Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2025-12-26 @ 2:34 AM
Study NCT ID:
NCT07165002
Status:
RECRUITING
Last Update Posted:
2025-12-04
First Post:
2025-09-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of the Pharmacokinetics and Safety of LY3537031 in Participants With Normal Liver Function and With Mild, Moderate, or Severe Liver Impairment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D048550', 'term': 'Hepatic Insufficiency'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 32}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-03', 'studyFirstSubmitDate': '2025-09-03', 'studyFirstSubmitQcDate': '2025-09-03', 'lastUpdatePostDateStruct': {'date': '2025-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3537031', 'timeFrame': 'Baseline to Study Completion (Up to 8 Weeks)', 'description': 'PK: AUC of LY3537031'}, {'measure': 'PK: Maximum Concentration (Cmax) of LY3537031', 'timeFrame': 'Baseline to Study Completion (Up to 8 Weeks)', 'description': 'PK: Cmax of LY3537031'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy', 'Hepatic Insufficiency']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trials.lilly.com/en-US/trial/651595', 'label': 'A Study of the Pharmacokinetics and Safety of LY3537031 in Participants With Normal Liver Function and With Mild, Moderate, or Severe Liver Impairment'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to measure how much LY3537031 gets into the bloodstream and how long it takes the body to eliminate it in participants with mild, moderate and severe impaired liver function and in healthy participants with normal liver function. The safety and tolerability of LY3537031 will also be evaluated. The study drug will be administered subcutaneously (SC) (under the skin).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have a body weight of 55 kilogram (kg) or more and body mass index (BMI) between 19.0 and 40.0 kilogram per square meter (kg/m²), inclusive\n* Have no significant history of spontaneous or ethanol-induced hypoglycemia\n\nAdditional Inclusion Criteria for Participants Without Hepatic Impairment in Group 1:\n\n* Are healthy participants as determined by medical history, physical examination, and other screening procedures, with clinically normal hepatic function at screening\n* Have normal blood pressure (BP) and pulse rate, as determined by the investigator\n\nAdditional Inclusion Criteria for Participants with Mild to Severe Hepatic Impairment in Groups 2 through 4:\n\n* Participants with hepatic impairment classified as Child-Pugh score A, B, or C who are considered acceptable for participation in this study by the investigator. Participants must have a diagnosis of chronic hepatic impairment of greater than 6 months per physician diagnosis and standard-of-care practice, with no clinically significant changes, in the opinion of the investigator, within 15 days prior to screening\n* Clinical laboratory test results with deviations that are judged by the investigator to be compatible with the hepatic impairment of the participant, or of no additional clinical significance for this study. Abnormalities of serum glucose, serum lipids and triglycerides, urinary glucose, and urinary protein consistent with Type 2 Diabetes Mellitus (T2DM) are acceptable\n* Have a systolic BP less than 150 millimeters mercury (mmHg), a diastolic BP less than 90 mmHg, and a pulse rate greater than 50 but less than 100 beats per minute\n* If participants have T2DM, they must have a hemoglobin A1c measurement equal to or less than 11.5% at the screening visit\n\nExclusion Criteria:\n\n* Have significant history of or current cardiovascular, respiratory, hepatic (hepatic applies to Group 1 only), renal, gastrointestinal (GI), endocrine, hematological, dermatological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the investigational medicinal product; or of interfering with the interpretation of data\n* Have a history of atopy; that is, severe or multiple allergic manifestations, or clinically significant multiple or severe drug allergies, or hyperesthesia, or severe posttreatment hypersensitivity reactions, or have known allergies to LY3537031, or related compounds\n* Have undergone any form of bariatric surgery\n* Have a history of or current acute or chronic pancreatitis, or elevation in serum lipase or amylase or both greater than 1.5× upper limits of normal (ULN)'}, 'identificationModule': {'nctId': 'NCT07165002', 'briefTitle': 'A Study of the Pharmacokinetics and Safety of LY3537031 in Participants With Normal Liver Function and With Mild, Moderate, or Severe Liver Impairment', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Phase 1, Multicenter, Parallel-Design, Single-Dose, Open-Label Study to Evaluate the Pharmacokinetics and Safety of LY3537031 in Participants With Normal Hepatic Function and Participants With Mild, Moderate, or Severe Hepatic Impairment', 'orgStudyIdInfo': {'id': '27392'}, 'secondaryIdInfos': [{'id': 'J2S-MC-GZML', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LY3537031 (Group 1)', 'description': 'Administered subcutaneously (SC) in participants with normal hepatic function', 'interventionNames': ['Drug: LY3537031']}, {'type': 'EXPERIMENTAL', 'label': 'LY3537031 (Group 2)', 'description': 'Administered SC in participants with mild hepatic impairment', 'interventionNames': ['Drug: LY3537031']}, {'type': 'EXPERIMENTAL', 'label': 'LY3537031 (Group 3)', 'description': 'Administered SC in participants with moderate hepatic impairment', 'interventionNames': ['Drug: LY3537031']}, {'type': 'EXPERIMENTAL', 'label': 'LY3537031 (Group 4)', 'description': 'Administered SC in participants with severe hepatic impairment', 'interventionNames': ['Drug: LY3537031']}], 'interventions': [{'name': 'LY3537031', 'type': 'DRUG', 'description': 'Administered SC', 'armGroupLabels': ['LY3537031 (Group 1)', 'LY3537031 (Group 2)', 'LY3537031 (Group 3)', 'LY3537031 (Group 4)']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H-243', 'city': 'Kistarcsa', 'status': 'RECRUITING', 'country': 'Hungary', 'contacts': [{'role': 'CONTACT', 'phone': '+36 28 999 640'}, {'name': 'Geza Lakner', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Clinical Research Units Hungary', 'geoPoint': {'lat': 47.54757, 'lon': 19.26247}}, {'zip': '1010', 'city': 'Auckland', 'status': 'RECRUITING', 'country': 'New Zealand', 'contacts': [{'role': 'CONTACT', 'phone': '0800 788 3437'}, {'name': 'Edward Gane', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'New Zealand Clinical Research Auckland', 'geoPoint': {'lat': -36.84853, 'lon': 174.76349}}, {'zip': '831 01', 'city': 'Bratislava', 'status': 'RECRUITING', 'country': 'Slovakia', 'contacts': [{'role': 'CONTACT', 'phone': '00 421 908 729 723'}, {'name': 'Viera Kupčova', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Summit Clinical Research, s.r.o. - Bratislava', 'geoPoint': {'lat': 48.14816, 'lon': 17.10674}}], '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'}}}}