Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2025-12-29 @ 2:10 AM
Study NCT ID:
NCT04923269
Status:
COMPLETED
Last Update Posted:
2021-12-17
First Post:
2021-06-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of LY3532226 in Healthy Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12-15', 'completionDateStruct': {'date': '2021-10-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-16', 'studyFirstSubmitDate': '2021-06-09', 'studyFirstSubmitQcDate': '2021-06-09', 'lastUpdatePostDateStruct': {'date': '2021-12-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration', 'timeFrame': 'Baseline up to Week 8', 'description': 'A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3532226', 'timeFrame': 'Day 1 through Day 43', 'description': 'PK: Cmax of LY3532226'}, {'measure': 'PK: Area Under the Concentration Versus Time Curve (AUC) of LY3532226', 'timeFrame': 'Day 1 through Day 43', 'description': 'PK: AUC of LY3532226'}, {'measure': 'PK: Time to Maximum Concentration (Tmax) of LY3532226', 'timeFrame': 'Day 1 through Day 43', 'description': 'PK: Tmax of LY3532226'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to evaluate the safety and tolerability of the study drug known as LY3532226 in healthy participants. Blood tests will be performed to check how much LY3532226 gets into the bloodstream and how long it takes the body to eliminate it. This study will last approximately 8 weeks including screening period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Overtly healthy males or females not of childbearing potential.\n* Body mass index (BMI) within the range of 18.5 to 40 kilograms per meter squared (kg/m²), inclusive\n\nExclusion Criteria:\n\n* Have a significant history of or current CV (e.g., myocardial infarction, congestive heart failure, cerebrovascular accident, venous thromboembolism), respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk while taking the study intervention; or of interfering with the interpretation of data\n* Have a history of malignancy within 5 years prior to screening\n* Have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis\n* Have serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \\>2X the upper limit of normal (ULN) or total bilirubin level (TBL) \\>1.5X ULN\n* Have serum triglyceride level ≥5 mmol/L (442.5 mg/dL)\n* Have undergone any form of bariatric surgery\n* Have received systemic or inhaled glucocorticoid therapy (excluding topical, intraarticular, and intraocular preparations); for more than 14 consecutive days within 4 weeks before screening'}, 'identificationModule': {'nctId': 'NCT04923269', 'briefTitle': 'A Study of LY3532226 in Healthy Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Single-Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3532226 in Healthy Participants', 'orgStudyIdInfo': {'id': '17834'}, 'secondaryIdInfos': [{'id': 'J2V-MC-GZLA', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LY3532226', 'description': 'Single ascending doses of LY3532226 administered subcutaneously (SC).', 'interventionNames': ['Drug: LY3532226']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo administered SC.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'LY3532226', 'type': 'DRUG', 'description': 'Administered SC.', 'armGroupLabels': ['LY3532226']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered SC.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '138623', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'Lilly Centre for Clinical Pharmacology', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], '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'}, 'responsibleParty': {'type': 'SPONSOR'}}}}