Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2025-12-26 @ 2:41 AM
Study NCT ID:
NCT07152002
Status:
RECRUITING
Last Update Posted:
2025-12-09
First Post:
2025-08-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of LY4064912 in Healthy Participants and With Overweight or Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 144}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-08', 'studyFirstSubmitDate': '2025-08-26', 'studyFirstSubmitQcDate': '2025-09-02', 'lastUpdatePostDateStruct': {'date': '2025-12-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}}, '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': 'Postdose to Approximately Week 27', 'description': 'A summary of SAEs regardless of causality, will be reported in the Reported Adverse Events module'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY4064912', 'timeFrame': 'Predose Up to Day 78', 'description': 'PK: AUC of LY4064912'}, {'measure': 'PK: Maximum Concentration (Cmax) of LY4064912', 'timeFrame': 'Predose Up to Day 78', 'description': 'PK: Cmax of LY4064912'}, {'measure': 'Change from Baseline in Body Weight', 'timeFrame': 'Baseline to Approximately Week 27', 'description': 'Change from Baseline in Body Weight'}, {'measure': 'Effects of LY4064912 on Renal Hemodynamics and Renal Function', 'timeFrame': 'Baseline Up to Day 31', 'description': 'Glomerular Filtration Rate (GFR)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Overweight or Obesity', 'Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate how well LY4064912 is tolerated and what side effects may occur in healthy participants and participants with overweight and obesity - global. The study drug will be administered either subcutaneously (SC) (under the skin) or infusion intravenously (IV) (into a vein in the arm).\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* Age is 21-65 years old at Singapore Sites\n* Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring\n\nPart A: Body Mass Index (BMI) within the range greater than or equal to 21 and less than 30 kilogram per square meter (kg/m²)\n\nPart B: a BMI greater than or equal to 27 and less than 45 kg/m²\n\nPart C: a BMI greater than or equal to 21 and less than 35 kg/m²\n\n* Parts A and C: Participants must weigh 60 kilograms (kg) or more at screening\n* Have had a less than 5% change in body weight for 3 months before screening\n* Safety laboratory tests are within normal reference range\n\nExclusion Criteria:\n\n* Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the investigational product; or of interfering with the interpretation of data\n* Have history of diabetes (except gestational diabetes) or current diagnosis of diabetes (any form), or have HbA1c greater than or equal to 6.5% (48 millimole per mole (mmol/mol)) at screening\n* Are individuals of childbearing potential (IOCBP).'}, 'identificationModule': {'nctId': 'NCT07152002', 'acronym': 'YHAA', 'briefTitle': 'A Study of LY4064912 in Healthy Participants and With Overweight or Obesity', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Phase 1, Randomized, Placebo-Controlled, Single and Multiple Ascending Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY4064912 in Healthy Participants and Participants With Overweight or Obesity', 'orgStudyIdInfo': {'id': '27192'}, 'secondaryIdInfos': [{'id': 'J5L-MC-YHAA', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part A: LY4064912 (Cohorts 1-6)', 'description': 'LY4064912 administered subcutaneously (SC)', 'interventionNames': ['Drug: LY4064912']}, {'type': 'EXPERIMENTAL', 'label': 'Part A: LY4064912 (Cohort 4b)', 'description': 'LY4064912 administered intravenously (IV)', 'interventionNames': ['Drug: LY4064912']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Part A: Placebo', 'description': 'Placebo administered SC and IV', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part B: LY4064912 (Cohorts 7-10)', 'description': 'LY4064912 administered SC', 'interventionNames': ['Drug: LY4064912']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Part B: Placebo', 'description': 'Placebo administered SC', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part C: LY4064912 (Cohort 11)', 'description': 'LY4064912 administered SC', 'interventionNames': ['Drug: LY4064912']}, {'type': 'EXPERIMENTAL', 'label': 'Part C: Placebo', 'description': 'Placebo administered SC', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'LY4064912', 'type': 'DRUG', 'description': 'Administered SC', 'armGroupLabels': ['Part A: LY4064912 (Cohorts 1-6)', 'Part B: LY4064912 (Cohorts 7-10)', 'Part C: LY4064912 (Cohort 11)']}, {'name': 'LY4064912', 'type': 'DRUG', 'description': 'Administered IV', 'armGroupLabels': ['Part A: LY4064912 (Cohort 4b)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered SC', 'armGroupLabels': ['Part A: Placebo', 'Part B: Placebo', 'Part C: Placebo']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered IV', 'armGroupLabels': ['Part A: Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90720', 'city': 'Los Alamitos', 'state': 'California', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '714-799-7799'}, {'name': 'Steven Reynolds', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Collaborative Neuroscience Network - CNS', 'geoPoint': {'lat': 33.80307, 'lon': -118.07256}}, {'zip': '78209', 'city': 'San Antonio', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '210-225-5437'}, {'name': 'Robert Bass', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'ICON Early Phase Services', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '138623', 'city': 'Singapore', 'status': 'NOT_YET_RECRUITING', 'country': 'Singapore', 'contacts': [{'role': 'CONTACT', 'phone': '+65-64139811'}, {'name': 'Jeffer Pang Hann Wei', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Lilly Centre for Clinical Pharmacology', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], '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'}}}}