Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-26 @ 3:31 AM
Study NCT ID:
NCT06709820
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-26
First Post:
2024-11-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of LY4060874 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': 'ESTIMATED', 'count': 132}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-12-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-25', 'studyFirstSubmitDate': '2024-11-26', 'studyFirstSubmitQcDate': '2024-11-26', 'lastUpdatePostDateStruct': {'date': '2025-09-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-11-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)', 'timeFrame': 'Baseline up to 22 Weeks', 'description': 'Number of participants with one or more TEAEs and SAEs.'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics (PK): Area Under the Concentration Versus Time (AUC) of LY4060874', 'timeFrame': 'PK: Part A: Baseline up to 13 weeks; Part B and C: Baseline up to 18 weeks', 'description': 'PK: Area Under the Concentration Versus Time (AUC) of LY4060874'}, {'measure': 'PK: Maximum Observed Concentration of LY4060874', 'timeFrame': 'PK: Part A: Baseline up to 13 weeks; Part B and C: Baseline up to 18 weeks', 'description': 'PK: Cmax of LY4060874'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Participants']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate safety and tolerability of LY4060874 in healthy participants.\n\nStudy participation may last up to 22 weeks and up to approximately 18 study visits.'}, '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, including medical history and physical examination.\n* Have a body mass index in the range of 20 to 29.9 kilogram per meter squared (kg/m²), inclusive, at screening.\n* To qualify as Chinese for this study, all 4 of the participant's biological grandparents must be of exclusive Chinese descent and born in China.\n* To qualify as a participant of first-generation Japanese origin, the participant, the participant's biological parents, and all the participants' biological grandparents must be of exclusive Japanese descent and born in Japan.\n\nExclusion Criteria:\n\n* Have a history of or have been diagnosed with Type 1 or Type 2 diabetes mellitus.\n* Have hemoglobin A1c (HbA1c) \\> 6.4% or 46 millimoles/mole (mmol/mol) at screening.\n* Have taken approved, including over the counter (OTC) or prescribed, medication or investigational medication for weight loss, including GLP-1 receptor agonists, within the previous 3 months of study screening.\n* Have had surgical treatment for obesity.\n* Are actively participating in a weight loss program or intend to initiate an intensive diet and/or exercise program during the study."}, 'identificationModule': {'nctId': 'NCT06709820', 'briefTitle': 'A Study of LY4060874 in Healthy Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY4060874 in Healthy Participants', 'orgStudyIdInfo': {'id': '27300'}, 'secondaryIdInfos': [{'id': 'J5X-MC-YJAA', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LY4060874 (Part A Subcutaneous)', 'description': 'Single ascending dose of LY4060874 administered subcutaneously (SC).', 'interventionNames': ['Drug: LY4060874']}, {'type': 'EXPERIMENTAL', 'label': 'LY4060874 (Part A Intravenous)', 'description': 'Single ascending dose of LY4060874 administered intravenously (IV).', 'interventionNames': ['Drug: LY4060874']}, {'type': 'EXPERIMENTAL', 'label': 'LY4060874 (Part B)', 'description': 'Multiple ascending doses of LY4060874 administered SC.', 'interventionNames': ['Drug: LY4060874']}, {'type': 'EXPERIMENTAL', 'label': 'LY4060874 (Part B Chinese)', 'description': 'Multiple ascending doses of LY4060874 administered SC in Chinese participants.', 'interventionNames': ['Drug: LY4060874']}, {'type': 'EXPERIMENTAL', 'label': 'LY4060874 (Part C Japanese)', 'description': 'Multiple ascending doses of LY4060874 administered SC in Japanese participants.', 'interventionNames': ['Drug: LY4060874']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo (SC)', 'description': 'Placebo administered SC in Part A, B, and C.', 'interventionNames': ['Drug: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo (IV)', 'description': 'Placebo administered IV in Part A.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'LY4060874', 'type': 'DRUG', 'description': 'Administered SC', 'armGroupLabels': ['LY4060874 (Part A Subcutaneous)', 'LY4060874 (Part B Chinese)', 'LY4060874 (Part B)', 'LY4060874 (Part C Japanese)']}, {'name': 'LY4060874', 'type': 'DRUG', 'description': 'Administered IV', 'armGroupLabels': ['LY4060874 (Part A Intravenous)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered SC', 'armGroupLabels': ['Placebo (SC)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered IV', 'armGroupLabels': ['Placebo (IV)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75247', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Fortrea, Inc.', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '138623', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'Lilly Centre for Clinical Pharmacology', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'overallOfficials': [{'name': '1-877-CTLILLY (1-877-285-4559) or 3176154559 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'}}}}