Ignite Creation Date:
2025-12-24 @ 11:09 PM
Ignite Modification Date:
2025-12-31 @ 9:44 AM
Study NCT ID:
NCT05444569
Status:
COMPLETED
Last Update Posted:
2023-03-01
First Post:
2022-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of LY3537021 in Healthy Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069450', 'term': 'Liraglutide'}], 'ancestors': [{'id': 'D052216', 'term': 'Glucagon-Like Peptide 1'}, {'id': 'D004763', 'term': 'Glucagon-Like Peptides'}, {'id': 'D052336', 'term': 'Proglucagon'}, {'id': 'D005768', 'term': 'Gastrointestinal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The study has two parts. Part A is parallel model and part B is crossover.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 47}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-08-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-02-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-28', 'studyFirstSubmitDate': '2022-06-30', 'studyFirstSubmitQcDate': '2022-06-30', 'lastUpdatePostDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-24', 'type': 'ACTUAL'}}, '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 up to Week 22', 'description': 'A summary of TEAEs and SAEs, regardless of causality, will be reported in the Reported Adverse Events module'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to evaluate the safety and tolerability of LY3537021 when administered in combination with glucagon-like peptide (GLP-1) receptor agonist called liraglutide in treatment-naïve healthy participants. The study will include 2 parts. The study will last up to 16 and 22 weeks for part A and B, respectively which includes a screening period of 6 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants who are overtly healthy as determined through medical evaluation\n* Participants with body weight at least 55 kilograms (kg) and body mass index (BMI) of 23.0 to 40.0 kilograms per meter squared (kg/m²)\n* Males, or females who are not of childbearing potential.\n* Capable of giving signed informed consent form\n* Have blood pressure of less than 150/90 millimeters of mercury (mm Hg) and pulse rate of less than 100 beats per minute (bpm) (supine)\n\nExclusion Criteria:\n\n* Have a significant history of current disorders capable of significantly altering the absorption, metabolism or elimination of drugs\n* History of malignancy within 5 years prior to screening\n* Have evidence of significant active psychiatric disorder(s)\n* Have undergone any form of bariatric surgery\n* Have an abnormality in the 12-lead electrocardiogram (ECG)\n* Are females who are lactating'}, 'identificationModule': {'nctId': 'NCT05444569', 'briefTitle': 'A Study of LY3537021 in Healthy Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Phase 1, Double-Blind, Randomized, Placebo-Controlled, Study to Evaluate the Safety and Tolerability of LY3537021 When Combined With GLP-1 Receptor Agonist in Healthy Participants', 'orgStudyIdInfo': {'id': '18449'}, 'secondaryIdInfos': [{'id': 'J2R-MC-YAAC', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LY3537021 + Liraglutide (Part A)', 'description': 'Liraglutide administered subcutaneously (SC) followed by liraglutide in combination with LY3537021 given SC.', 'interventionNames': ['Drug: LY3537021', 'Drug: Liraglutide']}, {'type': 'EXPERIMENTAL', 'label': 'Liraglutide + Placebo (Part A)', 'description': 'Liraglutide administered SC followed by liraglutide in combination with placebo given SC.', 'interventionNames': ['Drug: Liraglutide', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'LY3537021 + Liraglutide & Placebo + Liraglutide (Part B)', 'description': 'LY3537021 administered SC followed by liraglutide administered SC in treatment period 1.\n\nPlacebo administered SC followed by liraglutide administered SC in treatment period 2.', 'interventionNames': ['Drug: LY3537021', 'Drug: Liraglutide', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo + Liraglutide & LY3537021 + Liraglutide Part B)', 'description': 'Placebo administered SC followed by liraglutide administered SC in treatment period 1.\n\nLY3537021 administered SC followed by liraglutide administered SC in treatment period 2.', 'interventionNames': ['Drug: LY3537021', 'Drug: Liraglutide', 'Drug: Placebo']}], 'interventions': [{'name': 'LY3537021', 'type': 'DRUG', 'description': 'Administered SC.', 'armGroupLabels': ['LY3537021 + Liraglutide & Placebo + Liraglutide (Part B)', 'LY3537021 + Liraglutide (Part A)', 'Placebo + Liraglutide & LY3537021 + Liraglutide Part B)']}, {'name': 'Liraglutide', 'type': 'DRUG', 'description': 'Administered SC.', 'armGroupLabels': ['LY3537021 + Liraglutide & Placebo + Liraglutide (Part B)', 'LY3537021 + Liraglutide (Part A)', 'Liraglutide + Placebo (Part A)', 'Placebo + Liraglutide & LY3537021 + Liraglutide Part B)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered SC.', 'armGroupLabels': ['LY3537021 + Liraglutide & Placebo + Liraglutide (Part B)', 'Liraglutide + Placebo (Part A)', 'Placebo + Liraglutide & LY3537021 + Liraglutide Part B)']}]}, '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'}}}}