Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2025-12-26 @ 4:12 AM
Study NCT ID:
NCT07030127
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-20
First Post:
2025-06-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of LY3985863 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': 24}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-08-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-19', 'studyFirstSubmitDate': '2025-06-12', 'studyFirstSubmitQcDate': '2025-06-12', 'lastUpdatePostDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-06-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration', 'timeFrame': 'Baseline to Study Completion (Up to 19 Weeks)', 'description': 'A summary of TEAEs and SAEs regardless of causality, will be reported in the Reported Adverse Events module'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3985863', 'timeFrame': 'Predose on Day 1 up to Approximately Week 8 Post Dose', 'description': 'PK: Cmax of LY3985863'}, {'measure': 'PK: Area Under the Concentration Versus Time Curve (AUC) of LY3985863', 'timeFrame': 'Predose on Day 1 up to Approximately Week 8 Post Dose', 'description': 'PK: AUC of LY3985863'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate how well LY3985863 is tolerated and what side effects may occur in healthy Chinese participants. The study drug will be administered subcutaneously (SC) (under the skin).\n\nBlood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Are native Chinese participants\n* Are overtly healthy\n* Have body weight of at least 50.0 kilogram (kg) for male or 45.0 kg for female and a body mass index of 20.0 to 30.0 kilogram per square meter (kg/m²), inclusive\n* Have a stable body weight within 3 months\n\nExclusion Criteria:\n\n* Have known allergies to any components of the LY3985863 formulation\n* Have concomitant disease known to influence skeletal muscle protein\n* Have current or a history of comorbidities capable of significantly altering the absorption, metabolism, or elimination of drugs, of constituting a risk when taking the study medication or completing study procedures, or of interfering with the interpretation of the data\n* Have a 12-lead echocardiogram (ECG) abnormality\n* Have used within 3 months or intend to use medications during the study that promote weight loss'}, 'identificationModule': {'nctId': 'NCT07030127', 'briefTitle': 'A Study of LY3985863 in Healthy Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Phase 1, Participant- and Investigator-Blind, Randomized, Placebo-Controlled, Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Subcutaneous Doses of LY3985863 in Healthy Chinese Participants', 'orgStudyIdInfo': {'id': '27292'}, 'secondaryIdInfos': [{'id': 'J4Z-MC-GIDH', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LY3985863', 'description': 'Administered subcutaneously (SC)', 'interventionNames': ['Drug: LY3985863']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Administered SC', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'LY3985863', 'type': 'DRUG', 'description': 'Administered SC', 'armGroupLabels': ['LY3985863']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered SC', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100191', 'city': 'Beijing', 'country': 'China', 'facility': 'Peking University Third Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], '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'}}}}