Ignite Creation Date:
2025-12-24 @ 5:59 PM
Ignite Modification Date:
2025-12-31 @ 9:08 AM
Study NCT ID:
NCT07085468
Status:
TERMINATED
Last Update Posted:
2025-08-29
First Post:
2025-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of LY3549492 in Healthy Weight Adult Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001835', 'term': 'Body Weight'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'whyStopped': 'Study terminated for strategic business reasons', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2025-07-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-08-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-25', 'studyFirstSubmitDate': '2025-07-18', 'studyFirstSubmitQcDate': '2025-07-18', 'lastUpdatePostDateStruct': {'date': '2025-08-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-07-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants with One or More Serious Adverse Events (SAE) Considered by the Investigator to be Related to Study Drug Administration', 'timeFrame': 'Baseline through Week 48', 'description': 'A summary of treatment emergent adverse events (TEAEs), SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module.'}], 'secondaryOutcomes': [{'measure': 'Percent Change from Baseline in Body Weight', 'timeFrame': 'Baseline, Week 24, Week 48'}, {'measure': 'Number of Participants with Adverse Events Leading to Permanent Discontinuation of Study Intervention or Withdrawal', 'timeFrame': 'Baseline through Week 48'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Elderly', 'Body Weight', 'Body Composition'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to evaluate the safety and tolerability of LY3549492 in adult participants with a healthy body max index (BMI) of 22 to 25 kilograms per square meter (kg/m2).\n\nParticipation in the study will last about 13 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have a body mass index (BMI) within the range of 22 to 25 kilograms per square meter (kg/m2)\n* Have had a stable body weight for 3 months prior to screening\n\nExclusion Criteria:\n\n* Have type 1 diabetes, latent autoimmune diabetes in adults, or a history of ketoacidosis or hyperosmolar coma\n* Have:\n\n * type 2 diabetes and on antidiabetic therapy (except type 2 diabetes being managed with diet and/or stable dose of metformin)\n * rare forms of diabetes mellitus, or\n * hemoglobin A1c (HbA1c) \\>8%\n* Have poorly controlled hypertension\n* Have any of the following cardiovascular conditions within 12 months prior to screening:\n\n * acute myocardial infarction\n * stroke\n * unstable angina, or\n * hospitalization due to congestive heart failure.\n* Have a history of New York Heart Association Functional Classification III or IV congestive heart failure\n* Have signs and symptoms of liver disease\n* Have a history of pancreatitis\n* Have taken medications or alternative remedies for weight loss or weight gain within 3 months prior to screening'}, 'identificationModule': {'nctId': 'NCT07085468', 'briefTitle': 'A Study of LY3549492 in Healthy Weight Adult Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Parallel-Group, Double-Blind Study to Investigate the Safety and Tolerability of LY3549492 Compared With Placebo in Adult Participants Aged 55 to 80 Years With a BMI of 22 to 25 kg/m2', 'orgStudyIdInfo': {'id': '27357'}, 'secondaryIdInfos': [{'id': 'J3H-MC-GZNI', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LY3549492 Dose 1', 'description': 'Participants will receive LY3549492 orally', 'interventionNames': ['Drug: LY3549492']}, {'type': 'EXPERIMENTAL', 'label': 'LY3549492 Dose 2', 'description': 'Participants will receive LY3549492 orally', 'interventionNames': ['Drug: LY3549492']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants will receive placebo orally', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'LY3549492', 'type': 'DRUG', 'description': 'Administered orally', 'armGroupLabels': ['LY3549492 Dose 1', 'LY3549492 Dose 2']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered orally', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85260', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Headlands Research - Scottsdale', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '91723', 'city': 'Covina', 'state': 'California', 'country': 'United States', 'facility': 'Valley Clinical Trials, Inc.', 'geoPoint': {'lat': 34.09001, 'lon': -117.89034}}, {'zip': '91325', 'city': 'Northridge', 'state': 'California', 'country': 'United States', 'facility': 'Valley Clinical Trials, Inc.', 'geoPoint': {'lat': 34.22834, 'lon': -118.53675}}, {'zip': '90274', 'city': 'Rolling Hills Estates', 'state': 'California', 'country': 'United States', 'facility': 'Peninsula Research Associates', 'geoPoint': {'lat': 33.78779, 'lon': -118.35813}}, {'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Artemis Institute for Clinical Research', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '33462', 'city': 'Atlantis', 'state': 'Florida', 'country': 'United States', 'facility': 'JEM Research Institute', 'geoPoint': {'lat': 26.5909, 'lon': -80.10088}}, {'zip': '30281', 'city': 'Stockbridge', 'state': 'Georgia', 'country': 'United States', 'facility': 'Clinical Research Atlanta', 'geoPoint': {'lat': 33.54428, 'lon': -84.23381}}, {'zip': '60640', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Great Lakes Clinical Trials - Andersonville', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '40509', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Alliance for Multispecialty Research, LLC', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '73069', 'city': 'Norman', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Alliance for Multispecialty Research, LLC', 'geoPoint': {'lat': 35.22257, 'lon': -97.43948}}, {'zip': '29572', 'city': 'Myrtle Beach', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Trial Management Associates', 'geoPoint': {'lat': 33.68906, 'lon': -78.88669}}, {'zip': 'J4V 2G8', 'city': 'Greenfield Park', 'country': 'Canada', 'facility': 'Viacar Recherche Clinique', 'geoPoint': {'lat': 45.48649, 'lon': -73.46223}}, {'zip': 'N1G 0B4', 'city': 'Guelph', 'country': 'Canada', 'facility': 'Apex Trials', 'geoPoint': {'lat': 43.54594, 'lon': -80.25599}}, {'zip': 'V1Y 1Z9', 'city': 'Kelowna', 'country': 'Canada', 'facility': 'OCT Research ULC', 'geoPoint': {'lat': 49.88307, 'lon': -119.48568}}, {'zip': 'H3G 1H9', 'city': 'Montreal', 'country': 'Canada', 'facility': 'Clinique Mémoire de Montréal', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'K1Z 1G3', 'city': 'Ottawa', 'country': 'Canada', 'facility': 'Ottawa Memory Clinic', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'V6V 2L1', 'city': 'Richmond', 'country': 'Canada', 'facility': 'Richmond Clinical Trials', 'geoPoint': {'lat': 49.17003, 'lon': -123.13683}}, {'zip': 'J1J 2G2', 'city': 'Sherbrooke', 'country': 'Canada', 'facility': 'Q&T Research Sherbrooke Inc.', 'geoPoint': {'lat': 45.40008, 'lon': -71.89908}}, {'zip': 'M3B 2S7', 'city': 'Toronto', 'country': 'Canada', 'facility': 'Toronto Memory Program', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M9L 3A2', 'city': 'Toronto', 'country': 'Canada', 'facility': 'BioPharma Services', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'G9A 4P3', 'city': 'Trois-Rivières', 'country': 'Canada', 'facility': 'Diex Recherche Trois-Rivieres', 'geoPoint': {'lat': 46.34515, 'lon': -72.5477}}], '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': {'url': 'https://vivli.org/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.', 'ipdSharing': 'YES', 'description': 'Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.', 'accessCriteria': 'A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}