'ANIMA Research', 'geoPoint': {'lat': 50.87553, 'lon': 5.30558}}, {'zip': '9690', 'city': 'Kluisbergen', 'status': 'NOT_YET_RECRUITING', 'country': 'Belgium', 'contacts': [{'role': 'CONTACT', 'phone': '32 496 376259'}, {'name': 'Klaas Vercruysse', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kormont'}, {'zip': '9870', 'city': 'Machelen', 'status': 'NOT_YET_RECRUITING', 'country': 'Belgium', 'contacts': [{'role': 'CONTACT', 'phone': '32 496 376259'}, {'name': 'Klaas Vercruysse', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Gezondheidshuis De Gloed', 'geoPoint': {'lat': 50.91061, 'lon': 4.44174}}, {'zip': '2800', 'city': 'Mechelen', 'status': 'NOT_YET_RECRUITING', 'country': 'Belgium', 'contacts': [{'role': 'CONTACT', 'phone': '003215792797'}, {'name': 'Claudia Cornelis', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Meclinas', 'geoPoint': {'lat': 51.02574, 'lon': 4.47762}}, {'zip': '9636', 'city': 'Oudenaarde', 'status': 'NOT_YET_RECRUITING', 'country': 'Belgium', 'contacts': [{'role': 'CONTACT', 'phone': '32 496 376259'}, {'name': 'Klaas Vercruysse', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Medisch Centrum Saffrou', 'geoPoint': {'lat': 50.85168, 'lon': 3.60891}}, {'zip': '100088', 'city': 'Beijing', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaomeng Xing', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Beijing Anding Hospital - Affiliated Capital 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'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'zip': 'EC2Y 8EA', 'city': 'London', 'status': 'NOT_YET_RECRUITING', 'country': 'United Kingdom', 'contacts': [{'role': 'CONTACT', 'phone': '020 3865 1142'}, {'name': 'Graham Campbell', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'St Pancras Clinical Research', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SE5 9RS', 'city': 'London', 'status': 'NOT_YET_RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Irene Guerrini', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "National Institute for Health Research (NIHR) - King's Clinical Research Facility (CRF)", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'W1U 6RP', 'city': 'London', 'status': 'NOT_YET_RECRUITING', 'country': 'United Kingdom', 'contacts': [{'role': 'CONTACT', 'phone': '07948030295'}, {'name': 'Ahmed Elshashai', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Clerkenwell Health - London - Baker Street', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'M6 8HD', 'city': 'Salford', 'status': 'NOT_YET_RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Stephen Kaar', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Salford Royal Hospital', 'geoPoint': {'lat': 53.48771, 'lon': -2.29042}}, {'zip': 'SO16 6YD', 'city': 'Southampton', 'status': 'NOT_YET_RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Julia Sinclair', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Southampton General Hospital', 'geoPoint': {'lat': 50.90395, 'lon': -1.40428}}], '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 or approval of the indication studied in the US and EU, whichever is later. 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