Ignite Creation Date:
2025-12-24 @ 4:19 PM
Ignite Modification Date:
2025-12-28 @ 2:48 PM
Study NCT ID:
NCT05051566
Status:
COMPLETED
Last Update Posted:
2022-04-26
First Post:
2021-09-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Multiple Dose Study of LY3502970 in Healthy Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000729680', 'term': 'orforglipron'}, {'id': 'D064098', 'term': 'Esomeprazole'}], 'ancestors': [{'id': 'D009853', 'term': 'Omeprazole'}, {'id': 'D053799', 'term': '2-Pyridinylmethylsulfinylbenzimidazoles'}, {'id': 'D013454', 'term': 'Sulfoxides'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04-15', 'completionDateStruct': {'date': '2022-04-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-25', 'studyFirstSubmitDate': '2021-09-16', 'studyFirstSubmitQcDate': '2021-09-16', 'lastUpdatePostDateStruct': {'date': '2022-04-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3502970', 'timeFrame': 'Predose up to 24 hours postdose', 'description': 'PK: Cmax of LY3502970'}, {'measure': 'PK: Area Under the Concentration Versus Time Curve (AUC) of LY3502970', 'timeFrame': 'Predose up to 24 hours postdose', 'description': 'PK: AUC of LY3502970'}, {'measure': 'PK: Time of Maximum Observed Concentration (Tmax) of LY3502970', 'timeFrame': 'Predose up to 24 hours postdose', 'description': 'PK: Tmax of LY3502970'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to assess how fast LY3502970 gets into the blood stream and how long it takes the body to remove it when administered in multiple oral doses as new formulation compared to that of reference LY3502970 formulation. Information about safety and tolerability will be collected. The study is open to healthy participants. The study is conducted in two parts and it will last up to about 6 months, inclusive of screening period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Are overtly healthy as determined by medical evaluation.\n* Body mass index (BMI) of 18.5 to 35 kilograms per meter squared (kg/m²).\n\nExclusion Criteria:\n\n* Have an abnormal blood pressure and/or pulse rate as determined by the investigator -minor deviations acceptable to investigator are allowed\n* Have known liver disease, obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or have elevations in aminotransferases (alanine aminotransferase \\[ALT\\] and aspartate aminotransferase \\[AST\\]) greater than 2X ULN (Upper Limit of Normal)\n* Have an abnormality in the 12-lead ECG at screening that, in the opinion of the investigator, increases the risks associated with participating in the study\n* Are women of child-bearing potential\n* Are women who are lactating'}, 'identificationModule': {'nctId': 'NCT05051566', 'briefTitle': 'A Multiple Dose Study of LY3502970 in Healthy Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Multiple Dose Study in Healthy Participants to Investigate the Safety, Tolerability, and Pharmacokinetics of LY3502970', 'orgStudyIdInfo': {'id': '17783'}, 'secondaryIdInfos': [{'id': 'J2A-MC-GZGD', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}, {'id': 'QSC202755', 'type': 'OTHER', 'domain': 'Quotient Sciences'}, {'id': '2020-005750-15', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LY3502970 Prototype (Part A)', 'description': 'Multiple doses of LY3502970 prototype administered orally.', 'interventionNames': ['Drug: LY3502970']}, {'type': 'EXPERIMENTAL', 'label': 'LY3502970 Reference (Part A)', 'description': 'Multiple doses of LY3502970 reference administered orally.', 'interventionNames': ['Drug: LY3502970']}, {'type': 'EXPERIMENTAL', 'label': 'LY3502970 Prototype (Part B)', 'description': 'Multiple doses of LY3502970 prototype administered orally.', 'interventionNames': ['Drug: LY3502970']}, {'type': 'EXPERIMENTAL', 'label': 'LY3502970 Reference (Part B)', 'description': 'Multiple doses of LY3502970 reference administered orally.', 'interventionNames': ['Drug: LY3502970']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Esomeprazole (Part B)', 'description': 'Multiple doses of Esomeprazole (Proton Pump Inhibitor) administered orally.', 'interventionNames': ['Drug: Esomeprazole']}], 'interventions': [{'name': 'LY3502970', 'type': 'DRUG', 'description': 'Administered orally.', 'armGroupLabels': ['LY3502970 Prototype (Part A)', 'LY3502970 Prototype (Part B)', 'LY3502970 Reference (Part A)', 'LY3502970 Reference (Part B)']}, {'name': 'Esomeprazole', 'type': 'DRUG', 'description': 'Administered orally.', 'armGroupLabels': ['Esomeprazole (Part B)']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'NG11 6JS', 'city': 'Nottingham', 'country': 'United Kingdom', 'facility': 'Quotient Clinical Ltd', 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}], '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': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Quotient Sciences', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}