Ignite Creation Date:
2025-12-26 @ 10:36 AM
Ignite Modification Date:
2025-12-31 @ 5:19 PM
Study NCT ID:
NCT07101328
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-22
First Post:
2025-07-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of LY4152199 in Participants With Previously Treated B-cell Cancers and Leukemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015451', 'term': 'Leukemia, Lymphocytic, Chronic, B-Cell'}, {'id': 'D018442', 'term': 'Lymphoma, B-Cell, Marginal Zone'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D016393', 'term': 'Lymphoma, B-Cell'}, {'id': 'D008258', 'term': 'Waldenstrom Macroglobulinemia'}, {'id': 'D020522', 'term': 'Lymphoma, Mantle-Cell'}, {'id': 'D016403', 'term': 'Lymphoma, Large B-Cell, Diffuse'}, {'id': 'D002051', 'term': 'Burkitt Lymphoma'}, {'id': 'D008224', 'term': 'Lymphoma, Follicular'}, {'id': 'D015448', 'term': 'Leukemia, B-Cell'}], 'ancestors': [{'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010265', 'term': 'Paraproteinemias'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D020031', 'term': 'Epstein-Barr Virus Infections'}, {'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 215}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2029-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-15', 'studyFirstSubmitDate': '2025-07-28', 'studyFirstSubmitQcDate': '2025-07-28', 'lastUpdatePostDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Phase 1a - Number of Participants with Dose Limiting Toxicities (DLT) of LY4152199', 'timeFrame': 'Cycle 1 (28 days)'}, {'measure': 'Phase 1b - Overall Response Rate (ORR): Percentage of Participants with Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR)', 'timeFrame': 'Baseline up to approximately 4 years until disease progression or start of new anti-cancer therapy', 'description': 'Assessed by the Investigator per disease-specific response criteria as appropriate or death due to any cause, whichever occurs first'}], 'secondaryOutcomes': [{'measure': 'Phase 1a and 1b - Pharmacokinetics (PK): Area under the Concentration versus Time Curve (AUC) of LY4152199', 'timeFrame': 'Baseline up to approximately 91 weeks'}, {'measure': 'Phase 1a and 1b - PK: Maximum Concentration (Cmax) of LY4152199', 'timeFrame': 'Baseline up to approximately 91 weeks'}, {'measure': 'Phase 1a - Overall Response Rate (ORR): Percentage of Participants with Best Overall Response of Complete Response (CR) or Partial Response (PR)', 'timeFrame': 'Baseline up to approximately 4 years until disease progression or start of new anti-cancer therapy', 'description': 'Assessed by the Investigator per disease-specific response criteria as appropriate or death due to any cause, whichever occurs first'}, {'measure': 'Phase 1a and Ib - Duration of Response (DOR)', 'timeFrame': 'Baseline up to approximately 4 years until disease progression or start of new anti-cancer therapy', 'description': 'Time between the date of first documented response (CR or PR) to the date of first disease progression or death due to any cause, whichever occurs first'}, {'measure': 'Phase 1a and Ib - Time to Response (TTR)', 'timeFrame': 'Baseline up to approximately 4 years until disease progression or start of new anti-cancer therapy', 'description': 'Time from first dose date (or randomization date for the dose optimization cohort) to the date of first documented response (CR or PR)'}, {'measure': 'Phase 1a and Ib - Progression Free Survival (PFS)', 'timeFrame': 'Baseline up to approximately 4 years until disease progression or start of new anti-cancer therapy', 'description': 'Time from first dose date (or randomization date for the dose optimization cohort) to the date of first documented disease progression or death due to any cause, whichever occurs first'}, {'measure': 'Phase 1a and Ib - Disease Control Rate (DCR)', 'timeFrame': 'Baseline up to approximately 4 years until disease progression or start of new anti-cancer therapy', 'description': 'Percentage of efficacy-evaluable participants who achieved a BOR of CR, PR, or stable disease'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Richter Transformation'], 'conditions': ['Leukemia, Lymphocytic, Chronic, B-Cell', 'Lymphoma, B-cell Marginal Zone', 'Lymphoma, Non-Hodgkin', 'B-cell Lymphoma', 'Waldenstrom Macroglobulinemia', 'Lymphoma, Mantle-Cell', 'Lymphoma, Large B-Cell, Diffuse', 'Burkitt Lymphoma', 'Lymphoma, Follicular', 'Leukemia, B-Cell']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to measure the safety and efficacy of LY4152199 in participants with previously treated B-cell lymphoma and leukemia. This study has two parts. In the first part, the study will find the best dose of the drug. In the second part, the study will see how well the best dose works in participants with certain types of B-cell cancer and leukemia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Estimated life expectancy of greater than or equal to (≥)12 weeks as judged by the Investigator.\n* Participants with select tumor types must have measurable or assessable disease as defined below:\n* Must have at least 1 bi-dimensionally measurable lesion or in the absence of measurable lymphadenopathy, documentation of bone marrow involvement.\n* Participants with Waldenstrom macroglobulinemia (WM) must have measurable disease, defined as the presence of serum IgM with a minimum IgM level of greater than (\\>)2 times (×) upper limit of normal (ULN) based on local laboratory testing.\n* Participants with chronic lymphocytic leukemia (CLL) must have assessable disease in blood or bone marrow by flow cytometry or immunohistochemistry.\n* Must be able to comply with inpatient/outpatient treatment, laboratory monitoring, and required clinic visits for the duration of trial participation.\n* Must have adequate organ function.\n\nPhase 1a Dose Escalation (Cohort A) Participants\n\n\\- Must have histologically confirmed relapsed/refractory B-cell malignancy.\n\nPhase 1a Dose Optimization (Cohort B) Participants\n\n\\- Must have histologically confirmed relapsed/refractory diffuse large B-cell lymphoma (DLBCL) de novo or transformed.\n\nExclusion Criteria:\n\nAll Participants\n\n* Known or suspected central nervous system (CNS) involvement by systemic lymphoma.\n* Current or history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease\n* Any unresolved toxicities from prior therapy greater than National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 Grade 2 at the time of starting trial treatment except for alopecia.\n* Autologous stem cell transplantation within 100 days of this study for post autologous transplant individuals.\n* Residual symptoms of neurotoxicity or cytopenias from prior chimeric antigen receptor T-cell therapy (CAR-T) or bispecifics. Exception: Cytopenia related to prior CAR-T or bispecifics allowed if they meet the adequate organ function criteria.\n* Known or suspected history of macrophage activation syndrome or hemophagocytic lymphohistiocytosis (HLH).\n* Active second malignancies, unless in remission, with life expectancy greater than 2 years with Sponsor approval.\n* History of autoimmune disease\n* Significant cardiovascular disease\n* Active uncontrolled systemic bacterial, viral, fungal, or parasitic infection (except for fungal nail infection), or other clinically significant active disease process\n* Vaccination with a live vaccine within 4 weeks prior to signing informed consent form (ICF).\n* Have current or had a history of severe allergic or anaphylactic reactions to monoclonal antibody therapy (or recombinant antibody-related fusion proteins).\n* Prior treatment with B-cell activating factor receptor (BAFF-R) directed therapies (e.g., monoclonal antibody, CAR-T or bispecific antibody). This exclusion criterion does not apply to participants seeking retreatment.\n* Pregnant and/or planning to breastfeed during the trial or within 90 days of the last dose of study intervention.\n* Known hypersensitivity to any component or excipient of LY4152199.'}, 'identificationModule': {'nctId': 'NCT07101328', 'acronym': 'BAFFRontier-1', 'briefTitle': 'A Study of LY4152199 in Participants With Previously Treated B-cell Cancers and Leukemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'BAFFRontier-1, A First-in-Human, Phase 1 Trial to Assess Safety, Tolerability, and Preliminary Efficacy of LY4152199, a B-cell Activation Factor Receptor (BAFF-R) T-Cell Engager Bispecific Antibody in Adult Participants With Previously Treated B-cell Malignancies', 'orgStudyIdInfo': {'id': '27701'}, 'secondaryIdInfos': [{'id': 'J6N-MC-JUCA', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Phase 1A: Dose Escalation (Cohort A)', 'description': 'Escalating doses of LY4152199 administered intravenously (IV)', 'interventionNames': ['Drug: LY4152199 - IV']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 1A: Dose Optimization (Cohort B)', 'description': 'Two or more doses of LY4152199 (evaluated during dose escalation) administered SC', 'interventionNames': ['Drug: LY4152199 - SC']}], 'interventions': [{'name': 'LY4152199 - IV', 'type': 'DRUG', 'description': 'Administered by IV infusion', 'armGroupLabels': ['Phase 1A: Dose Escalation (Cohort A)']}, {'name': 'LY4152199 - SC', 'type': 'DRUG', 'description': 'Administered by SC injection', 'armGroupLabels': ['Phase 1A: Dose Optimization (Cohort B)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91010', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '80045-2559', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Denver - School of Medicine - Anschutz Medical Campus', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '80218', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Colorado Blood Cancer Institute', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '06520-8028', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale University School of Medicine - Yale Cancer Center', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'The University of Chicago Medical Center (UCMC)', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'University of Iowa', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Cancer Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana-Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan Comprehensive Cancer Center', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic - Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '08903', 'city': 'New Brunswick', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Rutgers Cancer Institute of New Jersey', 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York University (NYU) Clinical Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Weill Cornell Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania Abramson Cancer Center', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'SCRI Oncology Partners', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '75244', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Southwestern', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '84111', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Intermountain Healthcare', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Swedish Cancer Institute (SCI)', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Froedtert Hospital and the Medical College of Wisconsin', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'zip': '3002', 'city': 'East Melbourne', 'country': 'Australia', 'facility': 'Peter MacCallum Cancer Centre', 'geoPoint': {'lat': -37.81667, 'lon': 144.9879}}, {'zip': '3004', 'city': 'Melbourne', 'country': 'Australia', 'facility': 'The Alfred Hospital', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': '6009', 'city': 'Nedlands', 'country': 'Australia', 'facility': 'Linear Clinical Research', 'geoPoint': {'lat': -31.98184, 'lon': 115.8073}}, {'zip': 'H3T 1E2', 'city': 'Montreal', 'country': 'Canada', 'facility': 'Lady Davis Institute for Medical Research Jewish General Hospital', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'M5G 1Z5', 'city': 'Toronto', 'country': 'Canada', 'facility': 'University Health Network (UHN) - Princess Margaret Cancer Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'N 8200', 'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Aarhus University Hospital', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}, {'zip': '2100', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Center for Cancer and Organ Diseases - Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'zip': '59037', 'city': 'Lille', 'country': 'France', 'facility': 'CHU de Lille - Hopital Claude Huriez', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '75010', 'city': 'Paris', 'country': 'France', 'facility': 'AP-HP Hopital Saint-Louis', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '10117', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Charite Universitaetsmedizin Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '80336', 'city': 'München', 'country': 'Germany', 'facility': 'LMU Klinikum Muenchen-Campus Grosshadern', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'zip': '48149', 'city': 'Münster', 'country': 'Germany', 'facility': 'Universitaetsklinikum Muenster', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}, {'zip': '40138', 'city': 'Bologna', 'country': 'Italy', 'facility': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant Orsola', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'zip': '80131', 'city': 'Napoli', 'country': 'Italy', 'facility': 'Istituto Nazionale Tumori IRCCS Fondazione G. Pascale', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'zip': '20089', 'city': 'Rozzano', 'country': 'Italy', 'facility': 'Istituto Clinico Humanitas', 'geoPoint': {'lat': 45.38193, 'lon': 9.1559}}, {'zip': '277-8577', 'city': 'Chiba', 'country': 'Japan', 'facility': 'National Cancer Center Hospital East', 'geoPoint': {'lat': 35.6, 'lon': 140.11667}}, {'zip': '700-8558,', 'city': 'Okayama', 'country': 'Japan', 'facility': 'Okayama University Hospital', 'geoPoint': {'lat': 34.65, 'lon': 133.93333}}, {'zip': '135-8550', 'city': 'Tokyo', 'country': 'Japan', 'facility': 'Cancer Institute Hospital of JFCR', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': '30-727', 'city': 'Krakow', 'country': 'Poland', 'facility': 'Pratia MCM Krakow', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '60-185', 'city': 'Skorzewo', 'country': 'Poland', 'facility': 'AIDPORT Sp. z o.o.', 'geoPoint': {'lat': 54.16909, 'lon': 17.97006}}, {'zip': '03080', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '05505', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '08035', 'city': 'Barcelona', 'country': 'Spain', 'facility': "Hospital Universitario Vall d'Hebron", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08908', 'city': 'Barcelona', 'country': 'Spain', 'facility': "Institut Catala d'Oncologia - L'Hospitalet", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '28040', 'city': 'Madrid', 'country': 'Spain', 'facility': 'South Texas Accelerated Research Therapeutics (START) Madrid - Hospital Fundacion Jimenez Diaz', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': 'LS9 7TF', 'city': 'Leeds', 'country': 'United Kingdom', 'facility': 'Leeds Teaching Hospitals NHS Trust', 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}, {'zip': 'OX3 9DU', 'city': 'Oxford', 'country': 'United Kingdom', 'facility': 'Oxford University Hospitals NHS Foundation Trust', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}], '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': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}